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
DOI https://doi.org/10.22270/ijdra.v10i2.519

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

Downloads

Download data is not yet available.

References

1. Shah VP, Lesko LJ, Fan J, Fleischer N, Handerson J, Malinowski H, et al. FDA guidance for industry 1 dissolution testing of immediate release solid oral dosage forms. Dissolution Technol. 1997;4(4):15–22.
2. García-Arieta A, Gordon J. Bioequivalence requirements in the european union: Critical discussion. AAPS J. 2012;14(4):738–48.
3. Medicines Agency E. Committee for Medicinal Products for Human use (CHMP) Committee for Medicinal Products for Veterinary use (CVMP) Quality Working Party (QWP) Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic [Internet]. tinyurl.com; 2017 [cited 2022 March 03]. Available from:
tinyurl.com/nzac8ezb
4. Sathe PM, Tsong Y, Shah VP. In-vitro dissolution profile comparison: Statistics and analysis, model dependent approach. Vol. 13, Pharmaceutical Research. 1996. p. 1799–803.
5. Diaz DA, Colgan ST, Langer CS, Bandi NT, Likar MD, Van Alstine L. Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations? AAPS J. 2016;18(1):15–22.
6. Anand O, Yu LX, Conner DP, Davit BM. Dissolution testing for generic drugs: An FDA perspective. AAPS J. 2011;13(3):328–35.
7. European Medicines Agency. ICH guideline M9 on biopharmaceutics classification system based biowaivers. Ema. 2018;44(August):1–17.
8. CDER/FDA. U.S. Department of Health and Human Services Food and Drug Administration Center for Evaluation and Research (CDER). Guid Ind Vitr Metab Mediat Drug-Drug Transp Interact Stud Draft Guid [Internet]. 2017;(December):1–16. [cited 2022 March 03]. Available from:
https://www.fda.gov/drugs/guidances-drugs/all-guidances-drugs
9. Loebenberg R. Biowaiver for Immediate and Modified Release Dosage forms Scientific summary of the CSPS workshop. J Pharm Pharm Sci. 2020;23:48–77.
Statistics
360 Views | 343 Downloads
How to Cite
1.
Kanojiya S, Patel N, Patel RJ, Patel A. Comparison of Dissolution profile for Immediate-Release Dosage form for US and Europe. Int J Drug Reg Affairs [Internet]. 2022Jun.19 [cited 2025Apr.29];10(2):35-8. Available from: https://www.ijdra.com/index.php/journal/article/view/519
Issue
Vol 10 No 2 (2022): VOLUME 10, ISSUE 2, 2022
Section
Review
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.

I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.

Download link for COPYRIGHT FORM