ABSTRACT
In pharmaceutical sciences, significant research has been carried out in using liposomes, micelles, microemulsions, lipopolymers, and polymeric dendrimers as nanoparticulate drug delivery systems (NanoDDSs) and drug nanocrystals as nanoparticles (NPs). The biopharmaceutic modification is different for NPs that do not retain their nanoparticulate nature as the drug gets absorbed and distributed, compared to NPs that owe their biological function in the central compartment to their nanoparticulate size and/or structure. All the physicochemical characteristics of a NanoDDS or NP may or may not be critical to the functionality of the drug in a clinical setting. The pharmaceutical development and regulation of these materials, as confined to the use of Active Pharmaceutical Ingredient (API) NPs and NanoDDSs incorporating a drug, nevertheless, are often adequately covered with the current rigor of drug development process. NPs behave differently in the pharmacokinetic parameters of drug absorption, distribution, metabolism, and elimination compared to the dissolved API.
