QbD Approach in Formulation Design and Evaluation of Metformin HCl Tablet
Journal: International Journal of Pharmaceutical Sciences and Medicine (IJPSM) (Vol.7, No. 9)Publication Date: 2022-09-30
Authors : Ravi Waman; Gaurav Jain; Jeevan Patel; Ramakant Sharma; Shabnam Khan; Rakesh Patel;
Page : 27-58
Keywords : Quality by design; Metformin; Direct compression technique;
Abstract
This study reports the QbD Approach in Formulation Design and Evaluation of Metformin HCl Tablet. The concept of quality by design (QbD) has recently gained importance by application of design of experiments approach (DoE). QbD describes a pharmaceutical development approach especially in formulation design & development and manufacturing processes for the purpose of maintaining and improving the product quality. There are various elements of QbD are there such as Quality Target Product Profile (QTPP) ,Critical Quality Attributes (CQAS), Quality Risk (Assessment) Management (QRM), Design Space etc. The present work is aimed in the application of quality by design (QbD) concept especially Target Product profile in the formulation development of metformin tablet.
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