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Home > Knowledge Centre > Case Studies > Intravenous Formulation Phase 1 Study Challenge Case Study

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Challenge:

To develop stable sterile formulations of a drug substance for intravenous administration in phase I clinical trials.  The drug substance, intended for the treatment of CNS (Central Nervous System) related disorders, was physically and chemically unstable in aqueous media and there was a requirement for the product to be delivered both as a bolus and maintenance dose over an extended period of several days.

Customer:

Small biotech, USA based

Outcome:

IV formulations were successfully that remained physically and chemically stable for over 3 days.  Supporting analytical methodologies were validated to verify product stability.  The manufacturing process for sterile extemporaneous manufacture was transferred to clinic.

Phase 1 studies were initiated on a time frame that exceeded the client’s expectation by a factor of 2.  Subsequently, the client was able to complete Phase I trials ahead of initially predicted schedules and progress to Phase II.

Intravenous Formulation Phase 1 Study Challenge Case Study