Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
|Articles|September 28, 2020
Early Phase Drug Development
Author(s)Catalent Pharma Solutions
By adapting for each molecule’s unique characteristics and challenges, Catalent uses its expertise and a wide range of tools and technologies to create innovative dose forms that benefit patients.
From its three early-phase drug development centers of excellence in Nottingham, UK, Somerset, NJ, and San Diego, CA, Catalent offers its customers a number of solutions including analytical, pre-formulation, and formulation technologies. With its comprehensive bioavailability enhancing technology toolkit including lipid formulation, spray drying, and hot melt extrusion, Catalent supports the development and launch of over 100 new products every year.
Catalent’s proprietary OptiForm® Solution Suite platform assists in the development of optimised and innovative dose forms to improve a drug’s efficacy and success. OptiForm Solution Suite integrates multiple technologies and tools, and is fast, flexible, and fact-based to deliver data to ensure the right decisions are made at each stage of development and accelerate molecules to Phase I clinical trials. It includes a comprehensive range of candidate screening tools, ADME considerations, and in silico DMPK modeling, plus bioavailability enhancing tools, providing materials for cGLP toxicological studies, on to first-in-human studies.
When necessary, development projects can be easily tech transferred throughout the Catalent global network to one of the 30+ global manufacturing facilities that is most suitable for a program’s flexible commercial and clinical manufacturing needs.
Catalent Pharma Solutions
14 Schoolhouse Road Somerset, NJ 08873, USA
tel. +1.888.765.8846
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