Evidence map›Paper›PMID 22798037›Full record

ReviewAAPS PharmSciTech2012

Challenges with developing in vitro dissolution tests for orally inhaled products (OIPs).

Trevor Riley, David Christopher, Jan Arp, Andrea Casazza, Agnes Colombani, Andrew Cooper, Monisha Dey, Janet Maas, Jolyon Mitchell, Maria Reiners and 3 more

Abstract readReview
In one paragraph

Review in AAPS PharmSciTech, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing 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

32 citing papers in PubMed.

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  14. RespiCellPharmaceutics · 2021
    Article
  15. Review
  16. Optimization of the TranswellPharmaceutics · 2021
    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

13 authors.

Trevor RileyInhaled Product & Device Technology, GlaxoSmithKline, Hertfordshire, UK.
David Christopher
Jan Arp
Andrea Casazza
Agnes Colombani
Andrew Cooper
Monisha Dey
Janet Maas
Jolyon Mitchell
Maria Reiners
Nastaran Sigari
Terrence Tougas
Svetlana Lyapustina

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this article is to review the suitability of the analytical and statistical techniques that have thus far been developed to assess the dissolution behavior of particles in the respirable aerodynamic size range, as generated by orally inhaled products (OIPs) such as metered-dose inhalers and dry powder inhalers. The review encompasses all analytical techniques publicized to date, namely, those using paddle-over-disk USP 2 dissolution apparatus, flow-through cell dissolution apparatus, and diffusion cell apparatus. The available techniques may have research value for both industry and academia, especially when developing modified-release formulations. The choice of a method should be guided by the question(s) that the research strives to answer, as well as by the strengths and weaknesses of the available techniques. There is still insufficient knowledge, however, for translating the dissolution data into statements about quality, performance, safety, or efficacy of OIPs in general. Any attempts to standardize a dissolution method for compendial inclusion or compendial use would therefore be premature. This review reinforces and expands on the 2008 stimulus article of the USP Inhalation Ad Hoc Advisory Panel, which "could not find compelling evidence suggesting that such dissolution testing is kinetically and/or clinically crucial for currently approved inhalation drug products."

Indexed as

Administration, InhalationAdministration, OralAerosolsPharmaceutical PreparationsSolubilityAerosolsPharmaceutical Preparations

Identifiers

PMID22798037
PMCPMC3429693

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.