Biological activity of insulin in GMO gels and the effect of agitation

International Journal of Pharmaceutics

Volumn 191, Issue 1, 1999, Pages 65-74

  Sadhale, Yogesh ^a,b   Shah, Jaymin C ^a,c  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b Pentech Pharmaceuticals Inc   (United States)

^c PFIZER INC   (United States)

Author keywords

Cubic phase; GMO; In vivo activity; Insulin; Proteins; Rats; Stability

Indexed keywords

GLYCEROL OLEATE; GMORPHIC 80; HUMAN INSULIN; UNCLASSIFIED DRUG;

AGITATION; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CIRCULAR DICHROISM; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG STABILITY; GEL; GLUCOSE BLOOD LEVEL; IN VITRO STUDY; MALE; NONHUMAN; PRIORITY JOURNAL; PROTEIN AGGREGATION; RAT; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SUBCUTANEOUS DRUG ADMINISTRATION;

ANIMALS; BLOOD GLUCOSE; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; EXCIPIENTS; GELS; GLYCERIDES; HYPOGLYCEMIC AGENTS; INSULIN; MALE; RATS; RATS, SPRAGUE-DAWLEY; SOLUTIONS; TIME FACTORS;

EID: 0032753055     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-5173(99)00287-2     Document Type: Article

References (19)

1. Brange, J., Havelund, S., 1983. Insulin pumps and insulin quality: requirements and problems. Acta Med. Scand. Suppl. 671, 135-138.
2. Brange, J., Langkjaer, L., 1993. Insulin structure and stability. In: Wang, Y.J., Pearlman, R. (Eds.), Stability and Characterization of Protein and Peptide Drugs: Case Histories. Plenum Press, New York, pp. 315-350.
3. Brennan, J.R., Gebhart, S.S., Blackard, W.G., 1985. Pump-induced insulin aggregation. A problem with the Biostator. Diabetes 34, 353-359.
4. Bringer, J., Heldt, A., Grodsky, G.M., 1981. Prevention of insulin aggregation by dicarboxylic amino acids during prolonged infusion. Diabetes 30, 83-85.
5. Ericsson, B., Eriksson, P.O., Lofroth, J.E., Engstrom, S., 1991. Cubic phases as delivery systems for peptide drugs. In: Dunn, R.L., Ottenbrite, R.M. (Eds.), Polymeric Drug and Drug Delivery Systems. In: ACS Symposium Series, vol. 469. ACS, pp. 251-265.
6. Golomb, G., Avramoff, A., Hoffman, A., 1993. A new route of drug administration: intrauterine delivery of insulin and calcitonin. Pharm. Res. 10, 828-833.
7. Hanafusa, T., Miyagawa, J., Nakajima, H., Tomita, K., Kuwajima, M., Matsurawa, Y., Tarui, S., 1994. The NOD mouse. Diabetes Res. Clin. Pract. 24, S307-S311.
8. James, D.E., Jenkins, A.B., Kraegen, E.W., Chrisholm, D.J., 1981. Insulin precipitation in artificial infusion devices. Diabetologia 21, 554-557.
9. Larsson, K., 1989. Cubic lipid-water phases: structure and biomembrane aspects. J. Phys. Chem. 93, 7304-7314.
10. Li, Y., Mitra, A.K., 1994. A simple method of correlating pharmacodynamic equivalence with absolute bioavailability following noninvasive delivery of insulin. Pharm. Res. 11, 1505-1508.
11. Li, Y., Mitra, A.K., 1996. Effects of phospholipid chain length, concentration, charge, and vesicle size on pulmonary insulin absorption. Pharm. Res. 13, 76-79.
12. Lougheed, W.D., Albisser, A.M., Martindale, H.M., Chow, J.C., Clement, J.R., 1983. Physical stability of insulin formulations. Diabetes 32, 424-432.
13. Muranushi, N., Mack, E.J., Kim, S.W., 1993. The effects of fatty acids and their derivatives on the intestinal absorption of insulin in rat. Drug Dev. Ind. Pharm. 19, 929-941.
14. Sadhale, Y., Shah, J., 1999. Stabilization of insulin against agitation-induced aggregation by the gmo cubic phase gel. Int. J. Pharm. 191, 51-64.
15. Shao, Z., Li, Y., Krishnamoorthy, R., Chermak, T., Mitra, A.K., 1993. Differential effects of anionic, cationic, nonionic and physiologic surfactants on the dissociation, β-chymotryptic degradation, and enteral absorption of insulin hexamers. Pharm. Res. 10, 243-251.
16. 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.
17. Tachibana, K., 1992. Transdermal delivery of insulin to alloxan-diabetic rabbits by ultrasound exposure. Pharm. Res. 9, 932-934.
18. Touitou, E., Rubinstein, A., 1986. Targeted enteral delivery of insulin to rats. Int. J. Pharm. 30, 95-99.
19. Watson, E., Moore, C., Sadhale, Y.D., Shah, J., 1998. Glyceryl-monooleate (GMO)-water lamellar phase gel as stability enhancer of drugs. AACP Annual Meeting, Aspen, CO, July 1998.