Taxane pharmaceutical formulation, solid taxane composition,...

Details Taxane pharmaceutical formulation, solid taxane composition,... Taxane pharmaceutical formulation, solid taxane composition,...

A - Human Necessities

61

K

A61K 9/19 (2006.01) A61K 31/337 (2006.01)

Patent

CA 2637893

The invention relates to a taxane pharmaceutical formulation to be administered to mammals, preferably humans, comprising two compositions which are combined prior to administration such as to form a transparent solution free of precipitates, whereby said compositions comprise a lyophilised solid taxane composition free of surfactants, oils, polymers, solubility enhancers, preservatives and excipients, and a composition for solubilising said lyophilised solid taxane composition, containing at least one surfactant. Said formulation is free of polysorbate 80 and polyoxyethylated castor oil. The invention also relates to a method for preparing the solid composition, comprising the lyophilisation of taxane in an organic lyophilisation solvent. The invention further relates to a kit for the injectable taxane formulation, containing a pre-filled syringe, and a pharmaceutical taxane perfusion solution that is free of organic solvent.

L'invention concerne une formulation pharmaceutique de taxane destinée à être administrée à des mammifères, de préférence des humains. Cette formulation comprend deux compositions qui se combinent avant son administration de manière à former une solution transparente exempte de précipités. Ces compositions comprennent une composition solide de taxane lyophilisée, exempte de tensioactifs, des huiles, des polymères, des agents améliorants de la solubilité, des agents de conservation et des excipients et une composition solubilisante de cette composition solide de taxane lyophilisée qui comprend au moins tensioactif. Cette formulation est exempte de polysorbate 80 et d'huile de castor polyoxyéthylée. Un procédé de préparation de la composition solide par une lyophilisation du taxane en solvant organique de lyophilisation. L'invention concerne également un kit pour cette formulation de taxane injectable qui comprend une seringue préremplie. L'invention concerne enfin une solution pharmaceutique de perfusion de taxane exempte de solvant organique.

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