Farmarc Nederland Bv

Michiel Coenraad Van Oudtshoorn

Lawrence John Penkler

Lueta Ann Glintenkamp

Mark David Bodley

Douglas George Nicholson

Mino Rodolfo Caira

Vivienne Jean Griffith

Luigi Renzo Nassimbeni

Pharmaceutical composition

A method of preparing an injectable pharmaceutical or veterinary composition which comprises either diclofenac or a salt thereof and 2-hydroxypropyl beta-cyclodextrin, or an inclusion complex of diclofenac or a salt thereof and 2-hydroxypropyl beta-cyclodextrin, includes the step of dissolving either the diclofenac or salt thereof and the 2-hydroxypropyl beta-cyclodextrin, or the inclusion complex, in water to form a solution, the water having been acidified to a pH such that the pH of the solution is from 6.0 to 8.5 inclusive, in the absence of a phosphate buffer. The composition so produced has good stability on storage.

Pharmaceutical composition comprising diclofenac and cyclodextrin

An inclusion complex of diclofenac, preferably as diclofenac sodium, and an unsubstituted beta-cyclodextrin has the formula 1 molecule of diclofenac to 1 molecule of the unsubstituted beta-cyclodextrin and preferably from 5 to 11 water molecules. The inclusion complex may be formulated as a pharmaceutical composition.

Inclusion complex of beta-cyclodextrin and diclofenac, its preparation

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Pretoria, South Africa

Michiel Coenraad Van Oudtshoorn