Clinical Oral Liquid Emulsion for Phase 1 Clinical Trial

Clinical Oral Liquid Emulsion for Phase 1 Clinical Trial

Author: Professor Ben Boyd

PharmSky have worked with a client to produce a first-in-class oral liquid emulsion high dose MCT product for treatment and prevention of neurodegenerative diseases. MCT when consumed in sufficiently high doses can produce therapeutic levels of molecules known as ‘ketone bodies’ that have neuroprotective properties. The high doses required cannot be achieved using conventional capsule-based treatment. Consequently, PharmSky scientists have worked with their client to develop and manufacture a high dose liquid emulsion form that is stable and only uses excipients already approved for use in oral dose forms. Scale up of the manufacturing process to clinical scale has been achieved while producing a stable product to meet specifications set by regulation and the target product profile of the client. Phase I clinical trials can now proceed according to the client’s initial time frames and excellent stability characteristics mean that the product is anticipated to progress through the development phase without physicochemical liability.  


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