Solubility Enhancement and Formulation of Chronologically Triggered Pulsatile Press Coated Tablets of BCS II Drug - Zaltoprofen

Author(s): U. Mohan Kumar* and Y. Sudhakar

Abstract: Major drawback of several drug substances for oral delivery is poor solubility and gastrointestinal side effects. The present study was aimed at solubility enhancement and development of chronologically triggered pulsatile tablets of the poorly soluble drug zaltoprofen for the treatment of rheumatoid arthritis (RA) symptoms in the early morning. Zaltoprofen (ZAF) solid dispersions (SDs) prepared by conventional solvent evaporation technique using novel Hydrophilic carriers PVPVA64, Soluplus and Lutrol surfactants and evaluated. The SDs prepared with PVPVA64 and Lutrol F127 in the ratio of 1:1.6:0.4 (ZAF: PVPVA64: Lutrol F127) increased the aqueous solubility of ZAF by 18.80-fold. 15 batches of Fast dissolving tablets (FDT) were prepared by direct compression method using super disintegrating agents. Out of 15 batches of FDTs ZC13 batch prepared with 8% of co processed super disintegrating agents produced rapid releases in 30 min (95%) with short disintegration time (47±1.91 Sec).Swellable top layer pulsatile press coated tablets prepared by using Konjac glucomannan (KGM) gum ,HPMC E50 and lactose and obtained 6hrs lag time before rapid release of drug in GIT.

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