Evidence map›Paper›PMID 33215336›Full record

ArticlePharmaceutical research2020

Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations.

Maxime Le Merdy, Jessica Spires, Viera Lukacova, Ming-Liang Tan, Andrew Babiskin, Xiaoming Xu, Liang Zhao, Michael B Bolger

Open access · hybridAbstract readComparative Study
In one paragraph

Article in Pharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
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

14 citing papers in PubMed, 23 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Development of Gentamicin Bilosomes LadenAdvanced pharmaceutical bulletin · 2024
    Article
  10. Mathematical Models of Ocular Drug Delivery.Investigative ophthalmology & visual science · 2024
    Review
  11. Article
  12. Experimental and mathematical approaches for drug delivery for the treatment of wet age-related macular degeneration.Journal of controlled release : official journal of the Controlled Release Society · 2023
    Review
  13. Review
  14. Article
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

8 authors at 2 institutions in 1 country.

Maxime Le MerdySimulations Plus, Inc., 42505 10th Street West, Lancaster, California, 93534, USA. maxime@simulations-plus.com.ORCID http://orcid.org/0000-0003-2629-8039
Jessica SpiresSimulations Plus, Inc., 42505 10th Street West, Lancaster, California, 93534, USA.
Viera LukacovaSimulations Plus, Inc., 42505 10th Street West, Lancaster, California, 93534, USA.
Ming-Liang TanFood and Drug Administration, CDER/OGD/ORS/DQMM, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Andrew BabiskinFood and Drug Administration, CDER/OGD/ORS/DQMM, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Xiaoming XuFood and Drug Administration, CDER/OPQ/OTR/DPQR, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Liang ZhaoFood and Drug Administration, CDER/OGD/ORS/DQMM, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Michael B BolgerSimulations Plus, Inc., 42505 10th Street West, Lancaster, California, 93534, USA.
Simulations Plus (United States) · USUnited States Food and Drug Administration · US

Funding

U.S. Food and Drug Administration HHSF223201810255P
6 · The paper itself

Abstract

purposeThe purpose of this study is to show how the Ocular Compartmental Absorption & Transit (OCAT™) model in GastroPlus

methodsA newly OCAT™ model developed for fluorometholone, as well as a previously verified model for dexamethasone, were used to characterize the aqueous humor (AH) concentration following the administration of multiple ointment formulations to rabbit. The model uses the following parameters: application surface area (SA), a fitted application time, and the fitted Higuchi release constant to characterize the rate of passage of the active pharmaceutical ingredient from the ointment formulations into the tears in vivo.

resultsParameter sensitivity analysis was performed to understand the impact of ointment formulation changes on ocular exposure. While application time was found to have a significant impact on the time of maximal concentration in AH, both the application SA and the Higuchi release constant significantly influenced both the maximum concentration and the ocular exposure.

conclusionsThis initial model for ointment ophthalmic formulations is a first step to better understand the interplay between physiological factors and ophthalmic formulation physicochemical properties and their impact on in vivo ocular drug pharmacokinetic performance in rabbits.

Indexed as

Models, BiologicalOcular AbsorptionAdministration, OphthalmicAnimalsAqueous HumorComputer SimulationDexamethasoneEyeFluorometholoneGlucocorticoidsOintmentsRabbitsDexamethasoneFluorometholoneGlucocorticoidsOintmentsocular PBPKophthalmic ointmentPBPKproduct development

Identifiers

PMID33215336
PMCPMC7677276
OpenAlexW3100510055

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.