FIELD: medicine; pharmaceutics.
SUBSTANCE: invention refers to pharmaceutics, namely to a pharmaceutical single composition of acotiamide in a single dosage form and to the use of said composition. Pharmaceutical single composition of acotiamide in a single dosage form containing: i) a composition of acotiamide or its pharmaceutically acceptable salts in the form of a plurality of particles with sustained release, at least one diluent selected from the group consisting of lactose, microcrystalline cellulose or combinations thereof, one or more rate-controlling polymers selected from the group consisting of methylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, hydroxypropyl cellulose, hydroxyethylmethyl cellulose, carboxymethyl cellulose, polymethacrylates or combinations thereof, in the intragranular material and a lubricant in the extragranular material; ii) a composition of acotiamide or its pharmaceutically acceptable salts in the form of multiple particles with immediate release, in which the total dose of acotiamide or its pharmaceutically acceptable salts in a single composition is 300 mg, and wherein acotiamide or pharmaceutically acceptable salts thereof are present in an amount of more than 60% by weight of the entire single composition. Use of said composition for treating and/or inhibiting the development of functional dyspepsia, a feeling of fullness in the stomach after meals with functional dyspepsia, upper gastric distention, gastroesophageal reflux disease and other upper gastrointestinal problems or disorders.
EFFECT: invention enables to satisfy the need for a stable composition of acotiamide, which is easy to take.
7 cl, 1 dwg, 8 tbl, 7 ex
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Authors
Dates
2024-06-10—Published
2019-11-20—Filed