Sustained release poloxamer containing pharmaceutical compositions

Patent metadata

Field	Value
Publication number	US-9981022-B2
Application number	US-201615058824-A
Country	US
Kind code	B2
Filing date	Mar 2, 2016
Priority date	Feb 22, 2008
Publication date	May 29, 2018
Grant date	May 29, 2018

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.

First claim

I claim:

1. A thermoreversible, thermoplastic, gelable, pharmaceutical composition comprising a thermo-reversible thermoplastic poloxamer, a botulinum toxin and an additional ingredient made by a process consisting of the steps of: a) dissolving the thermo-reversible thermoplastic poloxamer in a solvent at a temperature below about 37 degrees Centigrade until dissolved; and b) adding and mixing the botulinum toxin and the additional ingredient, wherein the additional ingredient is selected from the group consisting of polysorbate, a second poloxamer, dextran, histidine, citrate buffer, isopropyl myristate, povidone, lactose, trehalose, hyaluronic acid, hydroxypropyl methylcellulose, and lecithin, to the thermo-reversible thermoplastic poloxamer in the solvent to thoroughly disperse the botulinum toxin and the additional ingredient therein; and wherein the thermoreversible, thermoplastic, gelable, pharmaceutical composition is transitionable from a low viscosity liquid solution for easy passage through a needle prior to administration by injection to a patient to a gel after administration.

2. The pharmaceutical composition of claim 1 , wherein the solvent is water or a saline solution.

Assignees

• Allergan Inc

Inventors

• Hunt Terrence J

Classifications

• A61P17/00

  Drugs for dermatological disorders · CPC title

• A61K47/34

  Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) · CPC title

• A61K8/042

  Gels · CPC title

• A61K9/06

  Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} · CPC title

• A61K8/66

  Enzymes · CPC title