Comparison of Dissolution profile for Immediate-Release Dosage form for US and Europe

  • Shivam Kanojiya
  • Neel Patel
  • Ravish J. Patel
  • Amit Patel Ramanbhai Patel College of Pharmacy, CHARUSAT, Changa

Abstract

Any oral medication product control strategy must include the creation of a dissolve method with appropriate specifications. In the creation of drug, dissolution testing is critical IV approach. In some cases, an IV dissolution test can be used instead of an in vivo dissolution test. As a result, regulatory agencies have formally acknowledged in vitro methods to determine the dissolution frequency of API from the solid oral form as a significant factor when manufacturing solid-oral-dosage forms. Dissolution tests have long been acknowledged as critical quality-control tools for ensuring batch-to-batch consistency. Following post-approval changes to pharmaceutical products, dissolution testing is also important in providing quality information of the product.

Keywords: Comparative dissolution profile (CDP), f1 and f2 factor, Office of Generic Drugs (OGD), Vitro/In-Vivo Correlations (IVIVC), European Medicines Agency (EMA), Scale up and post approval change (SUPAC), BCS Based Biowaiver, EMA, Dissolution

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References

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How to Cite
Kanojiya, S., N. Patel, R. J. Patel, and A. Patel. “Comparison of Dissolution Profile for Immediate-Release Dosage Form for US and Europe”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 2, June 2022, pp. 35-38, doi:10.22270/ijdra.v10i2.519.