QUALITY BY DESIGN (QbD) BASED APPROACH FOR DEVELOPMENT OF FAST DISSOLVING TABLETSAbstract
Background: Oral disintegrating tablets are strong dosage forms comprising medications that disintegrate throughout the oral cavity in less than 1 minute. Quality by designis a modern approach to pharmaceutical quality. Pharmaceutical Quality Design and discusses the use of Quality Design to maintain the quality of Pharmaceuticals. Methods: The frequent screening design, such as 32 factorial design, Box-Behnken, placket-Burman, optimization designs, 23 factorial design, and Central composite designs, including analysis of variance, are used. Conclusion: Quality by Design can be used to develop and evaluate methodological methods. Critical analytical variables are defined in an approach that is consistent with the process improvement referred to in ICH Q8 and Q9. This latest quality-by-design mechanism would incentivize even greater regulatory stability in the future. Formulations of Oral disintegration tablets were optimized with the help of quality by design. In the present article, an effort was made to review different screening designs employed in optimization formulations of oral disintegrating tablets.
Bhukya Yamuna, Thadipatri Reshma and Nawaz Mahammed *
Department of Pharmaceutics, Raghavendra Institute of Pharmaceutical Education and Research, K. R. Palli Cross, Anantapur, Andhra Pradesh, India.
18 July 2022
24 September 2022
20 November 2022
01 April 2023