The oral feasibility program is designed to provide clients with a proof-of-concept of the oral bioavailability enhancement that can be achieved from Peptelligence® and ProPerma® formulations. The feasibility study will provide clients with optimized tablet prototypes, specifically tailored to the client’s API, which are evaluated in preclinical PK studies.
The process begins with a transparent review of the physicochemical properties of the client’s API to determine if it is a likely candidate for oral delivery and compatible with the technology. Given an appropriate fit, the Enteris team conducts a series of preformulation experiments on the API to determine effects of potential enhancing excipients on solubility, and for peptides, proteolytic susceptibility. Based on the results, enterically-coated tablet prototypes containing API and enhancing excipients are manufactured and released for preclinical pharmacokinetic studies and post-dose stability analysis. The pharmacokinetic testing is either conducted by the partner or managed by Enteris through a trusted CRO.
The feasibility program is managed by an unparalleled technical team of scientists, ensuring outstanding account management and efficient project completion.