Abstract

A FACTORIAL STUDY, FORMULATION AND EVALUATION ROPINIROLE HYDROCHLORIDE TRANSDERMAL FILMS

Harshal B. Nannaware* and Dr. S. Z. Chemate

Abstract

The present work aimed at preparing transdermal films of Ropinirole Hydrochloride with the purpose of developing a dosage form for a sustain release 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 HPMC K4M and PEG 400 as plasticizer, by a solvent evaporation method. Formulation batches were formulated with the help of 3 2 full factorial designs. The transdermal films were designed using optimal design and numerical optimization technique was applied to find out the best formulation. The formulated Transdermal films were evaluated for physical characteristics such as uniformity of weight, thickness, folding endurance, drug content uniformity, surface pH, percentage and tensile strength and gave satisfactory results. The formulations were subjected to, In-vitro drug release tests. The IR and UV studies revealed that no physicochemical interaction between excipients and drug. Transdermal flim containing HPMC K4M showed 98.19% drug release. Transdermal films of Ropinirole Hydrochloride containing HPMC showed better tensile strength (9.67 ± 0.064g/mm2), folding endurance (162 No. of folds), surface pH (6.60 ± 0.10 pH), thickness (0.61 mm) and percentage content uniformity (98.19%). Stability studies revealed that optimized formulation was stable. Transdermal films of Ropinirole Hydrochloride can be considered suitable for clinical use in the treatment of parkinson’s disease and rest leg syndrome, where a sustain release of action for a dosage form is desirable along with the convenience of administration.

Keywords: Ropinirole Hydrochloride, HPMC K4M, Polyethylene Glycol 400, Solvent Evaporation method, Parkinson disease.