Topical anhydrous and ethanol-free ascomycin compositions

A - Human Necessities – 61 – K

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Details

A61K 31/436 (2006.01) A61K 31/445 (2006.01) A61K 47/10 (2006.01) A61K 47/14 (2006.01) A61K 47/26 (2006.01) A61P 29/00 (2006.01) A61K 47/02 (2006.01) A61K 47/06 (2006.01) A61K 47/38 (2006.01) A61K 47/44 (2006.01) A61K 47/46 (2006.01)

Patent

CA 2495345

Single-phase topical liquid or semi-solid pharmaceutical compositions substantially free of ethanol and water and comprising an ascomycin, such as pimecrolimus, in a carrier vehicle comprising a 3-component solvent mixture amounting to at least 40 % w/w of the total weight of the composition and consisting of: i) a C3-8 alkanol and/or C1-8 alkanediol; ii) a fatty alcohol; and iii) a further solvent selected from: a) an alkane carboxylic acid alkyl ester and/or alkane dicarboxylic acid alkyl ester and/or b) a hydrophilic co- component and/or c) a triglyceride; and optionally further conventional excipients.

L'invention concerne des compositions pharmaceutiques semi-solides ou liquides topiques à phase unique sensiblement dépourvues d'éthanol et d'eau et comprenant une ascomycine, telle que du pimecolimus dans un vecteur comprenant un mélange de solvants à trois composants s'élevant à au moins 40 % en poids du poids total de la composition et consistant en: I) un alcanol en C¿3?-¿8? et/ou un alcanediol en C¿1-8?; ii) un alcool gras, et iii) un autre solvant choisi parmi: a) un ester d'alkyle acide carboxylique alcane et/ou un ester d'alkyle d'acide dicarboxylique et/ou b) un co-composant hydrophile et/ou c) un triglycéride. Elle peut également comprendre d'autres excipients classiques.

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