Development of a new method for analyzing the behavior of rapidly dissolving films in contact with liquids
Oral Thin Film (OTF) is a promising dosage form, easy to use and patient-friendly drug delivery systems suitable for every consumer profile. This dosage form ensures safety, stability, and acceptability of the drug, that’s why it can be a good alternative for tablets and capsules for children and elderly therapies. As no detailed monography of OTFs including characterization methods and uniform requirements has been presented in any of the pharmacopoeias to date, this study focuses on the development of an innovative analyzing method to characterize the OTF behavior and particularly to determine its disintegration time by goniometry. These parameters are key for the development of OTFs and for studying, at an early stage, the impact of formulation and process variables on product quality and impacting Critical Quality Attributes (CQA) by a Quality by Design approach.
Highlights
- New analytical method for determining the disintegration time of oral thin film by goniometry.
- Better repeatability than the current method adapted from Pharmacopeia tablet monography.
- Additional information on the wettability properties and film behavior in contact with liquids to optimize film formulation.
Different model OTF preparations were investigated as models to determine the suitability of the disintegration test systems. These placebos OTF were used to compare the disintegration times obtained by the tablets pharmacopeial method (conducted in 800mL of distilled water) and the novel proposed method. As expected, the disintegration times determined by the proposed method were similar than those obtained by the conventional disintegration test. Moreover, they seem more reliable to the in vivo behavior because of the small amount of solvent used. The experiments showed acceptable reproducibility (low variation within sample replicates due to a well-defined determination of the measurement endpoint). This method provides clear endpoint detection and is applicable for different types of OTFs based on different polymers. Moreover, a better understanding of the physical-chemical properties of oral thin films towards water could be obtained. This new method of analysis could provide a valuable approach to the development of new OTF formulas, thanks to the different information that can be obtained, such as critical energy, free energy and polar and dispersive components.
Read more here
Mathieu Reuther, Nicolas Rollet, Frédéric Debeaufort, Odile Chambin, Development of a new method for analyzing the behavior of rapidly dissolving films in contact with liquids., Journal of Drug Delivery Science and Technology,
2024, 106205, ISSN 1773-2247, https://doi.org/10.1016/j.jddst.2024.106205.
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CPHI Milan 2024 – with a focus on excipients
