>>Back
Innovative but Practical Technologies to Tame Difficult APIs for Formulation Development & GMP Manufacture
- Publisher:
- Publication:2010/5/11
Biopharmaceuticals are becoming more complex and, by association, the physical characteristics are becoming more challenging, leading to the need for more careful handling and processing. This talk will introduce 3 new technologies which could revolutionize the formulation world and how you approach your product's development and life-cycle management. R5 Pharmaceuticals will introduce some of the challenges faced and innovative, but practical, technologies that can help. All of these technologies are available both for developmental and GMP phases of therapeutic development. The technologies we will be introducing are: Dr. Richard Johnson – Upperton Limited Pharmaceutical Spray Drying: Research, Development and Clinical Trials Manufacture Spray-drying is a cost-effective alternative to Freeze-Drying. The technology has a number of applications. This presentation will focus on: • How the technology works • Early R&D formulation with the technology • Clinical trial manufacture • Uses of the technology e.g. in controlled release therapies, to enhance stability Dr. Marcel de Matas – Lena Nanoceutics Nanomilling: Innovative Nanoparticle Formulation Development: Overcoming drug solubility challenges Nanomilling produces homogenous, nano-particle sizes to improve processing and to enhance bioavailability. This presentation will focus on: • Capability for rapid nanoparticle generation of APIs • Dealing with challenging mechanical properties • Production of nanoparticulate formulations with suitable physical and chemical stability • Methods for isolation of nanoparticulate formulations in solid form with suitable characteristics for tabletting • Improved dissolution kinetics and in vivo bioavailability approaches Mr. Steffen Mittwich & Dr. Rob Lammens - Atacama Labs Pneumatic Dry Granulation: A dry process to improve oral formulation design time and resource requirements PDG technology creates porous granules increasing options, including compression characteristics. This presentation will focus on: · PDG Technology - commercial and technical advantages · PDG-0260 equipment and its technology in detail · PDG Technology in detail for galenic developers and production heads · PDG granules: scientific data and study results