Evidence map›Paper›PMID 32679217›Full record

ArticleJournal of pharmaceutical sciences2020

Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts.

Michelle Cua, Daniel Martin, Patricia Meza, Gianni Torraca, Thomas Pearson, Shawn Cao, Changhuei Yang

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pharmaceutical sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 37% 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

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. 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

7 authors at 2 institutions in 1 country.

Michelle CuaCalifornia Institute of Technology, Electrical Engineering, Pasadena, CA 91125, USA. Electronic address: ecua@caltech.edu.
Daniel MartinCalifornia Institute of Technology, Electrical Engineering, Pasadena, CA 91125, USA. Electronic address: damartin@caltech.edu.
Patricia MezaAmgen Process Development, Thousand Oaks, CA 91320, USA.
Gianni TorracaAmgen Process Development, Thousand Oaks, CA 91320, USA.
Thomas PearsonAmgen Process Development, Thousand Oaks, CA 91320, USA.
Shawn CaoAmgen Process Development, Thousand Oaks, CA 91320, USA.
Changhuei YangCalifornia Institute of Technology, Electrical Engineering, Pasadena, CA 91125, USA.
Amgen (United States) · USCalifornia Institute of Technology · US

Funding

Predoctoral Biotechnology Leadership Training in Micro/NanomedicineT32GM112592 · NIGMS · CALIFORNIA INSTITUTE OF TECHNOLOGY · PI ARNOLD, FRANCES H · 2015 to 2019
$1.1M
NIGMS NIH HHS T32 GM112592
6 · The paper itself

Abstract

Prefilled syringes (PFSs) are commonly used for parenteral delivery of protein therapeutics. In PFSs, the inner surface of the syringe barrel is typically coated with silicone oil for lubrication. The total amount of silicone oil as well as its distribution can impact syringe functionality and particle formation. However, methods to non-destructively characterize the silicone oil distribution are limited. In this paper, we developed a method to visualize and quantify the relative distribution of silicone oil in unfilled syringes using a custom-built multi-color interferometric imaging system. We then applied the system in a preliminary study to investigate the impact of the silicone oil distribution on the number of particles formed in solution after filling and extrusion for two different types of syringes. The syringe type with significantly lower particle counts also exhibited significantly more homogeneous silicone oil distributions. Within syringe types, no significant association was found between silicone oil distribution and particle formation. Our method can be used in further studies that investigate the impact of syringe siliconization on PFS functionality and particle formation.

Indexed as

Silicone OilsSyringesLubricationSilicone OilsDrug delivery system(s)Image analysisImaging methods(s)InjectablesParticle size

Identifiers

PMID32679217
PMCPMC7572663
OpenAlexW3043690423

What OpenQuestion holds

Textmetadata
LicenceTDM
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.