In preclinical manufacturing, CD Formulation adheres to good manufacturing practices (GMP) standards and quality and safety standards, similar to those of commercial manufacturing, to ensure that the investigational products are produced consistently and are suitable for preclinical studies.

What is Oral Thin Film Preclinical Manufacturing?

Oral thin film preclinical manufacturing involves thin film products for testing and evaluation in preclinical studies. This process involves a comprehensive and systematic evaluation of the production unit (equipment, production process, personnel, raw materials, etc) to identify potential risk factors. Manufacturing facilities must adhere to strict regulations and guidelines set by regulatory authorities to ensure the safety, efficacy, and quality of the products being produced, and provide quality packaging for commercial production.

Our Oral Thin Film Preclinical Manufacturing Services

• Thin Film Casting: Casting the thin films to the desired thickness and shape based on the formula, preparation process and preparation method determined by pilot scale-up.
• Drying Procedure: Drying the cast films to remove moisture and achieve the desired mechanical properties.
• Cutting into Individual Doses: Precision cutting of the films into individual dose units.
• Packaging: Appropriate packaging to safeguard the films from environmental factors such as moisture and light.
• Quality Control: Implementing a range of tests to assess content uniformity, dissolution rate, disintegration time in vitro, mechanical strength, stability, etc., to ensure the quality and consistency of the thin films. Conducting in vitro and in vivo studies to evaluate the performance, safety, and effectiveness of the thin films.
• Risk Evaluation: Based on the preclinical production and testing results, conduct a comprehensive assessment of the process and product quality, analyze and identify problems and risks in the production process, optimize and improve in a timely manner, and provide a basis for commercial production.

Fig.1 Our Workflow of Oral Thin Film Preclinical Manufacturing Services. (CD Formulation)

Our Oral Thin Film Preclinical Manufacturing Capabilities

• X-ray Powder diffractometer
• Raman spectrometer
• Differential Thermal Analysis
• Gas adsorption Detector
• Texture Meter
• High performance Liquid Chromatography
• Fourier Transform Infrared
• Differential Scanning Calorimetry
• Solvent Casting Technology Platform
• Hot Melt Extrusion Technology Platform
• Semi-solid Casting Technology Platform
• Solid Dispersion Extrusion Technology Platform
• ......

What Problems Can We Solve?

• Identifying and addressing any potential manufacturing challenges or issues early on.
• Optimizing the manufacturing process to improve efficiency and reduce costs.
• Conducting validation studies to ensure the product meets quality standards.
• Meeting regulatory requirements for commercial production.
• Improving product quality and consistency.
• Minimizing risks associated with scale-up by conducting thorough testing and evaluation.
• Helping to accelerate the timeline for bringing a new product to market.

Why Choose Us for Oral Thin Film Preclinical Manufacturing?

• Our team consists of experts with extensive experience in oral thin film formulation and manufacturing, who can accurately solve any problems in the preclinical production process, and provide guidance for your commercial production.
• Comprehensive integrated CGMP supporting analysis services support the development of different types of oral thin film and offer a wide range of manufacturing devices.
• Our rigorous quality control measures ensure that each batch of oral thin film dosage forms meets the highest standards of stability and efficacy.
• World-class facilities and equipment.
• Professional technical support and consulting services to help customers achieve their drug development goals.
• Cost-effective and competitive prices.

We work closely with our clients throughout the preclinical manufacturing process, providing open communication and collaboration to ensure a successful outcome. We have the ability to provide you with services from pilot scale-up production to preclinical production of oral thin film to ensure the stability and consistency of the formulation. If you have a requirement about our oral thin film pilot scale-up manufacturing services, please contact us by phone or email, and our colleagues will reply to you within three working days.