Tacrolimus preparation for external applications

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/706 (2006.01) A61K 9/06 (2006.01) A61K 47/06 (2006.01) A61K 47/14 (2006.01) A61K 47/44 (2006.01) A61P 17/00 (2006.01) A61P 37/08 (2006.01)

Patent

CA 2738831

The present invention provides tacrolimus containing ointment having low dermal irritation and excellent stability. It was found that an ointment comprising triacetin as a solubilizer for tacrolimus may sufficiently solubilize tacrolimus, has low dermal irritation and excellent stability. Preferably, the ointment of the present invention is an o/o type (oil-in-oil type) ointment in which tacrolimus-solubilized triacetin droplets are dispersed in an ointment base, preferably a mixture of beeswax and petrolatum.

L'invention porte sur un onguent à base de tacrolimus qui présente une faible irritation cutanée et une excellente stabilité. Il est démontré que le tacrolimus peut être solubilisé dans un onguent de manière satisfaisante lorsque de la triacétine est utilisée en tant qu'agent solubilisant pour le tacrolimus, et que l'onguent présente une faible irritation cutanée et une excellente stabilité. De préférence, l'onguent est un onguent de type h/h (huile-dans-huile) dans lequel des gouttelettes liquides comportant du tacrolimus solubilisé dans de la triacétine sont dispersées dans une base d'onguent, de préférence un mélange de cire d'abeilles et de vaseline.

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