Recent Patents and Regulatory Aspects on Ophthalmic Drug Delivery Systems

Author(s): Soumyajit Majumdar, Ketan Hippalgaonkar, Tushar Hingorani and Walter G. Chambliss

Pp: 203-252 (50)

* (Excluding Mailing and Handling)

Abstract

The eye is protected from the external environment by various physiological and anatomical barriers. These barriers, through their protective actions, drastically diminish the ocular bioavailability of drugs. In the last decade, a number of innovations attempting to improve the ocular bioavailability of therapeutic agents have been reported. In the present chapter, some of the US patents and patent applications related to ocular drug delivery, published in the last decade, have been discussed. Additionally, an overview of US regulatory requirements and guidelines concerning transformation of innovations into commercial ophthalmic products have been presented.

Keywords: Ophthalmic, ocular, eye, patent, patent application, regulatory, investigational new drug, NDA, CMC, orphan drug, non-clinical, clinical trials, implants, ocular drug delivery, intravitreal, polymers, peptides, cGMP, GCP.