STUDY OF THE INFLUENCE OF EXCIPIENTS ON THE QUALITY INDICATORS OF ANTI-DIABETIC DRUG IN THE FORM OF TABLETS

Abstract

The aim of the work is the selection of auxiliary substances, the study of their influence on the pharmaco-technological indicators of the tablet mass and tablets of the antidiabetic medicinal product.

Materials and Methods. Auxiliary substances from the groups of fillers, disintegrants and lubricants, as well as magnesium stearate as a lubricant, were used in the experiments. The research was carried out on modern equipment for determining: a tablet press (Korsh XL-100, Germany);  the bulk density (ERWEKA SVM 202, Germany); the fluidity of powders (ERWEKA GT, Germany); resistance to crushing (ERWEKA TBH-525 WTO, Germany); abrasion resistance (ERWEKA TAR 200, Germany); decay (ERWEKA ZT 33, Germany). The active substance of the tablets of the antidiabetic drug is a pharmaceutically acceptable form based on the content of dapagliflozin 5 mg. The experimental data were subjected to statistical processing by the method of variance analysis. The desirability function is constructed.

Results and Discussion. According to the results of statistical processing of experimental data, the effect of excipients on the pharmaco-technological parameters of the tablet mass (bulk density, density after compaction, fluidity, slope angle), the tableting process and tablets (appearance, resistance to crushing, abrasion and disintegration) was investigated. Using the desirability function, the influence of the researched factors on the generalized quality indicators is shown.

Conclusions. The influence of excipients from the groups of fillers, disintegrants and glidants on the pharmaco-technological parameters of the tablet mass and tablets of the antidiabetic medicinal product with API – a pharmaceutically acceptable form of dapagliflozin – was studied. According to the results of dispersion analysis, ranked series of advantages were constructed. Using the desirability function, the conducted research allowed us to establish that the model compositions: a mixture of microcrystalline cellulose brand 102 with anhydrous lactose brand 22 AN in a ratio of 3:1, crospovidone XL-10 and silicon dioxide colloidal anhydrous (aerosil 200) and a mixture of microcrystalline cellulose brand 102 with anhydrous lactose brand 22 AN in a ratio of 3:1, sodium starch glycolate and PEG 8000 provide better indicators of fluidity, compressibility and quality of model tablet mass compositions and finished tablets.