FIELD: medicine; chemical and pharmaceutical industry.
SUBSTANCE: group of inventions relates to the field of medicine and the chemical and pharmaceutical industry and pertains to a preparation for treating anemia associated with a chronic renal disease, based on roxadustat. The preparation is made in form of tablets. A tablet consists of a core including roxadustat and excipients, and a film shell. The core comprises lactose monohydrate, Comprecel, sodium croscarmellose, starch, colloidal anhydrous silicon dioxide, Kollidon 25, and pharmaceutically acceptable salts of stearic acid in wt.% quantities specified in the claim of the invention, as excipients. AquaPolish® P. is used as a film shell. The invention also relates to a method for producing the preparation. Roxadustat concentrate is preliminarily obtained by adding ground lactose monohydrate to the substance at a mass ratio of 1:4 to 1:5. The resulting concentrate is then ground, the remaining lactose monohydrate, Comprecel, sodium croscarmellose, starch, colloidal silicon dioxide, Povidone are added to the resulting mixture and mixed to homogeneity. The resulting mixture is powdered with a pharmaceutically acceptable salt of stearic acid, pressed, followed by applying a film shell constituting 4.5 to 5.0% of the total mass of the preparation to the resulting tablet core by spraying an aqueous suspension of AquaPolish® P. at the final stages, drying and cooling.
EFFECT: group of inventions provides a possibility to produce a medicinal form stable to the impact of external environmental factors and to improve the technological characteristics for production thereof.
2 cl, 1 tbl, 4 ex
