DEVELOPMENT OF APPROACHES TO THE FORMATION OF THE STRATEGY FOR CONTROL OF TRANSDERMAL THERAPEUTIC SYSTEMS

Abstract

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). 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.