Evidence map›Paper›PMID 32737611›Full record

ArticlePharmaceutical research2020

Solvent-Assisted Secondary Drying of Spray-Dried Polymers.

Kimberly B Shepard, April M Dower, Alyssa M Ekdahl, Michael M Morgen, John M Baumann, David T Vodak

Open access · hybridAbstract read
In one paragraph

Article in Pharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 35% 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

2 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. 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

6 authors at 2 institutions in 2 countries.

Kimberly B ShepardResearch & Development, Lonza Pharma, Biotech and Nutrition, Bend, Oregon, USA. Kimberly.shepard@lonza.com.ORCID http://orcid.org/0000-0001-9298-7786
April M DowerProduct Development, Lonza Pharma, Biotech and Nutrition, Bend, Oregon, USA.
Alyssa M EkdahlDepartment of Chemical Engineering, University of Texas at Austin, Austin, Texas, USA.
Michael M MorgenResearch & Development, Lonza Pharma, Biotech and Nutrition, Bend, Oregon, USA.
John M BaumannResearch & Development, Lonza Pharma, Biotech and Nutrition, Bend, Oregon, USA.
David T VodakResearch & Development, Lonza Pharma, Biotech and Nutrition, Bend, Oregon, USA.
Lonza (United States) · USThe University of Texas at Austin · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this work is to introduce solvent-assisted secondary drying, a method used to accelerate the residual solvent removal from spray dried materials. Spray-drying is used to manufacture amorphous solid dispersions, which enhance the bioavailability of active pharmaceutical ingredients (APIs) with low aqueous solubility. In the spray-drying process, API and excipients are co-dissolved in a volatile organic solvent, atomized into droplets through a nozzle, and introduced to a drying chamber containing heated nitrogen gas. The product dries rapidly to form a powder, but small amounts of residual solvent (typically, 1 to 10 wt%) remain in the product and must be removed in a secondary-drying process. For some spray-dried materials, secondary drying by traditional techniques can take days and requires balancing stability risks with process time.

methodsSpray-dried polymers were secondary dried, comparing the results for three state-of-the-art methods that employed a jacketed, agitated-vessel dryer: (1) vacuum-only drying, (2) water-assisted drying, or (3) methanol-assisted drying. Samples of material were pulled at various time points and analyzed by gas chromatography (GC) and Karl Fischer (KF) titration to track the drying process.

resultsModel systems were chosen for which secondary drying is slow. For all cases studied, methanol-assisted drying outperformed the vacuum-only and water-assisted drying methods.

conclusionsThe observation that methanol-assisted drying is more effective than the other drying techniques is consistent with the free-volume theory of solvent diffusion in polymers.

Indexed as

DesiccationChromatography, GasDrug CompoundingExcipientsKineticsMass SpectrometryMethanolPolymersPowdersSolubilitySolventsVolatile Organic CompoundsWaterExcipientsMethanolPolymersPowdersSolventsVolatile Organic CompoundsWateramorphous solid dispersiondiffusioneudragit L100secondary dryingspray-drying

Identifiers

PMID32737611
PMCPMC7395053
OpenAlexW3046410489

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.