Evidence map›Paper›PMID 31525446›Full record

ArticleEuropean journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2019

Modelling the intradermal delivery of microneedle array patches for long-acting antiretrovirals using PBPK.

Rajith K R Rajoli, Charles Flexner, Justin Chiong, Andrew Owen, Ryan F Donnelly, Eneko Larrañeta, Marco Siccardi

Open access · greenAbstract read
In one paragraph

Article in European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.3field-weighted citation impact, top 13% 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

22 citing papers in PubMed, 51 citations in OpenAlex.

  1. Article
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  3. A closed-loop microneedle-integrated physiological model for predictive glycemic management.Proceedings of the National Academy of Sciences of the United States of America · 2025
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  15. The LEAP Process: Streamlining the Development of Long-Acting Products and Formulations for Infectious Diseases.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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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

7 authors at 3 institutions in 2 countries.

Rajith K R RajoliDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. Electronic address: rkrajoli@liverpool.ac.uk.
Charles FlexnerJohns Hopkins University School of Medicine and Bloomberg School of Public Health, Baltimore, MD, USA.
Justin ChiongDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Andrew OwenDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Ryan F DonnellySchool of Pharmacy, Queen's University Belfast, Medical Biology Centre, Belfast, UK.
Eneko LarrañetaSchool of Pharmacy, Queen's University Belfast, Medical Biology Centre, Belfast, UK.
Marco SiccardiDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. Electronic address: siccardi@liverpool.ac.uk.
University of Liverpool · GBQueen's University Belfast · GBJohns Hopkins University · US

Funding

The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)UM1AI069465 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner, Amita Gupta · 2012 to 2026
$34.1M
The Long-Acting/Extended Release Antiretroviral Resource Program (LEAP)R24AI118397 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner · 2015 to 2026
$9.4M
NIAID NIH HHS R24 AI118397NIAID NIH HHS UM1 AI069465
6 · The paper itself

Abstract

introductionExisting HIV therapy using oral antiretrovirals (ARVs) can result in pill fatigue and sub-optimal adherence. Microneedle array patches (MAPs) offer non-invasive, blood-free and painless drug delivery, and may improve patient adherence. The objective of this study was to develop a novel physiologically-based pharmacokinetic (PBPK) model to simulate the systemic pharmacokinetics of cabotegravir and rilpivirine MAPs using the intradermal route.

methodsThe developed PBPK models were qualified against observed pharmacokinetic data after intramuscular (IM) and intradermal administration of long-acting nanoformulated rilpivirine to rats, and for IM administration of both drugs to healthy adults. Qualified models were then utilised to estimate suitable MAP characteristics (e.g. nanoformulation dose and release rates) and inform dosing strategies to maintain plasma concentrations above target trough concentrations for the designated dosing interval.

resultsPBPK models simulated q4-weekly loading and maintenance doses of 360 mg and 180 mg for long-acting formulated cabotegravir between the release rates of 1 × 10 DISCUSSION: This model estimated optimal dose and release rates for cabotegravir and rilpivirine MAPs. Our approach provides a computational platform to support rational development of intradermal administration strategies to tackle problems associated with chronic oral ARV administration.

Indexed as

AdolescentAdultAnimalsAnti-Retroviral AgentsDrug Delivery SystemsFemaleHIV InfectionsHumansInjections, IntradermalMaleMiddle AgedNeedlesRatsRilpivirineYoung AdultAnti-Retroviral AgentsRilpivirineAntiretroviralIntradermalLong-actingMicroneedlePatchPBPK

Identifiers

PMID31525446
PMCPMC6917207
OpenAlexW2972898444

What OpenQuestion holds

Textmetadata
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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.