A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/045 (2006.01) A61K 31/047 (2006.01) A61K 31/19 (2006.01) A61K 31/215 (2006.01) A61K 31/335 (2006.01) A61K 31/336 (2006.01) A61K 31/35 (2006.01) C07D 407/06 (2006.01)
Patent
CA 2460970
Processes are provided for preparing mupirocin calcium dihydrate from pseudomonic acid in a two phase system by using an organic carboxylate. A highly pure composition of amorphous mupirocin calcium is provided, and processes for its preparation by solvent removal, lyophilization and precipitation with use of anti-solvent. Pharmaceutical compositions of amorphous form, and methods of using them to treat infections are also provided. Also provided are combined processes for preparing mupirocin clacium dihydrate and amorphous, by producing amorphous form first, followed by conversion of amorphous form into the dihydrate through crystallization from an aqueous solution. Also provided are processes for removing the water of crystallization of the dihydrate to obtain mupirocin calcium anhydrate.
L'invention concerne des procédés permettant de préparer du dihydrate de mupirocine calcique à partir d'acide pseudomonique dans un système à deux phases en utilisant un carboxylate organique. Cette invention concerne également une composition de mupirocine calcique amorphe de pureté élevée, ainsi que les procédés permettant la préparation de cette composition par élimination du solvant, lyophilisation et précipitation à l'aide d'un anti-solvant. L'invention concerne en outre des compositions pharmaceutiques de forme amorphe, et les utilisations de ces compositions pour le traitement d'infections. L'invention concerne par ailleurs des procédés combinés permettant de préparer un dihydrate de mupirocine calcique et une mupirocine calcique amorphe, consistant à former d'abord la forme amorphe, puis à convertir la forme amorphe en dihydrate par cristallisation à partir d'une solution aqueuse. L'invention concerne enfin des procédés permettant d'éliminer l'eau de cristallisation du dihydrate pour obtenir un anhydrate de mupirocine calcique.
Gyuricza Lorant
Meszaros Sos Erzsebet
Singer Claude
Szabo Csaba
Biogal Gyogyszergyar Rt
Heenan Blaikie Llp
Teva Gyogyszergyar Reszvenytarsasag
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