Evidence map›Paper›PMID 36741268›Full record

ArticleJournal of drug delivery science and technology2023

Development and Characterization of Different Dosage Forms of Nifedipine/Indomethacin Fixed-Dose Combinations.

Abdulmajeed A Althobaiti, Eman A Ashour, Ahmed Almotairy, Mashan Almutairi, Mohammed AlYahya, Michael A Repka

Abstract read
In one paragraph

Article in Journal of drug delivery science and technology, 2023. 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

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.

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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

6 authors.

Abdulmajeed A AlthobaitiDepartment of Pharmaceutics and Drug Delivery, University of Mississippi, School of Pharmacy, MS 38677.
Eman A AshourDepartment of Pharmaceutics and Drug Delivery, University of Mississippi, School of Pharmacy, MS 38677.
Ahmed AlmotairyDepartment of Pharmaceutics and Drug Delivery, University of Mississippi, School of Pharmacy, MS 38677.
Mashan AlmutairiDepartment of Pharmaceutics and Drug Delivery, University of Mississippi, School of Pharmacy, MS 38677.
Mohammed AlYahyaDepartment of Pharmaceutics and Drug Delivery, University of Mississippi, School of Pharmacy, MS 38677.
Michael A RepkaDepartment of Pharmaceutics and Drug Delivery, University of Mississippi, School of Pharmacy, MS 38677.

Funding

Pilot Project ProgramP30GM122733 · NIGMS · UNIVERSITY OF MISSISSIPPI · PI WILLETT, KRISTINE L · 2018 to 2022
$5.3M
NIGMS NIH HHS P30 GM122733
6 · The paper itself

Abstract

Studies have shown that 40 individuals out of 100,000 are diagnosed with rheumatoid arthritis (RA) yearly, with a total of 1.3 million in the United States. Furthermore, the impact of RA in some cases can extend to cardiovascular diseases (CVD), as the studies showed that 84% of RA patients are at risk of developing hypertension. This study aims to design and develop different dosage forms (capsule-in-capsule and three-dimensional (3D) printed tablet) of nifedipine/indomethacin fixed-dose combination (FDC). The hot-melt extrusion (HME) was utilized alone and with fused deposition modeling (FDM) techniques The developed dosage forms were intended to provide delayed-extended and immediate release profiles for indomethacin and nifedipine, respectively. FDC dosage forms were successfully developed and characterized. Nifedipine formulations showed significant improvement in release profiles, having 94% of the drug release at 30 minutes compared with pure nifedipine, which had a percent release of 2%. Furthermore, the release of indomethacin was successfully delayed at a pH of 1.2 and extended at a pH of 6.8. Differential scanning calorimetry results showed endothermic crystalline peaks at 165 °C and 176 °C for indomethacin and nifedipine, respectively. Moreover, the thermal analysis of all formulations showed the absence of the endothermic peaks indicating complete solubilization of indomethacin and nifedipine in the polymeric carriers. All formulations had post-processing drug content in the range of 95% to 98%. Moreover, results from the stability study showed that all formulations were able to remain chemically and physically stable with no signs of recrystallization or degradation. The designed FDC dosage forms could improve the quality of life by enhancing patient compliance and preventing the need for polypharmacy.

Indexed as

3D printingFixed dose combinationFused deposition modeling (FDM)Hot-melt extrusionIndomethacinNifedipine

Identifiers

PMID36741268
PMCPMC9897319

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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.