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Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products.
Pharm Res. 2019 Nov 14; 36(12):180.PR

Abstract

PURPOSE

To examine the potential of stratum corneum (SC) sampling via tape-stripping in humans to assess bioequivalence of topical acyclovir drug products, and to explore the potential value of alternative metrics of local skin bioavailability calculable from SC sampling experiments.

METHODS

Three acyclovir creams were considered in two separate studies in which drug amounts in the SC after uptake and clearance periods were measured and used to assess bioequivalence. In each study, a "reference" formulation (evaluated twice) was compared to the "test" in 10 subjects. Each application site was replicated to achieve greater statistical power with fewer volunteers.

RESULTS

SC sampling revealed similarities and differences between products consistent with results from other surrogate bioequivalence measures, including dermal open-flow microperfusion experiments. Further analysis of the tape-stripping data permitted acyclovir flux into the viable skin to be deduced and drug concentration in that 'compartment' to be estimated.

CONCLUSIONS

Acyclovir quantities determined in the SC, following a single-time point uptake and clearance protocol, can be judiciously used both to objectively compare product performance in vivo and to assess delivery of the active into skin tissue below the barrier, thereby permitting local concentrations at or near to the site of action to be determined.

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Authors+Show Affiliations

Pensado A
Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath, BA2 7AY, UK.
Chiu WS
Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath, BA2 7AY, UK.
Cordery SF
Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath, BA2 7AY, UK.
Rantou E
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, White Oak Campus, Silver Spring, MD, USA.
Bunge AL
Department of Chemical and Biological Engineering, Colorado School of Mines, Golden, CO, USA.
Delgado-Charro MB
Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath, BA2 7AY, UK.
Guy RH
Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath, BA2 7AY, UK. r.h.guy@bath.ac.uk.

MeSH

AcyclovirAdministration, TopicalAdultAntiviral AgentsBiological AvailabilityBiological TransportDrug LiberationFemaleHumansMaleMiddle AgedPermeabilitySkinSkin AbsorptionSkin CreamTherapeutic Equivalency

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31728737

Citation

Pensado, A, et al. "Stratum Corneum Sampling to Assess Bioequivalence Between Topical Acyclovir Products." Pharmaceutical Research, vol. 36, no. 12, 2019, p. 180.
Pensado A, Chiu WS, Cordery SF, et al. Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products. Pharm Res. 2019;36(12):180.
Pensado, A., Chiu, W. S., Cordery, S. F., Rantou, E., Bunge, A. L., Delgado-Charro, M. B., & Guy, R. H. (2019). Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products. Pharmaceutical Research, 36(12), 180. https://doi.org/10.1007/s11095-019-2707-3
Pensado A, et al. Stratum Corneum Sampling to Assess Bioequivalence Between Topical Acyclovir Products. Pharm Res. 2019 Nov 14;36(12):180. PubMed PMID: 31728737.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products. AU - Pensado,A, AU - Chiu,W S, AU - Cordery,S F, AU - Rantou,E, AU - Bunge,A L, AU - Delgado-Charro,M B, AU - Guy,R H, Y1 - 2019/11/14/ PY - 2019/08/25/received PY - 2019/09/20/accepted PY - 2019/09/20/revised PY - 2019/11/16/entrez PY - 2019/11/16/pubmed PY - 2020/1/8/medline KW - acyclovir KW - scaled average bioequivalence (SABE) KW - skin KW - stratum corneum sampling KW - topical bioavailability KW - topical bioequivalence SP - 180 EP - 180 JF - Pharmaceutical research JO - Pharm Res VL - 36 IS - 12 N2 - PURPOSE: To examine the potential of stratum corneum (SC) sampling via tape-stripping in humans to assess bioequivalence of topical acyclovir drug products, and to explore the potential value of alternative metrics of local skin bioavailability calculable from SC sampling experiments. METHODS: Three acyclovir creams were considered in two separate studies in which drug amounts in the SC after uptake and clearance periods were measured and used to assess bioequivalence. In each study, a "reference" formulation (evaluated twice) was compared to the "test" in 10 subjects. Each application site was replicated to achieve greater statistical power with fewer volunteers. RESULTS: SC sampling revealed similarities and differences between products consistent with results from other surrogate bioequivalence measures, including dermal open-flow microperfusion experiments. Further analysis of the tape-stripping data permitted acyclovir flux into the viable skin to be deduced and drug concentration in that 'compartment' to be estimated. CONCLUSIONS: Acyclovir quantities determined in the SC, following a single-time point uptake and clearance protocol, can be judiciously used both to objectively compare product performance in vivo and to assess delivery of the active into skin tissue below the barrier, thereby permitting local concentrations at or near to the site of action to be determined. SN - 1573-904X UR - https://www.unboundmedicine.com/medline/citation/31728737/Stratum_Corneum_Sampling_to_Assess_Bioequivalence_between_Topical_Acyclovir_Products_ DB - PRIME DP - Unbound Medicine ER -