Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits
Comparative assessment of cutaneous pharmacokinetics (cPK) by dermal microdialysis (dMD) appears to be suitable to evaluate the bioequivalence (BE) of topical dermatological drug products applied to the skin (TDDPs). Although dMD studies in the literature have reported inconclusive BE assessments, w...
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| Published in: | AAPS PharmSciTech Vol. 24; no. 7; p. 204 |
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| Abstract | Comparative assessment of cutaneous pharmacokinetics (cPK) by dermal microdialysis (dMD) appears to be suitable to evaluate the bioequivalence (BE) of topical dermatological drug products applied to the skin (TDDPs). Although dMD studies in the literature have reported inconclusive BE assessments, we have addressed several methodological deficiencies to improve dMD’s capability to assess BE between reference (R) and approved generic (referred to as test (T)) gel and cream products of metronidazole (MTZ). The 90% confidence interval (CI) of the geometric mean ratios for the Ln(AUC
0-24
) and Ln(C
max
) endpoints was centered within the BE limits of 80–125%. The CIs extended outside this range as the proof-of-principle study was not statistically powered to demonstrate BE (
N
= 7 rabbits). A power analysis suggests that, with the variability observed in this study, 21 rabbits for the cream and 11 rabbits for the gel would be sufficient to support an evaluation of BE with the 2 probe replicates we used, and only 10 and 5 rabbits would be sufficient to power the study for the cream and gel, respectively, if 4 probe replicates are used for each treatment per rabbit. These results indicate that dMD when properly controlling variables can be used to support BE assessments for TDDPs.
Graphical Abstract |
|---|---|
| AbstractList | Comparative assessment of cutaneous pharmacokinetics (cPK) by dermal microdialysis (dMD) appears to be suitable to evaluate the bioequivalence (BE) of topical dermatological drug products applied to the skin (TDDPs). Although dMD studies in the literature have reported inconclusive BE assessments, we have addressed several methodological deficiencies to improve dMD’s capability to assess BE between reference (R) and approved generic (referred to as test (T)) gel and cream products of metronidazole (MTZ). The 90% confidence interval (CI) of the geometric mean ratios for the Ln(AUC
0-24
) and Ln(C
max
) endpoints was centered within the BE limits of 80–125%. The CIs extended outside this range as the proof-of-principle study was not statistically powered to demonstrate BE (
N
= 7 rabbits). A power analysis suggests that, with the variability observed in this study, 21 rabbits for the cream and 11 rabbits for the gel would be sufficient to support an evaluation of BE with the 2 probe replicates we used, and only 10 and 5 rabbits would be sufficient to power the study for the cream and gel, respectively, if 4 probe replicates are used for each treatment per rabbit. These results indicate that dMD when properly controlling variables can be used to support BE assessments for TDDPs.
Graphical Abstract |
| ArticleNumber | 204 |
| Author | Stagni, Grazia Ghosh, Priyanka Rantou, Elena Kuzma, Benjamin A. Senemar, Sharareh Raney, Sam G. Ramezanli, Tannaz |
| Author_xml | – sequence: 1 givenname: Sharareh surname: Senemar fullname: Senemar, Sharareh organization: Division of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University – sequence: 2 givenname: Benjamin A. surname: Kuzma fullname: Kuzma, Benjamin A. organization: Division of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University, Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals – sequence: 3 givenname: Tannaz surname: Ramezanli fullname: Ramezanli, Tannaz organization: Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 4 givenname: Priyanka surname: Ghosh fullname: Ghosh, Priyanka organization: Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 5 givenname: Sam G. surname: Raney fullname: Raney, Sam G. organization: Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 6 givenname: Elena surname: Rantou fullname: Rantou, Elena organization: Division of Biometrics VIII, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration – sequence: 7 givenname: Grazia orcidid: 0000-0002-5991-2552 surname: Stagni fullname: Stagni, Grazia email: gstagni@gmail.com organization: Division of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University |
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| Cites_doi | 10.1208/s12248-012-9406-x 10.1007/s11095-020-02821-z 10.1016/S1773-2247(14)50044-5 10.1016/j.ejps.2021.105741 10.1159/000330489 10.1007/s40262-016-0442-z 10.1016/j.jaad.2014.08.027 10.1001/jamadermatol.2016.5538 10.1111/srt.12098 10.1159/000320151 10.1111/1523-1747.ep12378630 10.1208/s12248-008-9053-4 10.1038/s41598-017-15830-7 10.1016/0165-0270(91)90114-f 10.1016/s0003-2670(98)00598-4 10.1023/a:1018906821725 10.1007/s11095-013-1259-1 10.1016/j.ejps.2008.09.002 10.1007/s11095-019-2707-3 10.1038/sj.jid.5700495 10.1007/s11095-020-02920-x 10.1016/j.ejpb.2022.05.001 10.1016/j.jaad.2020.01.062 |
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| SubjectTerms | Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Pharmacology/Toxicology Pharmacy Research Article Theme: Novel Approaches for Cutaneous Pharmacokinetics |
| Title | Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits |
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