Patent ID: 6998410

Claim:
A method for preparation of a medicament composition in powder form for treatment of IRDS (Infant Respiratory Distress Syndrome) or ARDS (Adult Respiratory Distress Syndrome), the composition comprising at least one phospholipid-comprising lung surfactant and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide or a pharmaceutically tolerable salt thereof, wherein the method comprises either: i) a) lyophilizing an admixture of a liquid phospholipid-comprising lung surfactant preparation with an aqueous suspension of N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide or a pharmaceutically tolerable salt thereof, to obtain a lyophilized product, and b) micronizing the lyophilized product to obtain the composition in powder form; or ii) a) lyophilizing a solution in a suitable solvent of the phospholipid-comprising lung surfactant and of the N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide or the pharmaceutically tolerable salt thereof, to obtain a lyophilized product, and b) micronizing the lyophilized product to obtain the composition in powder form; or iii) spray-drying an admixture of an aqueous suspension of the phospholipid-comprising lung surfactant and an aqueous suspension of the N-(3,5-dichloropyrid-4-yl)-3- cyclopropyl-methoxy-4-difluoromethoxybenzamide to obtain the composition in powder form; or iv) spray-drying a solution of the phospholipid-comprising lung surfactant and the N-(3,5-dichloropyrid-4-yl) -3-cyclopropylmethoxy-4-difluoromethoxybenzamide in a suitable solvent, wherein the N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide is optionally in the form of a pharmaceutically tolerable salt thereof, to obtain the composition in powder form.