Evidence map›Paper›PMID 37936014›Full record

ArticlePharmaceutical research2024

Use of Resonant Acoustic Mixing Technology for Ultra-Low-Dose Blending in a Single-Step Mixing Process.

Kyle A Frey, Helen Baker, Dale K Purcell, Andrew L Lewis, David A Engers

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2024. 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
1.0field-weighted citation impact, top 27% 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, 9 citations in OpenAlex.

  1. Article
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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

5 authors at 1 institution in 1 country.

Kyle A FreyPharmaceutical Sciences, Quotient Sciences, 3080 McCann Farm Dr, Garnet Valley, PA, 19060, USA. kyle.frey@quotientsciences.com.ORCID http://orcid.org/0000-0003-1361-4960
Helen BakerPharmaceutical Sciences, Quotient Sciences, 3080 McCann Farm Dr, Garnet Valley, PA, 19060, USA.
Dale K PurcellAnalytical Microscopy and Microanalysis, Chemical Microscopy, West Lafayette, IN, USA.
Andrew L LewisPharmaceutical Sciences, Quotient Sciences, 3080 McCann Farm Dr, Garnet Valley, PA, 19060, USA.
David A EngersPharmaceutical Sciences, Quotient Sciences, 3080 McCann Farm Dr, Garnet Valley, PA, 19060, USA.
Quotient Clinical (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the use of resonant acoustic mixing (RAM) technology for homogenous blending of a morphologically challenging model API in low-dose concentrations (<0.1% w/w), and assess the potential for blend uniformity (BU) optimization.

methodsCaffeine (CAF) mixing was carried out using a LabRAM I benchtop mixer. Uniformity was assessed under a range of mixing conditions and sample preparation procedures in order to optimize system performance. The capacity for microscale mixing was evaluated from final parameters for 0.05% and 0.0125% CAF blends.

resultsUpon optimization, RAM was able to accurately prepare homogeneous mixtures of <0.1% CAF in dilutions of up to 1 part per 8,000. Results from a 0.05% blend targeting 125 μg CAF dosage amounts revealed an AV score of 8.8 while a 0.0125% w/w blend accurately prepared 25 μg of CAF with 99.3% accuracy (98.7% label claim) and AV of 10.1. Microscale mixing in the 0.05% w/w blend was confirmed from plots of BU data against sample size demonstrating a slope of 0.05 within the range of 250-10 mg sample (125-5 μg CAF). L1 BU criteria only failed at the level of 2 μg CAF, despite target precision to 26 nanograms (98.7% label claim).

conclusionsThis study presents the first instance of a homogenously mixed <0.1% (w/w) blend using RAM technology and demonstrate the suitability for reproducible dosing of single-digit microgram drug amounts. Uniformity is documented for API amounts 60x smaller than a recent report has shown and 10,000x smaller than achieved previously with CAF.

Indexed as

TechnologyTechnology, PharmaceuticalAcousticsParticle SizePowdersPowdersacicular morphologyblend uniformitycaffeineResonant Acoustic Mixing (RAM)ultra-low dose

Identifiers

PMID37936014
OpenAlexW4388449183

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.