Formulation and evaluation of fast dissolving tablets of Granisetron hydrochloride by vacuum drying technique.

ABSTRACT

The purpose of this investigation was to develop fast dissolving tablets (FDTs) of Granisetron hydrochloride (GHCl) by vacuum drying technique using camphor as subliming agent together with croscarmellose sodium (CCS), crospovidone (CP), sodium starch glycolate (SSG) and plantago ovate (PO) as superdisintegrants. The prepared formulations were evaluated for pre-compressional and post-compressional parameters. The compatibility of drug with other ingredients was checked by FTIR studies, the results revealed that there was no interaction between dug and other excipients. The values of pre-compressional parameters were within prescribed limits and indicated good free flowing properties. In all the formulations the hardness test indicates good mechanical strength. Friability of all formulations was less than 1. Drug content was found to be high (≥ 100.44%) and uniform in all the formulations. The tablet thickness was found to be 3.11 – 3.34. The weight variation results revealed that average percentage deviation was less then ± 7.5 %, which provides good uniformity in all formulations. The disintegration time of the tablets found to be in the range of 18 to 44 sec. The formulations SBC4, SBP4, SBG4, and SBO4 50 % of drug released in 0.41, 0.48, 0.59 and 0.47 min, and 90 % of drug released in 2.01, 3.05, 4.01 and 2.51min. Stability study carried out as per ICH guidelines for three months and results revealed that upon storage disintegration time of tablets decreased significantly (p<0.05). The release of drug from the SBC4 and SBO4 formulations was quick when compared to other formulations. It was concluded that fast dissolving tablets with improved Granisetron hydrochloride dissolution could be prepared by sublimation of tablets containing suitable subliming agent.