Release Testing is a process that ensures the quality and safety of oral thin film products before they are released to the market. It involves a series of tests and evaluations that are conducted on a batch of the product to ensure that it meets the required standards and specifications. CD Formulation provides our customers with oral thin film drug product release testing for raw materials, active pharmaceutical ingredients (APIs), final products, etc.

The Importance of Release Testing for Oral Thin Film

Release testing reflects changes in quality management concepts such as quality by design (QbD) and quality risk management (QRM). It emphasizes a science-based manufacturing process, with authorization under certain circumstances, can conduct batch release based on information collected during the manufacturing process, product knowledge, and process understanding and control. This form of batch release has more comprehensive quality assurance than traditional release relying on finished product testing. Release testing is essential to ensure the quality, safety and effectiveness of oral thin film drugs before they are marketed. Release testing is essential to ensure the quality, safety and effectiveness of oral thin film drugs before they are marketed.

Fig.1 Quality by design (QbD) concept as presented by U.S. Food and Drug Administration (FDA)

Our Oral Thin Film Release Testing Services

CD Formulation provides customers with release testing of raw materials, intermediates and finished products for oral thin films, including but not limited to content, impurities, dissolution, content uniformity, stability and microbial contamination testing, packaging, and routine testing.

Release Testing of Oral Thin Film Raw Materials, Intermediates and Finished Products

Considering that there is a certain degree of variation between batches of oral thin film raw materials, intermediates and final products, batch release testing must be performed before oral thin films can be used in clinical trials or marketed for sale. Release testing is a quality control process that typically requires analytical evaluation of the physical and chemical properties of the raw materials, intermediates, and finished products in accordance with validated pharmacopoeia (e.g., USP) testing strategies to determine product purity, concentration, consistency, identity, and safety. Typical tests include appearance, analysis and impurity, dissolution and microbial testing, etc.

Oral Thin Film Primary and Secondary Packaging Assessment

Packaging is critical to the storage, protection and stability of oral thin films. Packaging of orally thin films usually includes foil, paper or plastic pouches, single pouch or aluminium pouch, blister packaging with multiple units, barrier films. We will choose the appropriate packaging according to the property of the oral thin films.

Oral Thin Film Pharmaceuticals Routine Analysis

For oral thin film pharmaceuticals routine analysis, in addition to the same routine inspection items as ordinary oral preparations, we also analyze and evaluate the special physical, chemical and mechanical properties according to the characteristics of the dosage form to ensure the safety and effectiveness of the product.

Our Advantages in Oral Thin Film Release Testing

• Test Type: Batch release testing and lot release testing for raw materials, APIs, finished oral thin film products.
• Key Technologies: We have in-depth experience working with every type of modality and have the flexibility and extensive instrument capacity within our teams to meet the ever-changing demands of production schedules and timelines.
• Fast Turnaround Times: We provide fast turnaround times for all batch release testing services for oral thin films, minimizing the time between production and release.
• Strict Test Conditions: We test oral thin films against specification for identity, potency, impurities, physical properties and safety under strict cGMP compliance, and we customize individual programs to streamline lab documentation and reporting for the most efficient and quality-focused data deliverable possible.

Published Data

CD Formulation has an approved and accredited analytical testing laboratory with a long history in oral thin film release testing, and our experts use a wide range of analytical techniques for oral film drug release testing to ensure that oral thin film products are of high quality before they reach the market. In addition, we can create robust testing protocols to ensure the safety and integrity of your products, as well as repeatability to minimize off-spec or off-trend duplication. If you have a requirement about our oral thin film analytical method development and validation services, please contact us by phone or email, our colleagues will reply to you within three working days.