product design and preformulation development

We apply extensive product design, preformulation, and technology expertise to successfully advance challenging compounds and improve overall speed to market. We offer premier depth in addressing bioavailability challenges and modulating pharmacokinetics to meet target product profiles. Recognizing that every molecule presents its own set of challenges, our product development teams combine our unique drug and process design capabilities with a premier range of technologies to deliver the right solution for your drug product.

Building on decades of design, development and scale-up experience over thousands of compounds, our multi-disciplinary project teams routinely develop custom approaches to enhance the bioavailability, efficacy, and performance of drug candidates across oral solid and inhaled product applications. Best practices in compound characterization and technology selection have been developed, as well as specialized processing equipment and techniques that result in robust, scalable solutions and accelerated development timelines. Phase-appropriate processing is in place for oral solid and parenteral product development from proof-of-concept studies, early and late phase clinical trials, and commercial manufacture. 

Product development from proof of concept to commercialization

We work together to fully characterize your compound and its problem statements, and tailor the formulation and drug-delivery system to meet rigorous product specifications, even for the most challenging molecules. Our core technologies and expertise address key challenges presented by today's candidate compounds, including:

• bioavailability enhancement, solubility and dissolution rate issues
• targeted delivery, extended or delayed release, zero order and dual release 
• delivery of high-potency and low-dose compounds
• accelerated screening and development: powder-in-capsule studies
• abuse-deterrent formulations
• taste- and odor-masking solutions (pediatrics)
• pulmonary/inhaled delivery
• parenteral delivery

We have extensive experience with a range of proven enabling technologies, many of which have been developed or advanced by our teams:

• solid dispersions
• particle size reduction 
• lipid- and liquid-based formulations
• modified- and targeted-release formulations
• fixed-dose combinations 
• multiparticulates
• engineered particles for inhaled applications
• sterile fill / finish for parenteral applications

We employ efficient, science-based flowchart methodologies to identify the best formulation and delivery approaches for each drug candidate and then use production and testing capabilities appropriately scaled for each phase of development. Specialized facilities are in place to support highly potent compounds and the use of processes employing organic solvents. 

Technologies and products