Lyophilization method to improve excipient crystallization

Details Lyophilization method to improve excipient crystallization Lyophilization method to improve excipient crystallization

A - Human Necessities

61

K

A61K 9/00 (2006.01)

Patent

CA 2554018

The present invention provides improved methods to lyophilize (freeze-dry) active ingredients such as proteins, nucleic acids and viruses. The present methods improve the degree of excipient crystallization during lyophilization over prior methods. The improvement in excipient crystallization is based, in part, on a high-temperature annealing step that is conducted prior to or at the same time as secondary drying. Importantly, the high~temperature annealing step does not destabilize active ingredients. Further, the high~temperature annealing step does not require sub-zero annealing steps prior to its enactment in order to provide complete excipient crystallization.

La présente invention concerne des améliorations apportées à des procédés de lyophilisation (cryo-dessication) d'ingrédients actifs, tels que des protéines, des acides nucléiques et des virus. Ces procédés permettent d'obtenir un degré de cristallisation de l'excipient, lors de la lyophilisation, supérieur à celui obtenu dans les procédés actuels. Cette amélioration de la cristallisation de l'excipient repose, en partie, sur une étape de recuit à haute température menée avant ou pendant le séchage secondaire. De plus, l'étape de recuit à haute température ne déstabilise pas les ingrédients actifs. Par ailleurs, l'étape de recuit à haute température ne nécessite aucune étape préalable de recuit par le froid pour obtenir une cristallisation complète de l'excipient.

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