Drug Designing: Open Access
Open Access
ISSN: 2169-0138
ISSN: 2169-0138
Maotang Zhou
US Food and Drug Administration, USA
Posters & Accepted Abstracts: Drug Des
Liposomes are lipid bilayer vesicles that can encapsulate both hydrophilic and lipophilic drugs to protect them from degradation. Liposome-encapsulated drugs have multiple advantages over their non-encapsulated counterparts, including improved pharmacokinetics, selective targeting, reduced side effects and controlled drug release. Ever since their discovery in the mid-1960s, liposomes have been a subject of extensive studies for drug delivery and have been considered to be the most successful nano-carriers for drug deliver. The intense interest in this area has also translated into an increasing number of Investigational New Drug (IND) applications, New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for liposomal drug products to the United States Food and Drug Administration (FDA). Currently the FDA has received over 400 liposomal drug product submissions and there are eight FDA-approved liposomal drug products on the US market. While subjected to the same regulatory pathways and the same rigorous regulatory standards as typical drug products approved by FDA, the unique physical and chemical complexity of liposomal drug product may lead to additional scientific and regulatory considerations. In this presentation, we will discuss the current regulatory expectations for complex liposomal drug products including relevant FDA�s current guidance, application of Quality by Design principle in liposomal drug product development, physicochemical characterization and commercial manufacturing of liposomal drug products. In addition, some common CMC deficiencies that are relevant to liposomal drug product manufacturing processes will also be discussed.