发明名称 |
Injectable aqueous pharmaceutical compositions comprising a cyclodextrin, a hydrophobic drug, a co-solvent, and a preservative |
摘要 |
The invention relates to injectable pharmaceutical compositions, methods of use and formulation, wherein the compositions comprise: one or more water soluble complexes, each complex comprising a cyclodextrin or a cyclodextrin derivative and a hydrophobic drug; at least one preservative; and at least one co-solvent. The compositions are effectively preserved in accordance with the European Pharmacopoeia 2011 Test for Efficacy of Antimicrobial Preservation, satisfying at least the B criteria as it applies to parenterals, and the United States Pharmacopeia 2011 Guidelines for Antimicrobial Effectiveness Testing, satisfying the criteria for Category 1 (injectable) products. |
申请公布号 |
US9492552(B2) |
申请公布日期 |
2016.11.15 |
申请号 |
US201214361677 |
申请日期 |
2012.11.27 |
申请人 |
JUROX PTY LTD |
发明人 |
Pasloske Kirby Shawn;Lau Kai;Richardson Sarah Jane;Willis Amanda Aileen |
分类号 |
A61K31/573;A61K47/40;C08L5/16;C08B37/16;A61K31/05;A61K31/403;A61K31/5415;A61K31/57;A61K47/48;B82Y5/00 |
主分类号 |
A61K31/573 |
代理机构 |
Thorpe North & Western, LLP |
代理人 |
Thorpe North & Western, LLP |
主权项 |
1. An injectable pharmaceutical composition complying 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 comprising:
per liter of water, 80 g 2-hydroxypropyl-β-cyclodextrin, 10 g alfaxalone, 8 g sodium chloride, 940 mg disodium phosphate, 450 mg potassium dihydrogen phosphate, 1 g to 1.5 g chlorocresol, and 150 g ethanol wherein the pH is adjusted to a pH in a range of 6.0 to 7.5 with a pH adjuster. |
地址 |
New South Wales AU |