AN UPDATED RISK ASSESSMENT AS PART OF THE QBD-BASED ORALLY DISINTEGRATING TABLET DESIGN AND DEVELOPMENT
AbstractIn this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters. Direct compression method was applied for the preparation of ODT containing Brivaracetam using 22 factorial designs with the quantity of drug, pharmabust 500 and crosspovidone as independent variables. Pharmabust 500 and crosspovidone were used as Superdisintegrants. Design Expert 11.0 described adequately impact of selected variables as dependent (pharmabust 500 and crosspovidone) at various levels for response under study (DT and Drug Release at 2 min). Further Optimization of formulation was done using Factorial design (2 factor 2 levels) and established control strategy and design space of the formulation. Design validation was done and final optimized batch P7 was chosen from the design space. The final formulation P7 was tested for Accelerated Stability Studies for 1 month and found stable. As per the results obtained from the experiments, it can be concluded that QbD is an effective and efficient approach for developing quality into ODT with the application of QTPP, risk assessment and critical quality attributes (CQA).
Article Information
41
3550-3558
827 KB
403
English
IJPSR
Kinjal Solanki *, Archana Pillai, Ajaysinh Parmar and Sandip Dholakia
Department of Pharmaceutics, Shankersinh Vaghela Bapu Institute of Pharmacy, Vasan, Gandhinagar, Gujarat, India.
solanki@bapugkv.ac.in
05 November 2022
19 December 2022
01 May 2023
10.13040/IJPSR.0975-8232.14(7).3550-58
01 July 2023
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