FIELD: pharmaceuticals.
SUBSTANCE: invention relates to the chemical-pharmaceutical industry and is a process for the preparation of a pharmaceutical preparation glatiramer acetate and mannitol in a suitable container, comprising the steps of: (i) preparing an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering this aqueous pharmaceutical solution at a temperature ranging from above 0 °C to 17.5 °C, to obtain a filtrate; and (iii) filling a suitable container with a filtrate obtained after carrying out step (ii), so as to obtain a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container.
EFFECT: invention makes it possible to improve the method for producing glatiramer acetate drug products by improving the filtration process.
29 cl, 11 dwg, 7 tbl, 11 ex
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