INJECTABLE PHARMACEUTICAL COMPOSITIONS COMPRISING A CYCLODEXTRIN A HYDROPHOBIC DRUG, A CO-SOLVENT, AND A PRESERVATIVE
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United States of America Patent
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Issued Date -
May 2, 2019
app pub date -
Dec 18, 2018
filing date -
Dec 18, 2018
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Abstract
Injectable pharmaceutical compositions, methods of use and formulation are disclosed. 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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