Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Understanding of F2 Metrics Used to Evaluate Similarity of Dissolution Profiles

유사인자를 사용하여 용출양상 유사성을 비교하는 방법에 대한 고찰

  • Cho, Mi-Hyun (College of Pharmacy, Catholic University of Daegu) ;
  • Kim, Jeong-Ho (College of Pharmacy, Catholic University of Daegu) ;
  • Lee, Hyeon-Tae (College of Pharmacy, Catholic University of Daegu) ;
  • Sah, Hong-Kee (College of Pharmacy, Catholic University of Daegu)
  • 조미현 (대구가톨릭대학교 약학대학) ;
  • 김정호 (대구가톨릭대학교 약학대학) ;
  • 이현태 (대구가톨릭대학교 약학대학) ;
  • 사홍기 (대구가톨릭대학교 약학대학)
  • Published : 2003.09.20
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Abstract

Dissolution profile comparsions can be done by virtue of the similarity factor $(f_2)$. It is a logarithmic reciprocal square root transformation of the sum of squared error of % dissolution differences between two profiles at several time points. It gives information on the degree of similarity between the two profiles: An $f_2$ value between 50 and 100 suggests the similarity/equivalence of the two dissolution curves being compared. The objective of this report was to provide a careful examination on the $f_2$ metrics in detail. It was shown that $f_2$ values exceeded 50, when relative differences in % dissolved between two products were less than 15% at all time points. The similarity factor value was also found to be greater than 50, in cases when absolute % dissolution differences were below 10% at all time points. Interestingly, the $f_2$ value was changed by the number of the time points selected for calculation. In particular, $f_2$ tended to have higher values, when the $f_2$ metrics used a large number of time points in which % dissolved reached plateau. Finally, since the similarity factor was a sample statistics, it was impossible to infer type I/II errors and sampling error. Despite certain limitations inherited in the $f_2$ metrics, it was easy and convenient to evaluate how similar the two dissolution profiles were.

Keywords

References

  1. O. Andreas, Process validation of oral solid dosage forms: A semiscientific overview, Pharm. Technol. Eur., 9, 30-38 (1997)
  2. FDA, Center for Drug Evaluation and Research, Guidance for Industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system, August 2000
  3. FDA, Center for Drug Evaluation and Research, Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products General considerations, October 2000
  4. FDA, Center for Drug Evaluation and Research, Guidance for Industry: SUPAC-IR: Immediate release solid oral dosage forms: Scale-up and postapproval changes: Chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation, November 1995
  5. FDA, Center for Drug Evaluation and Research, Guidance for Industry: SUPAC-MR: Modified release solid oral dosage forms: Scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing and in vivo bioequivalence documentation, September 1997
  6. 식품의약품안전청고시 의약품동등성시험관리규정 제2002-19호, 2002년 4월
  7. 일본국립의약품식품위생연구소 (National Institute of Health Sciences), Guideline for bioequivalence studies of generic products, December 1997
  8. S. Dawoodbhai, et al., Optimization of tablet formulation containing talc, Drug Dev. Ind. Pharm., 17, 1343-1371 (1991) https://doi.org/10.3109/03639049109057301
  9. F. Langenbucher, Linerization of dissolution rate curves by the Weibull distribution, J. Pharm. Pharmacol., 24, 979-981 (1972) https://doi.org/10.1111/j.2042-7158.1972.tb08930.x
  10. L. Kervinen and J. Yiruusi, Modelling S-Shaped dissolution curves, Int. J. Pharm. 92, 115-122 (1993) https://doi.org/10.1016/0378-5173(93)90270-P
  11. P. Costa and J.M.S. Lobo, Influence of dissolution medium agitation on release profiles of sustained-release tablets, Drug Dev. Ind. Pharm., 27, 811-817 (2001) https://doi.org/10.1081/DDC-100107244
  12. J.W. Moore and H.H. Flanner, Mathematical comparison of dissolution profiles, Pharm. Tech. 20, 64-74 (1996)
  13. 일본국립의약품식품위생연구소 (National Institute of Health Sciences), Guideline for bioequivalence studies for formulation changes of oral solid dosage forms, February 2000
  14. 일본국립의약품식품위생연구소 (National Institute of Health Sciences), Guideline for bioequivalence studies for different strengths of oral solid dosage forms, February 2000
  15. J.P. Liu, M.C. Ma and S.C. Chow, Statistical evaluation of similarity factor $\f_{2}$ as a criterion for assessment of similarity between dissolution profiles, Drug Info. J., 31, 1255-1271 (1997) https://doi.org/10.1177/009286159703100426
  16. V.P. Shah, Y. Tsong, P. Sathe and J.P. Liu, In vitro dissolution profile comparison: Statistics and analysis of the similarity factor, $\f_{2}$, Pharm. Res., 15, 889-896 (1998) https://doi.org/10.1023/A:1011976615750
  17. H.L. Ju and S.J. Liaw, On the assessment of similarity of drug dissolution profiles: A simulation study, Drug Info. J., 31, 1273-1289 (1997) https://doi.org/10.1177/009286159703100427
  18. A. Rescigno, Bioequivalence, Pharm. Res., 9, 925-928 (1992) https://doi.org/10.1023/A:1015809201503
  19. M. C. Gohel and M.K. Panchal, Comparison of in vitro dissolution profiles using a novel, model-independent approach, Pharm. Tech., 24, 92-102 (2000)
  20. FDA, Center for Drug Evaluation and Research, Guidance for Industry: Dissolution testing of immediate release solid oral dosage forms, August 1997
  21. EMEA, Note for guidance on quality of modified release products: A: Oral dosage forms B: Transdermal dosage forms, Section 1 (Quality), January 2000

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