Technological aspects of the “Probioskin” emulgel development

Abstract

Aim. To develop a rational technology of a new semisolid preparation for skin application with a probiotic component in the form of an emulgel under the conditional name “Probioskin”. Materials and methods. When developing the technology the study objects were emulgel samples with selected substances – a lyophilized biomass of lactobacilli, dexpanthenol, lactic acid, and excipients – Aristoflex AVC gelling agent, propylene glycol, polysorbate-80, tocopherol, peach oil. To control the quality of the samples, the requirements of the monograph of the SPhU 2.4 on dosage forms “Semi-solid preparations for dermal use” and the general monograph of the SPhU 2.5 “Viable biotherapeutic drugs for human use” were observed. Results and discussion. The process of production of the “Probioskin” drug developed is carried out in the premises of purity class C according to the standard flowchart: the stage of auxiliary works, the stage of the main technological process, the stage of packaging, labeling and shipment of the finished product. The sequence of the technological stages in accordance with the technology of production of a semisolid preparation for skin application – the “Probioskin” emulgel consists of 8 stages: preparation of the raw material, preparation of an oil concentrate of a probiotic component, preparation of an aqueous concentrate of active substances, preparation of a gel base, preparation of an emulsion, packaging of tubes in packs, packaging of packs in group container. The specification for the “Probioskin” drug includes the following sections: “Description”, “Identification”, “pH”, “Uniformity”, “Mass of packaging contents”, “Microbiologicalpurity”, “Assay”. The results of control of the finished product meet the requirements of the MQC. Conclusions. Based on the complex of physicochemical, microbiological, biopharmaceutical, technological, rheological studies, a rational technology of a semisolid preparation for skin application under the conditional name “Probioskin”in the form of an emulgel has been developed. The indicators of quality, permissible norms, methods of control and critical parameters of production of the product developed have been determined.