Critical Reviews™ in Th erapeutic Drug Carrier Systems, 21(6):433–475 (2004) CRT2106(133) Orally Fast Disintegrating Tablets: Developments, Technologies, Taste-Masking and Clinical Studies Yourong Fu, Shicheng Yang, Seong Hoon Jeong, Susumu Kimura, & Kinam Park Purdue University, Departments of Pharmaceutics and Biomedical Engineering, West Lafayette, Indiana, USA Address all correspondence to Kinam Park, Purdue University, School of Pharmacy, 575 Stadium Mall Drive, Room G22, West Lafayette, IN 47907-2091;
[email protected] ABSTRACT: Fast disintegrating tablets (FDTs) have received ever-increasing demand during the last decade, and the fi eld has become a rapidly growing area in the pharmaceuti- cal indus try. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. Th e popularity and usefulness of the formulation resulted in development of several FDT technologies. Th is review describes various formulations and technologies de- veloped to achieve fast dissolution/dispersion of tablets in the oral cavity. In particular, this review describes in detail FDT technologies based on lyophilization, molding, sublimation, and compaction, as well as approaches to enhancing the FDT properties, such as spray- drying, moisture treatment, sintering, and use of sugar-based disintegrants. In addition, taste-masking technologies, experimental measurements of disintegration times, and clinical studies are also discussed. KEY WORDS: fast dissolving, fast disintegrating, fast melting, taste masking, disintegra- tion time, clinical studies I. INTRODUCTION I.A. Dysphagia and Fast Disintegrating Tablets (FDTs) Dysphagia, or diffi culty in swallowing, is common among all age groups.¹ Accord- ing to a study by Sastry et al.,²dysphagia is common in about 35% of the general 0743-4863/04$20.00 © 2004 by Begell House, Inc., www.begellhouse.com 433 Y.