Evidence map›Paper›PMID 33606113›Full record

ArticleAAPS PharmSciTech2021

A One-Step Twin-Screw Melt Granulation with Gelucire 48/16 and Surface Adsorbent to Improve the Solubility of Poorly Soluble Drugs: Effect of Formulation Variables on Dissolution and Stability.

Sandeep Sarabu, Venkata Raman Kallakunta, Arun Butreddy, Karthik Yadav Janga, Srinivas Ajjarapu, Suresh Bandari, Feng Zhang, S Narasimha Murthy, Michael A Repka

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Article in AAPS PharmSciTech, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
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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

9 authors.

Sandeep SarabuDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.
Venkata Raman KallakuntaDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.
Arun ButreddyDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.
Karthik Yadav JangaDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.
Srinivas AjjarapuDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.
Suresh BandariDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.
Feng ZhangCollege of Pharmacy, The University of Texas at Austin, Austin, Texas, 78712, USA.
S Narasimha MurthyDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.
Michael A RepkaDepartment of Pharmaceutics and Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA. marepka@olemiss.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fenofibrate is an effective lipid-lowering drug; however, its poor solubility and high log p (5.2) result in insufficient absorption from the gastrointestinal tract, leading to poor bioavailability. In this study, a one-step continuous twin-screw melt granulation process was investigated to improve the solubility and dissolution of fenofibrate using Gelucire® 48/16 and Neusilin® US2 as the solubilizer and surface adsorbent, respectively. The formulations (granules) were prepared at different ratios of fenofibrate, Gelucire® 48/16, and Neusilin® US2 based on phase-solubility studies and characterized using dissolution, differential scanning calorimetry, powder X-ray diffraction, and scanning electron microscopy analyses and studies on flow properties. In the phase-solubility studies, a linear relation was observed between Gelucire® 48/16 concentration and the amount of fenofibrate dissolved. In contrast, the dissolution rate of the prepared formulations was independent of the fenofibrate: Gelucire® 48/16 ratio and dependent on the Neusilin® US2 levels in the formulation. Increasing Neusilin® US2 levels decreased the rate of dissolution of the granules but improved the stability of the tablets under storage at accelerated stability conditions. Interestingly, higher Gelucire® 48/16 levels in the granules resulted in tablets with a hard matrix, which slowed disintegration and dissolution. All formulations exhibited improved dissolution compared to pure fenofibrate.

Indexed as

Technology, PharmaceuticalDrug CompoundingDrug StabilityFenofibrateSolubilityTabletsFenofibrateTabletscompressibilitydissolution ratefenofibrategelucire® 48/16neusilin US2solubility enhancementtwin-screw melt granulation

Identifiers

PMID33606113

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Registered trials

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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.