Physicochemical characterization and evaluation of buccal adhesive patches containing propranolol hydrochloride.
Buccal adhesive patches containing 20 mg of propranolol hydrochloride were prepared using solvent casting method. Chitosan was used as a natural bioadhesive polymer. Patches were prepared at different ratios of PVP K-30 and evaluated for various physicochemical characteristics such as weight variation, drug content uniformity, folding endurance, surface pH, ex-vivo mucoadhesive strength, ex-vivo residence time, in vitro drug release and in vitro buccal permeation study. Patches exhibited sustained release over a period of 7 hours. The mechanism of drug release was found to be Non-Fickian diffusion. Addition of PVP K-30 generally enhanced the releasing rate. The ex-vivo mucoadhesive strength was performed using sheep buccal mucosa on modified physical balance. Optimized patches (batch F4) showed satisfactory bioadhesive strength (9.6 degrees 2.0 gram) and ex vivo residence time (272 degrees 0.25 minutes). Swelling index was proportional to PVP K-30. The surface pH of all batches was within satisfactory limit (7.0+/-1.5) and hence patches would not cause irritation in the buccal cavity. Good correlation was observed between in vitro drug release and in vitro drug permeation with correlation coefficient of 0.9364. Stability of optimized patches was performed in natural human saliva showed that both drug and dosage forms were stable in human saliva.
Patel
V M
VM
S.K. Patel College of Pharmaceutical Education & Research, Ganpat Vidyanagar, Ganpat University, Kherva. PIN, 382711 City, Mehsana, State, Gujarat, Country, India. mmalai2003@yahoo.co.in
Prajapati
B G
BG
Patel
J K
JK
Patel
M M
MM
D000268:Adhesiveness; D000278:Administration, Buccal; D000818:Animals; D001682:Biological Availability; D048271:Chitosan / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000737:chemistry*; D016503:Drug Delivery Systems / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D006863:Hydrogen-Ion Concentration; D009061:Mouth Mucosa / Q000378:metabolism; D011205:Povidone / Q000737:chemistry; D011433:Propranolol / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D019946:Propylene Glycol / Q000737:chemistry; D012463:Saliva / Q000378:metabolism; D012756:Sheep; D013499:Surface Properties; D014867:Water / Q000737:chemistry
D003692:Delayed-Action Preparations; D014867:Water; D019946:Propylene Glycol; D048271:Chitosan; D011433:Propranolol; D011205:Povidone