Pharmaceutical compositions with enhanced stability
AssigneeForesee Pharmaceuticals Co., Ltd.
InventorsYuhua Li, Benjamin Chien
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Abstract
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 beneficial salt of a luteinizing hormone releasing hormone (LHRH) analogue formed with a strong acid that minimizes or prevents the interaction/reaction between the LHRH and the polymer in an organic solution; b) a biodegradable polymer; c) a pharmaceutically acceptable organic solvent; and d) optionally one or more excipients. The present invention also relates to a method of manufacturing and a method of use thereof.
Claims20
A pharmaceutical composition comprising:
- a) 4% to 40% by weight mesylate salt of leuprolide;
- b) a polymer selected from the group consisting of polylactide, poly(lactic acid), poly(lactic acid-co-glycolic acid), and poly(lactide-co-glycolide);
- and
- c) N-methyl-2-pyrrolidone (NMP).
An injectable pharmaceutical composition comprising:
- a) 4% to 40% by weight mesylate salt of leuprolide;
- b) 40% to 60% by weight at least one polymer selected from the group consisting of poly (DL-lactide) and poly(DL-lactide-co-glycolide), and
- c) 30% to 80% by weight N-methyl-2-pyrrolidone (NMP),
- wherein the mesylate salt of leuprolide is formed before the salt is combined with the at least one polymer and the NMP.
Dependencies are inferred from the claim text.