Stable injectable diclofenac compositions

Details Stable injectable diclofenac compositions Stable injectable diclofenac compositions

A - Human Necessities

61

K

A61K 47/18 (2006.01) A61K 47/20 (2006.01) A61K 47/40 (2006.01) A61P 29/00 (2006.01)

Patent

CA 2555429

This invention relates to stable parenteral aqueous solutions comprising either (a) diclofenac or a pharmaceutically acceptable diclofenac salt and a cyclodextrin, or (b) an inclusion complex of diclofenac or a pharmaceutically acceptable diclofenac salt and a cyclodextrin, or a mixture of (a) and (b), which are suitable for intramuscular and intravenous administration. The solutions contain diclofenac or diclofenac salt, cyclodextrin, and an antioxidant selected from monothioglycerol, or a combination of ethylene diamine tetra-acetic acid and N-acetyl-cysteine.

L'invention concerne des solutions aqueuses parentérales stables qui contiennent soit: (a) du diclofénac ou un sel de diclofénac pharmaceutiquement acceptable associé à une cyclodextrine, soit (b) un composé d'inclusion de diclofénac ou un sel de diclofénac pharmaceutiquement acceptable associé à une cyclodextrine, ou alors un mélange de (a) et (b); ces solutions convenant à l'administration intramusculaire et intraveineuse. Par ailleurs, ces solutions contiennent du diclofénac ou un sel de diclofénac, de la cyclodextrine, ainsi qu'un antioxydant sélectionné du monothioglycérol, ou une combinaison d'acide tétraacétique d'éthylènediamine et de N-acétyl-cystéine.

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