STABILITY STUDY OF A DRUG BASED ON NIFEDIPINE AND SEA BUCKTHORN OIL

Stability research is an integral stage in the pharmaceutical development of a medicinal product, during which the shelf life of a medicinal product is determined, suitable storage conditions are determined, and optimal packaging materials are selected. Stability assessment plays a key role in ensuring the quality, pharmacological activity and safety of a medicinal product. The purpose of this study was to conduct a stability study to obtain data on changes in the quality of the composition of the drug in the form of a gel containing nifedipine and sea buckthorn oil, followed by the establishment of optimal storage conditions. To study the stability of the drug, 3 series of formulations were obtained, which is a pharmaceutical composition containing nifedipine and sea buckthorn oil as active ingredients, dispersed in a mixture of synthetic polymers polyethylene glycol 400 and polyethylene glycol 1500, with the addition of the surfactant twin-20. In an accelerated stability study at a temperature of 40 ± 2 °C and humidity of 75 ± 5 %, deviations in all series of gel samples of the drug were detected at 9 months of storage, at 6 months of storage all samples remained stable. When conducting a long-term stability study at 25 ± 2 °C and relative humidity of 60 ± 5 %, it was found that after 18 months, samples of all series of gel for external use were stable and had no deviations in quality indicators from the developed specification and requirements of the State Pharmacopoeia of the Russian Federation. Based on the data obtained, the optimal temperature regime for storing the drug was selected – no higher than 25 ° C in a dry place protected from light, and the shelf life was calculated to be 2 years. The results of stability studies will be taken into account during the subsequent stages of pharmaceutical development.