FORMULATION POSSESSING MODULATORY ACTIVITY WITH ADEQUATE EFFECT, PHARMACEUTICAL SUBSTANCE (VERSIONS), USE OF PHARMACEUTICAL SUBSTANCE, PHARMACEUTICAL AND PARAPHARMACEUTICAL COMPOSITION (VERSIONS), METHOD FOR PREPARING PHARMACEUTICAL FORMULATIONS

摘要

FIELD: medicine.SUBSTANCE: invention refers to a formulation of (RS)-2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide possessing modulatory activity with an adequate effect, to a pharmaceutical substance of (RS)-2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide containing: 2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide - min. 99.0% and max. 100.5% at a dry substance; individual accompanying impurities, either single or total - max. 0.2%; the residual quantities of organic solvents, either single or total - max. 3000 ppm. The invention also refers to a method for preparing a pharmaceutical substance differing by the fact that the raw material is purified, crystallised, stabilised by treating the formulation in demineralised water that is followed by isothermal crystallisation from propanol, and drying. The invention also refers to compositions for internal and external application.EFFECT: invention provides higher efficacy, safety, stability and width of therapeutic application.55 cl, 3 dwg, 80 tbl, 27 ex