Development And Characterization of Sublingual Film Containing Ropinirole Hydrochloride.
Development And Characterization of Sublingual Film Containing Ropinirole Hydrochloride.
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Original abstract
The present work aimed at preparing mouth dissolving films (MDFs) of Ropinirole Hydrochloride with the purpose of developing a dosage form for a very quick onset of action, which is very convenient for administration, without the problem of swallowing and using water. The films of Ropinirole Hydrochloride were prepared by using polymers such as Hydroxy Propyl Methyl Cellulose (HPMC E-15) and Polyethylene Glycol (PEG-400) as plasticizer, by a solvent casting method for treatment of Parkinson disease. HPMC E-15 used as film forming agent were developed from the range of concentration (50 mg – 600 mg) and PEG-400 used as plasticizer developed range of concentration (0.3-1 ml) for solvent casting method. Thus, the optimized concentration of film forming agent was (400 mg) and plasticizer concentration was (0.7ml). By using optimized concentration, Ropinirole Hydrochloride MDFs were prepared by adding other excipients. The formulated mouth dissolving films (MDFs) were evaluated for physical characteristics such as uniformity of weight, thickness, folding endurance, drug content uniformity, percentage elongation, and tensile strength, and gave satisfactory results. The formulations were subjected to disintegration, In-vitro drug release studies. The FTIR and DSC studies revealed that no physicochemical interaction between excipients and drug. A marked increase in the % drug release was exhibited by mouth dissolving films of Ropinirole Hydrochloride containing HPMC E-15 as a polymer at below 1 min. when compared to other polymers films. 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 No. of folds), in-vitro disintegration time (35± 3.511 sec.), thickness (0.4± 0.17 mm).