PHARMACEUTICAL DEVELOPMENT OF A MILD DOSAGE FORM – GEL WITH SEROTONIN ADIPINATE

Currently, the field of research on the expansion of the spectrum of pharmacological action and medical use of serotonin adipinate continues to arouse interest in the scientific and industrial field of various profiles. The domestic pharmaceutical industry produces serotonin adipinate in only one dosage form – an injectable solution for intravenous and intramuscular administration, registered as a homeostatic and serotonergic drug. However, in the available scientific literature, there is information about the positive experience of using serotonin adipinate as a wound-healing and improving microcirculatory disorders agent for external use. Therefore, the issue of conducting research in the direction of expanding the range of dosage forms of serotonin adipinate, in particular, for external use, is becoming relevant today. The purpose of this work was to develop a mild dosage form for external use, a gel with serotonin adipinate. With the help of experimentally conducted comprehensive (biopharmaceutical, pharmaceutical-technological, physico-chemical and microbiological) studies, the optimal gel composition was selected: serotonin adipinate and sodium hyaluronate (active ingredients), sodium alginate (gelling agent), glycerin (plasticizer), nipagin (preservative), purified water (solvent). The gel with serotonin adipinate is homogeneous; it is stable from a thermodynamic and microbiological point of view. Due to its structural and mechanical properties, it has all the necessary thixotropic parameters in various temperature measurement modes (production, application, storage). The proposed technological scheme for gel production is easily reproducible in production conditions. The main quality indicators are proposed for the resulting drug: description, authenticity, quantification, microbiological purity and a preliminary shelf life.