Intestinal safety of water-soluble β-cyclodextrins in paediatric oral solutions of spironolactone: Effects on human intestinal epithelial Caco-2 cells

Journal of Pharmacy and Pharmacology

Volumn 49, Issue 1, 1997, Pages 43-48

  Tötterman, Ann M ^a,d   Schipper, Nicolaas G M ^b   Thompson, Diane O ^c   Mannermaa, J P ^a  

^a UNIVERSITY OF HELSINKI   (Finland)

^b UPPSALA UNIVERSITY   (Sweden)

^c CyDex LC   (United States)

^d Division of Pharmaceutical Chemistry   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; ACTIN; BETA CYCLODEXTRIN; BETA CYCLODEXTRIN SULFOBUTYL ETHER; DIMETHYL BETA CYCLODEXTRIN; DRUG ADDITIVE; DS 7; MANNITOL; OXIDOREDUCTASE; SOLUBILIZER; SPIRONOLACTONE; UNCLASSIFIED DRUG;

ARTICLE; CELL MEMBRANE PERMEABILITY; CELL MEMBRANE RESISTANCE; CELL STRAIN CACO 2; CONTROLLED STUDY; CYTOTOXICITY; DRUG EFFECT; DRUG SAFETY; ENTERIC FEEDING; ENZYME ACTIVITY; HUMAN; HUMAN CELL; INTESTINE EPITHELIUM; MEMBRANE DAMAGE; MONOLAYER CULTURE; TIGHT JUNCTION;

EID: 0031036821     PISSN: 00223573     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.2042-7158.1997.tb06750.x     Document Type: Article

References (28)

