Development of Valiloxybate Modified-Release Pellets for Extended-Release Suspension

Thorsteinn Thorsteinsson – Executive Director Product Development, Technical Services, Avadel Pharmaceutical; Maire Fenton – Senior Director Program Management, Technical Services, Avadel Pharmaceutical; Emma Lynch – Associate Director Quality, Quality Assurance, Avadel Pharmaceutical

Introduction: Avadel is marketing LUMRYZ^TM, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.  However, there are people that are sodium sensitive and would like to have a non-sodium or a low sodium alternative. Avadel is developing Valiloxybate, an amino acid conjugate of oxybate, as a drug product containing no sodium, but still is extended-release like LUMRYZ. The purpose of this study is to explore how different weight gain of a combination of ethylcellulose and hydroxypropylcellulose, using dibutyl sebacate as a plasticizer, can provide different modified release properties.

Learning Objectives:

• Develop modified release drug product
• Use dissolution profiles to select the amount of coating
• Use selected excipients to develop modified release product