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Oral Thin Film Mechanical Properties Characterization

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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.

Importance of Characterizing Oral Thin Film Mechanical Properties

  • Good mechanical properties help ensure the structural integrity and durability of the oral thin films during manufacturing, packaging, storage, and transportation.
  • Assessing factors such as tensile strength, elasticity and flexibility can guide optimization of thin film formulation to prevent problems such as tearing, cracking or brittleness.
  • The mechanical properties of oral thin films play a significant role in their performance and effectiveness in delivering medication or active ingredients. Proper characterization can adhere to the oral mucosa, disintegrate rapidly, and release the drug in a controlled manner.

Our Oral Thin Film Mechanical Properties Characterization Services

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 Testing

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

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 Testing

Tensile strength, also known as the strength limit, refers to the maximum force used when pulling off oral thin film.

Thickness Testing

The thickness of the oral thin film is usually controlled within 10 - 100 μm to ensure good mechanical strength and solubility.

Percentage Elongation Testing

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

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.

Our Strengths for Characterizing Oral Thin Film Mechanical Properties

  • Rich Experience: We have a team of skilled professionals with extensive experience in conducting mechanical properties characterization tests specifically tailored for oral thin films.
  • Advanced Equipment: Our state-of-the-art equipment and testing methodologies can accurately assess key parameters such as tear resistance, tensile strength, Young's Modulus, and flexibility of oral thin films.
  • Accuracy: We can provide comprehensive and precise data on the mechanical behavior of oral thin films.

Published Data

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 Oral thin film mechanical properties evaluation.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.

References

  1. Kai Bin Liew, Ganesan Gobal, et al. Orally Disintegrating Film: A Review of Its Formulation and Manufacturing Method. Malaysian Journal of Medicine and Health Sciences. 2023:297-303.
  2. Garsuch V, Breitkreutz J. Comparative investigations on different polymers for the preparation of fast-dissolving oral films. The Journal of pharmacy and pharmacology. 2010,62(4): 539-545.
  3. Samaneh Alaei, Yadollah Omidi, et al. In vitro evaluation of adhesion and mechanical properties of oral thin films. European Journal of Pharmaceutical Sciences. 2021, Vol(166).
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