Preparation and evaluation of ketoprofen hot-melt extruded enteric and sustained-release tablets

Drug Development and Industrial Pharmacy

Volumn 34, Issue 1, 2008, Pages 83-89

  Yang, Rui ^a   Wang, Yanjiao ^a   Zheng, Xin ^a   Meng, Jia ^a   Tang, Xing ^a,c   Zhang, Xuefeng ^b  

^a SHENYANG PHARMACEUTICAL UNIVERSITY   (China)

^b Coperion Keya Corporation ^*  (China)

^c NONE   (China)

Author keywords

Enteric; Hot melt extrusion; Ketoprofen; Sustained release

Indexed keywords

EUDRAGIT; HYDROCHLORIC ACID; KETOPROFEN; POLYMER;

ARTICLE; CONTROLLED DRUG RELEASE; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG DIFFUSION; DRUG MIXTURE; DRUG SCREENING; ENTERIC COATED TABLET; PHYSICAL CHEMISTRY; POROSITY; SCANNING ELECTRON MICROSCOPY; SUSTAINED RELEASE PREPARATION; TABLET COMPRESSION; TABLET FORMULATION; TENSILE STRENGTH; X RAY DIFFRACTION;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DELAYED-ACTION PREPARATIONS; KETOPROFEN; MICROSCOPY, ELECTRON, SCANNING; PHTHALIC ACIDS; PLASTICIZERS; POLYMETHACRYLIC ACIDS; SOLUBILITY; TABLETS, ENTERIC-COATED; TECHNOLOGY, PHARMACEUTICAL; TENSILE STRENGTH; X-RAY DIFFRACTION;

EID: 38549135371     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040701580572     Document Type: Article

References (28)

