US2008193546A1PendingUtilityA1

Solid dose delivery vehicle and methods of making same

76
Individually held — no corporate assignee on recordPriority: Dec 2, 1994Filed: Oct 31, 2007Published: Aug 14, 2008
Est. expiryDec 2, 2014(expired)· nominal 20-yr term from priority
Inventors:Bruce RoserJaap KampingaCamilo ColacoJulian Blair
A61K 9/1623A61K 9/145Y02A50/30A61K 9/0021
76
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

The present invention encompasses a solid dose delivery vehicle for ballistic administration of a bioactive material to subcutaneous and intradermal tissue, the delivery vehicle being sized and shaped for penetrating the epidermis. The delivery vehicle further comprises a stabilizing polyol glass loaded with the bioactive material and capable of releasing the bioactive material in situ. The present invention further includes methods of making and using the solid dose delivery vehicle of the invention.

Claims

exact text as granted — not AI-modified
1 . A therapeutic composition in solid dose form comprising a bioactive material and a carbohydrate, wherein
 a) the bioactive material is a protein,   b) the carbohydrate stabilizes the bioactive material in the presence of an organic solvent,   c) the therapeutic composition is in a glassy state,   d) the therapeutic composition is a powder suitable for pulmonary administration, and   e) the bioactive material and the carbohydrate are dispersed within particles of the powder.   
     
     
         2 . The therapeutic composition according to  claim 1 , further comprising a physiologically acceptable inhibitor of the Maillard reaction. 
     
     
         3 . The therapeutic composition according to  claim 1 , further comprising a biodegradable glass. 
     
     
         4 . The therapeutic composition according to  claim 1 , wherein the particles have a mean particle size of 0.1 to 10 μm. 
     
     
         5 . The therapeutic composition according to  claim 1 , wherein the particles have a mean particle size of 0.5 to 5 μm. 
     
     
         6 . The therapeutic composition according to  claim 1 , wherein the particles have a mean particle size of 1 to 3 μm. 
     
     
         7 . The therapeutic composition according to  claim 1 , wherein the carbohydrate is selected from the group consisting of monosaccharides, disaccharides, trisaccharides, oligosaccharides, and sugar alcohols. 
     
     
         8 . The therapeutic composition according to  claim 1 , wherein the carbohydrate is a sugar alcohol. 
     
     
         9 . The therapeutic composition according to  claim 1 , wherein the carbohydrate is trehalose. 
     
     
         10 . The therapeutic composition according to  claim 1 , wherein the protein is an enzyme. 
     
     
         11 . The therapeutic composition according to  claim 1 , wherein the protein is a hormone. 
     
     
         12 . The therapeutic composition according to  claim 1 , wherein the protein is a growth factor. 
     
     
         13 . The therapeutic composition according to  claim 1 , wherein the protein is an immunogen. 
     
     
         14 . The therapeutic composition according to  claim 1 , wherein the protein is a monoclonal antibody. 
     
     
         15 . The therapeutic composition according to  claim 1 , wherein the protein is an interferon. 
     
     
         16 . The therapeutic composition according to  claim 1 , wherein the protein is an interleukin. 
     
     
         17 . The therapeutic composition according to  claim 1 , wherein the protein is a cytokine. 
     
     
         18 . The therapeutic composition according to  claim 1 , wherein the protein is insulin. 
     
     
         19 . The therapeutic composition according to  claim 18 , wherein the particles have a mean particle size of 0.5 to 5 μm. 
     
     
         20 . The therapeutic composition according to  claim 18 , wherein the particles have a mean particle size of 1 to 3 μm. 
     
     
         21 . The therapeutic composition according to  claim 18 , wherein the insulin and the carbohydrate are in solid solution. 
     
     
         22 . The therapeutic composition according to  claim 1 , wherein the protein is insulin and the carbohydrate is trehalose. 
     
     
         23 . The therapeutic composition according to  claim 22 , wherein the particles have a mean particle size of 0.5 to 5 μm. 
     
     
         24 . The therapeutic composition according to  claim 22 , wherein the particles have a mean particle size of 1 to 3 μm. 
     
     
         25 . The therapeutic composition according to  claim 22 , wherein the insulin and the trehalose are in solid solution. 
     
     
         26 . The therapeutic composition according to  claim 1 , further comprising an amino acid. 
     
     
         27 . The therapeutic composition according to  claim 1 , wherein the organic solvent is selected from the group consisting of ethanol, acetone, chloroform, acetonitrile, dichloromethane, and methanol. 
     
