Formulations and methods of treating inflammatory bowel disease

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ortho-hydroxybenzoic acid or derivative doai

Reexamination Certificate

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C514S150000, C514S160000, C514S161000, C514S162000, C514S163000, C514S164000, C514S165000, C514S166000

Reexamination Certificate

active

07928092

ABSTRACT:
Methods and formulations for treating inflammatory bowel disease are disclosed. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of 4-aminosalicylic acid and/or 5-aminosalicylic acid to affected areas of the intestine. The methods and formulations comprise modified-release elements, providing for drug delivery to the affected or desired area. Diseases and conditions treatable with the present invention include Crohn's disease and ulcerative colitis.

REFERENCES:
patent: 4374932 (1983-02-01), Pitzele et al.
patent: 4496553 (1985-01-01), Halskov
patent: 4559330 (1985-12-01), Agback et al.
patent: 4591584 (1986-05-01), Agback
patent: 4608048 (1986-08-01), Cortese et al.
patent: 4627851 (1986-12-01), Wong et al.
patent: 4693895 (1987-09-01), Wong et al.
patent: 4705515 (1987-11-01), Wong et al.
patent: 4880794 (1989-11-01), Halskov
patent: 4904474 (1990-02-01), Theeuwes et al.
patent: 4980173 (1990-12-01), Halskov
patent: 5041431 (1991-08-01), Halskov
patent: 5482718 (1996-01-01), Shah et al.
patent: 5505966 (1996-04-01), Edman et al.
patent: 5519014 (1996-05-01), Borody
patent: 5541170 (1996-07-01), Rhodes et al.
patent: 5541171 (1996-07-01), Rhodes et al.
patent: 5681584 (1997-10-01), Savastano et al.
patent: 5716648 (1998-02-01), Halskov et al.
patent: 5840332 (1998-11-01), Lerner et al.
patent: 5866619 (1999-02-01), Sintov et al.
patent: 6004581 (1999-12-01), Jepsen et al.
patent: 6277412 (2001-08-01), Otterbeck
patent: 6506407 (2003-01-01), Watanabe et al.
patent: 6551620 (2003-04-01), Otterbeck
patent: 6602915 (2003-08-01), Uhrich
patent: 6733789 (2004-05-01), Stark et al.
patent: 6897205 (2005-05-01), Beckert et al.
patent: 6962717 (2005-11-01), Huber et al.
patent: 7737133 (2010-06-01), Devane et al.
patent: 2001/0026807 (2001-10-01), Watts
patent: 2001/0036473 (2001-11-01), Scott et al.
patent: 2002/0098235 (2002-07-01), Dittmar et al.
patent: 2002/0192282 (2002-12-01), Beckert et al.
patent: 2005/0090473 (2005-04-01), Devane et al.
patent: 2006/0223787 (2006-10-01), Devane et al.
patent: 0 140 848 (1985-05-01), None
patent: 0 453 001 (1991-10-01), None
patent: 1 101 490 (2001-05-01), None
patent: 2 692 484 (1993-12-01), None
patent: WO 95/16451 (1995-06-01), None
patent: WO 00/76481 (2000-12-01), None
patent: WO 02/17887 (2002-03-01), None
“Asacol® (mesalamine) Delayed-Release Tablets,” Asacol (mesalamine), pp. 1-8, 2000.
“Azulfidine® sulfasalazine tablets, USP,” pp. 1-18, 2002.
Ardizzone, S. et al., “Is Maintenance Therapy Always Necessary for Patients With Ulcerative Colitis in Remission?,”Aliment Pharm. Ther., vol. 13, No. 3, pp. 373-379, (1999).
Basit et al., “Perspectives on Colonic Drug Delivery,”Business Briefing: Pharmatech, pp. 185-190 (2003).
Bondesen, S. et al., “5- Aminosalicylic Acid in Patients with an Ileo-Rectal Anastomosis A Comparison of the Fate of Sulfasalazine and Pentasa,”Eur. J. Clin . Pharmacol., vol. 31, pp. 23-26, (1986).
Bondesen, S. et al., “Steady-State Kinetics of 5-Aminosalicylic Acid and Sulfapyridine During Sulfasalazine Prophylaxis in Ulcerative Colitis,”Scan. J. Gastroentero., vol. 21, No. 6, pp. 693-700, (1986).
Bondesen, S. et al., “Pharmacokinetics of 5-Aminosalicylic Acid in Man Following Administration of Intravenous Bolus and Per Os Slow-Release Formulation,”Digest. Dis. Sci., vol. 36, No. 12, pp. 1735-1740, (1991).
Bresci, G. et al., “Long-Term Therapy With 5-Aminosalicylic Acid in Crohn's Disease: is it Useful? Our Four Years Experience,”Int. J. Clin. Pharm. Res., vol. XIV, No. 4, pp. 133-138, (1994).
Brignola, C. et al., “Placebo-Controlled Trial of Oral 5-ASA in Relapse Prevention of Crohn's Disease,”Digest. Dis. Sci., vol. 37, No. 1, pp. 29-32, (1992).
