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 s). It distinguished between two clinically advanced antiretroviral containing films based on disintegration time (p value < 0.001): the tenofovir film (41.28 ± 3.35 s) and the dapivirine film (88.36 ± 10.61 s). 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.
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Acknowledgements
The current work was funded through the National Institute of Allergy and Infectious Diseases (grant numbers 5U19AI120249, 5U19AI082639) and the Bill & Melinda Gates Foundation. Tenofovir was graciously provided by CONRAD (Arlington, VA, USA), and dapivirine was graciously provided by the International Partnership for Microbicides (IPM, Silver Spring, MD, USA). We would like to acknowledge Jeanne Held of Texture Technologies for the guidance in the establishment of this method. We would also like to acknowledge Sravan Patel for his help in the preparation of this manuscript.
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Grab, S., Rohan, L.C. A Quantitative Disintegration Method for Polymeric Films. J Pharm Innov 13, 321–329 (2018). https://doi.org/10.1007/s12247-018-9325-1
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DOI: https://doi.org/10.1007/s12247-018-9325-1