Preformulation Challenges: The Concept Behind the Selection, Design and Preparation of Nanoformulations

Abstract

Nano-drug delivery carriers have fascinated researchers worldwide for the last two to three decades. The nanoformulations are preferred over conventional dosage forms as they provide improved drug solubility, bioavailability, drug stability under adverse external or physiological conditions, controlled drug release for prolonged action and target specificity using ligand binding and many more. Multiple essential aspects must be carefully studied and implemented for the development of efficient drug delivery vehicles. These aspects include rationale of nanoparticle preparation; use of polymeric or lipid nanoparticle; selection of polymer, lipid and excipients; method of preparation; screening of critical formulation or process parameters that affect the critical quality attributes; optimization of process to obtain the desired formulation characteristics; characterization of nanoparticles; strategy to improve the low entrapment efficiency and stability, etc. This chapter comprehensively summarizes all these aspects of nanoformulation development and proposes solutions for these challenges. Although a variety of nanoformulations have been described in literature, this chapter is restricted to discuss in detail the liposomes and polymeric and lipid nanoparticles.