Sheila Grab1,2, Lisa C Rohan1,2,3. 1. Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA. 2. Magee-Womens Research Institute, Pittsburgh, PA. 3. Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.
Abstract
PURPOSE: Current 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. METHODS: A 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. RESULTS: The 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. CONCLUSIONS: This 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.
PURPOSE: Current 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. METHODS: A 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. RESULTS: The 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. CONCLUSIONS: This 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.
Entities:
Keywords:
Polymeric films; disintegration; quality by design (QbD); texture analyzer
Authors: Anthony S Ham; Lisa Cencia Rohan; Ashlee Boczar; Lu Yang; Karen W Buckheit; Robert W Buckheit Journal: Pharm Res Date: 2012-03-06 Impact factor: 4.200
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