Oral thin film drug content testing is the process of determining the amount of active pharmaceutical ingredient (API) in the oral thin film drug product. This testing helps our clients ensure the content consistency, safety, and efficacy of the oral thin film drug. CD Formulation can provide our clients with oral thin film content testing services using our professional analytical techniques and advanced equipment.
Content testing is a fundamental aspect of quality assurance in the pharmaceutical industry. It is an integral part of the overall quality control process to ensure that the oral thin film drug meets established specifications and standards, this plays a vital role in ensuring patient safety, regulatory compliance, quality control, stability, formulation optimization, therapeutic efficacy, etc.
The content is an important index for quality control of the oral thin film, our oral thin film content testing usually includes UV-visible spectrophotometry and high-performance liquid chromatography. We can provide you with comprehensive, innovative, and timely solutions and help you quickly analyze the oral thin film content, including but not limited to sample preparation, calibration, standard preparation, method validation (such as accuracy verification, precision verification, and reproducibility verification), etc. Our oral thin film content testing process is as follows:
Fig.1 Process of Oral Thin Film Content Testing. (CD Formulation)
Sample Preparation: According to the properties of the API, the appropriate solvent is selected to dissolve oral thin film samples.
Selection of Analytical Method: Selecting an analytical method based on analytical objectives and requirements.
Calibration and Standard Preparation: According to the selected analysis method, the standard solution and standard curve are prepared.
Analysis and Validation: After establishing the analytical method, optimize and validate. It involves determining analytical conditions, and evaluating the reliability, accuracy, specificity, system suitability, etc.
Quality Control: Analyze the test results to determine whether they fall within the content range.
Content Testing Methods | Detailed Information |
UV-Visible Spectrophotometry | UV-Visible spectrophotometry can also be employed to quantify the API content in oral thin films. This method measures the absorption of light at specific wavelengths by the API, allowing its content to be determined. |
High-performance Liquid Chromatography (HPLC) | HPLC is one of the most commonly used analytical techniques for determining the content of oral thin film products. It provides an accurate quantification by separating and detecting components in a complex mixture. |
Technology: Drug Content Testing
Journal: PHARMA SCIENCE MONITOR
IF: 2.2
Published: 2013
Results: In this study, drug content determination of the film was carried out by dissolving the film of 4 cm2 in 100 ml of pH 7.2 artificial saliva using a magnetic stirrer for 1 hour. The drug concentration was then evaluated spectrophotometrically at λmax of 269 nm. The determination was carried out in triplicate for all the formulations, and the average with standard deviation was recorded. It was observed that all the formulations were satisfactory showing drug content as per labeled amount.
Table.1 Drug Content Testing of Different Batch Sublingual Film. (Yatin D. Kapadia, et al., 2013)
CD Formulation has a team with rich experience to provide oral thin film content testing services to support your oral thin film product development. If you require our oral thin film content 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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