DEVELOPMENT AND CHARACTERIZATION OF SUBLINGUAL FILM CONTAININGROPINIROLE HYDROCHLORIDE

摘要

In the present work films of ropinirole hydrochloride were prepared by using polymers such as hydroxy propyl methyl cellulose (HPMC E-15) and polyethylene glycol (PEG-400) as plasticizers, by a solvent casting method, for treatment of Parkinson's disease. HPMC E-15 was used as film forming agent in the range of concentration 50 mg - 600 mg and PEG-400 was used as plasticizer in the range of concentration 0.3-1.0 mL for solvent casting method. The optimized concentration of film forming agent was 400 mg and plasticizer concentration was 0.7mL. By using optimized concentration, Ropinirole Hydrochloride mouth dissolving films (MDFs) were prepared by additionof other excipients. The formulated MDFs were evaluated for different physical characteristics like uniformity of weight, thickness, folding endurance, drug content uniformity, percentage elongation, and tensile strength, disintegration, in vitro drug release studies and provided agreeable results. The FTIR and DSC studies confirmed that no physicochemical interaction in between drug and excipients accured. Mouth dissolving film of Ropinirole Hydrochloride containing HPMC E-15 as polymer showed 97.66 % drug release at 30 min. Mouth dissolving films of ropinirole hydrochloride containing HPMC E-15 showed better tensile strength (70.56 ± 0.9 g/mm2), percentage elongation (33.33 ± 2.88 %), folding endurance (168± 2.081 numbers of folds), in vitro disintegration time (35± 3.511 sec.) and thickness (0.4± 0.17 mm).