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Comparison of Clobetasol Propionate Generics Using Simplified In vitro Bioequivalence Method for Topical Drug Products.
Curr Drug Deliv. 2018; 15(7):998-1008.CD

Abstract

BACKGROUND

The aim of this paper is to evaluate a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or postapproval after changes to the product.

METHODS

Twelve clobetasol propionate (CP) formulations (six creams and six ointments, being five generics and one reference from each formulation type) from the local market were used as a model to challenge the evaluated methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction. To support the results, physicochemical tests for pH, viscosity, density and assay, as well as in vitro release were performed.

RESULTS

Both protocols, extracting the drug from the skin using the tape-stripping technique or extracting from the full skin were capable of differentiating CP formulations. Only one formulation did not present statistical difference from the reference drug product in penetration tests and only other two oitments presented equivalent release to the reference. The protocol is straightforward and reproducible.

CONCLUSION

Results suggest the bioinequavalence of tested CP formulations reinforcing the necessity of such evaluations.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Soares KCC
Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasilia, 70.910-900. Brasilia, DF, Brazil. Brazilian Health Surveillance Agency (Anvisa), Setor de Indústria e Abastecimento, 71205-050. Brasilia, DF, Brazil.
de Souza WC
Statistical analysis, Jardim America, 74275-060. Goiania, GO, Brazil.
de S Texeira L
Institute of Pharmaceutical Sciences of Studies and Research (ICF), Setor Marista. 74175-100. Goiania, GO, Brazil.
da Cunha-Filho MSS
Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasilia, 70.910-900. Brasilia, DF, Brazil.
Gelfuso GM
Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasilia, 70.910-900. Brasilia, DF, Brazil.
Gratieri T
Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasilia, 70.910-900. Brasilia, DF, Brazil.

MeSH

Administration, TopicalAnimalsChemistry, PharmaceuticalClobetasolDrug LiberationDrugs, GenericGlucocorticoidsHydrogen-Ion ConcentrationOintmentsSkinSkin AbsorptionSkin CreamSolubilitySwineTherapeutic EquivalencyViscosity

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

29165079

Citation

Soares, Kelen C C., et al. "Comparison of Clobetasol Propionate Generics Using Simplified in Vitro Bioequivalence Method for Topical Drug Products." Current Drug Delivery, vol. 15, no. 7, 2018, pp. 998-1008.
Soares KCC, de Souza WC, de S Texeira L, et al. Comparison of Clobetasol Propionate Generics Using Simplified In vitro Bioequivalence Method for Topical Drug Products. Curr Drug Deliv. 2018;15(7):998-1008.
Soares, K. C. C., de Souza, W. C., de S Texeira, L., da Cunha-Filho, M. S. S., Gelfuso, G. M., & Gratieri, T. (2018). Comparison of Clobetasol Propionate Generics Using Simplified In vitro Bioequivalence Method for Topical Drug Products. Current Drug Delivery, 15(7), 998-1008. https://doi.org/10.2174/1567201814666171120125333
Soares KCC, et al. Comparison of Clobetasol Propionate Generics Using Simplified in Vitro Bioequivalence Method for Topical Drug Products. Curr Drug Deliv. 2018;15(7):998-1008. PubMed PMID: 29165079.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of Clobetasol Propionate Generics Using Simplified In vitro Bioequivalence Method for Topical Drug Products. AU - Soares,Kelen C C, AU - de Souza,Weidson C, AU - de S Texeira,Leonardo, AU - da Cunha-Filho,Marcilio S S, AU - Gelfuso,Guilherme M, AU - Gratieri,Tais, PY - 2017/07/18/received PY - 2017/09/13/revised PY - 2017/11/08/accepted PY - 2017/11/23/pubmed PY - 2018/10/26/medline PY - 2017/11/23/entrez KW - Clobetasol propionate KW - in vitro release KW - in vitro skin penetration KW - pharmaceutical equivalence KW - topical bioequivalence. SP - 998 EP - 1008 JF - Current drug delivery JO - Curr Drug Deliv VL - 15 IS - 7 N2 - BACKGROUND: The aim of this paper is to evaluate a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or postapproval after changes to the product. METHODS: Twelve clobetasol propionate (CP) formulations (six creams and six ointments, being five generics and one reference from each formulation type) from the local market were used as a model to challenge the evaluated methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction. To support the results, physicochemical tests for pH, viscosity, density and assay, as well as in vitro release were performed. RESULTS: Both protocols, extracting the drug from the skin using the tape-stripping technique or extracting from the full skin were capable of differentiating CP formulations. Only one formulation did not present statistical difference from the reference drug product in penetration tests and only other two oitments presented equivalent release to the reference. The protocol is straightforward and reproducible. CONCLUSION: Results suggest the bioinequavalence of tested CP formulations reinforcing the necessity of such evaluations. SN - 1875-5704 UR - https://www.unboundmedicine.com/medline/citation/29165079/Comparison_of_Clobetasol_Propionate_Generics_Using_Simplified_In_vitro_Bioequivalence_Method_for_Topical_Drug_Products_ DB - PRIME DP - Unbound Medicine ER -