ABSTRACT:
The therapeutic activity of suppositories is influenced by a large number of factors, for example, the solubility of the drug substance in the base, molecular size, ability to penetrate the membrane, particle size, interaction with the base and excipients, as well as surfactant concentration. These circumstances necessitate the search for optimal compositions and preparation methods in order to increase the effectiveness of the drugs. In order to develop optimal suppository technology, it was necessary to study the influence of a number of technological factors on the quality of the developed dosage form: temperature conditions at the stages of preparing the suppository mass and bottling it into blister packaging; speed and duration of homogenization of components, as well as experimentally determine consumption coefficients and carry out appropriate technological calculations. Based on this, we set the task of theoretically and experimentally substantiating the composition and developing the technology of suppositories using carbon dioxide extract isolated from the herb rosemary. The main technological parameters were theoretically and experimentally substantiated: temperature, stirrer speed, homogenization duration at the stages of preparation of the concentrate and suppository mass, cooling mode of molded suppositories. As a result of the research, a technology for the production of suppositories with CO2 - rosemary extract and methods for quality control of the drug, included in the normative document, was developed. It was shown that the suppositories meet all the requirements of the State Pharmacopoeia of the Republic of Kazakhstan and remain stable over a 12-month observation period.