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METHODS OF PRESERVING INJECTABLE PHARMACEUTICAL COMPOSITIONS COMPRISING A CYCLODEXTRIN AND A HYDROPHOBIC DRUG
专利权人:
发明人:
申请号:
EP12853138.1
公开号:
EP2785352A1
申请日:
2012.11.27
申请国别(地区):
EP
年份:
2014
代理人:
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.
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