Karpenko I. Development of composition and technology of the nasal gel with licorice root extract and essential oils

The thesis presents the results of theoretical and experimental studies on the development of the composition and technology of nasal gel with dry extract of licorice root and essential oils of eucalyptus and Siberian pine for local treatment of infectious-viral rhinitis. Based on the data of microbiological studies, the concentrations of selected APIs in the composition of the medicine have been substantiated. For the first time, the presence of antiviral action of dry extract of licorice root against adenovirus type 3 has been established. The choice of the optimal gelling agent has been made taking into account researches on the study of organoleptic, physicochemical, structural-mechanical and biopharmaceutical parameters of model gel samples. Experimental researches have been conducted to study the effectiveness of the preservative action of model gel samples, which allowed not including additional antimicrobial preservatives in the medicine. It is shown that the technology of the nasal gel should consist of the preparation of the base and the introduction of active substances into it. Taking into account the physicochemical properties of active pharmaceutical ingredients, namely their solubility, dry extract of licorice root has been introduced into the gel in the form of an aqueous solution, and essential oils – in the form of a solution in ethanol. Based on a set of experimental studies, a rational technology of the nasal gel under the conditional name “Phytorin-plus” has been developed. Critical parameters in the process of its production have been established. Scaling of gel production technology in industrial conditions has been carried out, analysis and risk assessment for the quality have been performed. The development of methods for identification and quantification of glycyrrhizin acid of licorice root dry extract in the experimental series of the nasal gel “Phytorin-plus” has been carried out by high performance liquid chromatography. To confirm the presence of essential oils in the gel, their identification and quantification by gas chromatography. The microbiological purity of the medicine was studied. The physicochemical properties of the developed nasal gel were studied and the indicators of its quality were defined: description, identification and quantitative content of active pharmaceutical ingredients, homogeneity, microbiological purity, pH and the mass of the package’s content. The shelf life and storage conditions of the nasal gel have been determined. Based on pre-clinical pharmacological studies, it has been proved that the developed nasal gel has antiviral (against adenovirus) and antimicrobial activity. The novelty of the researches is protected by the patent of Ukraine for a utility model and by the patent of Ukraine for the invention