Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2007-08-21
2007-08-21
Lewis, Patrick (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C536S018700, C536S021000, C536S055000, C536S055100, C536S055200, C536S123100, C536S123120, C514S057000, C514S062000
Reexamination Certificate
active
09873234
ABSTRACT:
The present invention provides oral formulations of Sulodexide for the treatment of diabetic nephropathy in patients with both insulin dependent and non-insulin dependent diabetes mellitus. Oral formulations containing doses adapted for administration to obtain a reduction in albumin excretion in patients with both micro and macro albuminuria and to produce lasting improvement in albumin excretion rate are provided. Methods of treating diabetic nephropathy using these formulations are also provided.
REFERENCES:
patent: 3536809 (1970-10-01), Applezweig
patent: 3598123 (1971-08-01), Zaffaroni
patent: 3845770 (1974-11-01), Theeuwes
patent: 3916899 (1975-11-01), Theeuwes
patent: 3936351 (1976-02-01), Bianchini
patent: 4008719 (1977-02-01), Theeuwes
patent: 4945086 (1990-07-01), Benitz et al.
patent: 5010063 (1991-04-01), Piani et al.
patent: 5059595 (1991-10-01), Le Grazie
patent: 5073543 (1991-12-01), Marshall et al.
patent: 5073643 (1991-12-01), Marshall et al.
patent: 5104860 (1992-04-01), Piani et al.
patent: 5120548 (1992-06-01), McClelland
patent: 5236910 (1993-08-01), Egidio
patent: 5252339 (1993-10-01), Cristofori
patent: 5354556 (1994-10-01), Sparks
patent: 5380716 (1995-01-01), Conrad et al.
patent: 5405949 (1995-04-01), Ungarelli et al.
patent: 5410039 (1995-04-01), Ungarelli et al.
patent: 5430132 (1995-07-01), Silvano et al.
patent: 5430133 (1995-07-01), Piani et al.
patent: 5464942 (1995-11-01), Sakurai et al.
patent: 5470965 (1995-11-01), Baldacci et al.
patent: 5496807 (1996-03-01), Marchi et al.
patent: 5543403 (1996-08-01), Petitou et al.
patent: 5585361 (1996-12-01), Burns et al.
patent: 5591767 (1997-01-01), Mohr
patent: 5639476 (1997-06-01), Oshlack et al.
patent: 5672334 (1997-09-01), Ranney
patent: 5674533 (1997-10-01), Santus et al.
patent: 5674633 (1997-10-01), Santus et al.
patent: 5686432 (1997-11-01), Baggio et al.
patent: 5733566 (1998-03-01), Lewis
patent: 5861383 (1999-01-01), Cardin et al.
patent: 6080732 (2000-06-01), Palazzini et al.
patent: 6399078 (2002-06-01), Devico et al.
patent: 0 485 748 (1992-05-01), None
patent: 0 497 162 (1992-08-01), None
patent: 0 624 374 (1994-11-01), None
patent: 0 710 483 (1996-05-01), None
patent: 0513513 (1996-08-01), None
patent: 0 950 413 (1999-10-01), None
patent: 1 016 410 (2000-07-01), None
Ansel H.C.,Introduction to Pharmaceutical Dosage Forms, Lea and Febiger, Philadelphia, PA (1985) (Table of Contents).
Baggio B. et al., “Urinary Glycosaminoglycans, Sialic Acid and Lysosomal Enzymes Increase in Nonalbuminuric Diabetic Patients”, Nephron 43:187-190 (1986).
Callas D.D. et al., “Comparative Pharmacologic Pharmacologic Profile of a Glycosaminoglycan Mixture, Sulodexide, and a Chemically Modified Heparin Derivative, Suleparoide”, Sem. Thromb. Hemost. 19 (Suppl. 1):49-57 (1993).
Caulfield J.P. et al., “Loss of Anionic Sites from the Glomerular Basement Membrane in Aminonucleoside Nephrosis”, Lab. Invest. 39:505-512 (1978).
Cospite M. et al., “Haemodynamic Effects of Sulodexide in Post-Thrombophlebitic Syndromes”, Acta Therapeutica 18:149-159 (1992).
Crepaldi G. et al., “Double-Blind Multicenter Trial on a New Medium Molecular Weight Glycosaminoglycan. Current Therapeutic Effects and Perspectives for Clinical Use”, Atherosclerosis 81:233-243 (1990).
Dedov I. et al., “A Randomized, Controlled Study of Sulodexide Therapy for the Treatment of Diabetic Nephropathy”, Nephrol. Dial. Transplant 12:2295-2300 (1997).
Diamond J.R. and Karnovsky M., “Nonanticoagulant Protective Effect of Heparin in Chronic Aminonucleotide Nephrosis”, Renal Physiol. 9:366-374 (1986).
Ebert, “Soft Elastic Gelatin Capsule”, Pharm. Tech, 1(5):44-50 (1977).
Gambaro G. and Van Der Woude J., “Glycosaminoglycans: Use in Treatment of Diabetic Nephropathy”, Am. Soc. Nephrol. 11:359-368 (2000).
