Using the similarity factor f2 in practice: A critical revision and suggestions for its standard error estimation

Abstract The purpose of this research was to develop new procedures with the aim of improving the usage of the similarity factor f 2 in dissolution data analysis, and to evaluate them jointly with preexisting ones. We introduce bias-correction and standard error estimation procedures based on the delta, the jackknife and the bootstrap methods. These methods, jointly with the rule of declaring similarity when f 2 exceeds 50 and some alternative testing procedures based on bootstrap confidence intervals, are evaluated on experimental data and studied by simulation. The results indicate that no method is strictly the best, but the following conclusions seem to appear: for estimation purposes the most reliable approach is to use the plain sample f 2 instead of any bias-corrected alternative, any of the standard error estimates may be used in practice and, most importantly, there are evidences against the validity of the procedure declaring similarity if the sample f 2 exceeds 50; a decision rule based on a confidence interval seems to be more adequate. In any case the question should be further investigated.

[1]  G. Frutos,et al.  Nonlinear mixed-effects model for the dissolution assays of drugs. , 2004, Journal of controlled release : official journal of the Controlled Release Society.

[2]  C. Goodman United States Pharmacopeial Convention , 1988 .

[3]  Svetlana Ibrić,et al.  The application of generalized regression neural network in the modeling and optimization of aspirin extended release tablets with Eudragit RS PO as matrix substance. , 2002, Journal of controlled release : official journal of the Controlled Release Society.

[4]  Yi Tsong,et al.  In Vitro Dissolution Profile Comparison—Statistics and Analysis of the Similarity Factor, f2 , 1998, Pharmaceutical Research.

[5]  K. Pathak,et al.  Osmotic flow through asymmetric membrane: A means for controlled delivery of drugs with varying solubility , 2006, AAPS PharmSciTech.

[6]  Beom-Jin Lee,et al.  Formulation, release characteristics and bioavailability of novel monolithic hydroxypropylmethylcellulose matrix tablets containing acetaminophen. , 2005, Journal of controlled release : official journal of the Controlled Release Society.

[7]  M. A. Holgado,et al.  In vitro evaluation of a morphine polymeric complex: Flowability behavior and dissolution study , 2004, AAPS PharmSciTech.

[8]  J. Parojčić,et al.  Artificial neural networks in the modeling and optimization of aspirin extended release tablets with eudragit L 100 as matrix substance , 2008, AAPS PharmSciTech.

[9]  Michael Levin Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System , 2001 .

[10]  Yi Lu,et al.  Synchronized and sustained release of multiple components in silymarin from erodible glyceryl monostearate matrix system. , 2007, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[11]  Henry H. Flanner,et al.  Dissolution Fit Factors as Response Variables in Statistically Designed Experiments , 2001 .

[12]  M. Patel,et al.  Gastroretentive drug delivery system of ranitidine hydrochloride: Formulation and in vitro evaluation , 2004, AAPS PharmSciTech.

[13]  J. W. Moore,et al.  Mathematical comparison of dissolution profiles , 1996 .

[14]  Wendy I. Wilson,et al.  Comparison of statistical analysis and Bayesian Networks in the evaluation of dissolution performance of BCS Class II model drugs. , 2005, Journal of pharmaceutical sciences.

[15]  Shein-Chung Chow Encyclopedia of Biopharmaceutical Statistics , 2010 .

[16]  Jinhe Li,et al.  In vitro evaluation of dissolution behavior for a colon-specific drug delivery system (CODES™) in multi-pH media using United States Pharmacopeia apparatus II and III , 2002, AAPS PharmSciTech.

[17]  Gudrun Freitag,et al.  Guidelines on Dissolution Profile Comparison , 2001 .

[18]  M. Gohel,et al.  Refinement of Lower Acceptance Value of the Similarity Factor f2 inComparison of Dissolution Profiles , 2002 .

[19]  V. Kadam,et al.  Development and in vitro evaluation of an oral floating matrix tablet formulation of diltiazem hydrochloride , 2007, AAPS PharmSciTech.

[20]  S. Chow,et al.  Statistical Evaluation of Similarity Factor f_2 as a Criterion for Assessment of Similarity Between Dissolution Profiles , 1997 .

[21]  M. Gohel,et al.  Assessment of Similarity Factor Using Different Weighting Approaches , 2005 .

[22]  D. Patel,et al.  Floating granules of ranitidine hydrochloride-gelucire 43/01: Formulation optimization using factorial design , 2007, AAPS PharmSciTech.

[23]  J. Liu,et al.  ASSESSMENT OF SIMILARITY BETWEEN DISSOLUTION PROFILES* , 2000, Journal of biopharmaceutical statistics.