Evidence map›Paper›PMID 35595043›Full record

ArticleInternational journal of pharmaceutics2022

In vitro release testing method development for long-acting injectable suspensions.

Quanying Bao, Xiaoyi Wang, Yuan Zou, Yan Wang, Diane J Burgess

Open access · greenAbstract read
In one paragraph

Article in International journal of pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

13 citing papers in PubMed, 29 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. 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 at 2 institutions in 1 country.

Quanying BaoUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, USA. Electronic address: quanying.bao@uconn.edu.
Xiaoyi WangUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, USA.
Yuan ZouOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20993, USA.
Yan WangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20993, USA.
Diane J BurgessUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, USA.
University of Connecticut · USCenter for Drug Evaluation and Research · US

Funding

NHLBI NIH HHS HHSF223201710135C
6 · The paper itself

Abstract

Long-acting injectable (LAI) suspensions are complex parenterals intended to control drug release over a duration of weeks to months. Any unpredictive drug release behavior may cause serious side effects. Therefore, it is important to understand the in vitro and in vivo performance, as well as the in vitro-in vivo correlation (IVIVC) of these products. There are some US FDA recommended in vitro release testing methods for LAI suspensions. However, the release duration of all the recommended methods is less than two days which may not be appropriate for the establishment of IVIVCs for LAIs considering that their in vivo efficacies range from weeks to months. To develop in vitro release testing methods that may better correlate with in vivo release with longer durations, three compositionally equivalent medroxyprogesterone acetate suspensions were prepared with different particle size, using Depo-SubQ Provera 104® as the reference listed drug (RLD). Four different methods based on USP apparatus 2 (with dialysis sacs, enhancer cells or in-house designed devices) and USP apparatus 4 (with semisolid adapters) were utilized. USP apparatus 2 with enhancer cells and USP apparatus 4 with semisolid adapters showed the best discriminatory ability and reproducibility for the LAI suspensions investigated.

Indexed as

Renal DialysisDrug LiberationParticle SizeReproducibility of ResultsSuspensionsSuspensionsDepo-SubQ Provera 104®Float-A-LyzerIn vitro release testingLong-acting injectableMedroxyprogesterone acetateSuspensionsUSP apparatus

Identifiers

PMID35595043
PMCPMC9236550
OpenAlexW4280538188

What OpenQuestion holds

Textmetadata
LicenceTDM
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.