| 摘要 |
Disclosed herein are injectable pharmaceutical compositions, methods of use and formulation, wherein the compositions comprise: water, one or more water soluble complexes, each complex comprising a cyclodextrin or a cyclodextrin derivative and a hydrophobic drug; at least one preservative selected from chlorocresol, benzethonium chloride, benzalkonium chloride and mixtures thereof; and at least one co-solvent selected from the group consisting of: ethanol, glycerin, propylene glycol, isopropyl alcohol, glycerol formal, tetraglycol, and mixtures thereof. 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. |
