Evidence map›Paper›PMID 33803049›Full record

ArticlePharmaceutics2021

Particle Forming Amorphous Solid Dispersions: A Mechanistic Randomized Pharmacokinetic Study in Humans.

Andreas Schittny, Samuel Waldner, Urs Duthaler, Alexander Vorobyev, Rimma Abramovich, Stephan Krähenbühl, Maxim Puchkov, Jörg Huwyler

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03886766 (Bioavailability Mechanistic Study of Hot-Melt-Extruded Amorphous Solid Dispersions), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.1field-weighted citation impact, top 66% 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.

NCT03886766 nacompletednot on this map

Bioavailability Mechanistic Study of Hot-Melt-Extruded Amorphous Solid Dispersions

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2019 to 2020Enrolled16ConditionsBiological Availability, Amorphous Solid DispersionsArmsHot-melt extruded amorphous solid dispersion of Efavirenz, Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles, Efavirenz solution
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

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 at 2 institutions in 2 countries.

Andreas SchittnyDivision of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.ORCID 0000-0002-4588-2612
Samuel WaldnerDivision of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.
Urs DuthalerDivision of Clinical Pharmacology and Toxicology, Department of Biomedicine, University Hospital Basel and University of Basel, 4056 Basel, Switzerland.
Alexander VorobyevDepartment of Pharmtechnology, Faculty of Advanced Training of Medical Workers, Peoples' Friendship University of Russia (RUDN University), 117198 Moscow, Russia.
Rimma AbramovichDepartment of Pharmtechnology, Faculty of Advanced Training of Medical Workers, Peoples' Friendship University of Russia (RUDN University), 117198 Moscow, Russia.
Stephan KrähenbühlDivision of Clinical Pharmacology and Toxicology, Department of Biomedicine, University Hospital Basel and University of Basel, 4056 Basel, Switzerland.ORCID 0000-0001-8347-4145
Maxim PuchkovDivision of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.ORCID 0000-0002-7028-2774
Jörg HuwylerDivision of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.ORCID 0000-0003-1748-5676
University of Basel · CHPeoples' Friendship University of Russia · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Amorphous solid dispersions (ASDs) are a promising drug-delivery strategy to overcome poor solubility through formulation. Currently, the understanding of drug absorption mechanisms from ASDs in humans is incomplete. Aiming to gain insights in this matter, we conducted a randomized cross-over design open-label clinical study (NCT03886766) with 16 healthy male volunteers in an ambulatory setting, using micro-dosed efavirenz as a model drug. In three phases, subjects were administered (1) solid ASD of efavirenz 50 mg or (2) dissolved ASD of efavirenz 50 mg or (3) a molecular solution of efavirenz 3 mg (non-ASD) as a control in block-randomized order. Endpoints were the pharmacokinetic profiles (efavirenz plasma concentration vs. time curves) and derived pharmacokinetic parameters thereof (

Indexed as

amorphous solid dispersionsbioavailabilityclinical studyhot-melt extrusionpoorly soluble drugs

Identifiers

PMID33803049
PMCPMC8003007
OpenAlexW3138520763

What OpenQuestion holds

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Registered trials

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.