Processes for making pharmaceutical oral ecb formulations...

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01) A61K 38/12 (2006.01) A61P 31/10 (2006.01)

Patent

CA 2362482

A fluid bed spray process is described where one or more carbohydrates are incorporated into an echinocandin formulation to provide a significant improvement in thermal stability. The carbohydrate is solubilized with an echinocandin compound or echinocandin/carbohydrate complex in a solvent(s) to form a pharmaceutical solution which is sprayed onto the surface of a granular diluent or carrier. Alternatively, a granulating agent is added to the pharmaceutical solution which is then sprayed onto the surface of a non- granular diluent or carrier. The resulting granular oral formulations and medicaments derived therefrom are also described.

L'invention concerne un procédé de pulvérisation en lit fluidisé, au moins un hydrate de carbone étant incorporé dans une formulation d'échinocandine afin d'obtenir une amélioration significative de sa stabilité thermique. L'hydrate de carbone est dissous avec un composé d'échinocandine ou un complexe d'échinocandine/hydrate de carbone dans au moins un solvant, afin de former une solution pharmaceutique qui est pulvérisée sur la surface d'un diluant ou d'un excipient granulaire. Selon un autre mode de réalisation, on ajoute un agent de granulation à la solution pharmaceutique qui est alors pulvérisée sur la surface d'un diluant ou d'un excipient non granulaire. L'invention concerne également les formulations orales granulaires résultantes et les médicaments dérivés de celles-ci.

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