The oral thin film has received broad interest due to fast drug absorption and no first-pass metabolism, leading to high bioavailability. It is a promising and prominent pharmaceutical dosage form. With the development of oral thin film, people pay more and more attention to its quality, from appearance, taste, disintegration time, treatment indications, etc. CD Formulation can provide comprehensive quality control for formulation development and manufacturing stages of oral thin films.

Fig.1 Characterization of pullulan-based orally disintegrating films. (Esra Pezik, et al., 2021)

Our Oral Thin Film Quality Support Capabilities

Formulation Development of Oral Thin Film

Our oral thin film formulation development involves a systematic and comprehensive approach to ensure that the final product meets the required quality, safety, and regulatory standards, including preliminary research, formulation design, process development, analytical method development, preclinical studies, stability testing, etc.

Formulation Optimization of Oral Thin Film

To enhance and upgrade the quality of oral thin film products, optimize development methods and reduce risks, we applied the QbD approach to the formulation development and optimization of oral thin film.

Manufacture of Oral Thin Film

We provide one or a combination of the processes for manufacturing oral thin film, including solvent casting, semi-solid casting, hot-melt extrusion, solid-dispersion extrusion, rolling, 3D Printing, etc. In addition, we can also provide customers with pilot scale-up production, preclinical production, and commercial production that meets cGMP conditions.

Sound Quality Management System

We have a sound quality management system and a series of production, testing, and commissioning equipment with international standards so that the research and development process of oral thin film drugs follows the principles of scientific norms, authenticity, integrity and traceability, ensuring that the quality of oral thin film complies with relevant regulatory requirements.

Professional Technicians

We have professional technicians responsible for the quality of the entire R&D process of oral thin film, from the monitoring of API, excipients, and packaging materials, the review of experimental plans, and the verification of original records to the evaluation of the entire R&D process.

Explore Our Oral Thin Film Quality Support Services

Oral thin film quality support is designed to ensure that oral thin films meet the necessary quality standards and requirements for pharmaceutical products. This support can include various processes.

Advantages of Our Oral Thin Film Quality Support

• We have professional technicians and quality supervisors who can provide technical support for the quality of oral thin film throughout the process.
• We have a complete quality control system.
• We have a cGMP production workshop that meets the standards.

Published Data

Our quality support is designed to ensure the safety, efficacy and compliance of oral thin film drug systems, providing comprehensive quality control for the development and manufacturing stages of oral thin films. If you require our oral thin film quality support services, please contact us by phone or email, and our colleagues will get back to you within three working days.