Browse > Article
http://dx.doi.org/10.7841/ksbbj.2016.31.4.291

Effect of Polyethylene Glycol on Physicochemical Property in Dispersing Film Formulation  

Cho, Young Ho (Department of Pharmaceutics & Biotechnology, Konyang University)
Lee, Jong-Hwa (Division of Research and Development, Korea Institute of Toxicology)
Lee, Gye Won (Department of Pharmaceutics & Biotechnology, Konyang University)
Publication Information
KSBB Journal / v.31, no.4, 2016 , pp. 291-299 More about this Journal
Abstract
In this study, Indomethacin, the poorly water soluble drug, was selected and prepared dispersing oral disintegrating films according to the molecular weight of polyethylene glycol (PEG) which are sort of dispersing agents. Also the molecular weight and content of PEG were evaluated effect on the degree of dispersion, physical property and dissolution when making oral dispersing film containing indomethacin to find appropriate condition and suggested guidelines of making oral dispersing film. The appropriate dispersing ratio of the amount of surfactants and dispersing agent were 1% and 4%, also the stability dropped in the PEG molecular weight of 4000 or more. Drying time of oral dispersing film was $90^{\circ}C$ for 10 minutes to 12 minutes that dispersing film's property about flexibility, detachability were very good. The oral dispersion film's content used PEG 400 was $98.6{\pm}0.5%$ and the most uniform. As the molecular weight of PEG increased, dissolution time also increased. On the basis of evaluation parameter, PEG with 400~600 of molecular weight was selected as good dispersing agent in oral dispersing film. Therefore, it can be suggested guideline of preparation application study in oral dispersing film.
Keywords
Dispersing oral film; Indomethacin; Flexibility; Polyethylene glycol;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 Lin S. Y. (1988) Effect of excipients on tablet properties and dissolution behavior of theophylline-tableted microcapsules under different compression forces. J. Pharm. Sci. 77: 229-232.   DOI
2 Fouladi, F. and S. A. Mortazavi (2012) Preparation and in vitro evaluation of gastroretensive bupropion hydrochloride tablets. Trop. J. Pharm. Res. 11: 351-359.
3 Siepmann, J. and N. A. Peppas (2001) Modeling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC). Adv. Drug Deliv. Rev. 48: 139-157.   DOI
4 Ritger, P. L. and N. A. Peppas (1987) A simple equation for description of solute release II. Fickian and anomalous release from swellable devices. J. Control. Release. 5: 37-42.   DOI
5 Jyoti, A., S. Gurpreet, S. Seema, and A. C. Rana (2011) Fast dissolving films: A novel approach to oral drug delivery. Int. Res. J. Pharm. 2: 69-74.
6 Kalyan, S. and M. Bansal (2012) Recent trends in the development of oral dissolving film. Int. J. Pharm. Tech. Res. 2: 232-246.
7 Nagendrakumar, D., G. G. Keshavshetti, M. Pratibha, S. Swati, and S. Harshanand (2015) Formulation and evaluation of fast dissolving oral films of metoprolol succinate. Int. J. Eng. Appl. Sci. 6: 28-37.
8 ElMeshad, A. N. and A. S. ElHagrasy (2011) Characterization and optimization of orodispersible mosapride film formulations. AAPS Pharm. Sci. Tech. 12: 1384-1392.   DOI
9 Kalyan, S. and M. Bansal (2007) Recent trends in the development of oral dissolving film. Int. J. Pharm. Tech. Res. 4: 725-733.
10 Arya, A., A. Chandra, V. Sharma and K. Pathak (2010) Fast dissolving oral films: An innovative drug delivery system and dosage form. Int. J. Chem. Tech. Res. 2: 576-583.
11 Nagar, P., I. Chauhan, and M. Yasir (2011) Insights into polymers: Film formers in mouth dissolving films. Drug Invention Today. 3: 280-289.
12 Cilurzo, F., I. E. Cupone, P. Minghetti, F. Selmin, and L. Montanari (2008) Fast dissolving films made of maltodextrins. Eur. J. Pharm. Biopharm. 70: 895-900.   DOI
13 Ministry of Food and Drug Safety, Guideline on validation of analytical procedure. http:///www.mfds.go.kr (2015)
14 Shimoda, H., K. Taniguchi, M. Nishimura, K. Matsuura, T. Tsukioka, H. Yamashita, N. Inagaki, K. Hirano, M. Yamamoto, Y. Kinosada, and Y. Itoh (2009) Preparation of a fast dissolving oral thin film containing dexamethasone: a possible application to antiemesis during cancer chemotherapy. Eur. J. Pharm. Biopharm. 73: 361-365.   DOI
15 Jeon, H. Y., D. W. Kwon, B. S. Lee, S. J. Park, B. K. Cha, J. K. Kim, J. Y. Han, and M. C. Kil (2014) Film formulation containing tadalafil free base comprising polyethylene glycol based polymer and/or vinylpyrrolidone base polymer as dispersing agents. KR Patent 0043850.
16 Park, H. S., B. S. Cho, E. S. Yoo, J. B. Ahn, and S. T. Noh (2011) Shear shickening behavior of fumed silica, suspension in polyethylene glycol. Appl. Chem. Eng. 22: 384-389.
17 Pathare, Y. S., V. S. Hastak, and A. N. Bajaj (2013) Polymers used for fast disintegrating oral films: A review. Int. J. Pharm. Sci. Rev. Res. 21: 169-178.
18 US Pharmacopeia National Formulary (2003) USP 26-NF21. 3rd ed., pp. 2439. Mack Printing Company, Easton, USA.
19 Rowe, R., P. Sheskey, and S. Owen (2006) Handbook of Pharmaceutical Excipients. 5th ed., Pharmaceutical Press, London, UK.
20 Song, G. D., M. H. Kim, Y. T. Lee, and W. Y. Maeong (2013) Improvement in the dispersion stability of iron oxide (magnetite, $Fe_3O_4$) particles with polymer dispersant inject. Appl. Chem. Eng. 24: 656-662.   DOI
21 Jeon, H. R., D. W. Kwon, B. S. Lee, S. J. Park, B. G. Cha, J. K. Kim, J. Y. Han, and M. C. Kil (2014) Film preparation containing donepezil-free base and method for producing same. US Patent 14/890,247.
22 Paik, W. S., H. J. Kim, K. S. Kim, and H. B. Lee (1983) Dissolution rates of indomethacin preparations. J. Korean Pharm. Sci. 13: 104-109.
23 Bhupinder, B., S. Jangra, M. Kaur, H. Sihgh (2011) Orally fast dissolving films: Innovations in formulation and technology. Int. J. Pharm. Sci. Rev. Res. 9: 50-57.
24 Jadhav, S. D., R. N. Kalambe, C. M. Jadhav, B. W. Tekade, and V. R. Patil (2012) Formulation and evaluation of fast dissolving oral film of levocetirizine dihydrochloride. Int. J. Pharm. Pharm. Sci. 4: 337-341.