Comparison on physical property, dissolution and disintegration of four launched orally disintegration film (ODF) products for erectile dysfunction

다국어 초록 (Multilingual Abstract)

Commercially available orally disintegrationfilms (ODF) for erectile dysfunction were Viagra L 50 and100 mg by Pfizer Pharmaceuticals Korea Ltd., and Mvix S50 and 100 mg by SK Chemicals Co. The comparativestudies of physical property, disintegration and dissolutiontime of four ODFs were carried out to evaluate film formulation.
For film physical property, thickness and weightuniformity, tensile strength, dissolving pH, hygroscopicity,morphology, flexibility and polymeric characteristics wereinvestigated. In vitro disintegration studies were implementedby six methods. Conventional disintegration methodwas carried out using USP disintegration apparatus. One sidedisintegration method and both side disintegration methodwere performed by using shaking water bath. Slide framedisintegration method was conducted by contact anglemeasurement. Mouth disintegration method was performedby using two different mediums. One medium was a-amylasefree medium, another was add a-amylase. In vitro dissolutionstudies were carried out using pH 2.0 HCl and pH6.8 PBS. The results were validated statistically. Filmthickness of Mvix S 50 and 100 mg was thinner than that ofViagra L 50 and 100 mg, respectively. Film tensile strengthof Mvix S 50 mg and 100 mg was much higher than that ofViagra L 50 and 100 mg. However, Viagra L 50 and100 mg were more flexible so that it is easier to carry andstore. High hygroscopicity and high porosity in Viagra Lcould contribute to disintegrate film quickly. In six kinds ofdisintegration studies, both Viagra L 50 and 100 mgshowed not only muche faster disintegration time but alsomuch faster dissolution rate.

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