The new era of biotech insulin analogues

Diabetologia

Volumn 40, Issue SUPPL. 2, 1997, Pages

  Brange, J ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

Chemical stability; Insulin analogues; Insulin therapy; Iontophoresis; Monomeric insulin; Non invasive administration; Protein engineering; Transdermal delivery

Indexed keywords

INSULIN DERIVATIVE;

CONFERENCE PAPER; DIABETES MELLITUS; DRUG SYNTHESIS; HUMAN; INSULIN METABOLISM; INSULIN TREATMENT; PANCREAS ISLET BETA CELL; PRIORITY JOURNAL;

ANIMALS; BIOTECHNOLOGY; DRUG DESIGN; DRUG STABILITY; GENETIC ENGINEERING; HUMANS; INSULIN; IONTOPHORESIS; MODELS, CHEMICAL; PROTEIN ENGINEERING;

EID: 0030805003     PISSN: 0012186X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s001250051400     Document Type: Conference Paper

References (39)

1. Binder C (1969) Absorption of injected insulin. Acta Pharmacol Toxicol [Suppl 2]: 1-87
2. Mosekilde E, Jensen KS, Binder C, Pramming S, Thorsteinsson B (1989) Modeling absorption kinetics of subcutaneous injected soluble insulin. J Pharmacokinet Biopharm 17: 67-87
3. Brange J, Diers I, Hansen J, et al. (1987) Monomeric insulins by protein engineering. Protein Engn 1: 250 (Abstract)
4. Brange J, Ribel U, Hansen JF, et al. (1988) Monomeric insulins obtained by protein engineering and their medical implications. Nature 333: 679-682
5. Brems DN, Alter LA, Beckage MJ, et al. (1992) Altering the association properties of insulin by amino acid replacement. Protein Eng 5: 527-533
6. Baischmidt P, Brange J (1992) Fast acting human insulin analogues with a single amino acid deletion in the B-chain. Diabetologia 35 [Suppl 1]:A4 (Abstract)
7. Brange J, Owens DR. Kang S, Vølund A (1990) Monomeric insulins, and their experimental and clinical implications. Diabetes Care 13: 923-954
8. Vora JP, Owens DR, Dolben J, et al. (1988) Recombinant DNA derived monomeric insulin analogue: comparison with soluble human insulin in normal subjects. BMJ 297: 1236-1239
9. Heinemann L, Starke AAR, Heding L, Jensen I, Berger M (1990) Action profile of fast onset insulin analogues. Diabetologia 33: 384-386
10. Kang S, Brange J, Burch A, Vølund A, Owens DR (1991) Subcutaneous insulin absorption explained by insulin's physicochemical properties. Evidence from absorption studies of soluble human insulin and insulin analogues in humans. Diabetes Care 14: 942-948
11. Kang S, Brange J, Burch A, Vølund A, Owens DR (1991) Absorption kinetics and action profiles of subcutaneously administered insulin analogues (AspB9GluB27, AspB10, AspB28) in healthy subjects. Diabetes Care 14: 1057-1065
12. Heinemann L, Heisc T, Jorgensen LN, Starke AAR (1993) Action profile of the rapid acting insulin analogue: human insulin B28Asp. Diabet Med 10: 535-539
13. Howey DC, Bowsher RR, Brunelle RL, Woodworth JR (1994) [Lys(B28), Pro(B29)]-human insulin. A rapidly absorbed analogue of human insulin. Diabetes 43: 396-402
14. Trajanoski Z, Watch P, Kotanko P, Ott A, Skraba F (1993) Pharmacokinetic model for the absorption of subcutaneously injected soluble insulin and monomer insulin analogues. Biomed Tech 38: 224-231
15. Pöyry K, Kostamo E, Karonen S (1995) The effect of Finnish sauna on the absorption of short-acting insulin analogue. Diabetes 44[Suppl 1]:106A (Abstract)
16. Kang S, Owens DR, Vora JP, Brange J (1990) Recombinant DNA derived insulin analogue B9AspB27Glu: comparison with soluble human insulin in insulin treated diabetics. Lancet 335: 303-306
17. Kang S, Creag FM, Peters JR, Brange J, Vølund A, Owens DR (1991) Comparison of subcutaneous soluble human insulin and insulin analogues (AspB9, GluB27; AspB10; AspB28) on meal-related plasma glucose excursions in type I diabetic subjects. Diabetes Care 14: 571-577
