Pharmaceutical formulations
First Claim
1. A dosage form comprising a capsule having a shell with an outer surface and an opposed inner surface, the inner surface defining at least in part a confined space for holding a drug substance, and the outer surface being exposed to a gastro-intestinal environment, the shell being composed of an extruded and injection molded composition comprising(i) Ammonio methacrylate Copolymer Type A or ammonium methacrylate Copolymer Type B present in an amount of about 10 to about 80% w/w;
- (ii) at least one dissolution modifying excipient selected from a swellable solid present in an amount of about 20 to about 65% w/w, and wherein the swellable solid is a blend of hydroxypropylcelluloses having differing molecular weights and wherein such blend comprises a low molecular weight hydroxypropylcellulose having a molecular weight of about 80,000 and a high molecular weight hydroxypropyl cellulose selected from a hydroxyproplycellulose having a molecular weight of about 140,000 and a hydroxypropylcellulose having a molecular weight of about 370,000;
optionally in combination with a second dissolution modifying excipient selected from the group consisting of aa) disintegrant present in an amount of about 10 to 40%,b) a water soluble filler present in the range of about 5 to about 70% w/w,c) a low molecular weight solute present in the range of about 2.5 to about 70% w/w, andd) non-reducing sugar present in the range of about 2.5 to about 15% w/w;
(iii) a lubricant present in an amount of about 5% to about 25% w/w; and
(iv) optionally a surfactant present in an amount of 0 to about 10%, a plasticizer present in an amount of 0 to about 10% w/w and/or a processing agent present in an amount of 0 to about 10% w/w.
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Accused Products
Abstract
The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for melt extrusion and injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form.
154 Citations
32 Claims
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1. A dosage form comprising a capsule having a shell with an outer surface and an opposed inner surface, the inner surface defining at least in part a confined space for holding a drug substance, and the outer surface being exposed to a gastro-intestinal environment, the shell being composed of an extruded and injection molded composition comprising
(i) Ammonio methacrylate Copolymer Type A or ammonium methacrylate Copolymer Type B present in an amount of about 10 to about 80% w/w; -
(ii) at least one dissolution modifying excipient selected from a swellable solid present in an amount of about 20 to about 65% w/w, and wherein the swellable solid is a blend of hydroxypropylcelluloses having differing molecular weights and wherein such blend comprises a low molecular weight hydroxypropylcellulose having a molecular weight of about 80,000 and a high molecular weight hydroxypropyl cellulose selected from a hydroxyproplycellulose having a molecular weight of about 140,000 and a hydroxypropylcellulose having a molecular weight of about 370,000; optionally in combination with a second dissolution modifying excipient selected from the group consisting of a a) disintegrant present in an amount of about 10 to 40%, b) a water soluble filler present in the range of about 5 to about 70% w/w, c) a low molecular weight solute present in the range of about 2.5 to about 70% w/w, and d) non-reducing sugar present in the range of about 2.5 to about 15% w/w; (iii) a lubricant present in an amount of about 5% to about 25% w/w; and (iv) optionally a surfactant present in an amount of 0 to about 10%, a plasticizer present in an amount of 0 to about 10% w/w and/or a processing agent present in an amount of 0 to about 10% w/w. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32)
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31. A dosage form comprising at least one subcomponent having a wall portion made from an extruded material comprising a pharmaceutical composition selected from the group consisting of:
Specification