Evidence map›Paper›PMID 35057103›Full record

ArticlePharmaceutics2022

Tablet Disintegration and Dispersion under In Vivo-like Hydrodynamic Conditions.

Jan Lenz, Frederik Fuest, Jan Henrik Finke, Heike Bunjes, Arno Kwade, Michael Juhnke

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2022. 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
0.5field-weighted citation impact, top 44% of its field
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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. 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

6 authors at 3 institutions in 2 countries.

Jan LenzTechnical Research & Development, Novartis Pharma AG, Fabrikstrasse 2, CH-4056 Basel, Switzerland.ORCID 0000-0001-8192-1685
Frederik FuestResearch & Development, LaVision GmbH, Anna-Vandenhoeck-Ring 19, D-37081 Göttingen, Germany.
Jan Henrik FinkeInstitut für Partikeltechnik, Technische Universität Braunschweig, Volkmaroder Strasse 5, D-38104 Braunschweig, Germany.ORCID 0000-0001-6936-9795
Heike BunjesZentrum für Pharmaverfahrenstechnik-PVZ, Technische Universität Braunschweig, Franz-Liszt-Strasse 35a, D-38106 Braunschweig, Germany.ORCID 0000-0002-8670-6076
Arno KwadeInstitut für Partikeltechnik, Technische Universität Braunschweig, Volkmaroder Strasse 5, D-38104 Braunschweig, Germany.ORCID 0000-0002-6348-7309
Michael JuhnkeTechnical Research & Development, Novartis Pharma AG, Fabrikstrasse 2, CH-4056 Basel, Switzerland.
Technische Universität Braunschweig · DENovartis (Switzerland) · CHLaVision (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Disintegration and dispersion are functional properties of tablets relevant for the desired API release. The standard disintegration test (SDT) described in different pharmacopoeias provides only limited information on these complex processes. It is considered not to be comparable to the biorelevant conditions due to the frequent occurrence of high hydrodynamic forces, among other reasons. In this study, 3D tomographic laser-induced fluorescence imaging (3D Tomo-LIF) is applied to analyse tablet disintegration and dispersion. Disintegration time (DT) and time-resolved particle size distribution in close proximity to the tablet are determined in a continuously operated flow channel, adjustable to very low fluid velocities. A case study on tablets of different porosity, which are composed of pharmaceutical polymers labelled with a fluorescent dye, a filler, and disintegrants, is presented to demonstrate the functionality and precision of the novel method. DT results from 3D Tomo-LIF are compared with results from the SDT, confirming the analytical limitations of the pharmacopoeial disintegration test. Results from the 3D Tomo-LIF method proved a strong impact of fluid velocity on disintegration and dispersion. Generally, shorter DTs were determined when cross-linked sodium carboxymethly cellulose (NaCMCXL) was used as disintegrant compared to polyvinyl polypyrrolidone (PVPP). Tablets containing Kollidon VA64 were found to disintegrate by surface erosion. The novel method provides an in-depth understanding of the functional behaviour of the tablet material, composition and structural properties under in vivo-like hydrodynamic forces regarding disintegration and the temporal progress of dispersion. We consider the 3D Tomo-LIF in vitro method to be of improved biorelevance in terms of hydrodynamic conditions in the human stomach.

Indexed as

disintegrantshydrodynamicsin vivo conditionspharmaceutical polymerstablet disintegrationtablet performancetomographic imaging

Identifiers

PMID35057103
PMCPMC8779444
OpenAlexW4206776232

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.