Methods for the stabilization of atorvastatin

Details Methods for the stabilization of atorvastatin Methods for the stabilization of atorvastatin

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 31/40 (2006.01)

Patent

CA 2535225

Stabilization of the pharmaceutical active solid substance atorvastatin alone or in a mixture with other solid substances embedded in a gaseous mixture is carried out in such a manner that in the surrounding gaseous mixture a partial pressure of oxygen of at most 2 kPa, preferably less than 1 kPa, more preferably less than 0.4 kPa is maintained. The corresponding partial pressure is achieved either by use of oxygen absorbers, by packaging under a pressure of 0.3 - 10 kPa, or by packaging under a slight overpressure of an inert gas, preferably nitrogen, the gas being introduced, by means of nozzles, into the cavities, optionally also into the space of the press roller and of the wiper station.

Selon l'invention, la stabilisation d'une substance pharmaceutique solide active, l'atorvastatine, de manière isolée ou en combinaison avec d'autres substances solides incorporées dans un mélange gazeux est réalisée de sorte que, dans le mélange gazeux environnant, une pression partielle d'oxygène d'au moins 2 kPa, de préférence inférieure à 1 kPa, de préférence encore inférieure à 0,4 kPa, soit conservée. La pression partielle correspondante est obtenue par utilisation d'absorbeurs d'oxygène, par emballage sous une pression de 0,3 à 10 kPa, ou par emballage sous une légère surpression d'un gaz inerte, de préférence de l'azote, ce gaz étant introduit au moyen de buses dans les cavités, et éventuellement dans l'espace du rouleau presseur et de la station d'essuyage.

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