Evidence map›Paper›PMID 41184547›Full record

ArticlePharmaceutical research2025

Drum Filling of Thin-Film Freeze-Dried Monoclonal Antibody Powder in UniDose Powder Nasal Spray System.

Michael A Sandoval, Miguel O Jara, Thomas Henry, Bhupendra R Giri, David Wilcox, Alan B Watts, Robert O Williams, Zhengrong Cui

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

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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

1 citing paper in PubMed.

  1. 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.

Michael A SandovalDivision of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, 78712, USA.
Miguel O JaraDivision of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, 78712, USA.
Thomas HenryCatalent Pharma Solutions, Inc, Morrisville, NC, 27560, USA.
Bhupendra R GiriDivision of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, 78712, USA.
David WilcoxCatalent Pharma Solutions, Inc, Morrisville, NC, 27560, USA.
Alan B WattsCatalent Pharma Solutions, Inc, Morrisville, NC, 27560, USA. alan.watts@catalent.com.
Robert O WilliamsDivision of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, 78712, USA. bill.williams@austin.utexas.edu.
Zhengrong CuiDivision of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, 78712, USA. zhengrong.cui@austin.utexas.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIntranasal delivery of monoclonal antibodies (mAb) offers an attractive approach for preventing or treating respiratory viral infections. Previously, we showed that thin-film freeze-dried powder (TFFD powder) of AUG-3387, an anti-SARS-CoV-2 spike protein mAb, could be sprayed into the posterior nasal cavity region of a nasal cast model using Aptar's unidose powder (UDSp) nasal spray system. This work investigated the feasibility of filling TFFD mAb powders into the UDSp system using drum filling.

methodsNew TFFD AUG-3387 powders were prepared by including magnesium stearate and/or hydroxypropyl methylcellulose in them. The powders were comminuted and their flow properties measured. A selected powder was filled into UDSp systems using a Harro Höfliger Drum TT benchtop filler or a Quantos hand-held powder dispenser at target fill weights of 0.5 and 1.0 mg, and the performance of the filled systems was evaluated.

resultsThe F8 TFFD AUG-3387 powder was selected for drum filling due to its 'passable' to 'excellent' flowability and its minimal sensitivity to controlled moisture exposure. Drum filling succeeded at both target fill weights, consistently compacting the powder into pucks without ejection failures. The average fill weight was 0.54 ± 0.09 mg for the 0.5 mg target and 1.11 ± 0.08 mg for the 1.0 mg target. The drum-filled UDSp systems performed similarly to the Quantos-filled systems in shot weight uniformity, emitted particle size, and deposition in a nasal cast, although differences were observed in certain spray characteristics.

conclusionsIt is feasible to drum fill TFFD mAb powder at low fill weights.

Indexed as

Antibodies, MonoclonalNasal SpraysAdministration, IntranasalCOVID-19 Drug TreatmentDrug CompoundingFreeze DryingHumansHypromellose DerivativesParticle SizePowdersStearic AcidsAntibodies, MonoclonalHypromellose DerivativesNasal SpraysPowdersstearic acidStearic Acidsdrum fillingdry powderfreeze-dryingintranasalmonoclonal antibody

Identifiers

PMID41184547

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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.