The substantiation of the composition and technology of obtaining a microemulsion in laboratory conditions for pediatric use

Abstract

Aim. To substantiate the composition and parameters of the technological process of obtaining a microemulsion with the essential oil of common fennel fruit for pediatric use. Materials and methods. The study objects were experimental samples of an emulsion with fennel essential oil (active pharmaceutical ingredient), acacia, xanthan and guar gums, soy lecithin, PEG-40 hydrogenated castor oil, PEG-100 stearate, glycerin monostearate, polysorbate-80 (emulsifiers) and purified water. Information-search, information-analytical, organoleptic, physicochemical, rheological and pharmacotechnological research methods were used. The rheological parameters were determined on a “Reotest-2” rotary viscometer (Germany) with coaxial cylinders, pH was measured potentiometrically on a pH‒150 MI pH-meter (Khimtest Ukraine+), thermal stability was determined in a SP50 drying cabinet. The microscopic studies of experimental emulsion samples were carried out using a Granum microscope with a Toupcam UCMOS video camera. The statistical processing of the data obtained was performed using Microsoft Excel 2007 spreadsheets. Results and discussion. The composition and technology of obtaining a microemulsion with the essential oil of fennel fruit in the conditions of a pharmacy for pediatric use were experimentally substantiated. The technological process consisted of the following stages: preparatory work, weighing of ingredients, mixing of ingredients, packaging, and registration of the drug for dispensing. The drug was manufactured in aseptic conditions. Standardization of the drug obtained was carried out: description, thermal and colloidal stability, pH value, viscosity, uniformity of the mass of doses extracted from multi-dose containers, mass of the contents of the container. The presence of anethole and terpenoids was proven by TLC method. Conclusions. At the current level of development of the pharmaceutical industry, the improvement of providing consumers with high-quality medicines is implemented by choosing the optimal dosage form, the composition of excipients, rational technology, and the use of modern equipment.