HOT-MELT EXTRUSION OF MODIFIED RELEASE MULTI-PARTICULATES

The present invention includes compositions and methods of making a modified release pharmaceutical formulation and a method of preparation for the embedding of modified release multi-particulates into a polymeric or wax-like matrix. The modified release multi-particulates comprise an effective amou...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser:	MCGINITY JAMES W, SCHILLING SANDRA U
Format:	Patent
Sprache:	eng
Schlagworte:	AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PERFORMING OPERATIONS PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDEDFOR SHAPING OR JOINING OF PLASTICS TRANSPORTING WORKING OF PLASTICS WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
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Beschreibung
Zusammenfassung:	The present invention includes compositions and methods of making a modified release pharmaceutical formulation and a method of preparation for the embedding of modified release multi-particulates into a polymeric or wax-like matrix. The modified release multi-particulates comprise an effective amount of a therapeutic compound having a known or desired drug-release profile. Modified release multi-particulates may include a polymeric coat or may be incorporated into particle or core material. The polymer matrix comprises a thermoplastic polymer or lipophilic carrier or a mixture thereof that softens or melts at elevated temperature and allows the distribution of the modified release multi-particulates in the polymer matrix during thermal processing. Formulation compounds and processing conditions are selected in a manner to preserve the controlled release characteristics and/or drug-protective properties of the original modified release multi-particulates.