Catalent Spray Drying Technology
SPRAY DRYING TECHNOLOGY FOR BIOAVAILABILITY ENHANCEMENT OF YOUR POORLY SOLUBLE API
Catalent offers spray drying solutions from early-phase development through clinical supply to scale-up of commercialized finished dose forms. Catalent has made an agreement with Sanofi Active Ingredient Solutions (SAIS) to have immediate access to Niro PSD2 and PSD4 spray dryers. Combined with the investment made earlier in 2019 at Catalent’s Winchester facility with the addition of a Niro PSD2, these investments allow us to provide end-to-end services for our customers in the United States and Europe.
Poorly soluble compounds continue to dominate the development pipeline. Spray drying has proven to improve the bioavailability of poorly soluble compounds. A spray dried 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-dry the solution. SDD technology offers proven performance, stability and manufacturability.
Built on our expertise in spray drying technology for early-phase development, Catalent offers a streamlined spray drying scale-up manufacturing process for commercial final dose form manufacturing. Specific formulation and process information learned early on in feasibility and demo batches can be used to guide the project’s scale considerations for commercial-scale batches.
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
DEVELOPMENT SPRAY DRYING 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
- Solvent and acqueous processing of potent and non-potent molecules
- R&D and cGMP manufacturing: from pilot-scale to development-scale all the way through to commercial-spray drying
- Broadest selection of downstream processing technologies
Our experienced 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.
Having a partner who can take your program from bench-scale to registration-scale to commercial-scale is beneficial for the acceleration of your compound. Catalent has the end-to-end spray drying solution, offering a seamless transition of a tech transfer of your program from our early-development sites to our commercial manufacturing sites for finished dose forms. The benefits of this offering are:
- Versatile, efficient, and cost-effective
- Reproducible and scalable
- One cohesive project team with extensive knowledge of your program
To enhance our spray-drying expertise and capabilities, Catalent signed an agreement with Sanofi Active Ingredients Solutions, a subsidiary of Sanofi, under which Catalent’s customers will have access to Sanofi’s commercial spray-drying manufacturing capabilities at the Harverhill, U.K. facility. This state-of-the-art facility houses:
- Niro PSD2 and PSD4 spray dryers
- Solvent and acqueous processing of potent and non-potent molecules
- Integrated quality control and analytical capabilities
Catalent has also made a significant investment to add commercial spray drying to our Winchester, KY facility. The investment includes an expansion of the site’s capacity and its formulation of controlled-release tablet and capsule manufacturing. The Winchester facility will work alongside the Haverhill facility to support transfer and scale-up of spray drying programs from Catalent’s early-stage clinical development sites located in San Diego, CA; Somerset, NJ; and Nottingham, U.K.
FACILITIES WITH SPRAY DRYING CAPABILITIES
Nottingham, UK: Catalent’s Nottingham facility focuses on early stage development of small molecule candidates from bench to clinic. The facility offers an array of services that support oral dosage forms that include characterization, formulation and analytical development, manufacturing and clinical packaging, labeling and worldwide distribution. Our Nottingham facility is home to our bioavailability enhancement technologies, including spray drying and OptiMelt® hot melt extrusion to support the needs of our client’s challenging compounds.
Winchester, KY: Catalent’s Winchester facility focuses on the manufacturing of large-scale complex controlled-release oral dosage forms, with integrated analytical and development services. With more than 20 years of expertise in product development, technology transfers, and commercial manufacturing, our Winchester facility houses commercial spray drying technologies with downstream roller compaction capabilities.
Our spray-drying facilities offer:
- Aqueous and solvent Processing
- Potent and non-potent handling
- Pilot feasibility-scale spray dryers
- cGMP development-scale spray dryers
- Commercial-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
- Catalent 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.