finished drug products for clinical trials & commercial applications

Specialized drug products

As part of our integrated service offer, we provide specialized oral drug products in addition to drug substances and particle-engineered drug product intermediates. Our integrated services ensure that you can utilize one partner from concept through clinical studies and commercialization, thereby reducing program times, complexity and risk.

Specialized drug products, often utilizing enabling technologies to improve bioavailability and/or modulate pharmacokinetics, include:

• Tablets – immediate, extended and delayed release
• Powder-in-capsules inclusive of DPI applications
• Multiparticulates inclusive of mini-tabs
• Soft gel capsules
• Liquid-filled hard capsules

This range of formats ensures that optimal formulation approaches tailored to specific problem statements can be employed. Our product development team has also developed best practices for formulating particle-engineered intermediates, e.g. spray dried dispersions, based on decades of experience and innovation. Specialized and phase-appropriate processing is in place to support clinical and small-scale commercial production, and ensure rapid scale-up, of finished drug products

Finished dosage forms are produced at our integrated development and manufacturing sites in the US and Europe

This network has broad capabilities across a full range of solid oral dosing formats including specialized capabilities for key dosing challenges:

• Osmotic tablet technologies for zero order release applications
• Liquid and semi-solid encapsulation technologies for low dose / HPAPI or improved bioavailability applications
• Fixed dose combination options inclusive of bi-layered matrices and multiparticulates
• Pediatric options using multiparticulate technology options inclusive of multi-functional lipid multiparticulates
• Liquid filled hard capsules for targeting the colon
• Encapsulation of particle-engineered powdered formulations for dry powder inhaler applications

Proprietary technologies and phase-appropriate processing have been developed to optimize formulation performance and provide for accelerated development timelines. Ultimate manufacturability and QBD principle are built into formulation design and formulation strategy to ensure no later stage re-work is required.

Our manufacturing network has an established track record in scaling oral dosage forms to late phase clinical and commercialization. This network is equipped to meet the processing requirements of today's molecules. Containment is in place for the safe handling and manufacture of drug products based on highly potent compounds. The capability of processing with organic solvents, e.g. spray drying and fluid bed coating, is also in place.

Our network has an inspection record you can trust with the US FDA and other regulatory agencies around the globe.

All our finished dosage form manufacturing sites have an excellent inspection record by the U.S. FDA and other regulatory agencies. Our manufacturing network is also designed to support highly potent compounds, with our, USA site equipped to accommodate the use of processes employing organic solvents, such as spray drying and fluid bed coating.