Evidence map›Paper›PMID 39654002›Full record

ArticlePharmaceutical research2024

Effect of "In Use" Administration on Topical Product Metamorphosis and Skin Permeation of Acyclovir Creams: Implications for Bioequivalence.

Sarika N Namjoshi, K C Telaprolu, Jeffrey E Grice, Heather A E Benson, S G Raney, Michael S Roberts, Yousuf H Mohammed

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Article in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Sarika N Namjoshi *Therapeutics Research Centre, Frazer Institute, Translational Research Institute, Woolloongabba, QLD, Australia.
K C Telaprolu *Therapeutics Research Centre, Frazer Institute, Translational Research Institute, Woolloongabba, QLD, Australia.
Jeffrey E GriceTherapeutics Research Centre, Frazer Institute, Translational Research Institute, Woolloongabba, QLD, Australia.
Heather A E BensonCurtin Medical School, Curtin University, Perth, WA, Australia.
S G RaneyOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
Michael S RobertsTherapeutics Research Centre, Frazer Institute, Translational Research Institute, Woolloongabba, QLD, Australia.
Yousuf H MohammedTherapeutics Research Centre, Frazer Institute, Translational Research Institute, Woolloongabba, QLD, Australia. y.mohammed@uq.edu.au.

Funding

Center for Drug Evaluation and Research U01FD005226
6 · The paper itself

Abstract

purposeTypical clinical "in use" conditions for topical semisolids involve their application as a thin film, often with rubbing that can induce metamorphic stress. Yet, product quality and performance tests often characterize the manufactured product, and may not consider product metamorphosis (e.g., shear history) during dispensing and administration. This work sought to elucidate how such metamorphosis might alter product quality and performance.

methodsWe evaluated the effect of "in use" stresses on drug crystal metamorphosis in acyclovir creams by optical microscopy. The amount of dissolved acyclovir was determined by separation of the cream base by ultra-centrifugation and quantification by HPLC. IVPT was undertaken on Zovirax

resultsReduction in acyclovir particle size was seen after "in use" rubbing with increases in the amount of dissolved acyclovir after rubbing (30 and 60 s) compared to static for both products. "In use" application resulted in significantly higher acyclovir permeation from both products. The mechanistic IVPT study proved the role of product metamorphosis.

conclusionThese results highlight the role of metamorphosis of product microstructure and its influence on performance.

Indexed as

AcyclovirAdministration, CutaneousAntiviral AgentsSkin AbsorptionSkin CreamTherapeutic EquivalencyAnimalsHumansParticle SizePermeabilitySkinSwineAcyclovirAntiviral AgentsAcyclovirBioequivalenceIn use administrationMetamorphosisTopical formulation

Identifiers

PMID39654002

What OpenQuestion holds

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Registered trials

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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.