Our work and case studies
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.
Small biotech, USA based
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.