Process for making compositions with poorly compressible therapeutic compounds
First Claim
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1. A process for making a pharmaceutical composition comprising the steps of:
- combining a poorly compressible therapeutic compound with at least one granulating component to form a mixture;
kneading said mixture in an extruder while heating said mixture to a heating temperature less than a melting point of said therapeutic compound; and
extruding said mixture to form granules.
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Abstract
A process for preparing solid dosage forms that contain poorly compressible therapeutic compound. The process, for example, provides for the inventive use of an extruder, especially a twin screw extruder, to melt granulate a therapeutic compound(s) with a granulation excipient.
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Citations
19 Claims
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1. A process for making a pharmaceutical composition comprising the steps of:
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combining a poorly compressible therapeutic compound with at least one granulating component to form a mixture; kneading said mixture in an extruder while heating said mixture to a heating temperature less than a melting point of said therapeutic compound; and extruding said mixture to form granules. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14, 15, 17, 18)
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12. A process for making a pharmaceutical composition comprising the steps of:
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combining a moisture sensitive therapeutic compound with at least one granulating component to form a mixture; kneading said mixture in an extruder while heating said mixture to a heating temperature less than a melting point of said therapeutic compound; and extruding said mixture to form granules.
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13. A process for improving the friability of a tablet containing a poorly compressible therapeutic compound comprising the steps of:
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combining a poorly compressible therapeutic compound with at least one granulating component to form a mixture; kneading said mixture in an extruder while heating said mixture to a heating temperature less than a melting point of said therapeutic compound extruding said mixture to form granules; and compressing said granules into a tablet. - View Dependent Claims (16)
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19-21. -21. (canceled)
Specification