Development of glyburide fast-dissolving tablets based on the combined use of cyclodextrins and polymers

Drug Development and Industrial Pharmacy

Volumn 35, Issue 1, 2009, Pages 73-82

  Cirri, Marzia ^a   Righi, M Francesca ^a   Maestrelli, Francesca ^a   Mura, Paola ^a   Valleri, Maurizio ^b  

^a UNIVERSITY OF FLORENCE   (Italy)

^b Menarini Manufacturing Logistics and Services   (Italy)

Author keywords

Complexation; Cyclodextrin; Glyburide; Hydrophilic polymers; Tablets

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; AEROSIL; ALPHA CYCLODEXTRIN; BETA CYCLODEXTRIN; CARBOXYMETHYLCELLULOSE; GAMMA CYCLODEXTRIN; GLIBENCLAMIDE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; MAGNESIUM STEARATE; METHYL BETA CYCLODEXTRIN; POVIDONE IODINE; STARCH;

ARTICLE; DRUG SOLUBILITY; DRUG SYNTHESIS; HYDROPHILICITY; MAIZE; TABLET COMPRESSION; TABLET FORMULATION;

BIOLOGICAL AVAILABILITY; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CYCLODEXTRINS; GLYBURIDE; HYPOGLYCEMIC AGENTS; POLYMERS; POVIDONE; SOLUBILITY; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; TABLETS; TECHNOLOGY, PHARMACEUTICAL; THERAPEUTIC EQUIVALENCY; X-RAY DIFFRACTION;

EID: 56749173508     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040802192798     Document Type: Article

References (30)

1. Amidon, G. L., Lennernäs, H., Shah, V. P., & 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., & Pandit, J. K. (1999). Effect of aging on the dissolution stability of glibenclamide-β-cyclodextrin complex. Drug Dev. Ind. Pharm., 25, 1215-1219.
3. Bartsch, S. E., & Griesser, U. J. (2004). Physicochemical properties of the binary system glibenclamide and polyethylene glycol 4000. J. Therm. Anal. Calorim., 77, 555-569.
4. Bertageri, G. V., & Makarla, K. R. (1995). Enhancement of dissolution of glyburide by solid dispersion and lyophilization techniques. Int. J. Pharm., 126, 155-160.
5. Blume, H., Ali, S. L., & Siewert, M. (1993). Pharmaceutical quality of glibenclamide products: A multinational postmarket comparative study. Drug Dev. Ind. Pharm., 19, 2713-2741.
6. Cirri, M., Valleri, M., Maestrelli, F., Corti, G., & Mura, P. (2007). Fast-dissolving tablets of glyburide based on ternary solid dispersions with PEG6000 and surfactants. Drug Deliv., 14, 247-255.
7. Cordes, D., & Müller, B. W. (1996). Deactivation of amorphous glibenclamide during dissolution. Eur. J. Pharm. Sci., 4, 187-198.
8. Faucci, M. T., & Mura, P. (2001). Effect of water-soluble polymers on naproxen complexation with natural and chemically-modified-β- cyclodextrins. Drug Dev. Ind. Pharm., 27, 311-319.
9. Hassan, M. A., Najib, N. M., & Suleiman, M. S. (1991). Characterization of glibenclamide glassy state. Int. J. Pharm., 67, 131-137.
10. Higuchi, T., & Connors, K. A. (1965). Phase-solubility techniques. Adv. Anal. Chem. Instrum., 4, 117-212.
11. Hirayama, F., & Uekama, K. (1999). Cyclodextrin-based controlled drug release system. Adv. Drug Deliv. Rev., 36, 125-141.
12. Iwata, M., & Ueda, H. (1996). Dissolution properties of glibenclamide in combinations with polyvinylpyrrolidone. Drug Dev. Ind. Pharm., 22, 1161-1165.
13. Khan, K. A. (1975). The concept of dissolution efficiency. J. Pharm. Pharmacol., 27, 48-49.
14. Leuner, C., & Dressman, J. 2000. Improving drug solubility for oral delivery using solid dispersions. Eur. J. Pharm. Biopharm., 50, 47-60.
15. Loftsson, T., & Fririksdóttir, H. (1998). The effect of water-soluble polymers on the aqueous solubility and complexing abilities of β-cyclodextrin. Int. J. Pharm., 163, 115-121.
16. Loftsson, T., Fririksdóttir, H., Siguroardóttir, A. M., & Stefánsson, E. (1996). Drug-cyclodextrin-polymer ternary complexes. Eur. J. Pharm. Sci., 4(Suppl. 1), S144.
17. Loftsson, T., Frioriksdottir, H., Siguroadottir, A. M., & Ueda, H. (1994). The effect of water-soluble polymers on drug-cyclodextrin complexation. Int. J. Pharm., 110, 169-177.
18. Masereel, B., Ouedraogo, R., Dogné, J. M., Antoine, H. M., de Tullio, P., Pirotte, B., Pochet, L., Delarge, J., & Lebrun, P. (1997). Synthesis and biological evaluation of sulfonylcyanoguanidines and sulphonamidonitroethylenes. Eur. J. Med. Chem., 5, 453-456.
19. Mura, P., Bettinetti, G. P., Manderioli, A., Faucci, M. T., Bramanti, G., & Sorrenti, M. (1998). Interactions of ketoprofen and ibuprofen with β-cyclodextrins in solution and in the solid state. Int. J. Pharm., 166, 189-203.
20. Mura, P., Faucci, M. T., & Bettinetti, G. P. (2001). The influence of polyvinylpyrrolidone on naproxen complexation with hydroxypropyl-β- cyclodextrin. Eur. J. Pharm. Sci., 13, 187-194.
21. Mura, P., Maestrelli, F., Cirri, M., Furlanetto, S., & Pinzauti, S. (2003). Differential scanning calorimetry as an analytical tool in the study of drug-cyclodextrin interaction. J. Therm. Anal. Calorim., 73, 635-646.
22. Mura, P., Zerrouck, N., Faucci, M. T., Maestrelli, F., & Chemtob, C. (2002). Comparative study of ibuproxam complexation with amorphous β-cyclodextrin derivatives in solution and in the solid state. Eur. J. Pharm. Biopharm., 54, 181-191.
23. Ribeiro, L., Carvalho, R. A., Ferreira, D. C., & Veiga, F. J. B. (2005). Multicomponent complex formation between vinpocetine, cyclodextrins, tartaric acid and water-soluble polymers monitored by NMR and solubility studies. Eur. J. Pharm. Sci., 24, 1-13.
24. Ribeiro, L., Ferreira, D. C., & Veiga, F. J. B. (2003). Physicochemical investigation of the effects of water-soluble polymers of vinpocetine complexation with β-cyclodextrin and its sulfobuthyl ether derivative in solution and solid state. Eur. J. Pharm. Sci., 20, 253-266.
25. Savolainen, J., Jarvinen, K., Taipale, H., Jarho, P., Loftsson, T., & Jarvinen, T. (1998). Co-administration of a water-soluble polymer increases the usefulness of cyclodextrins in solid oral dosage forms. Pharm. Res., 15, 1696-1701.
26. Smith, A. (1982). Use of thermal analysis in predicting drug-excipient interactions. Anal. Proc., 19, 559-561.
27. Uekama, K., Hirayama, F., & Irie, T. (1998). Cyclodextrin in drug carrier system. Chem. Rev., 98, 2045-2076.
28. Valleri, M., Mura, P., Maestrelli, F., Cirri, M., & Ballerini, R. (2004). Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique. Drug Dev. Ind. Pharm., 30, 525-534.
29. Van Dooren, A. A., & Duphar, B. V. (1983). Design for drug-excipient interaction studies. Drug Dev. Ind. Pharm., 9, 43-55.
30. Vogelpoel, H., Welink, J., Amidon, G. L., Junginger, H. E., Midha, K. K., Moller, H., Olling M., Shah, V. P., & Barends, D. M. (2004). Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification systems (BCS) literature data. J. Pharm. Sci., 93, 1945-1956.