Background: This work was conducted in the framework of quality by design project involving the production of a pharmaceutical gel. Preliminary work included the identification of the quality target product profiles from historical values for previously laboratory batches, which were used to construct a D-optimal experimental design. Fungal disease of mycoses has long been known, since the days of antiquity. Our research gel high pharmacological effect (antifungal) in comparison with the drugs Flucytosine and Fucis.
Aims and Objectives: The purpose of this study is to develop the optimal composition and rational gel technology under the conventional name Antiсandid on the basis of the substance piperidinylethanone with an antifungal effect.
Materials and Methods: Thermogravimetric analysis and rotational viscometry, which affect the process of the formation of carbopol, were taken. Based on the physicochemical properties and technological properties of the gel, an optimal solvent system is selected that corresponds to the maximum solubility of the drug substances and ensures polymer swelling. At the same time, the materials dimexide (DMSO), propylene glycol (PG), carbol-floor, and triethanol were taken into account, which improve the process of solubility and gelling.
Results: The results were obtained, which, when the active substance is administered in the dissolved state, is the most therapeutic effect on the gel base. At the same time, active pharmaceutical ingredients (APIs) were dissolved in different solvents with gradual heating. The ratio of solvents DMSO-PG-water (1:4:1) at which the developed dosage form will be more structured, stable, and thixotropic is established.
Conclusion: Fungal skin diseases are one of the most frequently discussed problems in various dermatological forums and in the pages of scientific journals. The relevance of this topic is determined by the high prevalence of this pathology, which, according to the literature, accounts for 37-42% of all skin diseases. The results of the studies on the study of the microbiological, physicochemical properties of APIs, and carbopol Ultrez 20 for the development of optimal composition are taken into account. It was found that the gel model with an active substance content of 3% is more effective and has high antifungal activity.
Key words: Optimal Formulation; Efficient Technology; Antifungal Action; Gel; Active Pharmaceutical Ingredient; A Substance Derived 4H-pyrido [4,3:5,6]pyrano[2,3-d]pyrimidine
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