Okseniuk O. Development of the composition and technology of antiseptic agents for the treatment of mycoses and skin lesions

The thesis is devoted to the development of the composition and technology of liquid medicines (LM) based on the propolis tincture and synthetic compounds under the conditional name “Propolis–Derma” with the antifungal, antimicrobial and keratolytic action in the form of vials-pencils (markers) for the local treatment of mycoses and other fungal skin lesions. The analysis of the market range of antifungal drugs presented at the pharmaceutical market of Ukraine for the treatment of dermatological skin diseases, in particular dermatomycoses, has been performed. The limited range of medicines with the complex action registered in Ukraine and recommended for the treatment of dermatomycoses has been shown. According to the results of the screening of the ATC classification group conducted it has been found that the medicines studied belong to the group “D – Dermatologicals”, in particular “D01A – Antifungals for local dermatological use” with subgroups and “D01A E – Other antifungals for local use”. It indicates the prospects of using a broad-spectrum active pharmaceutical ingredient (API) to create complex medicines for the treatment of dermatomycoses. Based on the physical and chemical studies conducted, the quality control methods (QCM) of pharmaceutical compositions – “Propolis-PSCh”, “Propolis–PChD” and “Propolis–PNH” have been developed. According to them, their stability has been confirmed, and the shelf life of the medicines developed has been determined; it is 24 months when storing at a temperature of 15-25 °С. For the first time, based on the pharmacoeconomical, physical, physicochemical, microbiological and pharmacological studies, as well as taking into account biomedical requirements, the composition has been substantiated, and the rational technology of production of new medicines – “Propolis-Derma” with the propolis tincture and synthetic compounds in industrial and pharmacy conditions has been developed. The critical parameters of the technological process that affect the drug quality (temperature, speed of the stirrer, mixing time, etc.) have been determined; the methods for identification and quantitative determination of API have been developed. The validation of analytical methods has been performed; the stability has been proven; the storage conditions providing the constancy of their composition and properties throughout the shelf life specified in the QCM project have been determined (sole proprietor “Lenchin V. M.”, Kharkiv). Based on the results obtained the information letter on the technology of preparing “Propolis-Derma” medicines in pharmacies and the projects of master production instructions for their industrial manufacture have been compiled and published. The pharmacological and microbiological studies have found the presence of the antifungal, antimicrobial and keratolytic activity of the medicines “Propolis-Derma”. The novelty of the research has been confirmed by 3 patents of Ukraine for invention and the utility model.