Delivery by Design (DbD): A Standardized Approach to the Development of Efficacious Nanoparticle- and Microparticle-Based Delivery Systems.

The design and development of nanoparticle- and microparticle-based delivery systems for the encapsulation, protection, and controlled release of active agents has grown considerably in the agrochemical, cosmetic, food, personal care, and pharmaceutical industries. These colloidal delivery systems can be utilized to overcome problems such as poor solubility, low activity, and chemical instability of active agents, as well as to create novel functional attributes such as controlled or targeted delivery. The purpose of this article is to develop a systematic approach, referred to as "delivery-by-design" (DbD), to make the design and fabrication process more efficient and effective. Initially, a brief review of some of the challenges associated with incorporating active agents into commercial products is given, and then an overview of different kinds of simple and complex colloidal delivery systems is given. The DbD approach is then presented as a series of stages: (1) definition of the molecular and physicochemical properties of the active agent; (2) definition of the required physicochemical, sensory, and functional attributes of the end-product; (3) specification of the required attributes of the colloidal delivery system; (4) specification of particle properties and delivery system selection; (5) optimization of delivery system manufacturing process; (6) establishment and implementation of delivery system testing protocol; and (7) optimization of delivery system performance. Utilization of the DbD approach may lead to more rapid design of efficacious and economically viable colloidal delivery systems for commercial applications.