Is My Molecule Suitable for an Orally Disintegrating Tablet?
Summary: There is often confusion about whether an Orally Disintegrating Tablet (ODT) format would work for a drug of a particular weight, or for one with certain molecular characteristics or formulation requirements. ODTs are a versatile platform enabling quick and easy delivery of medications to patients; however, there remains considerable uncertainty about whether this dose form is an option for certain drugs and how the efficacy compares to that of standard tablets and capsules.
Patient, market, payor and regulatory considerations are key factors in determining whether an ODT is a suitable fit. Drug developers may consider an ODT format for New Chemical Entities (NCEs) to distinguish their brand or address challenging patient needs, or may look to an ODT format for established commercial products as part of a lifecycle management (LCM) project. This webinar aims to provide clarity on the types of molecules suitable for an ODT format as well as the regulatory pathways for new and established therapies.
A panel of four speakers will review the fundamentals of ODTs, including benefits, formats and development pathways, contrast with other oral dose forms, outline likely drug candidates and discuss Catalent’s proprietary ZYDIS® lyophilized ODT platform. The panel will further address the unique delivery routes associated with ODTs, including the potential for pre-gastric or gastrointestinal delivery and local activity at the oral mucosa, and review the physicochemical characteristics appropriate for each.