PHARMACEUTICAL COMPOSITION Russian patent published in 2022 - IPC A61K31/4045 A61K47/36 A61K9/00 A61P25/06 

FIELD: medicine.

SUBSTANCE: group of inventions relates to film suitable for the administration in the oral cavity for the trans-mucous delivery to a patient of sumatriptan or its pharmaceutically acceptable salt, as well as to methods for the treatment of a disease in a patient using such a film and manufacture of such a film. The proposed film contains: (i) alginate salt of a monovalent cation or a mixture of alginate salts containing at least one alginate salt of a monovalent cation, and (ii) triptan or its pharmaceutically acceptable salt, while alginate salt of a monovalent cation (a) contains from 25 to 35% by weight of β-D-mannuronate and/or from 65 to 75% by weight of α-L-guluronate, and (b) has an average molecular weight from 30,000 g/mol to 90,000 g/mol. The treatment method includes the administration of the specified film to a human patient for the treatment of a disease selected from migraine with or without aura, cluster pain or trigeminal neuralgia. The film manufacturing method includes: (a) mixing of sumatriptan or its pharmaceutically acceptable salt in water; (b) bringing pH of the solution to the required level by the addition of corresponding acid or base, usually a diluted aqueous solution of acid or alkali; (c) addition of alginate salt of a monovalent cation under appropriate conditions to form viscous mass; (d) pouring of mass on the surface and distribution of mass to the required thickness; and (e) drying of a mass layer, usually at a temperature from 45 to 70°C, until the residual water content in film is from 5 to 15% by weight and until solid film is formed. The use of alginate as the main film-forming substance provides the possibility of loading therapeutically effective doses of sumatriptan to film, preserving homogeneity and other required physical properties of films.

EFFECT: when administrating the above-mentioned film to the oral cavity, the required level of sumatriptan in the plasma (above 10 ng/ml) is reached during 60 min in most of patients, which provides for a clinical result, which is, in particular, the effective migraine elimination.

21 cl, 13 tbl, 2 ex, 4 dwg