Oral Thin Film Pilot Scale-up Manufacturing Services
Inquiry
Oral thin film pilot scale-up manufacturing refers to the process of transitioning a formulation for an oral thin film medication from small-scale laboratory production to a larger-scale pilot production, in order to achieve a larger quantity of the product for testing and evaluation. CD Formulation has rich experience and expertise and is able to provide customers with overall solutions to ensure the smooth progress of the pilot scale-up phase and lay a solid foundation for commercial production. We not only focus on oral thin film products' performance and stability, but also on process operability and production sustainability.
Importance of Oral Thin Film Pilot Scale-up Manufacturing
Oral thin film pilot scale-up manufacturing involves the determination of manufacturing processes, methods, product quality, safety and efficacy in preparation for final commercial production, while also identifying and resolving any potential issues that may arise.
Our Oral Thin Film Pilot Scale-up Manufacturing Services
As an oral thin film contract development and manufacturing organization (CDMO), CD Formulation provides unparalleled pilot scale-up services for the development of oral thin film, we have different manufacturing methods to meet the pilot scale-up of different types of oral thin films, including solvent casting method, hot melt extrusion method, semi-solid casting method, etc.
Fig.1 Oral film manufacturing processes. (Svenja Niese, et al., 2018)
Our oral thin film pilot scale-up services at competitive prices, including but not limited to:
- Preparation of API and Excipients
- Parameter Identification
Identification of critical process parameters (CPPs) and critical quality attributes (CQAs).
- Process Optimization
According to the different scale-up and production methods, the laboratory formula and process are optimized to improve the stability of thin film preparation.
- Pilot Scale-up Manufacturing
According to the optimized formula and process requirements, oral thin film pilot scale-up production is carried out.
- Product Evaluation
Conduct a comprehensive evaluation of the pilot scale-up production of oral thin film products, including physical properties, chemical properties, mechanical properties, in vitro disintegration time, in vitro dissolution and other aspects of the test and analysis to ensure that the product meets the specified quality requirements.
Our Oral Thin Film Pilot Scale-up Manufacturing Capabilities
Our oral thin film technology platform is equipped with the world's top brands of equipment, including x-ray diffractometer, Raman spectrometer, thermogravimetric differential thermal meter, gas adsorption detector, texture meter, high-performance liquid chromatography, vacuum emulsion tank, electrostatic spinning machine, coating machine, etc. It can meet the needs of various stages in the whole process of lab development, pilot scale-up and commercial production of oral thin film and can fully control the key process parameters and quality control of drugs.
Why Choose Us for Oral Thin Film Pilot Scale-up Manufacturing?
- Comprehensive integrated CGMP supporting analysis services support the development of different types of oral thin film and offer a wide range of pilot scale-up devices.
- Always at the forefront of oral thin film drug delivery system development and drug analysis.
- World-class facilities and equipment.
- Provide integrated services from early-stage formulation development of oral thin film to full commercial CGMP manufacturing.
- Professional technical support and consulting services to help customers achieve their drug development goals.
- Cost-effective and competitive prices.
Published Data
Technology: Orodispersible film product transfer from lab-scale to pilot-scale
Journal: Journal of Drug Delivery Science and Technology
IF: 4.5
Published: 2019
Results: In this study, transfer from lab-scale non-continuous production to pilot-scale continuous production of orodispersible films was provided using the solvent casting method under the framework of quality by design. The viscosity of the polymer dispersions, weight, thickness and disintegration time of the films were compared for the transfer of production. pH, moisture content, mechanical properties, folding endurance, uniformity of dosage units, dissolution, and stability studies were also performed in pilot-scale orodispersible films.
Fig.2 Product transfer from lab-scale to pilot-scale of quetiapine fumarate orodispersible films. (Ece Özcan Bülbül, et al., 2019)
CD Formulation has the ability to provide you with services from small-scale trial production to pilot scale-up production of oral thin film to ensure the stability and consistency of the formulation. Whether it is initial production or mass production, we can provide you with fast and efficient service to ensure that the quality of your oral thin film reaches the highest standards and help you achieve a successful launch of your product. 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.
References
- Svenja Niese, Julian Quodbach, et al. Application of a chromatic confocal measurement system as new approach for in-line wet film thickness determination in continuous oral film manufacturing processes. International Journal of Pharmaceutics. 2018, Vol(551):203-211.
- Ece Özcan Bülbül, Burcu Mesut, et al. Product transfer from lab-scale to pilot-scale of quetiapine fumarate orodispersible films using quality by design approach. International Journal of Pharmaceutics. 2019, Vol (554).
How It Works
STEP 2
We'll email you to provide your quote and confirm order details if applicable.
STEP 3
Execute the project with real-time communication, and deliver the final report promptly.
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