Process for producing injectable gabapentin compositions

Details Process for producing injectable gabapentin compositions Process for producing injectable gabapentin compositions

A - Human Necessities

61

K

A61K 9/08 (2006.01) A61J 3/00 (2006.01) A61K 31/52 (2006.01)

Patent

CA 2542537

Injectable compositions containing gabapentin and processes for preparing sterile injectable compositions containing gabapentin are discussed. The process includes subjecting the compositions to heat. Heating results in increased production of gabapentin lactam, which has previously been shown to be toxic. Surprisingly, heated injectable compositions containing gabapentin are found to be non-toxic when administered intrathecally. Thus, heating for the purposes of sterilization or to assure sterility provides a viable option in the production of injectable compositions containing gabapentin.

Cette invention concerne des compositions injectables contenant de la gabapentine et des méthodes de fabrication de telles compositions. Le procédé consiste à chauffer des compositions à la chaleur afin d'accroître la production de gabapentine lactame, dont la toxicité a été démontrée précédemment. Etonnamment, il est apparu que des compositions injectables chauffées renfermant de la gabapentine n'étaient pas toxiques si elles étaient administrées intrathécalement. Ainsi, le chauffage à des fins de stérilisation ou de maintien de la stérilité constitue une alternative viable pour la production de compositions contenant de la gabapentine.

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