Stable lyophilized preparation

Details Stable lyophilized preparation Stable lyophilized preparation

A - Human Necessities

61

K

A61K 31/496 (2006.01) A61K 9/19 (2006.01) A61K 47/10 (2006.01) A61K 47/12 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01) A61K 47/34 (2006.01) A61K 47/40 (2006.01) A61P 35/00 (2006.01)

Patent

CA 2659562

Disclosed is a lyophilized preparation comprising (8E,12E,14E)-7-((4-cycloheptylpiperazin-1-yl)carbonyl)oxy- 3,6,16,21-tetrahydroxy-6,10,12,16,20-pentamethyl-18,19- epoxytricosa-8,12,14-trien-11-olide, which has excellent long-term stability and excellent solubility upon dissolved in water. Specifically disclosed is a lyophilized preparation comprising 1) (8E,12E,14E)-7-((4-cycloheptylpiperazin-1- yl)carbonyl)oxy-3,6,16,21-tetrahydroxy-6,10,12,16,20- pentamethyl-18,19-epoxytricosa-8,12,14-trien-11-olide or a pharmacologically acceptable salt thereof, 2) a pH-adjusting agent for adjusting the pH value of the preparation to 5 to 8, and 3) at least one excipient selected from a sugar and a sugar alcohol.

La présente invention concerne une préparation lyophilisée qui comprend un (8E,12E,14E)-7-((4-cycloheptylpipérazin-1-yl)carbonyl)oxy-3,6,16,21-tétrahydroxy-6,10,12,16,20-pentaméthyl-18,19-époxytricosa-8,12,14-trién-11-olide et qui présente une excellente stabilité à long terme et une excellente solubilité après avoir été dissoute dans l'eau. L'invention concerne spécifiquement une préparation lyophilisée comprenant (1) un (8E,12E,14E)-7-((4-cycloheptylpipérazin-1-yl)carbonyl)oxy-3,6,16,21-tétrahydroxy-6,10,12,16,20-pentaméthyl-18,19-époxytricosa-8,12,14-trién-11-olide ou un sel pharmacologiquement acceptable de celui-ci, (2) un tampon permettant d'ajuster le pH de la préparation à une valeur de 5 à 8 et (3) au moins un excipient choisi parmi un sucre et un polyol.

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