Integrating Inverse problem to robust design for a generic drug development process

Truong, Nguyen Khoa Viet; Shin, Sang-Mun; Jeong, Seong-Hoon

Journal of Korean Society for Quality Management > Volume 39(3); 2011 > Article

Journal of Korean Society for Quality Management 2011;39(3): 365-.

역산문제 방법을 적용한 제네릭 의약품 개발 프로세스의 강건 설계

신상문¹, 정성훈²

¹인제대학교 시스템경영공학과
²부산대학교 약학대학

Integrating Inverse problem to robust design for a generic drug development process

Nguyen Khoa Viet Truong¹, Sang-Mun Shin¹, Seong-Hoon Jeong²

¹Department of Systems Management & Engineering, Inje University
²College of Pharmacy, Pusan National University

ABSTRACT

Robust design (RD) has emerged as a key feature in process design and development for more than twenty years. Many researchers and industrial engineers around the world have invested their intensive efforts to develop and apply RD in many fields in order to improve quality of output products. However, there is also room for improvement. The primary objective of this research is to determine "robust formulation" of a medicine by checking its gelation index. In order to achieve this target, based on the nature of problem, at first, a customized experimental format is designed for obtaining data. Second, time-depended responses based models are developed by the proposed inverse problem (IP) methodology. Third, an RD model based on mean square error (MSE) concept is introduced for time-depended responses. Finally, the proposed approach is illustrated by a case study while comparing obtained results to the response surface methodology (RSM) approach.

Key Words: Inverse Problem;Robust Design;Response Surface Methodology;Pharmaceutical Formulation;Mixture Experiment;