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

• Published in: Journal of pharmaceutical investigation Vol. 44; no. 4; pp. 297 - 307
• Main Authors: Kwon, Minjun, Kang, Han, Ahn, Jun Hyun, Cho, Wonkyung, Sun, Bokyung, Hwang, Sung-Joo
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.08.2014; 한국약제학회
• Subjects: Biomedical and Life Sciences; Biomedicine; Research Article; 약학; Physical property; Orally disintegration film (ODF); Dissolution; Disintegration; Viagra L; Mvix S
• ISSN: 2093-5552; 2093-6214
• DOI: 10.1007/s40005-014-0127-2

Commercially available orally disintegration films (ODF) for erectile dysfunction were Viagra L ® 50 and 100 mg by Pfizer Pharmaceuticals Korea Ltd., and Mvix S ® 50 and 100 mg by SK Chemicals Co. The comparative studies of physical property, disintegration and dissolution time of four ODFs were carried out to evaluate film formulation. For film physical property, thickness and weight uniformity, tensile strength, dissolving pH, hygroscopicity, morphology, flexibility and polymeric characteristics were investigated. In vitro disintegration studies were implemented by six methods. Conventional disintegration method was carried out using USP disintegration apparatus. One side disintegration method and both side disintegration method were performed by using shaking water bath. Slide frame disintegration method was conducted by contact angle measurement. Mouth disintegration method was performed by using two different mediums. One medium was α-amylase free medium, another was add α-amylase. In vitro dissolution studies were carried out using pH 2.0 HCl and pH 6.8 PBS. The results were validated statistically. Film thickness of Mvix S ® 50 and 100 mg was thinner than that of Viagra L 50 and 100 mg, respectively. Film tensile strength of Mvix S ® 50 mg and 100 mg was much higher than that of Viagra L 50 and 100 mg. However, Viagra L ® 50 and 100 mg were more flexible so that it is easier to carry and store. High hygroscopicity and high porosity in Viagra L ® could contribute to disintegrate film quickly. In six kinds of  disintegration studies, both Viagra L ® 50 and 100 mg showed not only muche faster disintegration time but also much faster dissolution rate.