Substantiation of the target quality profile and risk assessment in the development of a combined drug for injection

Abstract

Aim. To substantiate the target quality profile for planning the development of a combined drug for injection based on sodium hyaluronate (SH) and dihydroquercetin (DHQ) with an expanded spectrum of the specific activity, as well as to determine the risk factors affecting the quality of the combined drug for injections at the stage of pharmaceuticaldevelopment (PD). Materials and methods. The study objects were the active pharmaceutical ingredients (АРІ) of SH, DHQ and a drug in the form of a solution for injection based on them, as well as potential risk factors affecting the quality of the product. The target product quality profile (QTPP) was developed based on the review and analysis of scientific literature, materials of the State Register of Medicines of Ukraine, pharmacopoeias of the leading countries of the world, articles of scientific publications. The Ishikawa diagram was used to analyze potential risk factors for a drug for injection at the stage of PD. Results and discussion. The application of scientific approaches to the analysis of scientific materials from various information sources on combination therapy with drugs with multidirectional medicinal substances and the availability of information on parenteral medicines (PM) allowed us to plan a QTPP for the development of a combined drug for injection for intradermal administration. In order to identify the most dangerous factors affecting the quality of the drug, the causal analysis of these factors at the PD stage of the combined drug for injection was carried out, and an Ishikawa diagram was constructed. Conclusions. The QTPP has been developed. The expected set of quality indicators that would ideally be achieved to ensure the required quality of the drug has been determined taking into account its safety and efficacy. Based on the risk assessment methodology, the Ishikawa diagram for a combined drug for injection has been constructed; potential risks associated with the quality of active ingredients (AI) and excipients, quality of primary packaging, production conditions, quality control of the drug, the technological process affecting the quality of the combined drug for injection and the causes leading to deviations from these indicators have been identified. This diagram is used as a baseline for the overall assessment of quality risks at the stage of drug development.