PHARMACEUTICAL FORMULATION FOR A SOLID DOSAGE FORM OF OPIOID RECEPTOR ANTAGONISTS

The present disclosure provides a sustained release formulation of opioid receptor antagonists comprising a sustained release granule comprising at least one of the opioid receptor antagonist, at least one of pharmaceutical acceptable carrier, and a pH-dependent polymer, wherein the sustained releas...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: YANG, Syaulan S, SHEU, Eric Yueh-Lang, SHIH, Ying-Chu
Format: Patent
Sprache:eng
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Zusammenfassung:The present disclosure provides a sustained release formulation of opioid receptor antagonists comprising a sustained release granule comprising at least one of the opioid receptor antagonist, at least one of pharmaceutical acceptable carrier, and a pH-dependent polymer, wherein the sustained release granule is coated with the pH-dependent polymer, and the opioid receptor antagonist is selected from the group consisting of Nalmefene, Naltrexone, or a salt thereof. The present disclosure further provides a method for preparing a sustained release formulation of opioid receptor antagonists comprising steps of: mixing at least one of the opioid receptor antagonist and at least one of pharmaceutical acceptable carrier to form a mixture; performing a wet granulation on the mixture with a pH-dependent polymer to form a sustained release granule; sieving the sustained release granule through a mesh screen to obtain a sieved sustained release granule; and compressing the sieved sustained release granule to obtain a sustained release (SR) formulation.