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QbD approach of rapid disintegrating tablets incorporating indomethacin solid dispersion
Faculty
Pharmacy
Year:
2011
Type of Publication:
Article
Pages:
219-227
Authors:
Zidan, Ahmed S, Sammour, Omaima A, Hammad, Mohammed A, Mowafy, Ayman G
DOI:
10.3109/10837451003592209
Journal:
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY INFORMA HEALTHCARE
Volume:
16
Research Area:
Pharmacology \& Pharmacy
ISSN
ISI:000290164300004
Keywords :
Indomethacin, polyvinyl pyrrolidone, solid dispersion, rapid disintegrating tablets, factorial design
Abstract:
The development of rapid disintegrating tablets (RDT) requires the use of highly soluble components to support the intended use of these products. In an attempt to prepare RDT of indomethacin, its solid dispersion with polyvinyl pyrrolidone K25 (PVP) was incorporated in a fast disintegrating matrix. Drug polymer interactions were investigated using X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR). Indomethacin 1: 1 solid dispersion with PVP was used to prepare its RDT. Two factors at 3 levels full factorial design were employed as a statistical approach to optimize the amount of superdisintegrant (Ac-di-sol) and hardness value regarding the desired disintegration and release characteristics. Drug to carrier ratio was the controlling factor for dissolution improvement. XRD and FTIR data revealed a remarkable interaction between the drug and the carrier that might be responsible for the dissolution enhancement. Multiple regression analysis revealed a significant effect of the polynomial terms for obtaining rapid disintegrating tablets. It was inferred that the hardness value is the most important factor controlling the disintegration time and the release characteristics. In conclusion, this study demonstrated that quality by design (QbD) is a potential paradigm for understanding the quality and optimizing the formulation of RDT containing indomethacin solid dispersion.
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