Pimecrolimus foam composition containing hexylene glycol,...

A - Human Necessities – 61 – K

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A61K 9/12 (2006.01) A61K 31/445 (2006.01)

Patent

CA 2556993

Pharmaceutical foam compositions substantially free of ethanol and comprising pimecrolimus in a carrier vehicle comprising a mixture of oily solvents amounting to at least 40 % of the total weight of the composition and consisting of: i) hexylene glycol; ii) optionally oleyl alcohol; and iii) dimethylisosorbide and/or medium chain triglycerides; and additionally: iv) when oleyl alcohol is absent, water in an amount of less than 25 %; v) at least one consistency agent; vi) at least one preservative; and vii) at least one surfactant/emulgator; and propellant gas for foaming; and optionally further conventional excipients. They are indicated for use in the treatment of various skin, nail and mucosal diseases.

Des compositions de mousse pharmaceutiques sensiblement exempte d'éthanol et comprenant un pimecrolimus dans un véhicule support comprenant un mélange de solvant huileux dont la quantité s'élève au moins à 40 % du poids total de la composition et formées de: i) hexylène glycol; ii) éventuellement oléylalcool; et iii) diméthylisosorbide et/ou des triglycérides à chaîne moyenne; et éventuellement: iv) lorsque l'oléylalcool est absent, de l'eau dont la quantité est inférieure à 25 %; v) au moins un agent de consistance; vi) au moins un préservateur; et vii) au moins un tensioactif/émolient; un gaz propulseur pour la mousse; et éventuellement des excipients conventionnels. Les éléments se prêtent à une utilisation dans le traitement de différentes maladies de la peau, des ongles et des muqueuses.

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