Analytical method development and optimization are not only the key to obtaining approval for clinical studies of oral thin film drugs but also a crucial link that cannot be ignored to ensure the quality and efficacy of drugs and the safety of patients. CD Formulation provides customized analytical method development and optimization services to support your analysis requirements for oral thin film products.

What is Analytical Method Development and Optimization?

The development and optimization of analytical methods are to establish a set of experimental conditions to perform analytical procedures in oral thin film samples. Developed and optimized analytical methods can be used to identify, separate, quantify, and learn more about the physical and chemical properties of oral thin film products intended for commercial manufacturing. These methods are used throughout the drug development process, from early-stage development through commercialization and post-market surveillance. By developing and optimizing analysis methods, we can ensure the reliability and accuracy of analysis results, provide researchers with accurate data support, help them better understand drug characteristics, and guide subsequent drug research and development. Analytical method development and optimization generally include the selection, optimization, verification, and application of analytical methods in the drug development and production process for drug quality control, component analysis, content testing, etc.

Our Oral Thin Film Analytical Method Development and Optimization Services

The main objective of oral thin film analysis method development is to ensure the quality, safety, and effectiveness of the thin film products. This includes developing and validating analytical methods that can accurately and reliably analyze the properties of thin film products. CD Formulation can develop and test new analytical methods, including characterization of oral thin film products, literature search, method validation, and optimization of analytical elements.

Characterization of Oral Thin Films

Understanding the physicochemical properties and biological properties of oral thin film, such as surface pH, mechanical properties, contact angle, moisture absorption, swelling properties, content and content uniformity, in vitro disintegration, in vitro dissolution, release kinetics, etc., and establishing testing methods that meet approval and regulatory requirements.

Literature Search

We review information from journals, books, and other publications related to oral thin film, and establish relevant analytical methods.

Method Validation

Demonstrating that the analytical method is suitable for the intended testing purpose and can produce reliable and consistent results over time.

Optimization of Assay Elements

Include details of the test method in the standard operating procedure (SOP), such as mixing volumes, number of replicates, and statistical data reduction.

Our Oral Thin Film Analytical Method Development and Optimization Capabilities

• High-performance liquid chromatography (HPLC)
• Ultra-performance liquid chromatography (UPLC)
• High-performance liquid chromatography/mass spectrometry (HPLC/MS)
• Ultra-performance liquid chromatography/mass spectrometry (UPLC/MS)
• Gas Chromatography (GC)
• Gas Chromatography/Mass Spectrometry (GC/MS)
• Ultraviolet spectrum (UV)
• X-ray Diffraction (XRD)
• Differential Scanning Calorimetric (DSC)
• Thermogravimetric (TGA)
• Fourier Transform Infrared (FT-IR) Spectroscopy

Workflow of Our Oral Thin Film Analytical Method Development and Optimization

Oral thin film analytical method development and optimization is a complex and labor-intensive process that requires specific expertise to deliver accurate, selective, and robust analytical methods. We have professional analysis personnel, cutting-edge technology, first-class equipment, and standardized analysis procedures to meet your project needs. Our oral thin film analytical method development and optimization process is as follows:

Fig.1 Workflow of Oral Thin Film Analytical Method Development and
 Optimization Services. (CD Formulation)

Advantages of Our Oral Thin Film Analytical Method Development and Optimization

• Our team has extensive knowledge and experience in oral thin film development, allowing us to provide tailored analytical method development and optimization services that meet the unique needs of different types of oral thin film.
• We stay up to date on the latest regulatory guidelines for oral thin films, ensuring that our analytical methods comply with industry standards and regulations.
• We not only provide new method development services but also can further optimize the customer's method to ensure that the optimized method is stable and feasible.

CD Formulation is committed to creating robust and reliable oral thin film analysis methods to ensure the quality and safety of thin film products. Our team consists of experienced chemical analysts and oral thin film experts, with advanced instrumentation and professional knowledge. Whether you want to develop new methods or optimize existing old methods, we can provide professional technical support and services. If you require our oral thin film analytical method development and optimization services, please contact us by phone or email, and our colleagues will get back to you within three working days.