J. Bhaskar1*, T. Ramchandar2, V.L. Narasaiah3
1Dept. of Pharmaceutics, Princeton Institute of Pharmaceutical Sciences, Hyderabad, Telangana, India.
2Dept. of Pharmaceutics , Mother Teresa college of Pharmacy, Ghatkesar, Hyderabad, Telangana India.
3Dept. of Pharmaceutics, Dr Samuel George Institute of Pharmaceutical Sciences, Markapur, A.P, India.
A B S T R A C T
The purpose of this research was to study bioadhesive bilayer buccal tablets of Ondansetron HCl using the bioadhesive polymers Hydroxypropyl cellulose (HPC) and Carbopol 934P (CP) along with ethyl cellulose as an impermeable backing layer. The tablets were evaluated for weight variation, thickness, hardness, friability, surface pH, bioadhesive strength, swelling index, in vitro drug release, ex vivo drug permeation, ex vivo mucoadhesion, and stability studies. Tablets containing Hydroxypropyl cellulose and CP in the ratio of 1∶3 (F32) had the maximum percentage of in vitro drug release without disintegration in 8 hours. The swelling index was proportional to Hydroxypropyl cellulose content and inversely Ondansetron HCl to CP content. The surface pH of all tablets was found to be satisfactory (6.83), close to neutral pH; hence, buccal cavity irritation should not occur with these tablets. The tablets were evaluated for in vitro release in pH 6.6 phosphate buffer for 8 hr in standard dissolution apparatus. In order to improve the permeation of the drug, tauroglycholate (permeation enhancer) added in the optimized formulation at 10mM concentration. The mechanism of drug release was found to be non-Fickian diffusion and followed zero-order kinetics. The formulation F32 was optimized based on good biodhesive strength (34.8 g) and sustained in vitro drug permeation (99.6% for 8 hours). The behavior of formulation F32 was examined in human saliva, and both the drug and the buccal tablet were found to be stable.
Keywords: Bioadhesion, bilayer device, buccal drug delivery, Ondansetron HCl, Hydroxypropyl cellulose, Carbopol 934