Evidence map›Paper›PMID 26423236›Full record

ArticleJournal of controlled release : official journal of the Controlled Release Society2015

In vitro-in vivo correlation of parenteral risperidone polymeric microspheres.

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

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of controlled release : official journal of the Controlled Release Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 13% 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

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 117 citations in OpenAlex.

  1. Pooled it
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  8. In vitro-in vivo correlation (IVIVC) development for long-acting injectable drug products based on poly(lactide-co-glycolide).Journal of controlled release : official journal of the Controlled Release Society · 2025
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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.

Jie ShenSchool 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.
Center for Drug Evaluation and Research · USUniversity of Connecticut · US

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 determine whether an in vitro-in vivo correlation (IVIVC) can be established for polymeric microspheres that are equivalent in formulation composition but prepared with different manufacturing processes. Risperidone was chosen as a model therapeutic and poly(lactic-co-glycolic acid) (PLGA) with similar molecular weight as that used in the commercial product Risperdal® Consta® was used to prepare risperidone microspheres. Various manufacturing processes were investigated to produce the risperidone microspheres with similar drug loading (approx. 37%) but distinctly different physicochemical properties (e.g. porosity, particle size and particle size distribution). In vitro release of the risperidone microspheres was investigated using different release testing methods (such as sample-and-separate and USP apparatus 4). In vivo pharmacokinetic profiles of the risperidone microsphere formulations following intramuscular administration were determined using a rabbit model. Furthermore, the obtained pharmacokinetic profiles were deconvoluted using the Loo-Riegelman method and the calculated in vivo release was compared with the in vitro release of these microspheres. Level A IVIVCs were established and validated for the compositionally equivalent risperidone microspheres based on the in vitro release data obtained using USP apparatus 4. The developed IVIVCs demonstrated good predictability and were robust. These results showed that the developed USP apparatus 4 method was capable of discriminating PLGA microspheres that are equivalent in formulation composition but with manufacturing differences and predicting their in vivo performance in the investigated animal model.

Indexed as

Drug CarriersMicrospheresRisperidoneAnimalsDrug LiberationLactic AcidParticle SizePolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerPorosityRabbitsDrug CarriersLactic AcidPolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerRisperidoneIn vitro and in vivo correlationLevel AManufacturing differencesPoly(lactic-co-glycolic acid) (PLGA) microspheresRisperidoneUSP apparatus 4

Identifiers

PMID26423236
PMCPMC4721561
OpenAlexW1846364079

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.