Determine if your drug substance should receive further investment
Micro-dosing is the process of dispensing a precise amount of drug substance into a container, typically capsules, but also bottles or vials, for use in early phase human clinical studies. These "powder in capsule" (PIC) or "powder in bottle" (PIB) studies generally avoid the use of excipients – and the compatibility and stability studies associated with their use – 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 and first-in-human (FIH) studies.
Xcelodose® Precision Powder Micro-dosing Systems
- Our systems allow for precision weighing drug substances into capsules from 0.1mg to 200 mg per dose.
Accurate and rapid PIC/PIB studies
Our Xcelodose® Precision Powder Micro-dosing Systems are the industry standard for enabling accurate and rapid PIC/PIB studies. These systems allow for precision weighing of drug substances into capsules or bottles from 0.1mg to 200 mg per dose, dependent upon the physical characteristics of the API and capsule size. 2% RSD is achieved at typical speeds of 200-250 capsules per hour dependent upon dose specifics.
Our studies will help you:
- Streamline product development and reduce costs
- Minimize drug substance requirements
- Eliminate excipient compatibility screening
- Simplify analytical and stability evaluations
- Increase program efficiencies
- Document weights for each capsule or bottle produced
Benefits of Xcelodose® technology:
- Streamlined product development
- Supporting documentation including capsule weights
- Increased efficiencies via programmable & precise dispensing of drug substance to capsules
- Cost control: reduces wastewater, minimizes analytical & formulation development costs
- Allows multiple strengths for the clinic using similar process