Evidence map›Paper›PMID 34522087›Full record

ArticleDrug design, development and therapy2021

In vitro Comparison of Pancreatic Enzyme Preparations Available in the Indian Market.

Shailesh V Shrikhande, V G Mohan Prasad, J Enrique Domínguez-Muñoz, Kevin E Weigl, Kushal D Sarda

Open access · goldAbstract readComparative Study
In one paragraph

Article in Drug design, development and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Guideline
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  5. 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 4 institutions in 3 countries.

Shailesh V ShrikhandeDivision of Cancer Surgery and Gastrointestinal and Hepato-Pancreato-Biliary Service, Tata Memorial Hospital, Mumbai, Maharashtra, India.
V G Mohan PrasadDepartment of Gastroenterology, Dr. M.G.R. Medical University and VGM Hospital, Coimbatore, Tamil Nadu, India.
J Enrique Domínguez-MuñozDepartment of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.
Kevin E WeiglDepartment of Gastroenterology, Abbott Laboratories GmbH, Hannover, Germany.
Kushal D SardaEstablished Pharmaceuticals Division - Medical Affairs, Abbott India Ltd, Mumbai, Maharashtra, India.
Abbott (Germany) · DETamil Nadu Dr. M.G.R. Medical University · INTata Memorial Hospital · INUniversidade de Santiago de Compostela · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePancreatic enzyme replacement therapy (PERT) involves exogenous enzyme supplementation and is used in the treatment of pancreatic exocrine insufficiency. Clinical efficacy of PERT preparations is a function of physical properties and release kinetics that vary between commercially available products. In this study, we evaluated the physical properties, in vitro dissolution, and release kinetics of commercially available pancreatic enzyme preparations available in the Indian market.

methodsPhysical properties such as particle size distribution and water content of the capsules were measured by dynamic light scattering and Karl-Fischer titration method, respectively. An analytical procedure based on the European pharmacopoeia (EP) method was used to determine lipase activity, and a modified United States pharmacopoeia (USP)-based method was used for dissolution studies. Enzyme release was ascertained under gastroduodenal conditions in buffered media.

resultsConsiderable variations in physical properties such as particle size and water content were observed between pancreatic enzyme preparations. Some preparations failed to meet the labeled lipase content as per USP standards (>90% label claim) and showed inconsistent release behavior (>5% relative standard deviation).

conclusionDifferences exist between pancreatic enzyme preparations in terms of physical properties, dissolution, and release behavior that can affect their clinical efficacy. The present study suggests, therefore, that these preparations should not be used interchangeably.

Indexed as

CapsulesDrug LiberationEnzyme Replacement TherapyGastrointestinal AgentsHumansIndiaLipasePancreatinParticle SizeCapsulesGastrointestinal AgentsLipasePancreatinin vitro dissolutionlipase activitypancreatic enzymephysical propertiesrelease kinetics

Identifiers

PMID34522087
PMCPMC8434830
OpenAlexW3197380005

What OpenQuestion holds

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LicenceCC BY-NC
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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.