Xcelience, a leading pharmaceutical contract research organization, is the premier source for unsurpassed quality in drug development. We consistently and efficiently move our sponsors' Active Pharmaceutical Ingredients (APIs) through the drug formulation process, getting them to clinic and market faster. Xcelience combines the industry's top-performing formulation development scientists with state-of-the-art equipment.

Led by dedicated project managers, our scientific teams work as an extension of your organization throughout the development process.

Xcelience's Core Services

Preformulation:
Xcelience’s range of preformulation studies allows us to optimize your dosage form at the earliest stage of drug development. Our capabilities in this area include but are not limited to the following:

• Accelerated stability studies, pH temperature degradation profiles
• API lot-to-lot analysis
• Bulk and tap density
• Drug substance characterization, structural identity and confirmation
• Drug substance morphology
• Excipient selection and compatibility studies
• Identification and quantification of impurities
• Particle sizing
• Photostability
• pKa determination
• Solubility determination
• Thermal analysis
• Purity determination

Formulation:
Our scientific teams develop various formulation options that meet your dosage range and preferred route of delivery. We are able to formulate the following dosage forms:

• Solids
• Tablet formulation
• Hard gelatin capsule formulation
• Granules
• Powders
• Liquids:
• Oral and topical liquids
• Suspensions
• Emulsions
• Semi-solids:
• Creams
• Ointments
• Gels

Analytical:
Our state-of-the art facilities and instrumentation provide an optimal environment for stability studies, including a full range of temperature and relative-humidity conditions. Full analytical method development and validation are key offerings of support to our clients.

Manufacturing:
Our scientists are the industry’s most respected in the field of formulation development. Contact us for:

• Manufacturing batches for stability testing
• Scaling up and production of pilot batches
• Manufacturing of clinical trials supplies from Phase I to Phase IIb
• Process validation and technology transfer

We have expanded our early drug development capabilities by recently acquiring the Xcelodose® 600 S precision powder micro-doser and automated encapsulator system. The next generation S model fills at speeds of over 600 capsules an hour, and accompanies its predecessor the Xcelodose 600 in our effort to get sponsors to clinic. Additional capabilities in this arena include the CFS 1200 utilized for liquid fills of highly insoluble NCEs.

Xcelience has built up a wealth of drug development experience since purchasing its first Xcelodose system in 2005. Sponsors are drawn to the company's speed in helping get them to the clinic. The new model is faster and will add to our responsiveness time.
Xcelodose® is a registered trademark of Capsugel BVBA.

Facility Overview:
Xcelience has grown exponentially since its inception. In addition to expanding operations in 2007 with the acquisition of a new facility, the company boasts an array of new equipment, including the Vector TFC Roll Compactor, to further amplify our vast capabilities. Our laboratories are fully cGMP compliant and registered with the FDA and DEA.

Visit our Web site to download our equipment list and for an extensive list of our direct API-to-capsule filling, preformulation, formulation, analytical, and manufacturing capabilities.