Evidence map›Paper›PMID 34666142›Full record

ArticleInternational journal of pharmaceutics2021

Effect of crosslinking on the physicochemical properties of polydimethylsiloxane-based levonorgestrel intrauterine systems.

Suraj Fanse, Quanying Bao, Yuan Zou, Yan Wang, Diane J Burgess

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
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

5 authors.

Suraj FanseUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, USA.
Quanying BaoUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, USA.
Yuan ZouOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20993, USA.
Yan WangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20993, USA.
Diane J BurgessUniversity of Connecticut, School of Pharmacy, Storrs, CT 06269, USA. Electronic address: d.burgess@uconn.edu.

Funding

FDA HHS U01 FD005443
6 · The paper itself

Abstract

Polydimethylsiloxane (PDMS)-based levonorgestrel intrauterine systems (LNG-IUSs) such as Mirena® are long-acting drug-device combination products designed to release LNG for contraceptive purposes up to 6 years. LNG-IUSs consist of a hollow cylindrical drug-PDMS reservoir mounted with a polyethylene frame and covered by an outer PDMS membrane. PDMS is the release-controlling excipient present in both the matrix and the outer membrane. The degree of PDMS crosslinking is a key parameter in LNG-IUS manufacturing, dictating the elasticity and mechanical strength (which are critical parameters in molding and demolding of the cylindrical reservoirs). In addition, elasticity and mechanical strength are also important to prevent deformation during insertion into the uterine cavity. The objectives of this study were to investigate the impact of PDMS crosslinking on the physicochemical properties of LNG-IUSs and to develop appropriate testing methods for characterization of their mechanical strength. Formulations with different degrees of crosslinking were prepared by varying the ratio of the PDMS elastomer base and the crosslinking agent. A novel solvent swelling and extraction method was developed to determine the degree of PDMS crosslinking. The extent of crosslinking was also characterized via FTIR, Raman,

Indexed as

Contraceptive Agents, FemaleIntrauterine Devices, MedicatedDimethylpolysiloxanesFemaleHumansLevonorgestrelUterusContraceptive Agents, FemaleDimethylpolysiloxanesLevonorgestrelCrosslinkingDynamic mechanical analysisIntrauterine deviceLevonorgestrelPhysicochemical characterizationPolydimethylsiloxane

Identifiers

PMID34666142
PMCPMC9236551

What OpenQuestion holds

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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.