Evidence map›Paper›PMID 29518465›Full record

ArticleJournal of controlled release : official journal of the Controlled Release Society2018

In vitro and ex vivo correlation of drug release from ophthalmic ointments.

Quanying Bao, Bryan Newman, Yan Wang, Stephanie Choi, Diane J Burgess

Abstract read
In one paragraph

Article in Journal of controlled release : official journal of the Controlled Release Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing 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

28 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. International journal of pharmaceutics: X · 2026
    Article
  5. Article
  6. Article
  7. Design and PreliminaryCurrent pharmaceutical biotechnology · 2026
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Gels (Basel, Switzerland) · 2023
    Article
  17. Article
  18. Article
  19. Article
  20. 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

5 authors.

Quanying BaoUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, United States.
Bryan NewmanFDA/CDER, Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance, Silver Spring, MD 20993, United States.
Yan WangFDA/CDER, Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance, Silver Spring, MD 20993, United States.
Stephanie ChoiFDA/CDER, Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance, Silver Spring, MD 20993, United States.
Diane J BurgessUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, United States. Electronic address: d.burgess@uconn.edu.

Funding

Evaluation and Development of Dissolution Testing Methods for Semisolid Ocular Drug ProductsU01FD005177 · FDA · UNIVERSITY OF CONNECTICUT STORRS · PI BURGESS, DIANE JANE · 2014 to 2015
$436k
FDA HHS U01 FD005177
6 · The paper itself

Abstract

In vitro drug release testing and ex vivo transcorneal drug permeation can provide valuable information on the performance of the Q1/Q2 equivalent ointments prior to any animal studies. Good correlation between in vitro and ex vivo drug release may be indicative of good in vitro and in vivo correlation. Accordingly, it is important to investigate in vitro as well as ex vivo drug release from Q1/Q2 equivalent ophthalmic ointments and evaluate whether a correlation between these release profiles can be established. Four Q1/Q2 equivalent loteprednol etabonate ointments were prepared using different processing methods and excipient sources. The rheological parameters (crossover modulus and K value) of the four formulations were determined. The in vitro drug release testing of the four ointment formulations were performed using three different apparati (Franz diffusion cells, USP apparatus 2 with enhancer cells and USP apparatus 4 with semisolid adapters). Three models (zero order, logarithmic and the Higuchi model) were used to study the release kinetics of the ointment formulations. The transcorneal (rabbit corneas) permeation studies were performed using spherical joint Franz diffusion cells. The USP apparatus 4 method demonstrated better discriminatory ability compared to the USP apparatus 2 and the Franz diffusion cell methods. The in vitro release profiles of the four Q1/Q2 equivalent ointments with manufacturing differences showed a better fit using the Higuchi model (R

Indexed as

Administration, OphthalmicAnimalsAnti-Allergic AgentsCorneaDrug LiberationLoteprednol EtabonateOintmentsRabbitsRheologyAnti-Allergic AgentsLoteprednol EtabonateOintmentsEx vivoFranz diffusion cellsHydroxypropyl-beta-cyclodextrinIn vitroLotemaxOphthalmic ointmentRabbit corneasTranscorneal

Identifiers

PMID29518465
PMCPMC6681454

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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.