Tiotropium containing hfc solution formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/46 (2006.01) A61K 9/00 (2006.01) A61K 47/02 (2006.01) A61K 47/12 (2006.01)

Patent

CA 2510043

This invention relates to tiotropium containing stable pharmaceutical solution formulations suitable for aerosol administration. More particularly, this invention relates to tiotropium containing stable pharmaceutical solution formulations suitable for aerosol administration wherein either an inorganic acid or an organic acid is added to the aerosol solution formulation which contains a tiotropium salt, preferably tiotropium bromide in solution with an environmentally safe hydrofluorocarbon (HFC) as a propellant, together with an organic compound as a cosolvent. The acid provides stability against degradation or decomposition of the medicament resulting largely from interaction of the medicament with the cosolvent and/or water present in the solution formulation.

L'invention a trait à des formulations de solutions pharmaceutiques stables contenant du tiotropium et pouvant être administrées en aérosol. Plus précisément, la présente invention concerne une formulation de solution pharmaceutique stable contenant du tiotropium et pouvant être administrée en aérosol, dans laquelle un acide soit minéral soit organique est ajouté à la formulation de solution pour aérosol, qui contient un sel de tiotropium, de préférence du bromure de tiotropium en solution, un hydrofluorocarbone (HFC) servant de propulseur, et un composé organique faisant fonction de cosolvant. L'acide procure au médicament une stabilité lui permettant de résister à la dégradation ou la décomposition, lesquelles sont causées principalement par l'interaction du médicament avec le cosolvant et/ou l'eau présents dans la formulation de solution.

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