Sustained release poloxamer containing pharmaceutical compositions
AssigneeAllergan, Inc.
InventorTerrence J. Hunt
Life of this patent
Estimating the term…
Abstract
A thermo-reversible thermoplastic pharmaceutical composition, comprising a botulinum toxin and a biocompatible poloxamer which provides thermoreversibility to the composition and additionally stabilizes the botulinum toxin, is described. The pharmaceutical composition can be administered to a patient as a liquid, and gels after administration into a sustained release drug delivery system from which the biologically active botulinum toxin is released over a multi-day period thereby localizing the drug as a depot and controlling release to enhance the therapeutic effect per dose.
Claims18
A thermoreversible, thermoplastic, pharmaceutical composition comprising:
- (a) a biologically active botulinum toxin, and;
- (b) a thermoplastic poloxamer, wherein the poloxamer stabilizes the botulinum toxin so that the botulinum toxin retains biological activity when upon release of the botulinum toxin from the pharmaceutical composition in vivo.
A thermo-reversible, thermoplastic, pharmaceutical composition comprising:
- (a) a biologically active botulinum toxin type A, and;
- (b) a thermoplastic thermo-reversible poloxamer 407, wherein the poloxamer is present at a concentration of about 15 wt % to about 25 wt % of the pharmaceutical composition and stabilizes the botulinum toxin so that the botulinum toxin retains biological activity upon release of the botulinum toxin from the pharmaceutical composition in vivo.
-20. (canceled)
A thermoreversible, thermoplastic, gelable, pharmaceutical composition made by a process comprising the steps of:
- a) dissolving a thermo-reversible thermoplastic poloxamer in a solvent at a temperature below about 37 degrees Centigrade until dissolved;
- and
- b) adding and mixing a botulinum toxin to the thermo-reversible thermoplastic poloxamer in the solvent to thoroughly disperse the botulinum toxin therein, wherein poloxamer is present at a concentration of from about 15 wt % to about 25 wt % of the pharmaceutical composition, thereby making the thermoplastic, gelable, pharmaceutical composition.
-24. (canceled)
Dependencies are inferred from the claim text.