Abstract
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.
Similar content being viewed by others
References
Bandari S, Mittapalli RK, Gannu R, Rao YM (2008) Orodispersible tablets: an overview. Asian J Pharm 2:2
Basu B, Aviya KR, Bhattacharya A (2014) Development and characterization of mouth dissolving tablets of prednisolone. J Pharm Investig 44(2):79–102
Bhyan B, Jangra S, Kaur M, Singh H (2011) Orally fast dissolving films: innovations in formulation and technology. Int J Pharm Sci Rev Res 9:9
Chakraborty P, Parcha V, Chakraborty DD, Chanda I, Ghosh A (2013) Mathematical optimization and characterisation of pharmaceutically developed novel buccoadhesive wafers for rapid bioactive delivery of Loratadine. J Pharm Investig 43:133–143
Chauhan I, Yasir M, Nagar P (2012) Insights into polymers: film formers in mouth dissolving films. Drug Invent Today 3:12
Choi YH, Lee YS, Kim TK, Im G-J, Lee B-Y, Lee MG (2009) Simultaneous LC–UV analysis of mirodenafil and its two main metabolites in rat plasma and urine, and in tissue homogenates. Chromatographia 69:677–683
Dawes C (2003) What is the critical pH and why does a tooth dissolve in acid? J Can Dent Assoc 69:722–725
Dunn PJ, Galvin S, Hettenbach K (2004) The development of an environmentally benign synthesis of sildenafil citrate (Viagra™) and its assessment by Green Chemistry metrics. Green Chem 6:43–48
Janßen EM, Schliephacke R, Breitenbach A, and Breitkreutz J (2012) Drug-printing by flexographic printing technology—a new manufacturing process for orodispersible films. Int J Pharm 441(1–2):818–825
Kathpalia H, Sule B, Gupte A (2013) Development and evaluation of orally disintegrating film of Tramadol Hydrochloride. J Biomed Pharm Sci 3:27–32
Keshavarao KP, Mudit D, Gunashekara K, Anis S, Singh Mangla N, Ajay K (2011) Formulation and evaluation of mouth dissolving film containing Rofecoxib. IRJP 2:273–278
Kulkarni A, Deokule H, Mane M, Ghadge D (2010) Exploration of different polymers for use in the formulation of oral fast dissolving strips. J Current Pharm Res 2:33–35
Kunte S, Tandale P (2010) Fast dissolving strips: a novel approach for the delivery of verapamil. J Pharm Bioallied Sci 2:325
Liew KB, Tan YTF, Peh KK (2012) Characterization of oral disintegrating film containing donepezil for Alzheimer disease. Am Assoc Pharm Sci PharmSciTech 13:134–142
Lodhi M, Dubey A, Narayan R, Prabhu P, Priya S (2013) Formulation and evaluation of buccal film of Ivabradine hydrochloride for the treatment of stable angina pectoris. Int J Pharm Investig 3:47
Mahtre S (2012) Rapid dissolve oral dosage forms-a detail review. J Glob Pharm Technol 4:01–14
Mishra R, Amin A (2011) Formulation and characterization of rapidly dissolving films of cetirizine hydrochloride using pullulan as a film forming agent. Indian J Pharm Educ Res 45:75–76
Nater UM, Rohleder N, Gaab J, Berger S, Jud A, Kirschbaum C et al (2005) Human salivary alpha-amylase reactivity in a psychosocial stress paradigm. Int J Psychophysiol 55:333–342
Othman A, Rizk N, El-Shahawi M (2004) Polymer membrane sensors for sildenafil citrate (Viagra) determination in pharmaceutical preparations. Anal Chim Acta 515:303–309
Parejiya PB, Patel RC, Mehta DM, Shelat PK, and Barot BS (2012) Quick dissolving films of nebivolol hydrochloride: formulation and optimization by a simplex lattice design. J Pharm Investig 43(4):343–351
Patel J, Kevin G, Patel A, Raval M, Sheth N (2011) Design and development of a self-nanoemulsifying drug delivery system for telmisartan for oral drug delivery. Int J Pharm Investig 1:112
Preis M, Pein M, Breitkreutz J (2012) Development of a taste-masked orodispersible film containing dimenhydrinate. Pharmaceutics 4:551–562
Saini P, Kumar A, Sharma P, Visht S (2012) Fast disintegrating oral films: a recent trend of drug delivery. Int J Drug Dev Res 4:80–94
Sawatdee S, Srichana T (2013) Analytical validation of sildenafil citrate inhaler preparation. Chiang Mai J Sci 40(4):660–669
Shoukri RA, Ahmed IS, Shamma RN (2009) In vitro and in vivo evaluation of nimesulide lyophilized orally disintegrating tablets. Eur J Pharm Biopharm 73:162–171
Siddiqui MN, Garg G, Sharma PK (2011) A short review on “A novel approach in oral fast dissolving drug delivery system and their patents”. Adv Biol Res 5:291–303
Tung N-T, Hung M-V, Vo X-M, Nguyen T-H, Pham T-M-H (2014) Formulation optimization of orally disintegrating tablets containing solid dispersion of felodipine and hydroxypropyl methylcellulose using face-centered central composite design. J Pharm Investig 44(2):111–118
Wagh MA, Kothawade DP, Salunkhe KS, Chavan NV, Daga VR (2011) Techniques used in orally disintegrating drug delivery system. Int J Drug Deliv 2:2
Acknowledgments
All authors (M. Kwon, H.Kang, J.H. Ahn, W. Cho, B. Sun, S.-J. Hwang) declare that they have no conflict of interest. This work was supported and funded by Pfizer Pharmaceutical Korea Ltd., Seoul, Republic of Korea (2013-8-1071).
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Kwon, M., Kang, H., Ahn, J.H. et al. Comparison on physical property, dissolution and disintegration of four launched orally disintegration film (ODF) products for erectile dysfunction. Journal of Pharmaceutical Investigation 44, 297–307 (2014). https://doi.org/10.1007/s40005-014-0127-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40005-014-0127-2