One of the relatively new dosage forms for transmucosal drug delivery is the oral thin film with mucoadhesive properties. These films offer several advantages over conventional dosage forms, such as faster dissolution, higher patient compliance, and extended oral retention through reduced salivary washout. To prevent the thin film from being washed away by saliva, which could cause suffocation or failure to achieve therapeutic effects, adhesion testing becomes an important indicator for the quality control of oral thin films. CD Formulation can perform oral thin film adhesion testing using various technical methods, including texture analyzers, in vitro mucosal adhesion testing, and peel testing.
The oral thin film adhesion testing helps ensure that the thin film product adheres comfortably to the oral cavity, without causing discomfort or dislodging prematurely, and this is particularly important for patient acceptance and safety.
The oral thin film should have sufficient adhesiveness for its best performance, and this characterization is critical in the successful design and development of the oral thin film. There is currently no FDA or USP-recommended analytical procedure or standard for evaluating the adhesiveness of oral thin film. CD Formulation explores and researches oral thin film adhesion testing methods, including texture analyzers, in vitro mucosal adhesion testing, and peel testing.
Adhesion Testing Methods | Detailed Information |
Texture Analyzers | Texture analyzers are widely used to measure the adhesion strength of oral thin films. The film is placed on a surface that simulates the oral mucosa, and the texture analyzer applies force to the film to measure its adhesion properties. This method can provide quantitative data on the force required to detach the film from the surface, offering valuable insights into its adhesion strength. |
In Vitro Mucosal Adhesion Testing | This method involves using in vitro models to simulate the oral mucosa and assessing the adhesion of the thin film to the simulated mucosal surface. The thin film is placed on the model, and various parameters such as adhesion strength, contact time, and detachment force are measured to evaluate its adhesion properties. |
Peel Testing | This method provides adhesion properties by simulating the force required for the oral thin film to be removed from the oral mucosa. |
Our oral thin film analysis team can respond quickly to customers' thin film adhesion testing requirements to support their oral thin film formulation development needs, and our oral thin film adhesion testing process is as follows:
Fig.1 Process of Oral Thin Film Adhesion Testing. (CD Formulation)
Adhesion Testing Methods: We offer a variety of adhesion testing methods, including texture analyzers, in vitro mucosal adhesion testing, and peel testing. We select the method that best meets the needs of our customers. These methods help us to understand the adhesion properties of the oral thin film.
Sample Preparation: We prepare samples according to the selected methods, cutting the thin films into uniform sizes and shapes to ensure consistency during testing.
Testing: We use specialized equipment to measure the adhesion of the oral thin film by quantifying the force required to detach the film from the substrate.
Data Collection and Analysis: We analyze the data to assess the adhesive properties of the oral thin film.
Report: We provide comprehensive reports detailing the adhesion testing methodology, results, and analysis. These reports can be used for regulatory submissions, quality control, and product development purposes.
Technology: Assessment of test methods evaluating mucoadhesive polymers
Journal: European Journal of Pharmaceutics and Biopharmaceutics
IF: 4.9
Published: 2013
Results: In this review, several oral thin film mucoadhesion test methods are reviewed concerning the applicability for various polymers, different drug dosage forms and comparability of experimental setups. Different test methods and experimental setups lead to huge differences regarding the results.
Fig.2 The assessment of mucoadhesion test methods. (Christina Woertz, et al., 2013)
CD Formulation has a team with rich experience providing oral thin film adhesion testing services to support your oral thin film product development. If you require our oral thin film adhesion testing services, please contact us by phone or email, and our colleagues will get back to you within three working days.
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