Brunner, M. et al., “Gastrointestinal Transit and 5-ASA Release From A New Mesalazine Extended-Release Formulation,”Aliment Pharm. Ther., vol. 17, pp. 395-402, (2003).
Brunner, M. et al., “Gastrointestinal Transit and Release of 5-Aminosalicylic Acid From153Sm-Labelled Mesalazine Pellets vs. Tablets in Male Healthy Volunteers,”Aliment Pharm. Ther., vol. 17 pp. 1163-1169, (2003).
Campieri, M. et al., “Oral Beclometasone Dipropionate in the Treatment of Extensive and Left-Sided Active Ulcerative Colitis: A Multicentre Randomised Study,”Aliment Pharm. Ther., vol. 17, pp. 1471-1480 (2003).
Chourasia, M.K. et al., “Pharmaceutical Approaches to Colon Targeted Drug Delivery Systems,”J. Pharm. Pharmaceut Sci., vol. 6(1) pp. 33-66, (2003).
Christensen, L. A. et al., “5-Aminosalicylic Acid Derivatives. Clinical and Pharmaceutical Evaluation,”Neth J. Med., vol. 35, Suppl. 1:S3:10, (1989).
Christensen, L. A. et al., “Topical and Systemic Availability of 5-Aminosalicylate: Comparisons of Three Controlled Release Preparations in Man,”Aliment Pharm. Ther., vol. 4, pp. 523-533, (1990).
Christensen, L. et al., “Bioavailability of 5-Aminosalicylic Acid from Slow Release 5-Aminosalicylic Acid Drug and Sulfasalazine in Normal Children,”Digest. Dis. Sci., vol. 38, No. 10, pp. 1831-1836, (1993).
Christensen, L. A. et al., “Comparative Biovailability of 5-Aminosalicyclic Acid From a Controlled Release Preparation and an Azo-bond Preparation,”Aliment Pharm. Ther., vol. 8, pp. 289-294, (1994).
Christensen, L. et al., “5-Aminosalicylic Acid Containing Drugs Delivery, Fate, and Possible Clinical Implications in Man,”Dan. Med. Bull., vol. 47, No. 1, pp. 20-41, (2000).
Clemett, D. et al., “Prolonged-Release Mesalazine A Review of Its Therapeutic Potential in Ulcerative Colitis and Crohn's Disease,”Drugs, vol. 59 No. 4, pp. 929-956, (2000).
Corey, A. E. et al., “Biovailabily of single and Multiple Dose of Enteric-Coated Mesalamine and Sulphasalazine,”J. Int. Med. Res., vol. 18, pp. 441-453, (1990).
Davaran, S. et al., “Synthesis and Characterization of Methacrylic Derivatives of 5-Amino Salicylic Acid with pH-Sensitive Swelling Properties,”AAPS PharmaSciTech, vol. 2 (4) article 29 (2001).
Devane, J. et al., “Distal Ileum and Colon: Targeted Sites for 5-ASA Release,”Eur. J. Drug Metab. Phamacokinet, Spec., No. 3, pp. 300-303, (1991).
Dijkstra, G. et al., “Blockade of NF-κB Activation and Donation of Nitric Oxide: New Treatment Options in Inflammatory Bowel Disease?,”Scan. J. Gastroentero., Suppl. 236 (2002).
“Dipentum® olsalazine sodium capsules,” pp. 1-17, 2001.
Ewe, K. et al., “Inflammation Does Not Decrease Intraluminal pH in Chronic Inflammatory Bowel Disease,”Digest. Dis. Sci., vol. 44, No. 7, pp. 1434-1439, (1999).
Fallingborg, J. et al., “Effect of Olsalazine and Mesalazine on Intraluminal pH of the Duodenum and Proximal Jerjunum in Healthy Humans,”Scan. J. Gastroentero., vol. 29, No. 6, pp. 498-500, (1994).
Farup, P. et al., “Mesalazine 4 g Daily Given as Prolonged-Release Granules Twice Daily and Four Times Daily Is at Least as Effective as Prolonged-Release Tablets Four Times Daily in Patients with Ulcerative Colitis,”Inflamm. Bowel Dis., vol. 7, No. 3, pp. 237-242, (2001).
Fernandez-Banares et al., “Collagenous and Lymphocytic Colitis: Evaluation of Clinical and Histological Features, Response to Treatment, and Long-Term Follow-Up,”Am. J. Gastroenterol., vol. 98, No. 2, pp. 395-402, (2003).
Fischer, C. et al. “Disposition of 5-Aminosalicylic Acid, the Active Metabolite of Sulphasalazine, in Man,”Eur. J. Clin. Pharamcol., vol. 25, pp. 511-515, (1983).
Florent, C. et al., “Placebo-Controlled Clinical Trial of Mesalazine in the Prevention of Early Endoscopic Recurrences After Recurrences After Resection for Crohn's Disease,”Eur J. Gastroen. Hepat., vol. 8, No. 3, pp. 229-233, (1996).
Fockens, P. et al., “Comparison of the Efficacy and Safety of 1.5 Compared with 3.0 g oral Slow-Releas

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