Evidence map›Paper›PMID 38355916›Full record

ReviewAAPS PharmSciTech2024

Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation-Where Are We Now?

Hemlata Patil, Sateesh Kumar Vemula, Sagar Narala, Preethi Lakkala, Siva Ram Munnangi, Nagarjuna Narala, Miguel O Jara, Robert O Williams, Hibreniguss Terefe, Michael A Repka

Open access · hybridAbstract readReview
PubMed Publisher
In one paragraph

Review in AAPS PharmSciTech, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
14.1field-weighted citation impact, top 1% 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

28 citing papers in PubMed, 68 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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

10 authors at 4 institutions in 2 countries.

Hemlata PatilDepartment of Product Development, Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, New Jersey, 08873, USA.
Sateesh Kumar VemulaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Sagar NaralaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Preethi LakkalaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Siva Ram MunnangiDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Nagarjuna NaralaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Miguel O JaraMolecular Pharmaceutics and Drug Delivery Division, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Austin, Texas, 78712, USA.
Robert O WilliamsMolecular Pharmaceutics and Drug Delivery Division, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Austin, Texas, 78712, USA.
Hibreniguss TerefeDepartment of Product Development, Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, New Jersey, 08873, USA.
Michael A RepkaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA. marepka@olemiss.edu.ORCID http://orcid.org/0009-0000-0848-8379
University of Mississippi · USCatalent (United States) · USThe University of Texas at Austin · USLovely Professional University · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hot-melt extrusion (HME) is a globally recognized, robust, effective technology that enhances the bioavailability of poorly soluble active pharmaceutical ingredients and offers an efficient continuous manufacturing process. The twin-screw extruder (TSE) offers an extremely resourceful customizable mixer that is used for continuous compounding and granulation by using different combinations of conveying elements, kneading elements (forward and reverse configuration), and distributive mixing elements. TSE is thus efficiently utilized for dry, wet, or melt granulation not only to manufacture dosage forms such as tablets, capsules, or granule-filled sachets, but also for designing novel formulations such as dry powder inhalers, drying units for granules, nanoextrusion, 3D printing, complexation, and amorphous solid dispersions. Over the past decades, combined academic and pharmaceutical industry collaborations have driven novel innovations for HME technology, which has resulted in a substantial increase in published articles and patents. This article summarizes the challenges and models for executing HME scale-up. Additionally, it covers the benefits of continuous manufacturing, process analytical technology (PAT) considerations, and regulatory requirements. In summary, this well-designed review builds upon our earlier publication, probing deeper into the potential of twin-screw extruders (TSE) for various new applications.

Indexed as

Chemistry, PharmaceuticalTechnology, PharmaceuticalDrug CompoundingDrug IndustryHot Melt Extrusion TechnologyHot Temperature3D printingcontinuous manufacturinghot-melt extrusionnanoextrusionscale-uptwin-screw granulation

Identifiers

PMID38355916
OpenAlexW4391805850

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.