Researches on pharmaceutical development of solid gelatine capsules with dried multiple component extract of antiphlogogenic, diuretic and choleretic action

Abstract

Introduction. Pharmaceutical drug development is based on the selection and study of the drug-comparison, safety and efficacy, taking into account the route of administration, the dosage form, the substantiation of the composition and concentration of the active pharmaceutical ingredient (API) and the excipients, bioavailability, strength and stability; identifying potential critical quality indicators; the choice and proposals of optimal technological scheme for obtaining this drug, the definition of critical operations and parameters of the technological process; definition of strategy of control, development of specifications and methods of control of raw materials, intermediate, non-prepackaged and finished products; the choice of packaging; validation or verification of methods of quality control of a medicinal product; carrying out studies on the stability of the medicinal product during the predicted shelf life. One of the components of the delivery of the API to the site of the pathology is the dosage form of the drug, which significantly influences the preservation of its effectiveness, determining the degree of absorption and concentration in biological fluids. Recently, the attention of developers attracts a dosage form of capsule, which among the dosage forms of industrial production occupies the third place after tablets and solutions in ampoules. They have more advantages (accuracy of dosing, high bioavailability, stability and productivity of obtaining, corrective ability, minimization of production errors, aesthetics, the ability to provide medicinal products with planned properties: the ability to dissolve in certain parts of the gastrointestinal tract, possess prolonged release of the API), sparing technological mode, etc.). The aim of our work was to develop the technology of medicinal product in the form of capsules with an active pharmaceutical ingredient - a dry extract of urocholum, possessing anti-inflammatory, diuretic and choleretic properties, as well as to determine the critical parameters in their production. Material&methods. Pharmaco-technological research methods were applied. Results&discussion. The technological process of production of capsules with a multi-component dry extract consists of the following stages: sifting of raw materials, preparation of mass for encapsulation (mixing of components, rubbing); encapsulation; packing of capsules into blisters; packing blister packs; packing bundles in boxes. On 3 experimental industrial series (0040319, 0050319, 0060319), it was validated by the technological process of producing urocholum capsules and proved its reproduction in industrial conditions. With the help of the Ishikawa diagram, the most significant aspects that influence the technological process and which need to be controlled at the routine production of capsules of urocholum were identified. The design of a technological regulation for the production of gelatinous capsules with a multi-component dry extract possessing anti-inflammatory, bile and diuretic properties was developed and tested in industrial conditions of the LLC DKP "Pharmaceutical Factory", Zhytomyr. Conclusion. 1. Based on the complex of scientific and experimental researches, the optimum technological mode of production of hard gelatinous capsules with a multi-component dry extract with anti-inflammatory, choleretic and diuretic activity was established. 2. The critical stages of the process of gelatinous capsules being developed and the parameters of their control and the criteria of acceptability according to the requirements of the SPHU were determined. 3. Technology has been tested in the conditions of industrial production of LLC DKP "Pharmaceutical Factory", Zhytomyr, in accordance with the project of the technological regulations for the production of gelatin capsules with a multi-component dry extract.