USRE37872EExpiredUtility
Storage of materials
Assignee: INHALE THERAPEUTICS SYSTEMS INPriority: Feb 16, 1989Filed: Mar 17, 1999Granted: Oct 8, 2002
Est. expiryFeb 16, 2009(expired)· nominal 20-yr term from priority
C12N 11/087C12N 11/082C12N 11/10A61K 47/36A61K 47/26A61K 9/145A61K 9/146C12N 9/96
86
PatentIndex Score
67
Cited by
120
References
110
Claims
Abstract
A material or mixture of materials which is not itself storage stable is rendered storage stable by incorporation into a water-soluble or swellable glassy or rubbery composition which can then be stored at ambient temperature. Recovery is by adding aqueous solution to the composition.
Claims
exact text as granted — not AI-modifiedWe claim:
1. A composition which is storage stable at 20° C. comprising:
i) a carrier substance which is water-soluble or water-swellable and is in a glassy amorpous state;
ii) at least one material to be stored, which is unstable in aqueous solution at room temperature of 20° C. dissolved in said amorphous carrier substance, said composition existing in a glassy state at 20° C.
2. A composition according to claim 1 wherein the material to be stored is selected from proteins, peptides, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzyme cofactors, and derivatives of any of the foregoing having one or more additional moieties bound thereto.
3. A composition according to claim 1 having a water content not exceeding 4% by weight.
4. A composition according to claim 1 wherein the composition displays a glass transition temperature of at least 30° C.
5. A composition according to claim 1 wherein carrier substance is selected from carbohydrates and derivatives thereof which are polyhydroxy compounds.
6. A composition according to claim 5 wherein the carrier substance is a sugar polymer containing sugar residues linked through ether bridges to bifunctional groups other than carbohydrate.
7. A composition according to claim 1 wherein the carrier substance is a synthetic polymer.
8. A composition according to claim 1 wherein said material to be stored comprises a material which is unstable when alone in aqueous solution at room temperature.
9. A composition according to claim 1 wherein said material to be stored comprises a plurality of materials.
10. A composition according to claim 9 wherein said material to be stored comprises a plurality of materials which react together in aqueous solution.
11. A composition according to claim 1 which can be stored without refrigeration for at least 1 week.
12. A method of rendering a material storage stable at 20° C., which material is unstable in aqueous solution at room temperature of 20° C., comprising dissolving the material in a carrier substance which is water-soluble or water-swellable, or in a solution thereof, so that the material is dissolved in said carrier substance, and forming the resulting mixture into a glassy amorphous state, said mixture existing in said glassy state at 20° C.
13. A method according to claim 12 wherein forming the said mixture into an amorphous state is effected by evaporation under subatmospheric pressure.
14. A method according to claim 13 wherein evaporation is commenced at a temperature of 20 to 40° C. and subsequently continued at a temperature of 40 to 70° C.
15. A method according to claim 13 wherein the subatmospheric pressure is not greater than 90% of atmospheric.
16. In a method of storing a material, which material is stable in aqueous solution at 20° C., the improvement comprising dissolving the material in a carrier substance which is water-soluble or water-swellable, or in a solution thereof, so that the material is dissolved in said carrier substance, forming the resulting mixture into a glassy amorphous state and storing the mixture in said glassy amorphous state without refrigeration for at least one week.
17. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said composition contains no more than 4 percent by weight of water; and
wherein said at least one material is a hormone.
18. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said at least one material is an immunoglobulin.
19. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said at least one material is an enzyme cofactor.
20. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said at least one material is an oligonucleotide.
21. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance is selected from the group consisting of polyvinyl pyrrolidone, polyacrylamide and polyethyleneimine.
22. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance is a copolymer of sucrose and epichlorohydrin.
23. A method of rendering a purified biologically active material storage- stable at 20 ° C., which material is unstable in aqueous solution at 20 ° C., comprising:
dissolving a purified, biologically active material, which is unstable in aqueous solution at 20 ° C. selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto, and a carrier substance that is water - soluble or water - swellable with water to form an aqueous solution,
forming said solution into a glassy state composition containing no more than 4 percent by weight of water by evaporating liquid water, wherein said glassy state composition exists at 20 ° C., and
prior to storage said glassy state composition has an initial level of biological activity when reconstituted in water; and
wherein said evaporating is done without heating.
24. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises a sugar containing copolymer having a molecular weight between 5 , 000 and 1 , 000 , 000 .
25. The composition according to claim 24 , wherein said sugar containing copolymer contains sucrose residues.
26. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein the carrier substance comprises a sugar copolymer containing sugar residues linked through ether bridges to bifunctional groups other than carbohydrate.
27. The composition according to claim 24 , wherein said sugar containing copolymer is formed by the process of reacting sugar with at least one of a halohydrin or a bis- epoxy compound.
28. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises primarily maltotriose.
29. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises polydextrose.
30. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises inulin.
31. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises stachyose.
32. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises dextran.
33. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises sorbose.
34. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises polyacrylamide.
35. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises polyvinylpyrolidone.
36. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises GPS.
37. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water; and
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance comprises palatinit.
38. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a transport protein.
39. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance,
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a blood clotting factor.
40. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said purified biologically active material is a nucleoside.
41. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said purified biologically active material is a nucleotide.
42. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said purified biologically active material is a dinucleotide.
43. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a dehydrogenase.
44. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a restriction enzyme.
45. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
further comprising a second purified biologically active material.
46. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said at least one material comprises a first biologically active material and a second biologically active material, and the first and second biologically active materials react with one another when in aqueous solution with one another.
47. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material comprises an oxidase enzyme.
48. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material comprises a reductase enzyme.
49. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said carrier substance is a copolymer of sucrose and epichlorohydrin having a molecular weight of about 400 , 000 Daltons.
50. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said composition is in the form of a tablet.
51. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said purified biologically active material is a dimer of a nucleoside.
52. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said purified biologically active material is a dimer of a nucleotide.
53. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.; and
wherein said purified biologically active material is an oligomer of a nucleoside.
54. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto; and
wherein said purified biologically active material is an oligomer of a nucleotide.
55. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is LDH.
56. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a restriction endonuclease.
57. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a glutamate dehydrogenase.
58. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is an ascorbate oxidase.
59. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is Cytochrome C reductase.
60. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a Glycerol - 3 - phosphate reductase.
61. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
said composition formed by a process comprising the steps:
dissolving said carrier substance and said at least one material with water;
forming the carrier substance with said at least one material dissolved therein into said glassy state by evaporation of liquid water to produce a storage - stable composition that exists in said glassy state at 20 ° C.;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is an alpha - glucosidase.
62. A method of rendering a purified biologically active material storage- stable at 20 ° C., which material is unstable in aqueous solution at 20 ° C., comprising:
dissolving a quantity of a purified, biologically active material, which material is unstable in aqueous solution at 20 ° C., which material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto, and a quantity of carrier substance that is water - soluble or water - swellable, with water, to form an aqueous solution;
evaporating liquid water from said aqueous solution, thereby forming a composition;
determining whether said composition formed by said step of evaporating exists in a glassy state at or above 20 ° C.;
wherein, said composition stored in said glassy state has an initial level of biological activity immediately after being reconstituted in water.
63. A method according to claim 62 further comprising:
storing a quantity of said composition.
64. A method according to 63 further comprising reconstituting said quantity of said composition.
65. A method according to 62 further comprising determining a glass transition temperature of said composition.
66. A method according to 62 further comprising:
recovering said purified biologically active material without any substantial storage; and
comparing activity of the recovered purified biologically active material to activity of said purified biologically active material prior to storage.
67. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said at least one material is a hormone.
68. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said at least one material is an immunoglobulin.
69. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said at least one material is an enzyme cofactor.
70. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said at least one material is an oligonucleotide.
71. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance is selected from the group consisting of polyvinyl pyrrolidone, polyacrylamide and polyethyleneimine.
72. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance is a copolymer of sucrose and epichlorohydrin.
73. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises a sugar containing copolymer having a molecular weight between 5 , 000 and 1 , 000 , 000 .
74. The composition according to claim 73 , wherein said sugar containing copolymer contains sucrose residues.
75. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein the carrier substance comprises a sugar copolymer containing sugar residues linked through ether bridges to bifunctional groups other than carbohydrate.
76. The composition according to claim 73 wherein said sugar containing copolymer is formed by the process of reacting sugar with at least one of a halohydrin or a bis- epoxy compound.
77. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises primarily maltotriose.
78. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises polydextrose.
79. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises inulin.
80. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises stachyose.
81. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises dextran.
82. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises sorbose.
83. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises polyacrylamide.
84. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises polyvinylpyrolidone.
85. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises GPS.
86. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance comprises palatinit.
87. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a transport protein.
88. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a blood clotting factor.
89. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a nucleoside.
90. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a nucleotide.
91. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a dinucleotide.
92. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a dehydrogenase.
93. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a restriction enzyme.
94. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
further comprising a second purified biologically active material.
95. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said at least one material comprises a first biologically active material and a second biologically active material, and the first and second biologically active materials react with one another when in aqueous solution with one another.
96. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material comprises an oxidase enzyme.
97. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material comprises a reductase enzyme.
98. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said carrier substance is a copolymer of sucrose and epichlorohydrin having a molecular weight of about 400 , 000 Daltons.
99. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said composition is in the form of a tablet.
100. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a dinner of a nucleoside.
101. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a dimer of a nucleotide.
102. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is an oligomer of a nucleoside.
103. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is an oligomer of a nucleotide.
104. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is LDH.
105. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a restriction endonuclease.
106. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a glutamate dehydrogenase.
107. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is an ascorbate oxidase.
108. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is Cytochrome C reductase.
109. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material is a Glycerol - 3 - phosphate reductase.
110. A composition which is storage- stable at 20 ° C., comprising:
i ) a carrier substance which is water - soluble or water - swellable and is in a glassy amorphous state;
ii ) at least one material to be stored, which is dissolved in said amorphous carrier substance;
wherein said composition exists in a glassy state at 20 ° C.;
wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20 ° C.;
wherein said at least one material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto;
wherein said composition contains no more than 4 percent by weight of water; and
wherein said purified biologically active material an alpha - glucosidase.Join the waitlist — get patent alerts
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