Evidence map›Paper›PMID 36070842›Full record

ArticleInternational journal of pharmaceutics2022

Implications of particle size on the respective solid-state properties of naltrexone in PLGA microparticles.

Andrew Otte, Hazal Turasan, Kinam Park

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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 39% 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

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. PLGA-based long-acting injectable (LAI) formulations.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Review
  5. Article
  6. Review
  7. 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

3 authors at 1 institution in 1 country.

Andrew OttePurdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA. Electronic address: aotte@purdue.edu.
Hazal TurasanPurdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA.
Kinam ParkPurdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA; Purdue University, College of Pharmacy, West Lafayette, IN 47907, USA; Akina, Inc., West Lafayette, IN 47906, USA.
Purdue University West Lafayette · US

Funding

Injectable naltrexone 2-month depot formulationsUH3DA048774 · NIDA · PURDUE UNIVERSITY · PI PARK, KINAM · 2022 to 2024
$4.9M
Injectable naltrexone 2-month depot formulationsUG3DA048774 · NIDA · PURDUE UNIVERSITY · PI PARK, KINAM · 2019 to 2020
$2.9M
NIDA NIH HHS UG3 DA048774NIDA NIH HHS UH3 DA048774
6 · The paper itself

Abstract

A thorough understanding of the complexities in formulating and manufacturing polymeric microspheres is required for new and generic drug applications. Specifically, for an ANDA application for polymeric microsphere-based products, the applicant must meet Q1 (qualitative) and Q2 (quantitative) sameness, and in some cases, Q3 (e.g., microstructural) sameness. Herein, we report the naltrexone crystallinity in a PLGA microparticle system prepared from a dichloromethane-benzyl alcohol solvent system results in a crystallinity dependence as a function of microparticle size from the same batch - illustrating intrabatch microstructural variability. As the particle size increases, the crystallinity increases, with additional polymorphic forms more readily noted at the large particle sizes. Furthermore, during dissolution, a polymorphic transition and/or crystallization occurs at larger size fractions. This study highlights the importance of controlling the manufacturing parameters during microparticle formation, specifically solvent extraction and particle size control. Furthermore, with the approval of generic microparticles formulations on the horizon, this study highlights the importance of Q3, the same components in the same concentration with the same arrangement of matter, whereby microparticles can have varying microstructural properties across particle sizes from the same batch.

Indexed as

Methylene ChlorideNaltrexoneBenzyl AlcoholsDrug CarriersDrugs, GenericMicrospheresParticle SizePolylactic Acid-Polyglycolic Acid CopolymerSolventsBenzyl AlcoholsDrug CarriersDrugs, GenericMethylene ChlorideNaltrexonePolylactic Acid-Polyglycolic Acid CopolymerSolventsCrystallinityDrug releaseNaltrexonePLGA microparticles

Identifiers

PMID36070842
PMCPMC9529846
OpenAlexW4294969172

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.