Evidence map›Paper›PMID 32060670›Full record

ArticleThe AAPS journal2020

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products.

Robert Price, Jagdeep Shur, William Ganley, Gonçalo Farias, Nikoletta Fotaki, Denise S Conti, Renishkumar Delvadia, Mohammad Absar, Bhawana Saluja, Sau Lee

Abstract read
In one paragraph

Article in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Trial
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  8. Review
  9. Article
  10. Review
  11. RespiCellPharmaceutics · 2021
    Article
  12. Optimization of the TranswellPharmaceutics · 2021
    Article
  13. 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

10 authors.

Robert PricePharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, BA2 7AY, UK. r.price@bath.ac.uk.
Jagdeep ShurPharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, BA2 7AY, UK.
William GanleyPharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, BA2 7AY, UK.
Gonçalo FariasPharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, BA2 7AY, UK.
Nikoletta FotakiPharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, BA2 7AY, UK.
Denise S ContiOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Renishkumar DelvadiaOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Mohammad AbsarOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Bhawana SalujaOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Sau LeeOffice of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of the study was to develop a robust and standardized in vitro dissolution methodology for orally inhaled drug products (OIDPs). An aerosol dose collection (ADC) system was designed to uniformly deposit the whole impactor stage mass (ISM) over a large filter area for dissolution testing. All dissolution tests were performed under sink conditions in a sodium phosphate buffered saline solution containing 0.2%w/w sodium dodecyl sulphate. An adapted USP Apparatus V, Paddle over Disk (POD), was used throughout the study. The dissolution characteristics of the ISM dose of a commercial metered-dose inhaler (MDI) and a range of dry powder inhaler (DPI) formulations containing inhaled corticosteroids were tested. The uniform distribution of the validated ISM dose considerably reduced drug loading effects on the dissolution profiles for both MDI and DPI formulations. The improvement in the robustness and discriminatory capability of the technique enabled characterization of dissolution rate differences between inhaler platforms and between different DPI product strengths containing fluticasone propionate. A good correlation between in vivo mean absorption time and in vitro dissolution half-life was found for a range of the inhaled corticosteroids. The ADC system and the reproducible in vitro POD dissolution measurements provided a quantitative-based approach for measuring the relationship between the influence of device and the dispersion characteristics on the aerosol dissolution of low solubility compounds. The in vitro dissolution method could potentially be applied as a dissolution methodology for compendial, quality control release testing, and during development of both branded orally inhaled drug products and their generic counterparts.

Indexed as

Administration, InhalationAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAerosolsDrug CombinationsDrug CompoundingDrug LiberationDry Powder InhalersKineticsMetered Dose InhalersSolubilityTherapeutic EquivalencyAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAerosolsDrug Combinationsaerosolbioequivalencedissolutioninhaled corticosteroids

Identifiers

PMID32060670
PMCPMC7021740

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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.