ABSTRACT

M. M. CHOGALE1, A. A. DATE2, V. N. GHODAKE1, S. A. PAYGHAN3, J. I. DISOUZA3, and VANDANA B. PATRAVALE1*

1Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga (E), Mumbai 400019, Maharashtra, India

2The Center for Nanomedicine, Wilmer Eye Institute, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA

3Department of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar, Panhala, Kolhapur, Maharashtra, India

*Corresponding author. E-mail: vbp_muict@yahoo.co.in

ABSTRACT

Nanosuspensions are composed of nanosized crystals of pure drug dispersed in an aqueous or nonaqueous system containing a stabilizer/surfactant and/ or cosurfactant. Nanosuspensions have evolved as the delivery system of choice for formulation of most of Biopharmaceutics Classification System Class II and IV drugs. Ease of manufacture, amenability to be formulated for different drugs and feasibility for large-scale manufacture further present nanosuspensions as a popular approach for formulation of waterinsoluble drugs. This chapter focuses on the various aspects of nanosuspensions, including their formulation components, preparation methods, unique features, methods of characterization, and applications in various routes of administration. The chapter concludes with a case study that illustrates the development of a nanosuspension formulation based on the principles of Quality by Design and optimization by Design of Experiments.