US 12,303,519 B2
Injectable pharmaceutical compositions comprising a cyclodextrin a hydrophobic drug, a co-solvent, and a preservative
Kirby Shawn Pasloske, New South Wales (AU); Kai Lau, New South Wales (AU); Sarah Jane Richardson, New South Wales (AU); and Amanda Aileen Willis, New South Wales (AU)
Assigned to Zoetis Services LLC, Parsippany, NJ (US)
Filed by Zoetis Services LLC, Parsippany, NJ (US)
Filed on Dec. 18, 2018, as Appl. No. 16/224,433.
Application 16/224,433 is a continuation of application No. 15/280,826, filed on Sep. 29, 2016, granted, now 10,188,664.
Application 15/280,826 is a continuation of application No. 14/361,677, granted, now 9,492,552, issued on Nov. 15, 2016, previously published as PCT/AU2012/001452, filed on Nov. 27, 2012.
Claims priority of application No. 2011904970 (AU), filed on Nov. 29, 2011; and application No. 2012904962 (AU), filed on Nov. 9, 2012.
Prior Publication US 2019/0125762 A1, May 2, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/69 (2017.01); A61K 9/00 (2006.01); A61K 31/05 (2006.01); A61K 31/14 (2006.01); A61K 31/403 (2006.01); A61K 31/5415 (2006.01); A61K 31/57 (2006.01); A61K 31/573 (2006.01); A61K 45/06 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/40 (2006.01); A61P 23/00 (2006.01); A61P 25/04 (2006.01); A61P 29/00 (2006.01); A61P 43/00 (2006.01); B82Y 5/00 (2011.01); C08B 37/16 (2006.01); C08L 5/16 (2006.01)
CPC A61K 31/573 (2013.01) [A61K 9/0019 (2013.01); A61K 31/05 (2013.01); A61K 31/14 (2013.01); A61K 31/403 (2013.01); A61K 31/5415 (2013.01); A61K 31/57 (2013.01); A61K 45/06 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/40 (2013.01); A61K 47/6951 (2017.08); A61P 23/00 (2018.01); A61P 25/04 (2018.01); A61P 29/00 (2018.01); A61P 43/00 (2018.01); B82Y 5/00 (2013.01); C08B 37/0015 (2013.01); C08L 5/16 (2013.01)] 12 Claims
OG exemplary drawing
 
1. A method of anaesthetizing one or more subjects using a composition stored in a sealed multi-dose container, the composition comprising:
water,
one or more water soluble complexes, each comprising a β-cyclodextrin and a hydrophobic drug selected from the group consisting of alfaxalone, propofol, meloxicam and carprofen;
at least one preservative selected from the group consisting of: m-cresol, chlorocresol, methylparaben, ethylparaben, propylparaben, butylparaben, chlorobutanol, benzethonium chloride, benzalkonium chloride, boric acid, benzyl alcohol, cetylpyridinium chloride, cetrimide, phenol, phenylethanol and phenoxyethanol;
at least one co-solvent comprising 10% w/v to 15% w/v ethanol; and
optionally a buffer effective to provide a pH in the composition in a range of from about 4.0 to about 9.0,
the method comprising:
broaching the sealed multi-dose container and withdrawing a first anaesthetically effective dose of said composition and administering the dose to a first of said subjects; and subsequently withdrawing further anaesthetically effective doses, if required, and administering the doses to further subjects either until no further doses are available in the container or at least 28 days have elapsed since the first dose was withdrawn, wherein the injectable pharmaceutical composition complies with the European Pharmacopoeia 2011 Test for Efficacy of Antimicrobial Preservation, satisfying at least the B criteria for parenterals and the United States Pharmacopeia 2011 Guidelines for Antimicrobial Effectiveness Testing for Category 1 (injectable) products following the withdrawal of the first anaesthetically effective dose.