Gambaro G. et al., “Glycosaminoglycans Prevent Morphological Renal Alterations and Albuminuria in Diabetic Rats”, Kidney Int. 42:285-291 (1992).
Goldman L. and Claude Bennett J (editors), Cecil Textbook of Medicine (pp. 1281-1283), 21st Edition (2000), W.B. Saunders, Philadelphia.
Groggel G.C. et al., “Changes in Heparin Sulfate Correlate with Increased Glomerular Permeability”, Kidney Int. 33:517-523 (1988).
Harenberg J, “Review of Pharmacodynamics, Pharmacokinetics, and Therapeutic Properties of Sulodexide”,Medicinal Research Rev. 18:1-20 (1998).
Kanwar Y.S. et al., “Basement Membrane Proteoglycans of the Kidney”, Sem. Nephrol. 5:307-313 (1985).
Parthasarathy N. and Spiro, R., “Effect of Diabetes on the Glycosaminoglycan Component of the Human Glomerular Basement Membrane”, Diabetes 31:738-741 (1982).
Poplawska A. et al., “Effect of Glycosaminoglycans on Urinary Albumin Excretion in Insulin-Dependent Diabetic Patients with Micro- or Macroalbuminuria”, Diabetes Res Clin. Pract. 38:109-114 (1997).
Purkerson, M. et al., “N-Desulfated/Acetylated Heparin Ameliorates the Progression of Renal Disease in Rats with Subtotal Renal Ablation”, J. Clin. Invest. 81:69-74 (1988).
Radhakrishnamurthy B. et al., “Studies of Glycosaminoglycan Composition and Biologic Activity of Vessel®, a Hypolipidemic Agent”, Atherosclerosis 31:217-229 (1978).
Remington's Pharmaceutical Sciences, 1995, Mack Publ. Co., Easton, PA. (Table of Contents).
Salvetti A. et al., “Renal Protection and Antihypertensive Drugs”, Drugs 57:665-693 (1999).
{hacek over (S)}krha J. et al., “Glycosaminoglycan Sulodexide Decreases Albuminuria in Diabetic Patients”, Diabetes Res. Clin. Pract. 38:25-51 (1997).
Solini A. et al., “Therapy with Glycosaminoglycans Lowers Albumin Excretion Rate in Non-Insulin Dependent Diabetic Patients with Macroalbuminuria”, Diabetes Nutr. Metab. 7:304-307 (1994).
Sozzi C., “The Preventive Activity of an Extractive Glycosaminoglycane (Sulodexide) in Relapses of TIA. A Short Term Study”, Eur. Rev. Med. Pharmacol. Sci. 6:295-300 (1984).
Szelanowska M. et al., “A Pilot Study of the Effect of the Glycosaminoglycan Sulodexide on Microalbuminuria in Type I Diabetic Patients”, Curr. Med. Res. Opin. 13:539-545 (1997).
Thomas D.P. et al., “Relative Efficacy of Heparin and Related Glycosaminoglycans as Antithrombic Drugs”, Ann. N.Y. Acad. Sci. 556:313-322 (1989).
Shin, J. of the Med. Soc. of Toho Univ. vol. 38, No. 3, pp. 374-382 (1991).
Mogami, J. of the Jap. Diabetes Soc., (Abstract, p. 111) vol. 34, No. 2, pp. 105-111 (1991).
Shin et al., Current Status of Prev. and Treat. of Diabetic complications, pp. 567-569 (1990).
Kaizu et al., J. of Diabetic Complications, vol. 5, Nos. 2-3, pp. 92-94 (1991).
Gaddi et al., 1996, “Meta Analysisi of Some Results of Clinical Trials on Sulodexide Therapy in Peripheral Occlusive Arterial Disease”, J. of Int. Med. Res. 24:389-406.
International Search Report, PCT International Application No. PCT/US01/18411, filed Jun. 6, 2001.
Nielsen et al., 1999, “Transcapillary escape rate and albuminaria in Type II diabetes. Effect of short term treatement with low molecular weight heparin”, Diabetologia 42:60-67.
Solini et al., 1997, “Glycosaminoglycans Delay the Progression of Nephropathy in NIDDM”, Diabetes Care 20:819-823.
Sorrenti et al., 1997, “Glycosaminoglycans as a Possible Tool for Micro and Macroalbuminuria in Diabetic Patients”, J. of Int. Med. Res. 25:81-86.
Harenberg, 1998, Review of Pharmacodynamics, Pharmacokinetics, and Therapeutic Properties of Sulodexide, pp. 1-20, John Wiley & Sons, Inc., pub.
Messa et al., 1995, Pharmacodynamic Effects of Sulodexide on Profibrinolytic and Haemorrheological Patterns, Clin. Drug Invest. 10(3):165-171.
Saviano et al., 1993, Double-blind, double-dummy, randomized, multi-centre clinical assessment of the efficacy, tolerability and dose-effect relationship of sulodexide in chronic venous insufficiency, Curr. Med. Res. Opin. 13:96-108.
Gambaro Giovanni
Palazzini Ernesto
Alfa Wasserman, Inc.
Jones Day
Lewis Patrick
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