1. Anderberg, E. K., Nyström, C., Artursson, P. (1992) Epithelial transport of drugs in cell culture. VII: Effects of pharmaceutical surfactant excipients and bile acids on transepithelial permeability in monolayers of human intestinal epithelial (Caco-2) cells. J. Pharm. Sci. 81: 879-887
2. Anderberg, E. K., Lindmark, T., Artursson, P. (1993) Sodium caprate elicits dilatations in human intestinal tight junctions and enhances drug absorption by the paracellular route. Pharm. Res. 10: 857-864
3. Artursson, P. (1990) Epithelial transport of drugs in cell culture. I. A model for studying the passive diffusion of drugs over intestinal absorptive (Caco-2) cells. J. Pharm. Sci. 79: 476-482
4. Atkinson, S. A., Shah, J. K., McGee, C., Steele, B. T. (1988) Mineral excretion in premature infants receiving various diuretic therapies. J. Pediatr. 113: 540-545
5. Committee on Extemporaneous Formulations, ASHP Special Interest Group on Pediatric Pharmacy Practice (1987). Handbook on Extemporaneous Formulations. American Society of Hospital Pharmacists, Bethesda, MD, pp 45-47
6. Gerloczy, A., Hoshino, T., Pitha, J. (1994) Safety of oral cyclodextrins: effects of hydroxypropyl cyclodextrins, cyclodextrin sulfates and canonic cyclodextrins on steroid balance in rats. J. Pharm. Sci. 83: 193-196
7. Hovgaard, L., Brønstedt, H. (1995) Drug delivery studies in Caco-2 monolayers. IV. Absorption enhancer effects of cyclodextrins. Pharm. Res. 12: 1328-1332
8. Irie, T., Otagiri, M., Sunada, M., Uekama, K., Ohtani, Y., Yamada, Y., Sugiyama, Y. (1982) Cyclodextrin-induced haemolysis and shape changes of human erythrocytes in vitro. J. Pharmacobiodyn. 5: 741-744
9. Irie, T., Fukunaga, K., Pitha, J. (1992a) Hydroxypropylcyclodextrins in parenteral use. I: Lipid dissolution and effects on lipid transfers in vitro. J. Pharm. Sci. 81: 521-523
10. Irie, T., Wakamatsu, K., Arima, H., Aritomi, H., Uekama, K. (1992b) Enhancing effects of cyclodextrins on nasal absorption of insulin in rats. Int. J. Pharm. 84: 129-139
11. Karlsson, J. (1995) Drug Absorption in Cell Culture Models of the Intestinal Epithelium. Ph.D. Thesis, Uppsala University, Department of Pharmaceutics.
12. Leff, R., Roberts, R. (1987) Problems in drug therapy of pediatric patients. Am. J. Hosp. Pharm. 44: 865-870
13. Leroy-Lechat, F., Wouessidjewe, D., Andreux, J. P., Puisieux, F., Duchêne, D. (1994) Evaluation of cytotoxicity of cyclodextrins and hydroxypropylated derivatives. Int. J. Pharm. 101: 97-103
14. Madara, J. L. (1983) Increases in guinea pig small intestinal transepithelial resistance induced by osmotic loads are accompanied by rapid alterations in absorptive-cell tight-junction structure. J. Cell Biol. 97: 125-136
15. Madara, J. L. (1987) Intestinal absorptive cell tight junctions are linked to cytoskeleton. Am. J. Physiol. 253: C171-C175
16. Mathur, L. K., Wickman, A. (1989) Stability of extemporaneously compounded spironolactone suspensions. Am. J. Hosp. Pharm. 46: 2040-2042
17. Ohtani, Y., Irie, T., Uekama, K., Fukunaga, K., Pitha, J. (1989) Differential effects of α, β- and γ- cyclodextrins on human erythrocytes. Eur. J. Biochem. 186: 17-22
18. Pramar, Y., Gupta, V.D., Bethea, C. (1992) Development of a stable oral liquid dosage form of spironolactone. J. Clin. Pharmacol. Ther. 17: 245-248
19. Schipper, N. G. M., Verhoef, J., Romeijn, S. G., Merkus, F. W. H. M. (1992) Absorption enhancers in nasal insulin delivery and their influence on nasal ciliary functioning. J. Contr. Rel. 21: 173-186
20. Shao, Z., Li, Y., Chermak, T., Mitra, A. K. (1994) Cyclodextrins as mucosal absorption promoters of insulin. II. Effects of β-cyclodextrin derivatives on α-chymotryptic degradation and enteral absorption of insulin in rats. Pharm. Res. 11: 1174-1179
21. Shiotani, K., Uehata, K., Irie, T., Uekama, K., Thompson, D. O., Stella, V. J. (1995) Differential effects of sulfate and sulfobutyl ether of β-cyclodextrin on erythrocyte membranes in vitro. Pharm. Res. 12: 78-84
22. Szejtli, J. (1988) Cyclodextrin Technology. Kluwer Academic Publisher, Dordrecht, pp 186-306
23. Szejtli, J., Cserháti, T., Szögyi, M. (1986) Interactions between cyclodextrins and cell-membrane phospholipids. Carbohydr. Polym. 6: 35-49
24. Uekama, K. (1985) Pharmaceutical applications of methylated cyclodextrins. Pharm. Int. 6: 61-65
25. Uekama, K., Hirayama, F., Irie, T. (1991) Pharmaceutical uses of cyclodextrin derivatives. In: Szycher, M. (ed.), High Performance Biomaterials. Technomic Publishing Company, Inc., Lancaster, pp 789-806
26. Yeagle, P. L. (1985) Cholesterol and the cell membrane. Biochim. Biophys. Acta 822: 267-287
27. Yoshida, A., Arima, H., Uekama, K., Pitha, J. (1988). Pharmaceutical evaluation of hydroxyalkyl ethers of β-cyclodextrins. Int. J. Pharm. 46: 217-222
28. Yusuff, N. T. (1990) Studies of Cyclodextrin Complexes for Drug Delivery - Spironolactone: Cyclodextrin Systems. Ph.D. Thesis, University of Bradford, Postgraduate School of Studies in Pharmaceutical Technology