PII

API in a capsule technology dramatically shorten time to clinic for first in man studies.

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API in a Capsule

Pii understands the need to reduce development costs and to enter the clinic quickly to establish efficacy. For first in man enabling studies, Pii offers API in a capsule filling capabilities using Capsugel's Xcelodose®.

Pii understands the need to reduce development costs and enter the clinic quickly to establish efficiency. For First in man enabling studies, Pii offers API in a capsule filling capabilities using Capsugel’s Xcelodose®. The Xcelodose system is a precision powder micro-doser and automated encapsulator with a fill range of 100 micrograms to greater than 100 milligrams. It allows the direct fill of active pharmaceutical ingredients (APIs) into capsules at a rate of several hundred capsules per hour. By eliminating the need for excipients and drug product analytical methods development, API in a capsule technology dramatically shortens time to clinic for first in man studies.

Features

  • Consistent and repeatable dose accuracy
  • Fill ranges from 100 micrograms to 100 milligrams
  • Capsule sizes 00 to 4
  • Insturment records the weight of each capsule content enabling traceability of samples that meet cGMP requirements.

Benefits

  • Decreased development time & costs
  • Reduced API requirements
  • Removes need for excipient compatability studies and drug product stability
  • Minimal cleaning requirements

Additional Capabilities

Pii provides comprehensive product development services to compliment our API in a capsule capabilities:

  • Solid State Chemistry Characterization
  • Preformulation Testing
  • Formulation Development
  • cGMP Manufacturing
  • Analytical Service
  • Commercial Manufacturing

 

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