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.

中文翻译：

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一种聚合物薄膜的定量分解方法。

目的 目前聚合物薄膜的体外崩解方法是定性的，并引入了显着的用户偏见。这些研究的目的是开发一种新颖的定量崩解技术，可用于在体外表征聚合物薄膜。方法 使用质地分析仪仪器开发了一种评估薄膜崩解度的方法。在这些研究中使用了溶剂浇注的、临床先进的、抗 HIV 的阴道膜以及市售的阴道膜。方法开发遵循质量源于设计 (QbD) 流程，用于评估薄膜产品。结果 目前开发的方法为市售阴道避孕膜（57.88 ± 5.98 秒）提供了可重复的定量崩解时间。它根据崩解时间区分了两种临床先进的抗逆转录病毒薄膜（p 值 < 0.001）；替诺福韦片（41.28 ± 3.35 秒）和达匹韦林片（88.36 ± 10.61 秒）。该方法还可以区分根据崩解时间在体积 (p<0.0001) 和配方 (p<0.0001) 方面发生变化的替诺福韦和达匹韦林薄膜。结论 该方法可用于药用薄膜，以作为有力体外表征的一部分。测试的参数可以根据应用或指示的位置进行更改。该方法还可以区分根据崩解时间在体积 (p<0.0001) 和配方 (p<0.0001) 方面发生变化的替诺福韦和达匹韦林薄膜。结论 该方法可用于药用薄膜，以作为有力体外表征的一部分。测试的参数可以根据应用或指示的位置进行更改。该方法还可以区分根据崩解时间在体积 (p<0.0001) 和配方 (p<0.0001) 方面发生变化的替诺福韦和达匹韦林薄膜。结论 该方法可用于药用薄膜，以作为有力体外表征的一部分。测试的参数可以根据应用或指示的位置进行更改。