FIELD: chemistry; pharmaceutics.
SUBSTANCE: method of producing floating gastro-retentive controlled release sitagliptin tablets includes producing granules containing sitagliptin phosphate monohydrate, mixing the obtained granules with a sliding substance, pressing the obtained mixture to obtain tablets in the following ratio of components, % of the weight of the tablet: sitagliptin phosphate monohydrate 25.7; cross-linked polyvinylpyrrolidone as a flotation agent, 40-55; hydroxypropylmethylcellulose and/or sodium carboxymethylcellulose as matrix-forming substance 15-30; polyethylene glycol as lubricant 3.3; magnesium stearate as sliding substance 1. To obtain granules, matrix-forming substances, a flotation agent and a lubricant are mixed to obtain a powder mixture, mixing obtained powder mixture with sitagliptin phosphate monohydrate, preparing moisturizing and/or granulating purified water, moistening obtained powder mixture with purified water, the moistened mixture is granulated to obtain granules, the granules are dried, the dried granules are scattered by grinding or sieving through a sieve.
EFFECT: method provides extending the range of agents and methods for preparing the dosage form of sitagliptin phosphate monohydrate, which is a gastro-retentive controlled-release floating tablet.
1 cl, 1 dwg, 3 tbl, 8 ex
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Authors
Dates
2025-03-24—Published
2024-05-22—Filed