IMPLEMENTATION QUALITY BY DESIGN (QBD) CONCEPT IN SOLID ORAL MODIFIED RELEASE GENERIC PRODUCT DEVELOPMENT

• Main Author: Prima Pinastika A., Francisca
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/39910
• Institution: Institut Teknologi Bandung

In Indonesia, pharmaceutical companies need to implement Quality by Design (QbD) concept to develop generic product with systematic system development. PT. Kalbe Farma, Tbk is one of pharmaceutical companies in Indonesia that start implement QbD concept in new generic product development such as for develop solid oral immediate release (IR) dosage form, liquid oral, semisolid, and injection. Implementation QbD concept in new product development with solid oral modified release dosage form need some specific concern. This research is a descriptive type to implement QbD concept for develop new generic solid oral modified release product in PT. Kalbe Farma, Tbk. Desk research results are there are some specific concern in development and research for solid oral modified release generic product. Specific concern that need to study such as system and mechanism release modified release dosage form, bioavailability profile, dissolution profile in some medium. Laboratory research for develop solid oral modified release generic product such as develop predictive discriminative dissolution method, develop In Vitro In Vivo Relationship (IVIVR), and pilot bioequivalence study. A product with 500 mg dosage with extended release dosage form is used to be a model in laboratory research. Study for QbD elements for this research such as Quality Target Product Profile (QTPP), Critical Quality Attribute (CQA), Critical Material Attribute (CMA), and research for specific element for QbD modified release such as develop prototype formula, comparative dissolution test for in vitro study, pilot bioequivalence study for in vivo study, develop predictive discriminative dissolution method, optimation formula, and composing –completing QbD guidance. Results from this research are QbD concept can be implement in new generic product development for solid oral modified release dosage form with some specific concern and this implementation impact is improving existing QbD guidance.