Evidence map›Paper›PMID 27080252›Full record

ArticleDrug development and industrial pharmacy2016

Optimization of hot melt extrusion parameters for sphericity and hardness of polymeric face-cut pellets.

Abdullah S Alshetaili, Bjad K Almutairy, Saad M Alshahrani, Eman A Ashour, Roshan V Tiwari, Sultan M Alshehri, Xin Feng, Bader B Alsulays, Soumyajit Majumdar, Nigel Langley and 4 more

Abstract read
In one paragraph

Article in Drug development and industrial pharmacy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

14 authors.

Abdullah S Alshetailia Department of Pharmaceutics and Drug Delivery, School of Pharmacy , The University of Mississippi, University , MS , USA ;
Bjad K Almutairya Department of Pharmaceutics and Drug Delivery, School of Pharmacy , The University of Mississippi, University , MS , USA ;
Saad M Alshahranib Department of Pharmaceutics, College of Pharmacy , Prince Sattam Bin Abdulaziz University , Alkharj , Saudi Arabia ;
Eman A Ashoura Department of Pharmaceutics and Drug Delivery, School of Pharmacy , The University of Mississippi, University , MS , USA ;
Roshan V Tiwaria Department of Pharmaceutics and Drug Delivery, School of Pharmacy , The University of Mississippi, University , MS , USA ;
Sultan M Alshehric Department of Pharmaceutics, College of Pharmacy , King Saud University , Riyadh , Saudi Arabia ;
Xin Fenga Department of Pharmaceutics and Drug Delivery, School of Pharmacy , The University of Mississippi, University , MS , USA ;
Bader B Alsulaysb Department of Pharmaceutics, College of Pharmacy , Prince Sattam Bin Abdulaziz University , Alkharj , Saudi Arabia ;
Soumyajit Majumdara Department of Pharmaceutics and Drug Delivery, School of Pharmacy , The University of Mississippi, University , MS , USA ;
Nigel Langleyd BASF Corporation , Tarrytown , NY , USA ;
Karl Koltere R&D Project, Management Excipients, BASF SE , Ludwigshafen , Germany ;
Andreas Gryczkef Global Development and Technical Marketing, BASF SE , Ludwigshafen , Germany ;
Scott T Marting Thermo Fisher Scientific , Tewksbury , MA , USA ;
Michael A Repkaa Department of Pharmaceutics and Drug Delivery, School of Pharmacy , The University of Mississippi, University , MS , USA ;

Funding

Center of Research Excellence in Natural Products Neuroscience (CORE-NPN)P20GM104932 · NIGMS · UNIVERSITY OF MISSISSIPPI · PI MAJUMDAR, SOUMYAJIT · 2012 to 2016
$10.0M
NIGMS NIH HHS P20 GM104932
6 · The paper itself

Abstract

The aim of this study was to formulate face-cut, melt-extruded pellets, and to optimize hot melt process parameters to obtain maximized sphericity and hardness by utilizing Soluplus(®) as a polymeric carrier and carbamazepine (CBZ) as a model drug. Thermal gravimetric analysis (TGA) was used to detect thermal stability of CBZ. The Box-Behnken design for response surface methodology was developed using three factors, processing temperature ( °C), feeding rate (%), and screw speed (rpm), which resulted in 17 experimental runs. The influence of these factors on pellet sphericity and mechanical characteristics was assessed and evaluated for each experimental run. Pellets with optimal sphericity and mechanical properties were chosen for further characterization. This included differential scanning calorimetry, drug release, hardness friability index (HFI), flowability, bulk density, tapped density, Carr's index, and fourier transform infrared radiation (FTIR) spectroscopy. TGA data showed no drug degradation upon heating to 190 °C. Hot melt extrusion processing conditions were found to have a significant effect on the pellet shape and hardness profile. Pellets with maximum sphericity and hardness exhibited no crystalline peak after extrusion. The rate of drug release was affected mainly by pellet size, where smaller pellets released the drug faster. All optimized formulations were found to be of superior hardness and not friable. The flow properties of optimized pellets were excellent with high bulk and tapped density.

Indexed as

CarbamazepineDrug LiberationDrug StabilityHot TemperatureParticle SizePolyethylene GlycolsPolymersPolyvinylsSpectroscopy, Fourier Transform InfraredCarbamazepinePolyethylene GlycolsPolymersPolyvinylsBox–Behnken designcarbamazepinedesign of experimentface-cut pelletshardnesshot melt extrusionSoluplus®sphericity

Identifiers

PMID27080252
PMCPMC5041532

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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.