In addition to having extensive experience in development and validation of IVRT methods for various types of topical formulations, Zyleris has developed a number of proprietary and patent-pending IVRT technologies that can be applied successfully to challenging topical formulations such as ointments (water-miscible and oleaginous) and ophthalmic suspensions.

For example, the technologies have been applied to development and validation of IVRT methods for petrolatum-based ointments containing either hydrophilic or lipophilic APIs.  It is generally believed that the release of a hydrophilic API from a petrolatum-based ointment does not fit the classic Higuchi linear model.  However, the IVRT method developed using our technologies yields linear and proportional release of the hydrophilic API, allowing for easy data interpretation per FDA's SUPAC-SS Guidance.