Engineered nano-sized liposomes have attained the highest success rate in commercialization among the reported nanomedicines. However, developing industrially acceptable nanoliposomes is still challenging because the process, formulation factors and even their properties may critically influence the desired attributes of the final nanoliposomal product. Implementation of quality-by-design (QbD) in nanoliposomal fabrication has led to revolutionary advancement int better analysis of the interacting factors (drug and lipid ratio, hydration, sonication, etc), which, in turn, leads to better product performance with predefined attributes (entrapment efficiency percentage, drug release time and pattern, vesicles size, polydispersity index, surface charge and surface morphology). This review provides a summary of decade of research and an in-depth analysis of QbD-based nanoliposomes developed to address different cancers. The review aims to provide complete details of QbD-inspired nanoliposomal development from process to application.
Keywords: cancer; design space; nanoliposomes; quality by design; regulatory.
This review describes liposomal nanomedicines manufactured via applying quality-by-design (QbD) principals/methods for the treatment of cancer. QbD is industrially applicable technique of manufacturing for emerging pharmaceutical nano-formulations owing to its benefits, including reduced cost, a smaller number of trials, high risk assessment and control over different formulation factors.