     
         28 . The therapeutic composition according to  claim 1 , wherein the bioactive material and the carbohydrate are in solid solution. 
     
     
         29 . The therapeutic composition according to  claim 1 , wherein the therapeutic composition is suitable for delivering the bioactive material by transalveolar administration. 
     
     
         30 . A therapeutic composition in solid dose form comprising a bioactive material and a carbohydrate, wherein
 a) the bioactive material is a protein,   b) the carbohydrate stabilizes the bioactive material in the presence of an organic solvent,   c) the therapeutic composition is in a glassy state,   d) the therapeutic composition is a powder suitable for pulmonary administration,   e) the bioactive material and the carbohydrate are dispersed within particles of the powder, and   f) the therapeutic composition further comprises a glass modifier, wherein the glass modifier is not the bioactive material.   
     
     
         31 . The therapeutic composition according to  claim 30 , wherein the glass modifier is a protein. 
     
     
         32 . The therapeutic composition according to  claim 30 , further comprising a physiologically acceptable inhibitor of the Maillard reaction. 
     
     
         33 . The therapeutic composition according to  claim 30 , further comprising a biodegradable glass. 
     
     
         34 . The therapeutic composition according to  claim 30 , wherein the particles have a mean particle size of 0.1 to 10 μm. 
     
     
         35 . The therapeutic composition according to  claim 30 , wherein the particles have a mean particle size of 0.5 to 5 μm. 
     
     
         36 . The therapeutic composition according to  claim 30 , wherein the particles have a mean particle size of 1 to 3 μm. 
     
     
         37 . The therapeutic composition according to  claim 30 , wherein the carbohydrate is selected from the group consisting of monosaccharides, disaccharides, trisaccharides, oligosaccharides, and sugar alcohols. 
     
     
         38 . The therapeutic composition according to  claim 30 , wherein the carbohydrate is a sugar alcohol. 
     
     
         39 . The therapeutic composition according to  claim 30 , wherein the carbohydrate is trehalose. 
     
     
         40 . The therapeutic composition according to  claim 30 , wherein the protein is an enzyme. 
     
     
         41 . The therapeutic composition according to  claim 30 , wherein the protein is a hormone. 
     
     
         42 . The therapeutic composition according to  claim 30 , wherein the protein is a growth factor. 
     
     
         43 . The therapeutic composition according to  claim 30 , wherein the protein is an immunogen. 
     
     
         44 . The therapeutic composition according to  claim 30 , wherein the protein is a monoclonal antibody. 
     
     
         45 . The therapeutic composition according to  claim 30 , wherein the protein is an interferon. 
     
     
         46 . The therapeutic composition according to  claim 30 , wherein the protein is an interleukin. 
     
     
         47 . The therapeutic composition according to  claim 30 , wherein the protein is a cytokine. 
     
     
         48 . The therapeutic composition according to  claim 30 , wherein the protein is insulin. 
     
     
         49 . The therapeutic composition according to  claim 48 , wherein the particles have a mean particle size of 0.5 to 5 μm. 
     
     
         50 . The therapeutic composition according to  claim 48 , wherein the particles have a mean particle size of 1 to 3 μm. 
     
     
         51 . The therapeutic composition according to  claim 48 , wherein the insulin and the carbohydrate are in solid solution. 
     
     
         52 . The therapeutic composition according to  claim 30 , wherein the protein is insulin and the carbohydrate is trehalose. 
     
     
         53 . The therapeutic composition according to  claim 52 , wherein the particles have a mean particle size of 0.5 to 5 μm. 
     
     
         54 . The therapeutic composition according to  claim 52 , wherein the particles have a mean particle size of 1 to 3 μm. 
     
     
         55 . The therapeutic composition according to  claim 52 , wherein the insulin and the trehalose are in solid solution. 
     
     
         56 . The therapeutic composition according to  claim 30 , further comprising an amino acid. 
     
     
         57 . The therapeutic composition according to  claim 30 , wherein the organic solvent is selected from the group consisting of ethanol, acetone, chloroform, acetonitrile, dichloromethane, and methanol. 
     
     
         58 . The therapeutic composition according to  claim 30 , wherein the bioactive material and the carbohydrate are in solid solution. 
     
     
         59 . The therapeutic composition according to  claim 30 , wherein the therapeutic composition is suitable for delivering the bioactive material by transalveolar administration.

Join the waitlist — get patent alerts

Track US2008193546A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.