РАЗРАБОТКА СОСТАВА И ТЕХНОЛОГИИ КАПСУЛЬНОЙ МАССЫ БИОФАРМАЦЕВТИЧЕСКОЙ КОМПОЗИЦИИ С ПРИМЕНЕНИЕМ МЕТОДА МАТЕМАТИЧЕСКОГО ПЛАНИРОВАНИЯ ЭКСПЕРИМЕНТА

Abstract

The presented article demonstrates the application of the method of mathematical design of the experiment (MPE) in the development of the composition of the lyophilized capsule mass of a biopharmaceutical composition with antimicrobial and probiotic effects. The factors of the technological process that affect the quality indicators of the capsule mass of the biopharmaceutical composition were studied: carriers for immobilization, gastro-resistant formers, antifriction substances. The work studied the bacteriotropic properties of the lyophilized capsule mass of the biopharmaceutical composition, which include antimicrobial activity, gastric resistance, probiotic activity, as well as technological properties such as disintegration and residual moisture. Particularly important for the lyophilized capsule mass of the biopharmaceutical composition are the indicators of antimicrobial and probiotic activity, since they determine the therapeutic orientation of the composition, and the study of such indicators of the capsule mass as gastric resistance and disintegration are among the most critical properties, since the composition contains a bacteriophage, labile to the action of acids and, accordingly, to ensure the preservation of the bacteriotropic properties of the biopharmaceutical composition, the central task was to create a protective shell, in this regard, the method of introducing excipients is a key factor. Residual moisture for lyophilized capsule mass has a major impact on the stability of the pharmaceutical substance during storage, in connection with this, this indicator was studied in this experiment. Achieving all acceptable values for creating a gastro-resistant composition is based on the correct selection of the formulation. Based on the data obtained, partial and generalized Harrington desirability functions were calculated. In conclusion, a conclusion was made about the most acceptable model composition and the optimal technology for manufacturing the capsule mass of the biopharmaceutical composition.