Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1997-09-26
1999-09-14
Tsang, Cecilia J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
530380, A61K 3828
Patent
active
059522976
ABSTRACT:
The present invention discloses various parenteral pharmaceutical formulations having a protracted effect, which comprise: a sterile aqueous suspension of about 20 U/mL to about 500 U/mL insulin analog, about 5 mg/mL to about 10 mg/mL sodium chloride, about 0.2 to about 2.0 mg/mL physiologically acceptable buffer, a zinc ion content of about 0.07 mg/mL to about 0.1 mg/mL, and a physiologically acceptable preservative at a pH of about 6.5 to about 7.8; such that less than 5% of the analog present in the suspension is in the dissolved state.
REFERENCES:
patent: 2626228 (1953-05-01), Petersen
patent: 2648622 (1953-08-01), Waugh et al.
patent: 2799622 (1957-07-01), Schlichtkrull et al.
patent: 2819999 (1958-01-01), Schlichtkrull et al.
patent: 2849370 (1958-08-01), Petersen et al.
patent: 2882202 (1959-04-01), Petersen et al.
patent: 2882203 (1959-04-01), Petersen et al.
patent: 2920014 (1960-01-01), Petersen et al.
patent: 3060093 (1962-10-01), Poulsen et al.
patent: 3102077 (1963-08-01), Christensen et al.
patent: 4476118 (1984-10-01), Brange et al.
patent: 5070186 (1991-12-01), Joergensen
patent: 5177058 (1993-01-01), Dorschug
patent: 5461031 (1995-10-01), De Felippis
patent: 5474978 (1995-12-01), Bakayasa et al.
patent: 5504188 (1996-04-01), Baker et al.
patent: 5514646 (1996-05-01), Chance et al.
patent: 5534488 (1996-07-01), Hoffmann
Smirn, Caplus # 1992:228393.
Liang, Caplus # 1995:171408.
Brange, Medline # 94290674, 1993.
Whimngham, Caplus # 1995:910948.
Frank, B.H., Self-Association and Conformational Studies on Human Proinsulin and Insulin Analogs (1990).
Skyler, Insulin Treatment, Therapy for Diabetes Mellitus and Related Disorders, American Diabetes Assoc., Alexandria, VA, 127-137 (1991).
Tattersall, Bovine Insulin, BMJ , 305, 831 (1992).
Seigler et al., Pharmacokinetics of long-acting (ultralente) insulin preparations, Diabetes Nutrition & Metabolism, 4, 267-273 (1991).
Graham et al., An in-vitro test for the duration of action in insulin suspensions, J. Pharm. Pharmacol. 36, 427-430 (1984).
Francis et al., Human Ultralete Insulin, Diabetes Research, 3, 263-268 (1986).
Freeman et al., Use of human ultralente as the basal insulin component in treatment of patients with IDDM, Diabetes. Res. and Clin. Practice, 12, 187-192 (1991).
Fontbonne, Insulin-A Sex Hormone for Cardiolvascular Risk, Circulation, 84, 1442-1444 (1991).
Owens et al., Human, Procine and Bovine Ultralente Insulin:Subcutaneous Adminstration in Normal Man, Diabetic Medicine, 3, 326-329 (1986).
Holman et al., Human Ultralente Insulin, British Med. J., 288, 665-668 (1984).
Massey, et al., What Were Those Crystals? The Dissolution and Disintegration of Insulin, JAMA, 259:12, 1811-1812 (1988).
Hirsch et al., Intensive Insulin Therapy:Part I. Basic Principles, Amer. Family Physician, 45:5, 2141-2147 (1992).
Harding, et al., An Investigation of Rhombohedral Zinc Insulin Crystals and a report of Other Crystalline Forms, The Crystal Structure of Insulin II, 212-226 (1965).
Brems, et al., Improved insulin stability through amino acid substitution, Protein Engineering, 5:6, 519-525 (1992).
Brange, et al., Monomeric Insulins and Their Experimental and Clinical Implications, Diabetes Care, 13:9 923-954 (1990).
Jorgensen et al., NovoSol Basal:Pharmacokinetics of a Novel Soluble Long Acting Insulin Analogue, BMJ, 299, 415-419 (1989).
Hansen, The self-association of zinc-free human insulin and insulin analogue B13-glutamine, Biophysical Chemistry, 39, 107-110 (1991).
Kirk-Othmer, Encyclopedia & Chemical Technology, 3rd Ed. vol. 13, John Wiley and Sons, N.Y. 1981, pp. 607-614 (1980).
Home et al., Bioavailability of Highly Purified Bovine Ultralente Insulin, Diab. Care, 6:2, 210 (1983).
Owens, Long-acting Insulin Preparations, Human Insulin Clinical Pharmacological Studies in Normal Man, 170-177 (1986).
Dodson, et al., Insulin assembyl: its modification by protein engineering and ligand binding, Phil. Trans. R. Soc. Lond. A, 345, 153-164 (1993).
Brange, Galenics of Insulin: The Physico-chemical and Pharmaceutical Aspects of Insulin and Insulin Preparation, Springer-Verlag Berlin Heidelbert (1987).
Schlichtkrull, Chemical and Biological Studies on Insulin Crystals and Insulin Zinc Suspensions, Insulin Crystals (1958).
Hallas-M.o slashed.ller et al., Cystalline and Amorphous Insulin-Zinc Compounds with Prolonged Action, Science, 116, 394-398 (1952).
De Felippis Michael R.
Frank Bruce H.
Caltrider Steven P.
Delaney Patrick R.
Eli Lilly and Company
Stewart Mark J.
Tsang Cecilia J.
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