Using Quality by Design to Develop Fixed-Dose Combination Tablets

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In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 2³ factorial design. Precompression and post-compression parameters were determined indicating excellent flow properties of granules as well as good tableting characteristics of the final tablets. Dissolution study showed higher drug release nearly 80% within 30 min for all prepared batches attributed to conversion from crystalline to amorphous form of the drug. ANOVA studies revealed that there was a linear correlation between the predicted, and the observed responses gave higher values of r², indicating excellent fitting of the model (P < 0.001). Thus, the prepared FDC tablet executed a good relationship between selected critical formulation parameters and critical quality attributes. The drug release rate obtained met the selected dissolution criteria.

Peer-Reviewed

Submitted: August 5, 2020.
Accepted: October 12, 2020.

About the authors

Rajendra Kotadiya,* rajendrakotadiya.ph@charusat.ac.in; +91 8160701232, is assistant professor, Krunal Jasani is PG student, and Gayatri Patel is professor, all at Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), Changa, Gujarat, India.

*To whom all correspondence should be addressed.

Article details

Pharmaceutical Technology
Vol. 45, No. 6
June 2021
Pages: 34-42

Citation

When referring to this article, please cite it as Rajendra Kotadiya, Krunal Jasani, and Gayatri Patel, “Using Quality by Design to Develop Fixed-Dose Combination Tablets,” Pharmaceutical Technology 45 (6) 2021.