Characterization and evaluation of spray dried co-processed excipients and their application in solid dosage forms
1 Sinhgad College of Pharmacy, 44/1 Vadgaon (Bk.), Off Sinhgad Road, Pune-411 041, India 2 Department of Pharmacy, Faculty of Technology and Engineering, Kalabhavan, M. S. University, Vadodara-390 001, India
Amelia Avachat Sinhgad College of Pharmacy, 44/1 Vadgaon (Bk.), Off Sinhgad Road, Pune-411 041 India E-mail: [email protected]
Major challenge for tablet manufacture comes from the powder characteristics of the materials to be compressed. This in turn poses a challenge in achieving greater productivity and better quality product especially on the new generation high-speed machines. Advancement in directly compressible materials has come in the form of co-processed spray dried materials. The present work evaluates and characterizes two spray dried co-processed materials, one comprising of microcrystalline cellulose, colloidal silicon dioxide and cross povidone and the other composed of microcrystalline cellulose, colloidal silicon dioxide and sodium starch glycollate. Prototype tablet formulations were developed with these co-processed materials using actives such as diclofenac sodium, iron polymaltose complex and amoxycillin trihydrate. Their performance was compared vis-à-vis conventionally processed tablet formulations as well as with leading marketed brands. This study revealed that the co-processed materials have excellent flow properties, high compressibility, render low disintegration time to tablets and have better binding properties. These materials can be a good substitute for inert granules, which are normally used in tablet manufacturing.