POWDER-IN-CAPSULE (MICRODOSING) 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

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 
  • 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