Oral thin films are a novel drug delivery system that is gaining popularity due to their convenience, ease of administration, and rapid onset of action. As with any pharmaceutical product, it is essential to characterize the mechanical properties of oral thin films to ensure thin film products' performance and stability. Combined with the basic characteristics of oral thin film, CD Formulation comprehensively characterizes the mechanical properties of oral thin film based on ICH quality guidelines.
Our experienced team of experts uses state-of-the-art testing equipment and technology to ensure accurate and reliable results. Our oral thin film mechanical properties characterization services include folding endurance testing, tear resistance testing, tensile strength testing, thickness testing, Young's modulus testing, etc.
Folding endurance represents the brittleness of the thin film, that is, the number of folds that break or have obvious creases after folding in the same position, the fewer the number of folds, the higher the brittleness of the oral thin film.
Tear resistance testing is used to assess the ability of oral thin film to withstand tearing forces. This test measures the force required to tear the thin film material and provides insights into its strength and durability. Tear resistance testing of oral thin film ensures that the thin film maintains integrity during handling, packaging, and administration to patients.
Tensile strength, also known as the strength limit, refers to the maximum force used when pulling off oral thin film.
The thickness of the oral thin film is usually controlled within 10 - 100 μm to ensure good mechanical strength and solubility.
Percentage elongation in oral thin film is a measure of how much the thin film can stretch before it breaks. A higher percentage elongation indicates that the thin film can stretch further before breaking, making it more flexible and resistant to damage.
Young's modulus testing of oral thin film is a crucial evaluation method used to measure the stiffness and elasticity of thin film. Young's modulus is a material property that describes how a material deforms under stress and is an important parameter for understanding the mechanical behavior of oral thin film.
Technology: In vitro evaluation of adhesion and mechanical properties
Journal: European Journal of Pharmaceutical Sciences
IF: 5.1
Published: 2021
Results: In this study, we examined the film samples for their physico-mechanical properties to obtain a tangible and practical range of mechanical values for pharmaceutical OTFs using the puncture test and folding endurance test. We found a breaking factor above 34.5 N/mm, elongation to puncture less than 5.55% and folding endurance of at least 50 folds can be used as a starting point when designing and manufacturing OTFs.
Fig.1 In vitro evaluation of mechanical properties of oral thin films. (Samaneh Alaei, et al., 2021)
CD Formulation is committed to innovation and continuous improvement, always staying at the forefront of the oral thin film industry. We provide reliable test results and valuable insights into the mechanical properties characterization of oral thin films to help our customers enhance the development and commercialization of oral thin film products. If you have a requirement about our oral thin film mechanical properties characterization services, please contact us by phone or email, and our colleagues will reply to you within three working days.
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