The quality assurance of the medicinal composition using the “Antimicrobial activity” indicator

Abstract

The aim of the work is to determine the spectrum and strenght of antimicrobial activity of the studied compositions, to compare them with the activity of substancesand to select the most optimal concentration for further combination with each other. Topicality. Nowadays, one of the most common skin diseases is acne and demodicosis, the manifestations of which can be mild (comedones in seborrheic areas), more noticeable (papules-pustular rash) and severe (large cyanotic infiltrative elements in the back, prone to abscessing and scarring). The prevalence of acne and demodicosis currently reaches 90%. With these skin pathologies, it is desirable to use safe and effective drugs for external therapy, which provide rapid improvement of the skin (reduction of inflammation without side effects) to obtain a rapid and high-quality therapeutic effect. In the course of our research, we selected 3 active pharmaceutical ingredients (APIs): metronidazole, benzyl benzoate and benzoyl peroxide - according to the purpose of ICD-10 and their effectiveness in these pathologies. Mild medicines have an advantage over dermatological diseases such as acne and demodicosis because the use of soft medicines is local, namely a targeted effect on the microbial microflora. At present for production of soft medicines for local application such substances as macromolecular compounds are widely used, plasticizers, surfactants,etc. When creating a drug composition, a study was conducted aimed at obtaining soft medicines with certain consumer properties, in particular physicochemical (pH, osmotic activity, homogeneity,etc.) , physical and mechanical properties (rheological parameters). Materials for the study – soft medicines based on cetyl alcohol, Emulgade Sucro Plus, Polyvinylpyrrolidone, Carboxymethylcellulose, Tween 80, Triethanolamine, Propylene glycol, vaseline oil, which as (API) contains metronidazole, benzoyl peroxide, benzylbenzene. The specific antimicrobial activity of the samples was tested in accordance with Order № 167 of the Ministry of Health of Ukraine dated 05.04.2007 by the standard macromethod of serial dilutions in liquid nutrient medium and by the method of diffusion into agar. The minimum inhibitory concentration (MIC) of API (substrates) was determined. Results. The studied compositions of soft medicines and substrates revealed to presence of antibacterial (bacteriostatic) action against the test strains of microorganisms. Conclusions. The test of the compositions of soft medicines and the substance revealed the presence of a slight antibacterial (bacteriostatic) effect against the test strains of microorganisms. Key words: antimicrobial activity; active pharmaceutical ingredients (API); excipients; soft dosage form