Design of Experiment Approach for Development...

Design of Experiment Approach for Development of Localized Controlled Release Tablets and Beads Enclosed in Capsules of Vancomycin Hcl for The Treatment of Pseudomembraneous Colitis

Author Name : Venkateswarlu Kudupudi , Teella Prasanthi , Venkata Ramana Murthy Kolapalli

ABSTRACT Earlier reports indicated insignificant plasma concentrations of vancomycin HCl. Vancomycin HCl remains in the GIT tract and gets excreted in an unchanged form. Thus, it is more practical to measure the concentration of vancomycin HCl in the faecal matter which provides insights about the drug concentration. Hence, pharmacodynamic studies are carried out using faecal matter of rabbits.Three treatment study was used in which the rabbit dose colon targeted tablets, rabbit dose colon targeted beads in capsule and oral solution of pure vancomycin HCl 65 mg/mL prepared in distilled water were used. The faecal matter at intervals of 12 hours, 24 hours and 48 hours was collected and estimated for vancomycin HCl. Total drug excreted from RH2C10, RCHP3C8 and oral solution of pure drug were 61%, 64% and 72% of vancomycin HCl respectively. Statistical analysis using two way ANOVA followed by Tukey-Kramer test indicated that there was a significant difference between the three treatments for all the time intervals (p<0.05) except at 12th hour where the drug release from pure vancomycin HCl and RCHP3C8 are almost equal (p = 0.055).Thus, these results suggested that the colon targeted tablets and capsules with chitosan and hupu gum formulations were more effective in delivering vancomycin HCl to the colon for prolonged periods.

Key words: Vancomycin HCl, pharmacodynamics, faecal matter, ANOVA