Process for preparation of isotonic aqueous injection of...

Details Process for preparation of isotonic aqueous injection of... Process for preparation of isotonic aqueous injection of...

A - Human Necessities

61

K

A61K 9/10 (2006.01) A61P 23/02 (2006.01)

Patent

CA 2608730

The preparation of an injectable solution of ropivacaine by dissolving ropivacaine base in aqueous acidic solution having a molar ratio of acid to ropivacaine base greater than 1:1 eliminates the need for a hydrochloride or hydrochloride monohydrate intermediate in the manufacture of the injectable. The osmolality can be adjusted as needed. The excess acid is neutralized with a base.

L'invention porte sur la préparation d'une solution injectable de ropivacaïne, par dissolution d'une base de ropivacaïne dans une solution aqueuse acide présentant un rapport molaire acide/ropivacaïne supérieur à 1:1. Ce procédé permet de supprimer l'intermédiaire chlorhydrate ou à l'intermédiaire monohydrate de chlorhydrate lors de la production de la solution injectable. L'osmolarité peut être régulée selon les besoins. L'acide excédentaire est neutralisé à l'aide d'une base.

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