Resnytskyi I. Technology development of polymeric composite materials with controlled release of antiseptic substances

The dissertation is devoted to solving the problem of creating a technology for producing a polymer composite material on modified starch, which will provide the development of new antiseptic compositions for transdermal therapeutic systems. The relationship between the composition and rheological, physicochemical and physico-mechanical characteristics of polymer composite materials in the form of films with controlled release of antiseptic substances has been studied. The pattern of regulation of release rate of API from the composition of the polymer composite depending on the chemical structure and proportion of components were established. Technological approaches to the creation of a film based on a polymer composite material with controlled release of antiseptic substances are shown. The dissertation solves an important scientific and technical problem, which related with the scientific substantiation of the composition, method of production and technological process of obtaining polymer compositions based on modified starch for use in polymeric composite materials in the form of films with controlled release of antiseptic substances. The proposed technology is socially oriented and environmentally friendly. The expediency and possibility of using the developed polymer composite materials in the form of films with controlled release of antiseptic substances for use in transdermal therapeutic systems are theoretically substantiated. It was first discovered that PVA/starch (50:50), PVA/starch (75:25), PVA/Na-CMS (50:50) have the highest degree of thixotropic viscosity recovery at 99%. It is shown that Na-CMS /PVA (25:75) is the best composition of the polymer composite material with modified starch and decamethoxine in terms of water resistance. It was found that increasing the percentage of PVA has a positive effect on the physical and mechanical qualities of the polymer composite material in the form of a film, and the addition of the antiseptic substance decamethoxine partially reduces indicators of samples for breaking load and restorative stretching. The formation of stable complexes of Na-CMS/PVA, Na-CMS/Alginate, Na-CMS /Gelatin (polymer-API) was established mainly due to hydrogen bonds, which will affect the stability of the polymer composite material in the water environment and the kinetics of API release from it. It was first discovered that the maximum release rate of decamethoxine from the polymer composite material with a content of 5% API at the level of the rate constant of the first order of 0.0076 1/min is characteristic of the polymer composite PVA/Na-CMS in a ratio of 3:1. This value exceeds the value of the relevant rate constants for other investigated polymer compositions in 3-7 times. It was first shown that behind the values of the release rate constants of the antiseptic decamethoxine from the polymer film PVA/Na-CMS for compositions with a ratio of 75:25 and 50:50 is a stable release of API. When increasing the content of Na-CMS over 50 wt.h. the value of the rate constant of decamethoxine release decreases. This shows that the increase in the amount of Na-CMS in the composition can be used to prolong the release time of decamethoxine from the polymer film. It is shown that the best composition of the polymer composite material with modified starch and decamethoxine in terms of water resistance - Na- CMS/ PVA (25:75). It was found that the increase in the percentage of PVA has a positive effect on the physical and mechanical properties of the polymer composite material in the form of a film, and the addition of the antiseptic substance decamethoxine partially reduces the samples for tensile load and elongation at break. According to the results of microbiological studies, it is concluded that the proposed parts of polymer compositions with using modified polysaccharides and with the addition of decamethoxine provide antifungal pharmacological properties of the polymer composite material. The bactericidal effect of samples based on Na-CMC and etonia on gram-positive (Bacillus subtilis, Staphilococus aureus) bacteria and bacteriostatic - on gram-negative (Esheriehia coli) bacteria. The technological scheme of obtaining a polymer composite material in the form of a film by irrigation method has been developed and implemented in laboratory research and industrial conditions. This will accelerate the development of new transdermal therapeutic systems with controlled release of antiseptic substances, reduce their cost and final price for the Ukrainian consumer, expand the range of available drugs and medical devices for the treatment of dermatological diseases