18. Wiefels K, Kuglin B, Hübinger A, Jorgensen LN, Gries FA (1993) Insulin kinetics and dynamics in insulin-dependent diabetic patients after injections of human insulin or the insulin analogues X14 and X14 + Zn. In: Berger M, Gries FA (eds) Frontiers in insulin pharmacology. Thieme, Stuttgart New York, pp 97-101
19. Luttermann JA, Pijpers E, Netten PM, Jørgensen LN (1993) Glycaemic control in IDDM patients during one day with injection of human insulin or the insulin analogues insulin X14 and insulin X14 (+ Zn). In: Berger M, Gries FA (eds) Frontiers in insulin pharmacology. Thieme, Stuttgart New York, pp. 102-109
20. Brange J, Langkjaer L (1993) Insulin structure and stability. In: Wang YJ, Pearlman R (eds) Stability and characterization of protein and peptide drugs: case histories. Plenum Press, New York, pp. 315-350
21. Brange J, Langkjær L, Havelund S, Vølund A (1992) Chemical stability of insulin: 1. Hydrolytic degradation during storage of pharmaceutical preparations. Pharm Res 9: 715-726
22. Brange J, Havelund S, Hougaard P (1992) Chemical stability of insulin: 2. Formation of higher molecular weight transformation products during storage of pharmaceutical insulin preparations. Pharm Res 9: 727-734
23. Brange J, Hallund O, Sørensen E (1992) Chemical stability of insulin: 5. Isolation, characterization and identification of insulin transformation products. Acta Pharm Nord 4: 223-232
24. Ratner RE, Phillips TM, Steiner M (1990) Persistent cutaneous insulin allergy resulting from high-molecular-weight insulin aggregates. Diabetes 39: 728-733
25. Rohhins DC, Cooper SM, Fineberg SE, Mead PM (1987) Antibodies to covalent aggregates of insulin in blood of insulin-using diabetic patients. Diabetes 36: 838-841
26. Rohbins DC, Mead PM (1987) Free covalent aggregates of therapeutic insulin in the blood of insulin-dependent diabetics. Diabetes 36: 147-151
27. Brange J (1994) Stability of insulin. Studies on the physical and chemical stability of insulin in pharmaceutical formulation. Thesis, Royal Danish School of Pharmacy, MTP Press, Lancaster
28. Brange J, Havelund S (1991) Novel insulin analogues stabilized against chemical modifications. European Patent No. 0419504
29. Cullander C (1992) What are the pathways of iontophoretic current flow through mammalian skin? Adv Drug Del Rev 9: 119-135
30. Sage BH Jr, Riviere JE (1992) Model systems in iontophoresis - transport efficacy. Adv Drug Delivery Rev 9: 265-287
31. Banga AK, Chien YW (1993) Characterisation of in vitro transdermal iontophoretic delivery of insulin. Drug Dev Ind Pharm 19: 2069-2087
32. Stephen RL, Petelenz TJ, Jacobsen SC (1984) Potential novel methods for insulin administration: I. Iontophoresis. Biomed Biochim Acta 43: 553-558
33. Kari B (1986) Control of blood glucose levels in alloxan diabetic rabbits by iontophoresis of insulin. Diabetes 35: 217-221
34. Siddiqui O, Sun Y, Liu J-C, Chien YW (1987) Facilitated transdermal transport of insulin. J Pharm Sci 76: 341-345
35. Chien YW, Siddiqui O, Sun Y, Shi WM, Liu JC (1987) Transdermal iontophoretic delivery of therapeutic peptides/proteins. I: Insulin. Ann NY Acad Sci 507: 32-50
36. Liu J-C, Sun Y, Siddiqui O, Chien YW, Shi WM. Li J (1988) Blood glucose control in diabetic rats by transdermal iontophoretic delivery of insulin. Int J Pharmaceutics 44: 197-204
37. Meyer BR, Katzeff HL, Eschbach JC et al. (1989) Transdermal delivery of human insulin to albino rabbits using electrical current. Am J Med Sci 297: 321-325
38. Chien YW (1991) Transdermal route of peptide and protein drug delivery. In: Lee VHL (ed) Peptide and protein drug delivery. Dekker, New York Basel Hong Kong pp 667-689
39. Langkjær L, Brange J, Grodsky GM, Guy RH (1994) Transdermal delivery of monomeric insulin analogues by iontophoresis. Proceed Intern Symp Control Rel Bioact Mater 21: 172-173