Evidence map›Paper›PMID 34977558›Full record

ArticleInternational journal of pharmaceutics: X2021

Silicone elastomer formulations for improved performance of a multipurpose vaginal ring releasing dapivirine and levonorgestrel.

Yahya H Dallal Bashi, Diarmaid J Murphy, Clare F McCoy, Peter Boyd, Leeanne Brown, Matthew Kihara, François Martin, Nicole McMullen, Kyle Kleinbeck, Bindi Dangi and 4 more

Open access · goldAbstract read
In one paragraph

Article in International journal of pharmaceutics: X, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.0field-weighted citation impact, top 21% 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

11 citing papers in PubMed, 18 citations in OpenAlex.

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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

14 authors at 2 institutions in 2 countries.

Yahya H Dallal BashiSchool of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK.
Diarmaid J MurphySchool of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK.
Clare F McCoySchool of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK.
Peter BoydSchool of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK.
Leeanne BrownElkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA.
Matthew KiharaElkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA.
François MartinElkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA.
Nicole McMullenElkem Silicones, Two Tower Centre Boulevard, Suite 1802, East Brunswick, NJ 08816, USA.
Kyle KleinbeckInternational Partnership for Microbicides, Silver Spring, MD 2910, USA.
Bindi DangiInternational Partnership for Microbicides, Silver Spring, MD 2910, USA.
Patrick SpenceInternational Partnership for Microbicides, Silver Spring, MD 2910, USA.
Bashir HansrajInternational Partnership for Microbicides, Silver Spring, MD 2910, USA.
Brid DevlinInternational Partnership for Microbicides, Silver Spring, MD 2910, USA.
R Karl MalcolmSchool of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK.
International Partnership for Microbicides · USQueen's University Belfast · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A dapivirine-releasing silicone elastomer vaginal ring for reducing women's risk of HIV acquisition has recently been approved. A next-generation multipurpose vaginal ring releasing dapivirine and levonorgestrel is currently in development, offering hormonal contraception and HIV prevention from a single device. Previously, we reported challenges with incorporating levonorgestrel into rings manufactured from addition-cure silicone elastomers due to an irreversible chemical reaction between the levonorgestrel molecule and the hydride-functionalised crosslinker component of the silicone elastomer formulation, leading to low drug content assay, cure inhibition, and reduced ring mechanical properties (which may account for the increased incidence of ring expulsion in vivo). Here, we report on the development and testing of various custom silicone elastomer materials specifically formulated to circumvent these issues. After extensive testing of the custom silicones and subsequent manufacture and testing (Shore M hardness, pot life, content assay, oscillatory rheology, mechanical testing) of rings containing both dapivirine and levonorgestrel, a lead candidate formulation was selected that was amenable to practical ring manufacture via injection molding, exhibited no substantial levonorgestrel binding, and offered suitable mechanical properties.

Indexed as

HIV microbicideHormonal contraceptionMechanical propertiesMultipurpose prevention technology (MPT)RheologySilicone elastomerVaginal rings

Identifiers

PMID34977558
PMCPMC8683669
OpenAlexW3184660114

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.