Evidence map›Paper›PMID 30559901›Full record

ArticleJournal of pharmaceutical innovation2018

A Quantitative Disintegration Method for Polymeric Films.

Sheila Grab, Lisa C Rohan

Abstract read
In one paragraph

Article in Journal of pharmaceutical innovation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
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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

2 authors.

Sheila GrabDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Lisa C RohanDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.

Funding

Project-002U19AI120249 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L., ROHAN, LISA CENCIA · 2015 to 2019
$17.4M
Pharmaceutical and Regulatory CoreU19AI082639 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI FRIEND, DAVID R · 2010 to 2014
$13.0M
NIAID NIH HHS U19 AI082639NIAID NIH HHS U19 AI120249
6 · The paper itself

Abstract

purposeCurrent in vitro disintegration methods for polymeric films are qualitative and introduce significant user bias. The goal of these studies is to develop a novel, quantitative disintegration technique which can be used to characterize polymeric films in vitro.

methodsA method was developed using a Texture Analyzer instrument to evaluate film disintegration. Solvent casted, clinically advanced, anti-HIV, vaginal films as well as marketed vaginal films were used throughout these studies. Method development followed a Quality by Design (QbD) process and was used to evaluate film products.

resultsThe current method developed provided reproducible, quantitative disintegration times for the commercially available Vaginal Contraceptive Film (57.88 ± 5.98 sec.). It distinguished between two clinically advanced antiretroviral containing films based on disintegration time (p value < 0.001); the tenofovir film (41.28 ± 3.35 sec.) and the dapivirine film (88.36 ± 10.61 sec.). This method could also distinguish between tenofovir and dapivirine films which had been altered in terms of volume (p<0.0001) and formulation (p<0.0001) based on disintegration time.

conclusionsThis method can be applied for pharmaceutical films for ranging indications as part of vigorous in vitro characterization. Parameters of the test can be altered based on site of application or indication.

Indexed as

disintegrationPolymeric filmsquality by design (QbD)texture analyzer

Identifiers

PMID30559901
PMCPMC6294315

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