Acta Pharm. 57 (2007) 61-72
Original research
paper
Design and
characterization of chitosan-containing mucoadhesive buccal patches of propranolol hydrochloride
VISHNU M. PATEL*, BHUPENDRA G. PRAJAPATI and MADHABHAI M.
PATEL
mmalai2003@yahoo.co.in
S. K. Patel College of Pharmaceutical Education & Research, Ganpat Vidyanagar, Kherva-382711,
Mehsana, Gujarat, India
Accepted October 17, 2006
Mucoadhesive buccal
patches containing propranolol hydrochloride were
prepared using the solvent casting method. Chitosan
was used as bioadhesive polymer and different ratios
of chitosan to PVP K-30 were used. The patches were
evaluated for their physical characteristics like mass variation, drug content
uniformity, folding endurance, ex vivo
mucoadhesion strength, ex vivo mucoadhesion time, surface pH, in vitro drug release, and in vitro buccal
permeation study. Patches exhibited controlled release for a period of 7 h. The
mechanism of drug release was found to be non-Fickian
diffusion and followed the first-order kinetics. Incorporation of PVP K-30
generally enhanced the release rate. Swelling index was proportional to the
concentration of PVP K-30. Optimized patches (F4) showed satisfactory bioadhesive strength of 9.6 ± 2.0 g, and ex vivo mucoadhesion
time of 272 minutes. The surface pH of all patches was between 5.7 and 6.3 and
hence patches should not cause irritation in the buccal
cavity. Patches containing 10 mg of drug had higher bioadhesive
strength with sustained drug release as compared to patches containing 20 mg of
drug. Good correlation was observed between the in vitro drug release and in
vitro drug permeation with a correlation coefficient of 0.9364. Stability
study of optimized patches was done in human saliva and it was found that both
drug and buccal patches were stable.
Keywords: mucoadhesion, buccal patch, propranolol hydrochloride, buccal
delivery, chitosan