Lyophilized formulation

Details Lyophilized formulation Lyophilized formulation

A - Human Necessities

61

K

A61K 31/282 (2006.01) A61K 9/19 (2006.01) A61P 35/00 (2006.01) A61K 47/14 (2006.01) A61K 47/44 (2006.01)

Patent

CA 2461187

For clinical application of cis[((1R,2R)-1,2- cyclohexanediamine-N, N')bis(R1)]platinum(II) (R1 is an alkanoyloxy group having 6 to 20 carbon atoms), the present invention aims at providing a formulation which prevents layer separation and changes in viscosity, shows fine suspendability, and which is easy to handle during administration. The formulation of the present invention is a lyophilized formulation for injection obtained by dissolving a cis[((1R,2R)-1,2-cyclohexanediamine-N,N')bis(R1)]platinum(II) in 2-methyl-2-propanol and lyophilizing this solution, which has a central particle size distribution of around 3 - 25 µm and a D90% value of not more than 40 µm.

L'invention concerne une préparation lyophilisée pour injection qui rend un cis[((1R,2R)-1,2-cyclohexanédiamine-N,N')bis(R?1¿)] de platine (II) (R?1¿ représentant alcanoyloxy C¿6-20?) approprié pour un usage clinique, et qui est réduite en séparation de phases et variations de viscosité et présente une suspensibilité et une maniabilité satisfaisante lors de son administration. On l'obtient en dissolvant le cis[((1R,2R)-1,2-cyclohexanédiamine-N,N')bis(R?1¿)] de platine (II) dans 2-méthyl-2-propanol et en lyophilisant la solution. Sa répartition de diamètre particulaire se situe autour de 3 à 25 µm et sa valeur de D90 % est d'au maximum 40 µm.

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