Development of a dissolution medium for glibenclamide

International Journal of Pharmaceutics

Volumn 140, Issue 1, 1996, Pages 69-76

  El Massik, M A ^a   Darwish, I A ^a   Hassan, E E ^a   El Khordagui, L K ^a  

^a Alexandria University Faculty of Pharmacy   (Egypt)

Author keywords

Alcohol; Dissolution medium; Glibenclamide; Hydroalcoholic surfactant solution; Tween 80

Indexed keywords

ALCOHOL; GLIBENCLAMIDE; GLIPIZIDE; POLYSORBATE 80; SURFACTANT;

ARTICLE; DISSOLUTION; DRUG SOLUBILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; TABLET DISINTEGRATION;

EID: 0029845241     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/0378-5173(96)04580-2     Document Type: Article

References (30)

1. Abdou, H.M., Dissolution, Bioavailability and Bioequivalence, Mack Publishing Co., Easton, Pennsylvania, 1989, pp. 153-161.
2. Bayne, C.K. and Rubin, I.B., Practical Experimental Designs and Optimization Methods for Chemists, VCH Publishers Inc., Beach, Florida, 1986, pp. 150-152.
3. Blume, H., Ali, S.L. and Stewert, M., Pharmaceutical quality of glibenclamide products. A multinational postmarket comparative study. Drug Dev. Ind. Pharm., 19 (1993) 2713-2741.
4. Chiou, W.L. and Riegelman, S., Oral absorption of griseofulvin in dogs: Increased absorption via solid dispersion in polyethylene glycol 6000. J. Pharm. Sci., 59 (1970) 937-942.
5. Corrigan, O.I., Co-solvent systems in dissolution testing: Theoretical considerations. Drug Dev. Ind. Pharm., 17 (1991) 695-708.
6. Dodge, A. and Gould, P.I., Dissolution of Chlorpropamide tablets in a methanol-water binary solvent system. Drug Dev. Ind. Pharm., 13 (1987) 1817-1826.
7. Elworthy, P. and Lipscomb, F., The effect of some non-ionic surfactants and a polyoxyethylene glycol on the dissolution rate of griseofulvin. J. Pharm. Pharmacol., 20 (1968) 923-933.
8. Emilsson, H., Sjoberg, S., Svedner, M. and Christenson, I., High-performance liquid chromatographic determination of glibenclamide in human plasma and urine. J. Chromatogr. Biomed. Appl., 56 (1986) 93-102.
9. FDA, FDA Division of Bioequivalence Guidance. In-vivo bioequivalence study in-vitro dissolution testing for carba-mazepine tablets (Sept. 30, 1987).
10. Gibaldi, M. and Feldman, S., Establishment of sink conditions in dissolution rate determinations and application to non-disintegrating dosage forms. J. Pharm. Sci., 56 (1967) 1238-1242.
11. Goehl, T.J., Sundaresan, G.M. and Prasad, V.K., Analytical methodology applicable in dissolution testing of norethindrone-mestranol tablets. Int. J. Pharm., 11 (1982) 181-186.
12. Green, F.A., Interactions of a non-ionic detergent III. Hydrophobic interactions. J. Colloid Interface Sci., 41 (1972) 124-129.
13. Guyot-Hermann, A.M. and Ringard, J., Disintegration mechanisms of tablets containing starches. Hypothesis about the particle-particle repulsive force. Drug Dev. Ind. Pharm., 7 (1981) 155-177.
14. Hassan, M.A., Najib, N.M. and Suleiman, M.S., Characterization of glibenclamide glassy state. Int. J. Pharm., 67 (1991) 131-137.
15. Heng, W.S. and Wan, L.S.C., Surfactant effect on the dissolution of sulfanilamide granules. J. Pharm. Sci., 74 (1985) 269-272.
16. Itai, S., Nemoto, M., Kouchiwa, S., Murayama, H. and Nagai, T., Dissolution profile in relation to available surface area. Part II. Influence of wetting factors on the dissolution behaviour of flufenamic acid. Chem. Pharm. Bull., 33 (1985) 5464-5473.
17. Kaali, R.N., Rye, R.M., Wiseman, D. and York, P., Dissolution of glibenclamide: The role of particle size. J. Pharm. Pharmacol., 39 (1987) 44p.
18. Katchen, B. and Symchowicz, S., Correlation of dissolution rate and griseofulvin absorption in man. J. Pharm. Sci., 56 (1967) 1108-1111
19. Nicklasson, M. and Brodin, A., The relationship between dissolution rates and solubilities in the water-ethanol binary solvent system. Int. J. Pharm., 18 (1984) 149-156.
20. Nicklasson, M., Brodin, A. and Nyqvist, H., Studies on the relationship between solubility and intrinsic rate of dissolution as a function of pH. Acta Pharm. Suec., 18 (1981) 119-128.
21. Nishikido, N., Moroi, Y., Uehara, H. and Matuura, R., Effect of alcohol on the micelle formation of non-ionic surfactants in aqueous solutions. Bull. Chem. Soc. Jpn., 47 (1974) 2634-2638.
22. Pandit, N.K., Strykowski, J.M., Mcnally, E.J. and Waldbillig, A.M., Surfactant solutions as media for dissolution testing of a poorly water-soluble drug. Drug Dev. Ind. Pharm., 11 (1985) 1797-1818.
23. Parrott, E. and Sharma, V., Dissolution kinetics of benzoic acid in high concentrations of surface-active agents. J. Pharm. Sci., 56 (1967) 1341-1343.
24. Poirier, H., Lewis, G.A., Shott, M.J. and Stevens, H.N.E. Problems with a pharmacopoeial dissolution test using a binary medium. Drug Dev. Ind. Pharm., 9 (1983) 443-452.
25. SAS/stat User's Guide (Release 6.03), SAS Institute, Inc., Gary, North Carolina, 1988.
26. Schott, H., Kwan, L.C. and Feldman, S., The role of surfactants in the release of very slightly soluble drugs from tablets. J. Pharm. Sci., 71 (1982) 1038-1045.
27. Shah, V.P., Konecny, J.J., Everett, R.L., McCullough, B., Carol Noorizadeh, A. and Skelly, J.P., In-vitro dissolution profile of water-insoluble drug dosage forms in the presence of solubilizers. Pharm. Res., 6 (1989) 612-618.
28. U.S.P. 23 rev., US Pharmacopeial Convention, Rockville, M.D., 1995 p. 267, 429 and 722.
29. U.S.P. 23-NF 18, Supp. 1, January 1995, 12601 Twinbrook Parkway, Rockville, Maryland 20852.
30. Walkling, W.D., Nayak, R.K., Plostnieks, J. and Cressman, W.A., A partially organic dissolution medium for griseofulvin dosage forms. Drug Dev. Ind. Pharm., 5 (1979) 17-27.