FIELD: medicine.
SUBSTANCE: invention relates to medicine, in particular to a process for the preparation of a solid dosage form of sodium mycophenolate and to an oral solid dosage form for use as an immunosuppressant for treating or preventing rejection of an organ or tissue transplant. Method for preparing preoral solid dosage form with mycophenolic acid or a pharmaceutically acceptable salt thereof comprises the extrusion of a mixture of a pharmaceutically acceptable polymer with an active ingredient with the subsequent addition of auxiliary substances, grinding, pressing and applying an enteric coating.
EFFECT: implementation of the invention makes it possible to create a more convenient solid dosage form of mycophenolic acid without the use of organic solvents and a reduced process, without using a granulation step.
20 cl, 2 dwg, 13 ex
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Authors
Dates
2018-10-23—Published
2016-11-17—Filed