Patent ID: 7671042
Filing Date: 2010-03-02
Classification: A61K,A61P,B82Y

Abstract:
1. A process for the preparation of instantly soluble solid products for pharmaceutical parenteral comprising: (a) dissolving in ethanol a taxoid selected from the group consisting of paclitaxel or a salt or hydrate thereof and docetaxel, or a salt or hydrate thereof, to form a solution and thereafter, (b) adding to the solution a lyophilized solid cyclodextrin derivative selected from the group consisting of acetyl-γ-cyclodextrin having a degree of acetylation between about 2 to about 12 acetyl groups per cyclodextrin ring and hydroxyl-propyl-β-cyclodextrin having a degree of substitution between about 2 to about 12 hydroxypropyl groups per cyclodextrin ring, (c) evaporating the solvent and drying to obtain an instant soluble solid, (d) dissolving said solid in an aqueous solvent selected from the group consisting of water, aqueous glucose and aqueous dextrose, thus obtaining an aqueous solution, and (e) freezing the solution and lyophilising it to obtain an instantly soluble lyophilisate including with the restriction that when hydroxyl-propyl-β-cyclodextrin is used the taxoid can be only docetaxel in a 1:25 to 1:100 taxoid:cyclodextrin weight ratio.