Evidence map›Paper›PMID 32155962›Full record

ArticlePharmaceutics2020

A Rational Design of a Biphasic DissolutionSetup-Modelling of Biorelevant Kinetics for a Ritonavir Hot-Melt Extruded Amorphous Solid Dispersion.

Alexander Denninger, Ulrich Westedt, Jörg Rosenberg, Karl G Wagner

Abstract read
In one paragraph

Article in Pharmaceutics, 2020. 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. From prediction to performance:International journal of pharmaceutics: X · 2026
    Article
  2. Article
  3. Liquisolids as a platform for the formulation of cannabis tablets.International journal of pharmaceutics: X · 2026
    Article
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  5. Review
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  14. International journal of pharmaceutics: X · 2021
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  15. Review
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  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

4 authors.

Alexander DenningerDepartment of Pharmaceutical Technology and Biopharmaceutics, University of Bonn, Gerhard-Domagk-Strasse 3, 53121 Bonn, Germany.
Ulrich WestedtAbbVie Deutschland GmbH & Co. KG, Knollstrasse 50, D-67061 Ludwigshafen, Germany.
Jörg RosenbergAbbVie Deutschland GmbH & Co. KG, Knollstrasse 50, D-67061 Ludwigshafen, Germany.
Karl G WagnerDepartment of Pharmaceutical Technology and Biopharmaceutics, University of Bonn, Gerhard-Domagk-Strasse 3, 53121 Bonn, Germany.

Funding

AbbVie Deutschland not available
6 · The paper itself

Abstract

Biphasic dissolution systems achieved good predictability for the in vivo performance of several formulations of poorly water-soluble drugs by characterizing dissolution, precipitation, re-dissolution, and absorption. To achieve a high degree of predictive performance, acceptor media, aqueous phase composition, and the apparatus type have to be carefully selected. Hence, a combination of 1-decanol and an optimized buffer system are proposed as a new, one-vessel biphasic dissolution method (BiPHa+). The BiPHa+ was developed to combine the advantages of the well-described biorelevance of the United States Pharmacopeia (USP) apparatus II coupled with USP apparatus IV and a small-scale, one-vessel method. The BiPHa+ was designed for automated medium addition and pH control of the aqueous phase. In combination with the diode array UV-spectrophotometer, the system was able to determine the aqueous and the organic medium simultaneously, even if scattering or overlapping of spectra occurred. At controlled hydrodynamic conditions, the relative absorption area, the ratio between the organic and aqueous phase, and the selected drug concentrations were identified to be the discriminating factors. The performance of a hot-melt extruded ritonavir-containing amorphous solid dispersion (ritonavir-ASD) was compared in fasted-state dissolution media leading to different dissolution-partitioning profiles depending on the content of bile salts. An advanced kinetic model for ASD-based well described all phenomena from dispersing of the ASD to the partitioning of the dissolved ritonavir into the organic phase.

Indexed as

biorelevant mediabiphasic dissolutionhot melt extruded amorphous solid dispersionkinetic modellingliquid-liquid-phase-separation

Identifiers

PMID32155962
PMCPMC7150762

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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.