PHARMACOCHEMICAL AND TECHNOLOGICAL QUALITY INDICATORS OF THE VETERINARY MEDICINAL PRODUCT BASED ON BIRCH TAR

Abstract

To characterize and determine the quality of the veterinary medicinal drug «Kubazol» (solution for external use, aerosol), which includes birch tar as an active substance and auxiliary substances: ethyl acetate, polybutyl methacrylate, it is important to control the quality of the incoming raw materials and properly manufacture the medicinal product. The purpose of research is the development of a leaflet-tab of a veterinary drug, methods of quality control of the active substance and auxiliary substances of a solution for external use based on birch tar, and the technology of drug production. The veterinary drug «Kubazol» is a viscous liquid from yellow to brown in color with a specific smell of its components. 1 ml of the drug contains: birch tar – 40 mg, auxiliary substances: ethyl acetate, polybutyl methacrylate – up to 1 ml. «Kubazol» is prescribed for the treatment and prevention of lesions of the skin (wounds, dermatitis, eczema), claws (injuries, superficial panaritium), hooves (rot of the hooves, etc.) in dogs, wild pigs, wild birds, sport horses and pigs (boars after castration). The work presents the characteristics of the raw materials of the veterinary medicinal drug «Kubazol» (solution for external use, aerosol), describes the technological features of the manufacture and standardization of the drug based on birch tar, and offers a specification for the active substance and auxiliary substances. The technological scheme for the production of the drug included: preparation of aluminum cylinders, filling with the finished solution, removal of air from the cylinders, fastening of the valve, introduction of the propellant, testing for strength and tightness, drying of the cylinders, pressure testing, installation of the atomizer and checking of the quality of spraying and marking. On the basis of the proposed specification and approaches to laboratory quality control of the solution for external application of an aerosol based on birch tar, production documentation was developed that corresponds to the materials of the registration dossier for the veterinary drug «Kubazol». Test results are properly investigated and documented in accordance with the Standard Operating Procedure (SOP).