Pharmaceutical Formulations

Abstract

Capsule formulations are provided containing at least two different fill compositions which are prevented from mixing either by providing both of the fill compositions as solids or by providing a physical barrier which separates the fill compositions so that they are prevented from mixing. The invention has the advantage that two different formulations can be provided in a single capsule without one of the formulations having an adverse effect on the other.

1 . A pharmaceutical formulation which is a capsule, said capsule having a shell formed from a material selected from the group consisting of hard gelatin and starch, said capsule containing at least a first fill composition and a second fill composition different from the first fill composition, wherein the first fill composition is hydrophilic and the second fill composition is hydrophilic, wherein said shell defines a single compartment and wherein said first and second fill compositions are prevented from mixing with one another by a third fill composition, said third fill composition defining a physical barrier between said first and second fill compositions, wherein the physical barrier is selected from the group consisting of a hydrophobic fill composition and a lipophilic fill composition.  
     
     
         2 . The pharmaceutical formulation according to  claim 1 , wherein the physical barrier comprises a material having a melting point higher than 25° C.  
     
     
         3 . The pharmaceutical formulation according to  claim 2 , wherein the physical barrier comprises a material having a melting point higher than 37° C.  
     
     
         4 . The pharmaceutical formulation according to  claim 1 , wherein the physical barrier comprises a glyceride.  
     
     
         5 . The pharmaceutical formulation according to  claim 4 , wherein the physical barrier material comprises a hydrogenated fatty acid ester or mixture of esters.  
     
     
         6 . The pharmaceutical formulation according to  claim 4 , wherein the physical barrier comprises a di- or tri-glyceride, or a mixture of glycerides.  
     
     
         7 . A pharmaceutical formulation which is a capsule, said capsule having a shell formed from a material selected from the group consisting of hard gelatin and starch, said capsule containing at least a first fill composition and a second fill composition different from the first fill composition, wherein the first fill composition is hydrophobic and the second fill composition is hydrophobic, wherein said shell defines a single compartment and wherein said first and second fill compositions are prevented from mixing with one another by a third fill composition, said third fill composition defining a physical barrier between said first and second fill compositions, wherein the physical barrier is a lipophilic fill composition.  
     
     
         8 . The pharmaceutical formulation according to  claim 7 , wherein the physical barrier comprises a material having a melting point higher than 25° C.  
     
     
         9 . The pharmaceutical formulation according to  claim 8 , wherein the physical barrier comprises a material having a melting point higher than 37° C.  
     
     
         10 . The pharmaceutical formulation according to  claim 7 , wherein the physical barrier comprises a glyceride.  
     
     
         11 . The pharmaceutical formulation according to  claim 10 , wherein the physical barrier material comprises a hydrogenated fatty acid ester or mixture of esters.  
     
     
         12 . The pharmaceutical formulation according to  claim 10 , wherein the physical barrier comprises a di- or tri-glyceride, or a mixture of glycerides.  
     
     
         13 . A biphasic pharmaceutical formulation comprising a solid rapid-release phase and a solid sustained-release phase, wherein the solid rapid-release phase remains solid at a temperature below about 30° C.  
     
     
         14 . The biphasic pharmaceutical formulation according to  claim 13 , wherein the rapid-release phase comprises a pharmaceutically active substance and a glyceride having a melting point above 30° C.  
     
     
         15 . The biphasic pharmaceutical formulation according to  claim 14 , wherein the glyceride is a hydrogenated fatty acid ester.  
     
     
         16 . The biphasic pharmaceutical formulation according to  claim 14 , wherein the glyceride is a saturated polyglycolyzed glyceride.  
     
     
         17 . The biphasic pharmaceutical formulation according to  claim 14 , wherein the rapid-release phase and sustained-release phase comprise a C 12 -C 24  fatty acid.  
     
     
         18 . The biphasic pharmaceutical formulation according to  claim 17 , wherein the C 12 -C 24  fatty acid is oleic acid.