Evidence map›Paper›PMID 39349693›Full record

ArticlePharmaceutical research2024

Impact of Different Packaging Configurations on A Topical Cream Product.

Yousuf H Mohammed, S N Namjoshi, K C Telaprolu, N Jung, H M Shewan, J R Stokes, H A E Benson, J E Grice, S G Raney, E Rantou and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. 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

12 authors.

Yousuf H Mohammed *Therapeutics Research Centre, Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, Australia. y.mohammed@uq.edu.au.ORCID http://orcid.org/0000-0002-7825-7557
S N Namjoshi *Therapeutics Research Centre, Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, Australia.
K C TelaproluTherapeutics Research Centre, Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, Australia.
N JungInstitute of Pharmaceutical Technology, Goethe University, Frankfurt, Germany.
H M ShewanSchool of Chemical Engineering, The University of Queensland, Brisbane, QLD, 4072, Australia.
J R StokesSchool of Chemical Engineering, The University of Queensland, Brisbane, QLD, 4072, Australia.
H A E BensonCurtin Medical School, Curtin University, Perth, WA, Australia.
J E GriceTherapeutics Research Centre, Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, 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.
E RantouOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
Maike WindbergsInstitute of Pharmaceutical Technology, Goethe University, Frankfurt, Germany. windbergs@em.uni-frankfurt.de.
Michael S RobertsTherapeutics Research Centre, Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, Australia. m.roberts@uq.edu.au.

Funding

Characterization of Critical Quality Attributes for Semisolid Topical Drug ProductsU01FD005226 · FDA · UNIVERSITY OF SOUTH AUSTRALIA · PI ROBERTS, MICHAEL · 2014 to 2018
$1.2M
FDA HHS U01 FD005226U.S. Food and Drug Administration U01FD005226
6 · The paper itself

Abstract

purposeThe objective of this study was to investigate whether different dispensing processes can alter the physicochemical and structural (Q3) attributes of a topical cream product, and potentially alter its performance.

methodsAcyclovir cream, 5% (Zovirax®) is sold in the UK and other countries in a tube and a pump packaging configurations. The structural attributes of the cream dispensed from each packaging configuration were analyzed by optical microscopy, confocal Raman microscopy and cryo-scanning electron microscopy. Rheological behavior of the products was also evaluated. Product performance (rate and extent of skin delivery) was assessed by in vitro permeation tests (IVPT) using heat-separated human epidermis mounted in static vertical (Franz-type) diffusion cells.

resultsDifferences in Q3 attributes and IVPT profiles were observed with creams dispensed from the two packaging configurations, even though the product inside each packaging appeared to be the same in Q3 attributes. Visible globules were recognized in the sample dispensed from the pump, identified as dimethicone globules by confocal Raman microscopy. Differences in rheological behaviour could be attributed to these globules as products not dispensed through the pump, demonstrated a similar rheological behaviour. Further, IVPT confirmed a reduced rate and extent to delivery across human epidermis from the product dispensed through a pump.

conclusionsDifferent methods of dispensing topical semisolid products can result in metamorphosis and Q3 changes that may have the potential to alter the bioavailability of an active ingredient. These findings have potential implications for product developers and regulators, related to the manufacturing and comparative testing of reference standard and prospective generic products dispensed from different packaging configurations.

Indexed as

Drug PackagingRheologySkin AbsorptionSkin CreamAcyclovirAdministration, CutaneousAntiviral AgentsEpidermisHumansAcyclovirAntiviral AgentsBioequivalenceComplianceConfocal Raman microscopyCryo-SEMIVPTMicrostructurePhysicochemical and structuralPump dispensersQ3Quality attributes of semisolidsRheology

Identifiers

PMID39349693
PMCPMC11530498

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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.