POWDER-IN-CAPSULE (MICRODOSING) EQUIPMENT

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 
• Cost effective 
• 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 North America (Xcelience – Tampa, FL) and Europe (Ploermel, FR). Both sites have 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.

Select the Micro-dosing System that meets your needs 

• Xcelolab for lab-scale 
• Xcelodose 120S: semi-automated 
• Xcelodose 600S: fully automated