Design and Development of Ophthalmic Liposomes from the QbD Perspective.

Abstract

Due to significant lachrymation, drug washing out, and poor adhesion to the lipophilic outer layer of the precorneal and cornea membrane, topical ophthalmic solution drops have poor ocular bioavailability. The rate of transcorneal absorption is impacted in the case of hydrophilic drug molecules as brimonidine tartrate, timolol maleate, cyclosporine, etc. Ophthalmic solution administered in many doses is less patient-compliant. The limitation of multiple-dose and its negative effects can be overcome by the development of delayed- release liposomes. Liposomes are regulatory-approved novel drug delivery systems. Its vesicular form aids in delaying medication release, and its lipidic makeup enables it to stick to the cornea's lipophilic layer. As a result, it will prevent precorneal clearing, extend corneal contact time, and provide sufficient transcorneal absorption. The aim of this review article is to portray the benefits of liposomes for ophthalmic drug delivery and its formulation development in the light of QbD. The review discusses the composition, preparatory methods and quality aspects of ophthalmic liposomes. It then accordingly reasonably proposes the quality target product profile, critical quality attributes, critical material attributes and critical process parameters, involved in liposome development for ophthalmic drug delivery. This review shall help formulation scientists to formulate ophthalmic liposomes of desirable quality.