Technologies and Engineering

Development of approaches to the formation of the strategy for control of transdermal therapeutic systems

Purpose. Development of a set of control parameters that are necessary for the formation of a control strategy for drugs related to transdermal therapeutic systems (TTS). Methodology. The complex of control parameters for the transdermal therapeutic systems was developed using the methodology of risk assessment. This includes the identification, analysis of risks associated with the mechanism of release of active pharmaceutical ingredients (APIs) from the dosage form, the penetration of APIs through the skin, taking into account the physical and chemical properties of APIs and polymeric materials. Findings. There were developed approaches to the formation of a drug quality control strategy in the form of transdermal therapeutic systems. They are based on a risk assessment that includes monitoring the physical and chemical characteristics of pharmaceutical ingredients, polymer materials and components for the formation of transdermal therapeutic systems, critical parameters in the production process, specifications for finished products, as well as the application of appropriate techniques and the frequency of monitoring and control. Originality. A set of control parameters for the formation of the quality control strategy was proposed for the transdermal therapeutic systems. Practical value. Approaches to the formation of the transdermal therapeutic systems control strategy can be used in the pharmaceutical development of the transdermal therapeutic systems, the implementation of the technological process, quality control and the determination of stability. This will reliably guarantee the quality of drugs during their life cycle

transdermal therapeutic systems, ТТS, strategy for control, medicines, risk assessment, polymers, quality control