Compositions for nasal administration of desmopressin

A - Human Necessities – 61 – K

Patent

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Details

A61K 38/08 (2006.01) A61K 9/00 (2006.01) A61K 9/12 (2006.01) A61K 9/72 (2006.01) A61K 38/11 (2006.01)

Patent

CA 2166312

An aqueous composition for spray nasal administration of a synthetic analog of vasopressin (desmopressin; 1-deamino-8-D-arginine- vasopressin) contains between 2.5 and 75 µg per 100 µl. The composition may additionally contain an osmotic-pressure controlling agent, such as sodium chloride, a preservative, such as chlorobutanol or benzalkonium chloride, and a buffer stabilizing the pH between about 4 and 6. Buffers containing citrate and/or phosphate are preferred. Also disclosed is a sealed container filled with the composition, an assembly comprising the container and a spray pump, and the use of the composition, the container, and the assembly in the management of urinary disorders.

Composition aqueuse permettant l'administration par pulvérisation dans le nez d'un analogue synthétique de vasopressine (desmopressine; 1-désamino-8-D-arginine-vasopressine). La composition contient de 2,5 à 7,5 mu g de desmopressine par 100 mu l. Elle peut également contenir un agent régulateur de la pression osmotique, par exemple le chlorure de sodium, un agent de conservation, par exemple le chlorobutanol ou le chlorure de benzalkonium, et un tampon stabilisant le pH entre 4 et 6 environ. On préfère les tampons renfermant un citrate et/ou un phosphate. On a également prévu un récipient hermétique rempli de cette composition, un ensemble comportant ce récipient et une pompe de pulvérisation, et l'application de la composition, du récipient et de l'ensemble à la gestion des troubles urinaires.

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