The choice of the optimal moisturizer in the development of the composition and technology of capsules with nifuroxazide
Keywords:capsules, nifuroxazide, moisturizer, excipients, composition, technology, quality indicators
Aim. To choose the optimal moisturizer and its concentration to obtain the granulate with the necessary technological parameters and high-quality capsules with nifuroxazide.
Materials and methods. The objects of the study were the substance of nifuroxazide by “SP QUIMICA” company, Spain, moisturizing agents: 15 % aqueous and alcoholic solutions of polyvinylpyrrolidone (PVP) of K-25 brand, 15 % aqueous solution of PVP of K-29/32 brand, 10 % corn paste, 64 % sugar syrup, 14 % aqueous solution of PVP of K-17 brand, the mass for encapsulation and capsules obtained from them. The following quality indicators were studied: description, average mass, mass homogeneity, uniformity of dosage units, disintegration, flowability, bulk density, fractional composition, dissolution, admixture A and related impurities, the quantitative content of nifuroxazide. The following methods were used: liquid chromatography method (SPhU, 2.2.29), absorption spectrophotometry method in the ultraviolet region (SPhU, 2.2.25).
Results and discussion. The effect of the type and concentration of binders and other excipients on the physicochemical, pharmacotechnological properties of the masses for encapsulation, the quality indicators of the capsules and the “Dissolution” test in the borate buffer solution with pH 10.0 have been studied.The dependence of the quality of the finished product on the nature of the moisturizing agents introduced has been determined. It has been shown that the optimal moisturizer is 14 % aqueous solution of PVP of K-17 brand. The ptimal amounts of excipients for obtaining a stable drug have been determined. The capsules developed are equivalent to the reference drug Enterofuril capsules, 200 mg, manufactured by Bosnalijek, Bosnia and Herzegovina by their functional characteristics.
Conclusions. Based on the pharmacotechnological studies conducted and the analysis of the quality of the capsules obtained the compositions of excipients and moisturizer, as well as the method of obtaining the capsule mass, were selected. The study conducted is the necessary part of the pharmaceutical development (PD) of the drug when substantiating its composition and technology. A promising direction for further research is conducting further stages of PD, as well as the completion of section 3.2.P.2.3 “Development of the production process” of the Common Technical Documentation (CTD) format registration dossier.
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