Quality by design assisted rectification of technology transfer issue for tablet dosage form

Abstract

quotAbstract newline newlineQuality by Design Assisted Rectification of Technology Transfer Issue for Tablet Dosage Form newline newlineSubmitted by: ASHISH KUMAR MISRA newlineResearch Scholar, Pharmaceutics, newlineSchool of Pharmacy, R.K. University newlineSupervised By: Dr. DHARMIK MEHTA, newlineProfessor, School of Pharmacy, R.K. University newline newlineKeywords: QbD, Tablets, Mixing, Granulation, Compression, Risk free Manufacturing newlineBackground: Development of tablet dosage forms involves multiples steps. The successful outcome of this individual step depends on the characteristics of powder as well as processing parameters. Performing the steps in the range of optimized conditions makes manufacturing of tablets easy and robust. Application of various QbD and DoE tools assist into outline risk free control strategy of manufacturing of tablets. newlineAim: The aim of present study was to address the issues raised in tablet manufacturing and to rectify the same by using QbD principles. newlineMaterials and Methods: newlineOral dosage form is a maximally prescribed formulation amongst all possible pharmaceutical products. Formulation of tablet is multistep process where each step has meaningful effect on quality of final product. The concept of QbD was employed on various critical unit operations of tablet such as blending, granulation and compression. The processes were started with identification of QTPP and CQAs. In risk estimation matrix various independent factors were finalized having impact on CQAs of critical steps. Placket barman and other important design of experiments were employed to relate independent variables and responses. newlineResults and Discussion: Paracetamol drug was used as a model drug in the proposed study. Robust analytical method was developed for estimation of PCM in bulk and formulation. QTPP and relevant CQAs were judiciously selected for critical steps. The interpretation of various contour plots and response surface plots assisted in selection of optimized range. The developed MLR models were accurate which were further validated by check point batches. The %PE values we