1. Ahn, H. J., Kim, K. M., & Kim, C. K. (1998.) Enhancement of bioavailability of ketoprofen using dry elixir as a novel dosage form. Drug Dev. Ind. Pharm. 24, 697-701.
2. Breitenbach, J., (2002). Melt extrusion: From process to drug delivery technology. Eur. J. Pharm. Biopharm., 54, 107-117.
3. Chi, S. C., & Jun, H. W. (1990). Anti-inflammatory activity of ketoprofen gel on carrageenan-induced paw edema in rats. J. Pharm. Sci. 79, 974-977.
4. Crowley, M. M., Fredersdorf, A., Schroeder, B., Kucera, S., Prodduturi, S., Repka, M. A., et al. (2004). The influence of guaifenesin and ketoprofen on the properties of hot-melt extruded polyethylene oxide films. Eur. J. Pharm. Sci., 22, 409-418.
5. Crowley, M. M., Schroeder, B., Fredersdorf, A., Obara, S., Talarico, M., Kucera, S., et al. (2004). Physicochemical properties and mechanism of drug release from ethyl cellulose matrix tablets prepared by direct compression and hot-melt extrusion. Int. J. Pharm. 269, 509-522.
6. De Brabander, C., Vervaet, C., & Remon, J. P. (2003). Development and evaluation of sustained release mini-matrices prepared via hot melt extrusion. J. Control. Release 89, 235-247.
7. Follonier, N., Doelker, E., & Cole, E. T. (1994). Evaluation of hot-melt extrusion as a new technique for the production of polymer-based pellets for sustained-release capsules containing high loading of freely water soluble drugs. Drug Dev. Ind. Pharm., 20,1323-1339.
8. Forster, A., Hempenstall, J., Tucker, I., & Rades, T. (2001). Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis. Int. J. Pharm., 226, 147-161.
9. Fukuda, M., Peppas, N. A., & McGinity, J. W. (2006). Properties of sustained release hot-melt extruded tablets containing chitosan and xanthan gum. Int. J. Pharm., 310, 90-100.
10. Greenhalgh, D. J., Williams, A. C., Timmins, P., & York, P. (1999). Solubility parameters as predictors of miscibility in solid dispersions. J. Pharm. Sci., 88, 1182-1190.
11. Hülsmann, S., Backensfeld, T., Keitel, S., & Bodmeier, R. (2000). Melt extrusion-an alternative method for enhancing the dissolution rate of 17β-estradiol hemihydrate. Eur. J. Pharm. Biopharm., 49, 237-242.
12. Liu, J., Zhang, F., & McGinity, J. W. (2001). Properties of lipophilic matrix tablets containing phenylpropanolamine hydrochloricde prepared by hot-melt extrusion. Eur. J. Pharm. Biopharm. 52, 181-190.
13. Liversidge, G. G. (1981). Ketoprofen. In: K. Florey (Ed.), Analytical profiles of drug substances (pp. 443-471). New York: Academic Press.
14. Mehuys, E., Remon, J. P., & Vervaet, C. (2005). Production of enteric capsules by means of hot-melt extrusion. Eur. J. Pharm. Sci., 2, 207-212.
15. Mehuys, E., Vervaet, C., & Remon, J. P. (2004). Hot-melt extruded ethylcellulose cylinders containing a HPMC-Gelucire® core for sustained drug delivery. J. Control. Release., 94, 273-280.
16. Miller-Chou, B. A., & Koenig, J. L. (2003). A review of polymer dissolution. Prog. Polym. Sci., 28, 1223-1270.
17. Nakamichi, K., Nakano, T., & Yasuura, H. (2002). The role of the kneading paddle and the effects of screw revolution speed and water content on the preparation of solid dispersions using a twin-screw extruder. Int. J. Pharm., 241, 203-211.
18. Nakamichi, K., Yasuura, H., Fukui, H., Oka, M., & Izumi, S. (2001). Evaluation of a floating dosage form of nicerdipine hydrochloricde and hydroxylpropylmethylcellulose acetate succinate prepared using a twin-screw extruder. Int. J. Pharm., 218, 103-112.
19. Perissutti, B., Newton, J. M., Podczeck, F., & Rubessa, F. (2002). Preparation of extruded carbamazepine and PEG4000 as a potential rapid release dosage form. Eur. J. Pharm. Biopharm., 53, 125-132.
20. Prodduturi, S., Manek, R. V., Kolling, W. M., Stodghill S. P., & Repka, M. A. (2004). Water vapor sorption of hot-melt extruded hydroxypropyl cellulose films: Effect on physico-mechanical properties, release characteristics, and stability. J. Pharm. Sci., 93, 3047-3056.
21. Prodduturi, S., Manek, R. V., Kolling, W. M., Stodghill, S. P., & Repka, M. A. (2005). Solid-state stability and characterization of hot-melt extruded poly(ethylene oxide) films. J. Pharm. Sci. 94, 2232-2245.
22. Repka, M. A., Gutta, K., Prodduturi, S., Munjal, M., & Stodghill, S. P. (2005). Characterization of cellulosic hot-melt extruded films containing lidocaine. Eur. J. Pharm. Biopharm., 59, 189-196.
23. Repka, M. A., & McGinity, J. W. (2001). Bioadhesive properties of hydroxypropylcellulose topical films produced by hot-melt extrusion. J. Control. Release, 70, 341-351.
24. Roda, A., Sabatini, L., Mirasoli, M., Baraldini, M., & Roda, E. (2002). Bioavailability of a new ketoprofen formulation for once-daily oral administration. Int. J. Pharm., 241, 165-172.
25. Six, K., Berghmans, H., Leuner, C., Dressman, J., Van Werde, K., Mullens, J., et al. (2003). Characterization of solid dispersions of itraconazole and hydroxypropylmethylcellulose prepared by melt extrusion, part II. Pharm Res., 20, 1047-1054.
26. Takayama, K., & Nagai, T. (1991). Simultaneous optimization for several characteristics concerning d-percutaneous absorption. Int. J. Pharm., 74, 115-126.
27. Van Krevelen, D. W. (1990). Properties of polymers. Amsterdam: Elsevier.
28. Verreck, G., Six, K., Van den Mooter, G., Baert, L., Peeters, J., & Brewster, M. E. (2003). Characterization of solid dispersions of itraconazole and hydroxypropylmethylcellulose prepared by melt extrusion-part?. Int. J. Pharm., 251, 165-174.