Xcelience Provides Flexible API into Capsule Solutions using Capsugel’s Xcelodose® precision powder micro-dosing system for Speed to First-in-Human Studies

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Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply. By: Balaji V. Kadri - Featured in the August 2008 Issue of Pharmaceutical Technology

Xcelience Provides Flexible API into Capsule Solutions using Capsugel's Xcelodose® precision powder micro-dosing system for Speed to First-in-Human Studies

Watch Our Xcelodose® In Action!

Xcelience has a solution for clients trying to do more with less.
Xcelience offers a defined program using Capsugel’s Xcelodose® 600 and 600S precision powder micro-dosing systems to provide a faster, cost effective path to Phase I studies. Xcelience API into capsule services enable greater flexibility in dosing for the clinic without resulting loss in quality. The system can accommodate small or large quantity batches, and provides the ability to adjust the dose with minimal loss of active pharmaceutical ingredient (API).
		Expertise: Having worked with more than 30 APIs and 80 batches, Xcelience has more experience with API in capsule services than other contract research organization.
		Capacity: Xcelience owns two of Capsugel’s Xcelodose® units providing more capacity and reliable back-up.
		Preparedness: To minimize downtime, Xcelience maintains a full inventory of change parts to accommodate all capsule sizes and instrument spare parts.

Instrument benefits:

Precision micro-filling of API into capsules – equates to low waste of API

Records the weight of drug in each capsule – allowing traceability of samples that meet GMP requirements.

Removes the need for excipients that are normally required for filling purposes and associated stability studies

Faster time to ‘first-in-human' studies

Products to suit both pre-clinical, clinical trial filling requirements and small-scale product manufacturing

Eliminates drug/excipient compatibility issues

Reduces pre-formulation time and effort

Creates flexibility needed for dose ranging doses

Simplifies development of drug product stability indicating assays

Simplifies stability protocols

Drug substance is fully retrievable

Minimizes drug loss

Specifications:

Capsule sizes 00 to 4 change parts available

2 gm micro balance fill range from 100 micrograms to 300 milligrams

5 gm micro balance fill range from 300 milligrams to over 2 grams (dependent on material density)

RSD of less than 4%

Part 11 compliant - data run reports to capture individual capsule fill information

Click here for more information on Xcelodose® 600 features.
Click here for news on Xcelodose® 600.
Xcelodose® 600 Case Study, Featured in the March 2007 Issue of Tablets & Capsules
Xcelodose® is a registered trademark of Capsugel BVBA.

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