Stabilized dry powder formulations

Details Stabilized dry powder formulations Stabilized dry powder formulations

A - Human Necessities

61

K

A61K 9/14 (2006.01) A61K 31/045 (2006.01) A61K 31/075 (2006.01) A61K 31/095 (2006.01) A61K 31/12 (2006.01) A61K 31/13 (2006.01) A61K 31/167 (2006.01) A61K 31/56 (2006.01) A61K 47/00 (2006.01)

Patent

CA 2404064

A dry powder formulation for treatment of pulmonary conditions, via inhalation, includes an effective amount of formoterol or a salt or solvate thereof, in a dry powder form, an effective amount of fluticasone, in a dry powder form, and an excipient. A method for preparing a physically stable dry powder formulation for inhalation includes the steps of micronizing a first active polar drug, a second active non-polar drug, and a polar excipient. The second non-polar active drug is first blended with the excipient to form an intermediate mixture. The intermediate mixture is then blended with the first active polar drug. The increased separation of the polar drug and polar excipient stabilizes the formulation.

L'invention concerne une formulation sous forme de poudre sèche destinée au traitement, par inhalation, d'affections pulmonaires. Cette formulation comprend une quantité efficace de formotérol ou un sel ou un solvate de celui-ci sous forme de poudre sèche; une quantité efficace de fluticasone, sous forme de poudre sèche, et un excipient. L'invention concerne également un procédé permettant de préparer une formulation sous forme de poudre sèche physiquement stable se prêtant à l'inhalation. Ce procédé consiste à microniser un premier médicament actif polaire, un second médicament actif non polaire et un excipient polaire. Le second médicament actif non polaire est d'abord mélangé avec l'excipient afin de former un mélange intermédiaire. Le mélange intermédiaire est ensuite mélangé avec le premier médicament actif polaire. Une plus grande séparation du médicament polaire et de l'excipient polaire permet de stabiliser la formulation.

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