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Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Asia,Middle East,Africa
Sample Provided: no
Payment Terms: L/L
Powder Micro-Dosing Equipment
Micro-dosing is the process of dispensing a precise amount of drug substance into a capsule (or other container, e.g. vial or bottle), for use in early phase human studies (phase I safety evaluations).
PREFORMULATION & PRECLINICAL SERVICES
Drug substance “powder-in-capsule” (PIC) studies generally avoid the use of excipients – and the compatibility and stability studies associated with their use – for these initial evaluations thereby accelerating early phase product development timelines. Accelerating these initial studies to determine if the drug substance should receive further investment is critical in cost-effective product development.
A summary of PIC program benefits using Xcelodose® Micro-dosing Systems follows:
Streamlines product development
Minimizes drug substance usage in formulation development
Eliminates excipient compatibility screening
Simplifies analytical and stability evaluations
Increases efficiencies via programmable and precise dispensing of drug substance into capsules
Provides supporting documentation including weights for each capsule produced
Reduces waste of material
Minimizes analytical and formulation development costs
Allows for multiple strengths to be prepared for the clinic using the same process
Centers of Excellence
Lonza offers PIC services using Xcelodose® Systems in support of early phase clinical programs around the world. Our Center-of-Excellence for PIC studies is based in Tampa, FL which includes micro-dosing, primary and secondary packaging, kitting, global distribution and return services. The Tampa site offers integrated product development and manufacturing, and multiple Xcelodose® units to support both pre-clinical assessments and clinical PIC manufacture.
A full range of preformulation, analytical and formulation development services support phase I-IV studies and commercialization. Best practices have been developed for process transfers from Xcelodose® systems to larger-scale clinical and/or commercial scale batches utilizing Harro Modu-C units.
We offer a range of Micro-dosing Systems to meet your needs: