Fast-dissolving tablets of glyburide based on ternary solid dispersions with PEG 6000 and surfactants

Drug Delivery

Volumn 14, Issue 4, 2007, Pages 247-255

  Cirri, Marzia ^a   Maestrelli, Francesca ^a   Corti, Giovanna ^a   Mura, Paola ^a   Valleri, Maurizio ^b  

^a UNIVERSITY OF FLORENCE   (Italy)

^b Menarini Manufacturing Logistics and Services   (Italy)

Author keywords

Dissolution Rate; Fast Dissolving Tablets; Glyburide; Polyethylene Glycol; Surfactant; Ternary Solid Dispersions

Indexed keywords

AEROSIL; CELLULOSE; CREMOPHOR; DODECYL SULFATE SODIUM; DRUG CARRIER; FLOWLAC; GLIBENCLAMIDE; GRANULAC; LACTOSE; MACROGOL 6000; MAGNESIUM STEARATE; PHARMGEL; POLYSORBATE 80; SILICON DIOXIDE; STARCH; SURFACTANT; TEXAPON; UNCLASSIFIED DRUG; VIVAPUR;

ARTICLE; DISPERSION; DRUG SOLUBILITY; HYDROPHILICITY; HYDROPHOBICITY; PRIORITY JOURNAL; SOLID STATE; TABLET COMPRESSION; TABLET FORMULATION;

CHEMISTRY, PHARMACEUTICAL; DRUG CARRIERS; GLYBURIDE; HYPOGLYCEMIC AGENTS; POLYETHYLENE GLYCOLS; SOLUBILITY; SURFACE-ACTIVE AGENTS; TABLETS; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS; WETTABILITY;

EID: 34248589379     PISSN: 10717544     EISSN: 15210464     Source Type: Journal    
DOI: 10.1080/10717540601067802     Document Type: Article

References (38)

1. Amidon, G. L., Lennernäs, H., Shah, V. P., and Crison, J. R. 1995. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12:413-420.
2. Babu, R. J., and Pandit, J. K. 1995. Enhancement of dissolution rate and hypoglycaemic activity of glibenclamide with β-cyclodextrin. S.T.P. Pharma. 5:196-201.
3. Bakatselou, V., Oppenheim, R. C., and Dressman, J. B. 1991. Solubilization and wetting effects of bile salts on the dissolution of steroid. Pharm. Res. 8:1461-1469.
4. Bertageri, G. V., and Makarla, K. R. 1995. Enhancement of dissolution of glyburide by solid dispersion and lyophilization techniques. Int. J. Pharm. 126:155-160.
5. Bertageri, G. V., and Makarla, K. R. 1996. Characterization of glyburide polyethylene glycol solid dispersions. Drug Dev. Ind. Pharm. 22:731-734.
6. Blume, H., Ali, S. L., and Siewert, M. 1993. Pharmaceutical quality of glibenclamide products: a multinational postmarket comparative study. Drug Dev. Ind. Pharm. 19:2713-2741.
7. Chalk, J. B., Patterson, M., Smith, M. T., and Eadie, M. J. 1986. Correlations between in vitro dissolution, in vivo bioavailability and hypoglycaemic effect of oral glibenclamide. Eur. J. Clin. Pharm. 31:177-187.
8. Chiou, W. L., and Riegelman, S. 1971. Pharmaceutical applications of solid dispersion systems. J. Pharm. Sci. 60:1281-1302.
9. Cirri, M., Mura, P., Rabasco, A. M., Ginés, J. M., Moyano, J. R., and González-Rodríguez, M. L. 2004. Characterization of ibuproxam binary and ternary dispersions with hydrophilic carriers. Drug Dev. Ind. Pharm. 30:65-74.
10. Cordes, D., and Müller, B. W. 1996. Deactivation of amorphous glibenclamide during dissolution. Eur. J. Pharm. Sci. 4:187-198.
11. Ford, J. L. 1986. The current status of solid dispersions. Pharm. Acta Helv. 61:69-88.
12. Galal, S., El-Massik, M., Abdallah, O., and Daabis, N. 2003. Formulation of fast release glibenclamide liquid and semi-solid matrix filled capsules. Acta Pharmaceut. 53:57-64.
13. Ghorab, M. M., Abdel-Salam, H. M., El-Sayad, M. A., and Mekhel, M. M. 2004.Tablet formulation containing meloxicam and β-Cyclodextrin: mechanical characterization and bioavailability evaluation. AAPS Pharm.Sci. Techn. 5:59-64.
14. Ghosh, L. K., Thakur, R. S., Sharma, P. K., Ghosh, N. C., and Gupta, B. K. 1998. Development and evaluation of an ideal formulation of glibenclamide by solid dispersion techniques. Boll. Chim. Farm. 137:26-29.
15. Groop, L., Wahlin-Boll, E., Totterman, K. J., Melander, A., Tolppanen, E. M., and Fyhrqvist, F. 1985. Pharmacokinetics and metabolic effects of glibenclamide and glipizide in type 2 diabetics. Eur. J. Clin. Pharm. 28:697-705.
16. Hartke, K. (Ed.). 2001. Comments to the European Pharmacopoeia, 14th ed., WV GmbH, Stuttgart.
17. Heng, P. W. S., and Wan, L. S. C. 1985. Surfactant effect on the dissolution of sulfanilamide granules. J. Pharm. Sci. 74:269-272.
18. Iwata, M., and Ueda, H. 1996. Dissolution properties of glibenclamide in combinations with polyvinylpyrrolidone. Drug Dev. Ind. Pharm. 22:1161-1165.
19. Khan, K. A. 1975. The concept of dissolution efficiency. J. Pharm. Pharmacol. 27:48-49.
20. Lerk, P. C., and Sucker, H. 1993. Application of sucrose laurate, a new pharmaceutical excipient in peroral formulations of cyclosporine-A. Int. J. Pharm. 92:197-202.
21. Melander, A., Donnellym, R., and Rydberg, T. 1998. Is there a concentration-effect relationship for sulphonylureas? Clin. Pharmacokin. 34:181-188.
22. Miseta, M., Kedvessy, G., and Selmeczi, B. 1983. Influence of the pressing force on the physical features of sulfathiazole tablets and the dissolution rate of the active ingredient. Pharmazie 38:326-327.
23. Mitrevej, A., Sinchaipanid, N., Juniaprasert, V., and Warintornuwat, L. 1996. Effect of grinding of β-cyclodextrin and glibenclamide on tablet properties. Drug Dev. Ind. Pharm. 22:1237-1241.
24. Moore, J.W., and Flanner, H. H. 1996. Mathematical comparison of dissolution profiles. Pharm. Tech. 20:64-74.
25. Mukerjee, P., and Mysels, K. J. 1971. Critical micelle concentrations of aqueous surfactant systems." In National Standard Reference Data Service. Washington, D.C: Natl. Bureau of Standards.
26. Mura, P., Faucci, M. T., Manderioli, and A. Bramanti, G. 1999. Thermal behaviour and dissolution properties of naproxen from binary and ternary solid dispersions. Drug Dev. Ind. Pharm. 25:257-264.
27. Mura, P., Moyano, J. R., González-Rodríguez, M. L., Rabasco, A. M., Cirri, M., and Maestrelli, F. 2005. Characterization and dissolution properties of ketoprofen in binary and ternary solid dispersions with polyethylene glycol and surfactants. Drug Dev. Ind. Pharm. 31:427-435.
28. Ruddy, S. B., Matuszewska, B. K., Grim, Y. A., Ostovic, D., and Storey, D. E. 1999. Design and characterization of a surfactant-enriched tablet formulation for oral delivery of a poorly water-soluble immunosuppressive agent. Int. J. Pharm. 182:173-186.
29. Schott, H., Kwan, L. C., and Feldman, S. 1982. The role of surfactants in release of very slightly soluble drugs from tablets. J. Pharm. Sci. 71:1038-1043.
30. Serajuddin, A. T. M. 1999. Solid dispersions of poorly-water-soluble drugs: early premises, subsequent problems and recent breakthroughs. J. Pharm. Sci. 88:1058-1066.
31. Shangraw, R. F., and Demarest, D. A. Jr. 1993. A survey of current industrial practices in the formulation and manufacture of tablets and capsules. Pharm. Technol. 17:32-44.
32. Sheen, P. C., Khetarpal, V. K., Cariola, M. C., and Rowlings, C. E. 1995. Formulation studies of a poorly water-soluble drug in solid dispersions to improve bioavailability. Int. J. Pharm. 118:221-227.
33. Souto, C., Gòmez-Amoza, J. L., Landìn, M., Vila-Jato, J. L., Concheiro, A., and Martìnez-Pacheco, R. 1989. Use of crushing strength parameter for quality control of phenobarbital-microcrystalline cellulose tablets." Il Farmaco 44:731-737.
34. Tashtoush, B. M., Al-Oashi, Z. S., and Najib, N. M. 2004. In vitro and in vivo evaluation of glibenclamide in solid dispersion systems." Drug Dev. Ind. Pharm. 30:601-607.
35. Valleri, M., Mura, P., Maestrelli, F. Cirri, M., and Ballerini, R. 2004. Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique. Drug Dev. Ind. Pharm. 30:525-534.
36. Vippagunta, S. R., Maul, K. A, Tallavajhala, S., and Grant, D. J. W. 2002. Solid-state characterization of nifedipine solid dispersions. Int. J. Pharm. 236:111-123.
37. Vlachou, M., hani, N., Efentakis, M., Tarantili, P. A., and Andreopoulos A. G. 2000. Polymers for use in controlled release systems: the effect of surfactants on their swelling properties. J. Biomater. Appl. 15:65-77.
38. Won, D. H., Kim, M. S., Lee, S., Park, J. S., and Hwang, S. J. 2005. Improved physicochemical characteristics of felodipine solid dispersion particles by supercritical anti-solvent precipitation process. Int. J. Pharm. 301:199-208.