Evidence map›Paper›PMID 28799097›Full record

ArticlePharmaceutical research2017

Predicting Pulmonary Pharmacokinetics from In Vitro Properties of Dry Powder Inhalers.

Sharvari Bhagwat, Uta Schilling, Mong-Jen Chen, Xiangyin Wei, Renishkumar Delvadia, Mohammad Absar, Bhawana Saluja, Günther Hochhaus

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

20 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Optimization of the TranswellPharmaceutics · 2021
    Article
  12. Review
  13. Article
  14. Asian journal of pharmaceutical sciences · 2021
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Design and development of a biorelevant simulated human lung fluid.Journal of drug delivery science and technology · 2018
    Article
  20. 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.

Sharvari BhagwatCollege of Pharmacy, University of Florida, Gainesville, Florida, USA.
Uta SchillingCollege of Pharmacy, University of Florida, Gainesville, Florida, USA.
Mong-Jen ChenCollege of Pharmacy, University of Florida, Gainesville, Florida, USA.
Xiangyin WeiDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, Virginia, USA.
Renishkumar DelvadiaCDER, FDA, Silver Spring, Maryland, USA.
Mohammad AbsarCDER, FDA, Silver Spring, Maryland, USA.
Bhawana SalujaCDER, FDA, Silver Spring, Maryland, USA.
Günther HochhausCollege of Pharmacy, University of Florida, Gainesville, Florida, USA. Hochhaus@UFL.edu.ORCID http://orcid.org/0000-0002-7406-5558

Funding

U.S. Food and Drug Administration 1U01 FD004950-01
6 · The paper itself

Abstract

purposeThe ability of two semi-mechanistic simulation approaches to predict the systemic pharmacokinetics (PK) of inhaled corticosteroids (ICSs) delivered via dry powder inhalers (DPIs) was assessed for mometasone furoate, budesonide and fluticasone propionate.

methodsBoth approaches derived the total lung doses and the central to peripheral lung deposition ratios from clinically relevant cascade impactor studies, but differed in the way the pulmonary absorption rate was derived. In approach 1, the rate of in vivo drug dissolution/absorption was predicted for the included ICSs from in vitro aerodynamic particle size distribution and in vitro drug solubility estimates measured in an in vivo predictive dissolution medium. Approach 2 derived a first order absorption rate from the mean dissolution time (MDT), determined for the test formulations in an in vitro Transwell

resultsApproach 1 suggested PK profiles which agreed well with the published pharmacokinetic profiles. Similarly, within approach 2, input parameters for the pulmonary absorption rate constant derived from dissolution rate experiments were able to reasonably predict the pharmacokinetic profiles published in literature.

conclusionApproach 1 utilizes more complex strategies for predicting the dissolution/absorption process without providing a significant advantage over approach 2 with regard to accuracy of in vivo predictions.

Indexed as

Administration, InhalationAdrenal Cortex HormonesAnti-Inflammatory AgentsBronchodilator AgentsBudesonideDry Powder InhalersFluticasoneHumansLungModels, BiologicalMometasone FuroateAdrenal Cortex HormonesAnti-Inflammatory AgentsBronchodilator AgentsBudesonideFluticasoneMometasone Furoatedissolutioninhalationinhaled corticosteroidsin vitro/in vivosolubility

Identifiers

What OpenQuestion holds

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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.