FIELD: medicine; pharmaceuticals.
SUBSTANCE: group of inventions relates to pharmaceutics, specifically: to an orally disintegrating film formulation and a method for its preparation. Orally disintegrating film formulation contains tadalafil as an active ingredient, and, as a film-forming agent, a combination of pullulan, having an average molecular weight in the range from 50,000 to 200,000 g/mol, and polyvinylpyrrolidone K-90, wherein the weight ratio of tadalafil, pullulan and polyvinylpyrrolidone K-90 is 1:1.8–2.5:0.8–1.3. According to the proposed method, the components of the formulation are dissolved or dispersed in ethanol or a mixture of ethanol and water to form a solution or dispersion; and the solution or dispersion obtained in the previous step is applied on a hydrophobic film, followed by drying of the product.
EFFECT: group of inventions provides a film formulation with good stability, without buccal absorption and exhibiting bioequivalence to a tadalafil-containing tablet.
19 cl, 3 dwg, 5 tbl, 5 ex
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