FIELD: pharmaceutics.
SUBSTANCE: first invention is a pharmaceutical composition containing benzocaine or its pharmaceutically acceptable salt, an auxiliary agent containing an admixture of reducing sugar and amino acid as a stabilizing agent, in which amino acid is selected from a group consisting of lysin, arginine, asparagine, glutamine or mixtures thereof, while a ratio of the stabilizing agent to a pharmaceutically active agent is from 0.5:1 to 6:1. The second invention relates to a method for producing the specified composition, and the third one relates to the use of amino acid as a stabilizing agent in a pharmaceutical composition for at least sufficient reduction of the Maillard reaction between a nucleophilic amino group of benzocaine or its pharmaceutically acceptable salt and reducing sugar.
EFFECT: group of inventions provides for the solution of the problem of a decrease in the stability of benzocaine compositions due to the Maillard reaction.
10 cl, 3 ex
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Authors
Dates
2021-12-13—Published
2018-11-26—Filed