QbD 접근법을 이용한 트리메부틴말레인산염 정제의 타정 공정 개발

초록

This study aimed to devise a model for the QbD-based development of a trimebutine maleate tablet compression process. The development was conducted in five steps in accordance with ICH guidelines Q8, Q9, and Q10. The first step was to establish a Quality Target Product Profile (QTPP). The second was to determine the raw material composition of the 250 mg tablets and establish a mixing process, involving granulation, drying, sizing, and lubrication, for trimebutine maleate and the excipients. The third step was to decide on the Critical Quality Attributes (CQAs) of the tablets produced. The fourth step involved determining the effects of process compression parameters (force, speed, and time) on the CQAs through Risk Assessment (RA) - compression force and speed were identified as Critical Process Parameters (CPPs). Finally, a control strategy was established based on the results obtained. This model provides a practical framework for implementing QbD principles in tablet compression processes and can serve as a reference for future Korean regulations.

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