Pharmatek™ SD Spray Drying Technology
Spray Drying Technology for Bioavailability Enhancement of your poorly soluble API
Spray drying has been proven to improve the bioavailability of poorly soluble compounds. A spray dry dispersion (SDD) is an amorphous molecular dispersion of a drug in a polymer matrix created by dissolving drug and polymer in an organic solvent and then spray-drying the solution. SDD technology offers proven performance, stability and manufacturability.
Spray Drying Benefits
A widely used processing technology, spray-drying offers a number of advantages, including:
- Enhanced bioavailability of poorly soluble compounds
- Consistent particle size distribution
- Long-term stability
- Robust, scalable process
- Higher drug loading
- Enables taste masking or controlled release dosage forms
Pharmatek™ SD Capabilities
As part of our integrated bioavailability enhancement platform, Catalent offers a holistic approach to the development and manufacture of spray dried dispersions. We combine our expertise in formulation and process development with our capabilities in spray drying to overcome some of the most difficult product development challenges.
- Full analytical and physical characterization
- Preformulation testing and formulation and process development
- Research and Development and GMP manufacturing: Pilot to Development scale spray drying capabilities
- Broadest selection of downstream processing technologies, co-located with Pharmatek SD
- Integrated solutions provider, with over 75 years of industry experience
Through expert analysis and interpretation of data, our Pharmatek SD spray drying team will fully characterize your API and associated formulations throughout feasibility, development, and commercialization to provide a robust data package in support of regulatory filings. We will accelerate scale-up and technical transfer of your program at all product stages.
- Feasibility and Development programs
- Tailored to meet your product requirements
- Consideration of the relevant API characteristics identified during the technical evaluation of preformulation data
- A range of prototype formulations prepared under different processing conditions (bench-scale); analytical techniques applied as appropriate to determine optimum formulation and process parameters
- Short-term accelerated physical stability studies typically undertaken before recommendations for a full development program are made
- Full in-house analytical and regulatory services
Full characterization of your API and associated formulations via expert analysis and interpretation of data throughout the development and scale-up process to provide a robust data package in support of regulatory filings
Catalent Pharmatek™ SD Facilities
Our Pharmatek™ SD facility capabilities include:
- Aqueous and Solvent Processing
- Potent handling
- Pilot feasibility scale spray dryers
- cGMP development scale spray dryers
- Complete oral dosage form processing technologies
- Closed and Open Loop Systems
When conventional formulation technologies are not enough to achieve targeted in-vivo performance, Catalent offers the broadest portfolio of technologies to meet the needs of challenging compounds. We have 20 research and development teams with development and formulation expertise to help solve some of the most complex bioavailability challenges. With over 80 years of experience and multiple, proven and innovative formulation technologies to help you deliver more effective treatments that can improve the performance of your product.
Bioavailability Enhancement Platform
The fastest and most effective way to unlock the potential of your molecule is to follow a rigorous, data-driven, parallel screening of appropriate available formulation technologies. We developed Optiform® Solution Suite to do this quickly and efficiently for small molecules and OptiForm® Solution Suite Bio for your large molecules.
Bioavailability Enhancement Technologies:
- OptiForm® API Salt Form Optimization
- Catalent Micron Particle Size Reduction
- OptiMelt® Hot Melt Extrusion
- Pharmatek™ SD Spray Dried Dispersions
- Lipid-based Drug Delivery
Catalent can partner with you to accelerate and optimize your molecule through the clinic and all the way to market, ensuring robust and scalable formulations, and integrated clinical manufacturing to accelerate your program with full clinical packaging and distribution services as well as scale-up and commercial supply.