Stable pharmaceutical composition of bdnf

Details Stable pharmaceutical composition of bdnf Stable pharmaceutical composition of bdnf

A - Human Necessities

61

K

A61K 38/18 (2006.01) A61K 9/19 (2006.01) A61K 47/14 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2256410

The present invention is directed to a stable pharmaceutical composition of brain derived neurotrophic factor (BDNF) in the form of an aqueous solution or lyophilized one being suitable for long-term storage, which contains a surfactant, especially nonionic surfactant of 0.001 to 10 %, whereby the polymerization and the denaturation of BDNF are inhibited, and the biological activities of BDNF are maintained for a long time. The lyophilized composition can be made more stable by the addition of a sugar alcohol (e.g., mannitol) and/or an amino acid (e.g., glycine).

Cette invention se rapporte à une composition pharmaceutique stable du facteur neurotrophique dérivé du cerveau (BDNF) sous la forme d'une solution aqueuse ou d'une solution lyophilisée, appropriée pour une conservation de longue durée, qui contient un tensioactif, en particulier un tensioactif non ionique (par exemple Tween 80) à raison de 0,001 à 10 %, de sorte que la polymérisation et la dénaturation de ce facteur BDNF sont empêchées et les activités biologiques de ce facteur BDNF sont maintenues sur une longue période. Cette composition lyophilisée peut être rendue plus stable par addition d'un itol (par exemple du mannitol) et/ou d'un acide aminé (par exemple la glycine).

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