Accelerated Flexible-Dose Trial Supplies For Early-Stage Clinical Studies

There is an increasing demand for early-stage supplies with minimum formulation development. The demand is especially high when dealing with unformulated active pharmaceutical ingredients (APIs) in capsules and liquid-filled hard capsules. This presentation will assist in formulation development and will help you avoid the risks associated with these developments.

Accelerated Flexible-Dose Trial Supplies for Early-Stage Clinical Studies

• Increasing demand for earlystage supplies with minimum formulation development
• Unformulated API in capsules
• Liquid-filled hard capsules

Risks in Early-Stage Clinical Development

• Risk to subjects of adverse reactions
• Risk of the wrong data
• Risk of the right data too late
• Risk of uncontrolled costs

Challenges In Early-Stage Supplies

• Multiple strengths needed to support dose escalation
• Major formulation effort deferred until development commitment
• Timelines are very short
• Cost of missed deadlines is high:
  • Complexity of clinical contracts
  • Limited availability of Phase I beds

Challenges in Early-Stage Supplies

• Material supply is very limited
• Physical properties of NMEs are incompletely known
• Unsuitable formulation can cause low or erratic bioavailability and clinical artifact
  • Aqueous solubility
  • Rate of dissolution
  • Physical or chemical stability