Pharmaceutical formulations
First Claim
Patent Images
1. A pharmaceutical composition for moulded components comprising Eudragit 4135F present in an amount of about 15 to about 50% w/w;
- at least two hydroxypropyl cellulose polymers, each having a differing molecular weight, present in a total amount of about 20% to about 70% w/w;
a lubricant present in an amount of about 10% to about 25% w/w; and
optionally a dissolution modifying excipient present in an amount of about 0% to about 70% w/w;
a surfactant present in an amount of 0 to 10%, a plasticizer present in an amount of 0 to 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 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 by a weld between parts of the assembled dosage form.
115 Citations
43 Claims
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1. A pharmaceutical composition for moulded components comprising Eudragit 4135F present in an amount of about 15 to about 50% w/w;
- at least two hydroxypropyl cellulose polymers, each having a differing molecular weight, present in a total amount of about 20% to about 70% w/w;
a lubricant present in an amount of about 10% to about 25% w/w; and
optionally a dissolution modifying excipient present in an amount of about 0% to about 70% w/w;
a surfactant present in an amount of 0 to 10%, a plasticizer present in an amount of 0 to 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, 31, 34, 35, 36)
- at least two hydroxypropyl cellulose polymers, each having a differing molecular weight, present in a total amount of about 20% to about 70% w/w;
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32. The pharmaceutical composition for molded capsule shells comprising:
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33. A pharmaceutical composition for molded capsule shells comprising:
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37. 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 4135F present in an amount of about 15 to 25% w/w, at least two hydroxypropyl cellulose polymers, each having a differing molecular weight being present in a total amount of about 30% to about 64% 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 in an assembled dosage form.
Specification