ArticlePharmaceutical research2019
Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products.
Article in Pharmaceutical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 36 citations in OpenAlex.
- Assessment of Drug Delivery Kinetics to Epidermal Targets In Vivo.The AAPS journal · 2021Trial
- Cutaneous pharmacokinetics of a volatile drug post-application to the skin.Drug delivery and translational research · 2026Article
- Raman-assessed cutaneous pharmacokinetics of doxepin topical products.International journal of pharmaceutics · 2026Article
- Refining Bioequivalence Assessment of Topical Drug Products for Local Action: A Comparative Analysis of Tape Stripping Methodologies.Pharmaceutics · 2026Review
- Liposomal Encapsulation of Ascorbyl Palmitate: Influence on Skin Performance.Pharmaceutics · 2024Article
- Reverse Iontophoresis: Noninvasive Assessment of Topical Drug Bioavailability.Molecular pharmaceutics · 2024Article
- Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits.AAPS PharmSciTech · 2023Article
- Application of a Customised Franz-Type Cell Coupled with HPTLC to Monitor the Timed Release of Bioactive Components in Complex Honey Matrices.Methods and protocols · 2023Article
- Rational Design of Topical Semi-Solid Dosage Forms-How Far Are We?Pharmaceutics · 2023Review
- Quantification of Chemical Uptake into the Skin by Vibrational Spectroscopies and Stratum Corneum Sampling.Molecular pharmaceutics · 2023Article
- Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union.Pharmaceutics · 2023Review
- Raman Spectroscopic Tools to Probe the Skin-(Trans)dermal Formulation Interface.Molecular pharmaceutics · 2022Article
- Investigator Impact on Reproducibility of Drug Bioavailability in Stratum Corneum Sampling by Tape Stripping.Pharmaceutical research · 2022Article
- Assessment of dermal bioavailability: predicting the input function for topical glucocorticoids using stratum corneum sampling.Drug delivery and translational research · 2022Article
- The Implications of Regulatory Framework for Topical Semisolid Drug Products: From Critical Quality and Performance Attributes towards Establishing Bioequivalence.Pharmaceutics · 2021Review
- Cutaneous Pharmacokinetics of Acyclovir Cream 5% Products: Evaluating Bioequivalence with an In Vitro Permeation Test and an Adaptation of Scaled Average Bioequivalence.Pharmaceutical research · 2020Article
- Franz Cell Diffusion Testing and Quantitative Confocal Raman Spectroscopy: In Vitro-In Vivo Correlation.Pharmaceutics · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
Abstract
purposeTo 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.
methodsThree 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.
resultsSC 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.
conclusionsAcyclovir 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.