Injection solutions of torasemide which are ready to use and...

A - Human Necessities – 61 – K

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A61K 31/44 (2006.01) A61K 31/64 (2006.01) A61K 47/10 (2006.01) A61K 47/02 (2006.01) A61K 47/18 (2006.01)

Patent

CA 1302278

ABSTRACT Injection solutions of torasemide which are ready to use and processes for the preparation thereof The present invention provides an aqueous, alkaline injection solution of torasemide ready for injection, wherein it contains a physiologically compatible alkaline buffer with a pH value of from 9.3 to 9.9 and with a buffer capacity of up to 0.1 val/ litre and an organic solvent in an amount of from 5 to 20% by weight selected from the group polyethylene glycols with a molecular weight of from 100 to 1500, polypropylene glycols with a molecular weight of from 50 to 1000, glycerol, propylene glycol, ethanol and propanol, the torasemide being present in a concent- ration of from 2 to 40 mg./ml. The present invention also provides a process for the preparation of this solution, wherein torasemide is suspended in an organic solvent selected from the group polyethylene glycols with a molecular weight of from 100 to 1500 polypropylene glycols with a molecular weight of from 50 to 1000, glycerol, propylene glycol, ethanol and propanol, brought into solution by the addition of an aqueous alkali, the buffer and other adjuvants are added thereto, the pH value is adjusted to 9.3 to 9.9 by the addition of acid or alkali and the solution is filtered off from undissolved particles and sterilised.

540941

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