STUDIES TO DETERMINE SHELF LIFE AND STORAGE CONDITIONS WOUND HEALING GEL WITH CYCVALONE
One of the urgent tasks in the process of drug development is to obtain stable pharmaceutical products in the process of storage and use. To establish the expiration date, it is necessary to determine the time during which the developed drug is able to maintain stability and meet all the requirements stated in the regulatory documentation. The aim of the study was to study the stability of laboratory samples of wound healing gel with cycvalone during long-term storage in natural conditions. The developed composition of the wound healing gel includes the antioxidant agent cycvalone, which has a pronounced manifestation of antioxidant and anti-radical activity, as well as has a wound healing, immunotropic and anti-inflammatory effect. Carbomer (Carbopol-940), potassium hydroxide solution and purified water were used as excipients. Gel samples were stored in the primary packaging at room temperature in a place protected from light. The stability of the dosage form was studied according to the following parameters: description, pH of water extraction, authenticity, colloidal and thermal stability, quantitative determination, rheological parameters in accordance with the developed methods. The measurement was performed on 6 series of dosage forms: after preparation, after 6, 12, 18 and 24 months of storage in vivo. The results of determining the quality indicators of the wound healing gel with an antioxidant agent (cycvalone) indicate a rational selection of active and auxiliary substances and their concentration, the choice of a rational technology and the absence of interaction between the components of the developed dosage form. Based on the conducted studies, it is proved that the wound healing gel with cycvalone remains stable during storage at a temperature of 15 to 25 °Cfor 24 months.