Evidence map›Paper›PMID 34683975›Full record

ArticlePharmaceutics2021

Amorphous Solid Dispersions (ASDs): The Influence of Material Properties, Manufacturing Processes and Analytical Technologies in Drug Product Development.

Raman Iyer, Vesna Petrovska Jovanovska, Katja Berginc, Miha Jaklič, Flavio Fabiani, Cornelius Harlacher, Tilen Huzjak, Manuel Vicente Sanchez-Felix

Abstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing 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

40 citing papers in PubMed.

  1. Article
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  7. A Novel FloatingGels (Basel, Switzerland) · 2026
    Article
  8. Review
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  10. Article
  11. Article
  12. Review
  13. Article
  14. CharacterizingMolecular pharmaceutics · 2025
    Article
  15. Article
  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

8 authors.

Raman IyerTechnical Research and Development, c/o Global Drug Development, Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936, USA.
Vesna Petrovska JovanovskaProduct Development, Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia.
Katja BergincProduct Development, Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia.
Miha JakličProduct Development, Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia.
Flavio FabianiTechnical Research and Development, c/o Global Drug Development, Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland.
Cornelius HarlacherTechnical Research and Development, c/o Global Drug Development, Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland.ORCID 0000-0002-4091-7759
Tilen HuzjakProduct Development, Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia.
Manuel Vicente Sanchez-FelixNovartis Institute for BioMedical Research, Cambridge, MA 02139, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Poorly water-soluble drugs pose a significant challenge to developability due to poor oral absorption leading to poor bioavailability. Several approaches exist that improve the oral absorption of such compounds by enhancing the aqueous solubility and/or dissolution rate of the drug. These include chemical modifications such as salts, co-crystals or prodrugs and physical modifications such as complexation, nanocrystals or conversion to amorphous form. Among these formulation strategies, the conversion to amorphous form has been successfully deployed across the pharmaceutical industry, accounting for approximately 30% of the marketed products that require solubility enhancement and making it the most frequently used technology from 2000 to 2020. This article discusses the underlying scientific theory and influence of the active compound, the material properties and manufacturing processes on the selection and design of amorphous solid dispersion (ASD) products as marketed products. Recent advances in the analytical tools to characterize ASDs stability and ability to be processed into suitable, patient-centric dosage forms are also described. The unmet need and regulatory path for the development of novel ASD polymers is finally discussed, including a description of the experimental data that can be used to establish if a new polymer offers sufficient differentiation from the established polymers to warrant advancement.

Indexed as

amorphous solid dispersionscharacterizationmanufacturing processesmaterial propertiesnovel stabilizing polymers

Identifiers

PMID34683975
PMCPMC8540358

What OpenQuestion holds

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LicenceCC BY
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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.