micro-dosing for powder-in-capsule / powder-in-bottle studies

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. Precision micro-dosing is an increasingly effective tool given the trend towards highly potent compounds requiring very small and precise dose levels.

By combining our market-leading experience in micro-dosing and Lonza Xcelodose® Precision Powder Micro-Dosing Systems, we provide premier PIC evaluations and services for preclinical studies in support of client projects. Our experience indicates that PIC programs are generally completed approximately 50% faster than traditional formulation development approaches using excipients, resulting in time savings of 13-17 weeks. Our micro-dosing services – performed across non-GMP and GMP conditions - are complemented by a full range of clinical supply services including primary and secondary packaging, labeling, kitting, distribution and overall clinical supply management.

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. Best-in-class filling accuracy (2% RSD) is achieved at typical speeds of 200-250 capsules per hour dependent upon dose specifics.

Benefits achieved in using Xcelodose-based PIC/PIB studies for early phase studies include:

• Streamlined product development and reduced costs
• Minimizes drug substance requirements
• Eliminates excipient compatibility screening
• Simplifies analytical and stability evaluations
• Increased program efficiencies via programmable and precise dispensing of drug substance
• Documentation provided including weights for each capsule or bottle produced
• Flexibility: allows for multiple strengths to be prepared for clinical studies using the same process

Xcelodose-based PIC / PIB Centers of Excellence in the US and Europe

We have Centers of Excellence for PIC/PIB studies at our integrated product development and manufacturing sites in Tampa FL (US) and Ploërmel, France. Multiple Xcelodose 120 and 600S systems are in place to support both early design work and clinical manufacture of PIC/PIB drug product.

Our integrated network of sites in the US and Europe include the (HP)API development and manufacture, bioavailability enhancement and drug delivery technologies, and drug product manufacture across a range of dosage forms including PIC, multiparticulates, immediate and modified release tablets, soft gels and liquid-filled hard capsules. Full analytical and clinical packaging services ensure that you have the option of utilizing one partner in advancing your compound to clinic and commercialization.