Evidence map›Paper›PMID 39375241›Full record

ArticlePharmaceutical research2024

Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques.

Gonçalo Farias, William J Ganley, Robert Price, Denise S Conti, Sharad Mangal, Elizabeth Bielski, Bryan Newman, Jagdeep Shur

Abstract read
PubMed Full text at PMC Publisher
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
–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

2 citing papers in PubMed.

  1. Article
  2. Article
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.

Gonçalo FariasPharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, UK. goncalo.farias01@aptar.com.ORCID http://orcid.org/0000-0001-9717-4565
William J GanleyPharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, UK.
Robert PricePharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, UK.
Denise S ContiOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Sharad MangalOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Elizabeth BielskiOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Bryan NewmanOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Jagdeep ShurPharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, UK.

Funding

Center for Drug Evaluation and Research HHSF223201710116C
6 · The paper itself

Abstract

purposeFor locally-acting dry powder inhalers (DPIs), developing novel analytical tools that are able to evaluate the state of aggregation may provide a better understanding of the impact of material properties and processing parameters on the in vivo performance. This study explored the utility of the Morphologically-Directed Raman Spectroscopy (MDRS) and dissolution as orthogonal techniques to assess microstructural equivalence of the aerosolized dose of DPIs collected with an aerosol collection device.

methodsCommercial DPIs containing different strengths of Fluticasone Propionate (FP) and Salmeterol Xinafoate (SX) as monotherapy and combination products were sourced from different regions. These inhalers were compared with aerodynamic particle size distribution (APSD), dissolution, and MDRS studies.

resultsAPSD testing alone might not be able to explain differences reported elsewhere in in vivo studies of commercial FP/SX drug products with different Advair® strengths and/or batches. Dissolution studies demonstrated different dissolution rates between Seretide™ 100/50 and Advair® 100/50, whereas Flixotide™ 100 and Flovent® 100 had similar dissolution rates between each other. These differences in dissolution profiles were supported by MDRS results: the dissolution rate is increased if the fraction of FP associated with high soluble components is increased. Principle component analysis was used to identify the agglomerate classes that better discriminate different products.

conclusionsMDRS and dissolution studies of the aerosolized dose of DPIs were successfully used as orthogonal techniques. This study highlights the importance of further assessing in vitro tools that are able to provide a bridge between material attributes or process parameters and in vivo performance.

Indexed as

AerosolsDry Powder InhalersFluticasoneParticle SizeSalmeterol XinafoateSolubilitySpectrum Analysis, RamanAdministration, InhalationBronchodilator AgentsChemistry, PharmaceuticalDrug CompoundingFluticasone-Salmeterol Drug CombinationPowdersAerosolsBronchodilator AgentsFluticasoneFluticasone-Salmeterol Drug CombinationPowdersSalmeterol Xinafoatebioequivalencedissolutiondry powder inhalerorthogonal analytical techniquesraman spectroscopy

Identifiers

PMID39375241
PMCPMC11530509

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Registered trials

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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.