Evidence map›Paper›PMID 37100926›Full record

ArticleAAPS PharmSciTech2023

Influence of Poloxamer on the Dissolution and Stability of Hot-Melt Extrusion-Based Amorphous Solid Dispersions Using Design of Experiments.

Ashay Shukla, Nagi Reddy Dumpa, Rishi Thakkar, Abhishek Shettar, Eman Ashour, Suresh Bandari, Michael A Repka

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Article in AAPS PharmSciTech, 2023. 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
  2. Review
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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

7 authors.

Ashay ShuklaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, 38677, Mississippi, USA.
Nagi Reddy DumpaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, 38677, Mississippi, USA.
Rishi ThakkarDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, 38677, Mississippi, USA.
Abhishek ShettarDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, 38677, Mississippi, USA.
Eman AshourDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, 38677, Mississippi, USA.
Suresh BandariDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, 38677, Mississippi, USA.
Michael A RepkaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, 38677, Mississippi, USA. marepka@olemiss.edu.ORCID http://orcid.org/0009-0000-0848-8379

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The current study aimed to see the effects of poloxamer P407 on the dissolution performance of hydroxypropyl methylcellulose acetate succinate (AquaSolve™ HPMC-AS HG)-based amorphous solid dispersions (ASD). A weakly acidic, poorly water-soluble active pharmaceutical ingredient (API), mefenamic acid (MA), was selected as a model drug. Thermal investigations, including thermogravimetry (TG) and differential scanning calorimetry (DSC), were conducted for raw materials and physical mixtures as a part of the pre-formulation studies and later to characterize the extruded filaments. The API was blended with the polymers using a twin shell V-blender for 10 min and then extruded using an 11-mm twin-screw co-rotating extruder. Scanning electron microscopy (SEM) was used to study the morphology of the extruded filaments. Furthermore, Fourier-transform infrared spectroscopy (FT-IR) was performed to check the intermolecular interactions of the components. Finally, to assess the in vitro drug release of the ASDs, dissolution testing was conducted in phosphate buffer (0.1 M, pH 7.4) and hydrochloric acid-potassium chloride (HCl-KCl) buffer (0.1 M, pH 1.2). The DSC studies confirmed the formation of the ASDs, and the drug content of the extruded filaments was observed to be within an acceptable range. Furthermore, the study concluded that the formulations containing poloxamer P407 exhibited a significant increase in dissolution performance compared to the filaments with only HPMC-AS HG (at pH 7.4). In addition, the optimized formulation, F3, was stable for over 3 months when exposed to accelerated stability studies.

Indexed as

Chemistry, PharmaceuticalPoloxamerCalorimetry, Differential ScanningDrug CompoundingDrug StabilityHot TemperatureSolubilitySpectroscopy, Fourier Transform InfraredPoloxameramorphous solid dispersionsdesign of experimentshot-melt extrusionHPMC-ASmefenamic acidpoloxamer P407

Identifiers

PMID37100926

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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.