Catalent Spray Drying Technology
FROM DEVELOPMENT TO COMMERCIAL MANUFACTURING
Poorly soluble compounds continue to make up a large share of the pharmaceutical development pipeline. Amorphous systems generated through spray drying have been proven to improve the bioavailability of poorly soluble compounds. Additionally, spray drying can offer enhanced particle size engineering, established performance criteria, stability, and manufacturability.
Amorphous Solid Dispersions (ASD) is an amorphous molecular dispersal of a drug in a polymer matrix. Spray dried dispersions (SDD) are created by dissolving drug and polymer in a solvent and then spray drying the solution.
Catalent offers comprehensive spray drying solutions, spanning from early phase development to clinical supply and scaling up to commercial finished dose forms. Starting in 2024, Catalent has expanded its best-in-class commercial spray drying capacity to include the GEA Niro PSD-4 at its Boston, Massachusetts facility. This expansion caters specifically to late clinical supplies, registration, and commercialization of ASDs. The new expansion, alongside existing strategic collaboration with EUROAPI, which provides access to commercial spray drying capacity in Haverhill, UK, and Catalent’s global network of downstream dosage form manufacturing facilities, makes Catalent exceptionally positioned to meet the needs of global customers with end-to-end SDD solutions.
SPRAY DRYING BENEFITS
A widely used processing technology, spray-drying offers numerous 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 CAPABILITIES
Expertise in formulation and process development is combined with proven capabilities in spray drying to overcome difficult product development challenges. Catalent’s solutions include:
- Full analytical and physical characterization
- Pre-formulation testing, formulation, and process development
- Organic and aqueous solvent processing of potent and non-potent molecules
- R&D and cGMP manufacturing: From early development through to early clinical trial supply (Phase 1 and 2a)
- The broadest selection of downstream processing technologies including granulation, roller compaction, tableting, and stick pack packaging
SCALE-UP AND COMMERCIALIZATION
Catalent offers seamless transition and tech transfer from our early-development sites to strategically located commercial finished dose manufacturing sites in the U.S. and Europe.
Key scale-up and commercial capabilities include:
- Design, modeling and considerations
- Formulation and process optimization
- Aqueous and solvent processing of potent or non-potent molecules
- Integrated teams and process alignment for seamless transfer and scale-up
- cGMP manufacturing (Phase 2b to commercial scale)
- Flexibility to scale solutions from orphan programs and pediatric variants to large-scale blockbuster products
- Full range of granulators, blenders, pan coaters, tablet presses and encapsulators to support a diverse variety of finished dosage forms
- Clinical to commercial primary and secondary packaging solutions including bottles, blisters, and stick packs
WHY CATALENT SPRAY DRYING TECHNOLOGY?
Accelerated Development & Tech Transfer – Move quickly and efficiently from early development through the final phases of process optimization to cost efficient commercial-scale manufacturing.
Deep Expertise Highly skilled scientists and engineers with decades of development and commercial spray drying experience to overcome complex challenges.
Integrated Solutions Extensive network with small- and large-scale downstream manufacturing capability, offering a diverse variety of finished dose forms and associated analytical capabilities for a fully integrated solution.
OTHER FORMULATION ENHANCEMENT TECHNOLOGIES
- OptiForm® API Salt Form Optimization
- Catalent Micron Particle Size Reduction
- Nano-milling
- OptiMelt® Hot Melt Extrusion
- 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.