Evidence map›Paper›PMID 26705156›Full record

ArticleInternational journal of pharmaceutics2016

A reproducible accelerated in vitro release testing method for PLGA microspheres.

Jie Shen, Kyulim Lee, Stephanie Choi, Wen Qu, Yan Wang, Diane J Burgess

Abstract read
In one paragraph

Article in International journal of pharmaceutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing 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

22 citing papers in PubMed.

  1. Article
  2. Review
  3. Exploring New Horizons in Wound Healing: A Comprehensive Analysis.Recent advances in inflammation & allergy drug discovery · 2026
    Review
  4. Review
  5. PLGA-based long-acting injectable (LAI) formulations.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Review
  6. Review
  7. Article
  8. A review of current advancements for wound healing: Biomaterial applications and medical devices.Journal of biomedical materials research. Part B, Applied biomaterials · 2022
    Review
  9. Review
  10. In vitro dissolution considerations associated with nano drug delivery systems.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2021
    Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Formulation composition, manufacturing process, and characterization of poly(lactide-co-glycolide) microparticles.Journal of controlled release : official journal of the Controlled Release Society · 2021
    Review
  17. Article
  18. [Effect of bone morphogenetic protein 7/poly (lactide-co-glycolide) microspheres on theZhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2018
    Article
  19. Article
  20. 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

6 authors.

Jie ShenSchool of Pharmacy, University of Connecticut, Storrs, CT 06269, USA.
Kyulim LeeSchool of Pharmacy, University of Connecticut, Storrs, CT 06269, USA.
Stephanie ChoiOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20993, USA.
Wen QuOffice 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 BurgessSchool of Pharmacy, University of Connecticut, Storrs, CT 06269, USA. Electronic address: d.burgess@uconn.edu.

Funding

In vitro-In vivo Correlations of Parentral Microsphere Drug ProductsU01FD004931 · FDA · UNIVERSITY OF CONNECTICUT STORRS · PI BURGESS, DIANE JANE · 2013 to 2015
$1.1M
FDA HHS 1U01FD004931-01FDA HHS U01 FD004931
6 · The paper itself

Abstract

The objective of the present study was to develop a discriminatory and reproducible accelerated in vitro release method for long-acting PLGA microspheres with inner structure/porosity differences. Risperidone was chosen as a model drug. Qualitatively and quantitatively equivalent PLGA microspheres with different inner structure/porosity were obtained using different manufacturing processes. Physicochemical properties as well as degradation profiles of the prepared microspheres were investigated. Furthermore, in vitro release testing of the prepared risperidone microspheres was performed using the most common in vitro release methods (i.e., sample-and-separate and flow through) for this type of product. The obtained compositionally equivalent risperidone microspheres had similar drug loading but different inner structure/porosity. When microsphere particle size appeared similar, porous risperidone microspheres showed faster microsphere degradation and drug release compared with less porous microspheres. Both in vitro release methods investigated were able to differentiate risperidone microsphere formulations with differences in porosity under real-time (37 °C) and accelerated (45 °C) testing conditions. Notably, only the accelerated USP apparatus 4 method showed good reproducibility for highly porous risperidone microspheres. These results indicated that the accelerated USP apparatus 4 method is an appropriate fast quality control tool for long-acting PLGA microspheres (even with porous structures).

Indexed as

MicrospheresChemistry, PharmaceuticalLactic AcidParticle SizePolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerReproducibility of ResultsLactic AcidPolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerAccelerated in vitro releaseCompositionally equivalentPLGA microspheresPorousRisperidoneUSP apparatus 4

Identifiers

PMID26705156
PMCPMC4721604

What OpenQuestion holds

Textmetadata
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.