FIELD: pharmaceutics.
SUBSTANCE: invention relates to chemical-pharmaceutical industry and represents a method of producing a water-soluble lyophilisate, involving producing a combined solution of an active substance and a compound containing hydroxyl and amino groups (amino alcohol), characterized by that the active substance is 4-((3-oxo-3-ethoxypropanoyl)amino)benzoic acid (EPABA) possessing anti-ischemic and antioxidant activity. Amino alcohol is selected from a group of N-methylglucamine or tris(hydroxymethyl)aminomethane; herewith the said substance and amino alcohol taken in the molar ratio from 1:1 to 1:10 are dissolved in water, the solution is added with an acid agent up to pH 6.8-7.5, neutral solution is filtered, frozen and dried by sublimation.
EFFECT: invention enables to obtain water-soluble stable neutral lyophilisates of EPABA corresponding to process requirements of preparations for parenteral administration.
3 cl, 4 dwg, 4 tbl, 2 ex
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Authors
Dates
2016-11-20—Published
2015-06-22—Filed