Pharmaceutical Compositions having a Selected Release Duration

The present invention provides for a stabilized biodegradable polymeric composition useful as a controlled release delivery system for peptide agents. The compositions of the present invention comprise a) a strong acid salt and a weak acid of a LHRH agonist or antagonist; b) a biodegradable polymer...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: LI, Yuhua, GUARINO, Andrew J
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:The present invention provides for a stabilized biodegradable polymeric composition useful as a controlled release delivery system for peptide agents. The compositions of the present invention comprise a) a strong acid salt and a weak acid of a LHRH agonist or antagonist; b) a biodegradable polymer of poly(lactide-co-glycolide), wherein the ratio of lactide:glycolide of the copolymer is from 50:50 to about 100:0; and c) N-methyl-2-pyrrolidone (NMP), wherein the composition does not contain excess strong acid in addition to the strong acid used to form the salt of the LHRH agonist or antagonist. The composition, when injected, can provide a controlled release of leuprolide for a period of up to 6 months.