A STUDY OF THE COMBINATION OF MICROCRYSTALLINE CELLULOSE AND MANNITOL IN A CO-PROCESSED DRY BINDER AND IN A PHYSICAL MIXTURE FOR THE USE IN ORALLY DISINTEGRATING TABLETS

摘要

Avicel (R) HFE-102 is a co-processed dry binder containing 90% microcrystalline cellulose and 10% mannitol. This paper compares this co-processed dry binder and a physical mixture of related dry binders, microcrystalline cellulose (Avicel (R) PH-102) and mannitol (Pearlitol (R) 100SD) in the ratio of 9 : 1. Flow properties, compressibility, lubricant sensitivity, tensile strength, friability and disintegration time of tablets are evaluated. Compressibility is evaluated by means of the energy profile of compression process, and lubricant sensitivity by means of the lubricant sensitivity ratio. The results are also compared with the microcrystalline cellulose for direct compression Avicel (R) PH-102 alone. The flow properties of the co-processed dry binder Avicel (R) HFE-102 alone and the physical mixture were comparable. Avicel (R) HFE-102 showed higher values of the energy of plastic deformation, tensile strength of tablets, and a markedly lower lubricant sensitivity and tablet friability than the physical mixture of dry binders. Addition of lubricants exerted different effects on the disintegration of tablets. The co-processed excipient Avicel (R) HFE-102 is suitable for the use in orally dispersible tablets.