Pharmaceutical formulations
First Claim
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1. A pharmaceutical composition comprising Eudragit RL 100 or RS 100 present in an amount of about 10 to about 80% w/w;
- at least one dissolution modifying excipient, present in a total amount of about 20% to about 70% w/w;
a lubricant present in an amount of about 5% to about 25% w/w; and
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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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.
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Citations
47 Claims
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1. A pharmaceutical composition comprising Eudragit RL 100 or RS 100 present in an amount of about 10 to about 80% w/w;
- at least one dissolution modifying excipient, present in a total amount of about 20% to about 70% w/w;
a lubricant present in an amount of about 5% to about 25% w/w; and
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, 30, 31, 32, 33, 41, 42, 43)
- at least one dissolution modifying excipient, present in a total amount of about 20% to about 70% w/w;
- 27. A pharmaceutical composition comprising Eudragit RL100 present in an amount of about 15 to 50% w/w, a lubricant which is stearyl alcohol, and at least one dissolution modifying excipient which is a hydroxypropylcellulose derivative.
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40. The pharmaceutical composition for molded capsule shells comprising:
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44. A multi-component pharmaceutical dosage form which comprises a plurality of sub-units, each sub-unit being selected from
a) a drug substance-containing capsule compartment which is soluble or disintegrable in a patient'"'"'s gastro-intestinal environment for release of the drug substance contained in the capsule compartment, and b) a solid matrix comprising Eudragit RL100 or RS100 present in an amount of about 15 to 80% w/w, at least one hydroxypropyl cellulose present in an amount of about 30% to about 70% w/w and containing a drug substance, the polymer being soluble, dispersible or disintegrable in a patient'"'"'s gastro-intestinal environment for release of the drug substance contained in the solid matrix, and in which, at least prior to administration to a patient, the sub-units are welded together or mechanically joined in an assembled dosage form.
Specification
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Current AssigneeCapsugel Belgium NV (Lonza Group AG)
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Original AssigneeCapsugel Belgium NV (Lonza Group AG)
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InventorsRaby, Ronald K., Margetson, Daniel M., Brown, Adrian, Matthews, Wayne M., McAllister, Stephen Mark
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current424/464
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CPC Class CodesA61K 47/32 Macromolecular compounds ob...A61K 9/1617 Organic compounds, e.g. pho...A61K 9/1623 Sugars or sugar alcohols, e...A61K 9/1647 Polyesters, e.g. poly(lacti...A61K 9/1652 Polysaccharides, e.g. algin...A61K 9/4816 Wall or shell materialA61K 9/5026 obtained by reactions only ...A61K 9/5047 Cellulose ethers containing...
