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). 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.
Micro-dosing for PIC evaluations is a key component of our early stage product development offering aimed at accelerated feasibility studies and first-in-human (FIH). By combining Xcelience’s market-leading experience in micro-dosing and Capsugel’s Xcelodose® Precision Powder Micro-Dosing Systems, we provide premier PIC evaluations and services for preclinical studies in support of client projects. PIC programs are generally completed 45% faster than traditional formulation development approaches using excipients, resulting in time savings of 13-17 weeks. Our micro-dosing service is complemented by a full range of clinical supply services including primary and secondary packaging, labeling, kitting, distribution and overall clinical supply management.
A summary of PIC program benefits using Xcelodose 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
Capsugel 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.