Evidence map›Paper›PMID 33709196›Full record

ArticleThe AAPS journal2021

Impact of Formulation Parameters on In Vitro Release from Long-Acting Injectable Suspensions.

Quanying Bao, Yuan Zou, Yan Wang, Stephanie Choi, Diane J Burgess

Abstract read
In one paragraph

Article in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
  2. Article
  3. PLGA-based long-acting injectable (LAI) formulations.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. 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

5 authors.

Quanying BaoDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, Connecticut, 06269, USA.
Yuan ZouOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, 20993, USA.
Yan WangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, 20993, USA.
Stephanie ChoiOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, 20993, USA.
Diane J BurgessDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, Connecticut, 06269, USA. d.burgess@uconn.edu.

Funding

FDA HHS HHSF223201710135CNHLBI NIH HHS HHSF223201710135C
6 · The paper itself

Abstract

The development of long-acting injectable (LAI) suspension products has increased in recent years. A better understanding of the relationship between the physicochemical properties of these products and their in vitro as well as in vivo performance is expected to further facilitate their development and regulatory review. Using Depo-SubQ Provera 104® as the reference listed drug (RLD), four qualitatively and quantitatively (Q1/Q2) equivalent LAI suspensions with different formulation properties were prepared. Two recrystallization methods (solvent evaporation and antisolvent) were utilized to obtain active pharmaceutical ingredient (API) with different properties and solid-state characterization was performed. In addition, two different sources of the major excipient were used to prepare the Q1/Q2 equivalent suspensions. Physiochemical characterization and in vitro release testing of the prepared Q1/Q2 equivalent suspension formulations and the RLD were conducted. In vitro drug release was dependent not only on the particle size, the morphology, and the crystallinity of the API but also on the residual solvent in the API. The excipient source also affected the drug release rates.

Indexed as

Chemistry, PharmaceuticalCrystallizationDelayed-Action PreparationsDrug CompoundingDrug LiberationExcipientsInjections, IntramuscularInjections, SubcutaneousMedroxyprogesterone AcetateParticle SizeSolubilitySuspensionsDelayed-Action PreparationsExcipientsMedroxyprogesterone AcetateSuspensionsDepo-SubQ Provera 104®drug releaselong-acting injectablemedroxyprogesterone acetatesuspensions

Identifiers

PMID33709196
PMCPMC8684597

What OpenQuestion holds

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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.