Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ortho-hydroxybenzoic acid or derivative doai
Reexamination Certificate
2006-03-10
2010-11-02
Anderson, Rebecca L (Department: 1626)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ortho-hydroxybenzoic acid or derivative doai
C514S159000, C514S160000, C514S161000, C514S162000, C514S163000, C514S164000, C514S165000
Reexamination Certificate
active
07825106
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, and pharmaceutically acceptable salts and pro-drugs thereof, to affected areas of the intestine, i.e., distal gut. 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: 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: 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: 0 140 848 (1985-05-01), None
patent: 0 453 001 (1991-10-01), None
patent: 1 101 490 (2001-05-01), None
patent: 2692484 (1992-06-01), 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
patent: WO 2005/021009 (2005-03-01), None
Sun et al. Pharmaceutical Research 2001, 18(3), 304-310.
Rutesh, D.H., http://license.icopyright.net/user/viewFreeUse.act?fuid=Mzc0NjkyNw%3D%3D, Oct. 24, 2008.
Chapter 11 of The Theory and Practice of Industrial Pharmacy 1986, Banker et al., Lea & Febiger, 293-345.
Schafer et al. Drug Discovery Today 2008, 13 (21/22), 913-916.
Horig et al. Journal of Translational Medicine 2004, 2(44).
Jhala, et al., Studies on Toxicity and Tuberculostatic Behaviour of 4:4-Biazosalicylic Acid, Indian J. Pharm. 13, 3-5 (1951), pp. 3-5.
Khan, et al., A pH-Dependent Colon-Targeted Oral Drug Delivery System Using Methacrylic Acid Copolymers. II. Manipulation of Drug Release Using Eudragit® L100 and Eudragit S100 Combinations, Drug Development and Industrial Pharmacy, 26(5), 549-554 (2000).
International Search Report for PCT/IB2004/003059, mailed May 26, 2005.
“Azulfidine® sulfasalazine tablets, USP,” pp. 1-18, 2002.
“Dipentum® olsalazine sodium capsules,” pp. 1-17, 2001.
“Ulcerative Colitis (Uc)—Clinical Presentation and Evolution Treatment,”Asacol.com Monograph: Introduction, pp. 1-6, 2001.
Nugent, et al., “Intestinal luminal pH in inflammatory bowel disease: ossibel determinants and implications for therapy with aminosalicylates and other drugs,”Gut, 48:pp. 571-577, 2001.
“Asacol® (mesalamine) Delayed-Release Tablets,”sacol(mesalamine) pp. 1-8, 2000.
“PENTASA® Sachet: Prolonged Release Granules 1g,” http://www.pentasa.com/site/ferrinq—com/view.asp?ID=510&printmode=3, pp. 1-4,2001.
“PENTASA® Sachet: Prolonged Release Tablets, 250 & 500 mg.” http://www.pentasa.com/site/ferring—com/view.asp?ID=522&printmode=3, pp. 1-4,2001.
Camilleri, M., et al.: “Review article: irritable bowel syndrome,”Alimentary Pharmacology&Therapeutics, Blackwell Scientific Publications Ltd., Cambridge, GB, vol. 11, No. 1, 1997, pp. 3-15, XP001145860.
Khan, M. Z. I., et al.: “A PH-Dependent Colon-Targeted Oral Drug Delivery System Using Methacrylic Acid Copolymers II. Manipuliation of Drug Release Using Eudragite® L100 and Eudragit S100 Combinations,”Drug Development and Industrial Pharmacy, New York, NY, US, vol. 26, No. 5, 2000, pp. 549-554, XP000981442.
International Search Report, PCT/IB2007/002029, mailed May 7, 2008.
Kruis et al., “The Optimal Dose of 5-Aminosalicyclic Acid in Active Ulcerative Colitis: A Dose-Finding Study With Newly Developed Mesalamine,” Clinical Gastroenterology and Hepatology, vol. 1 pp. 36-43, (2003).
Mantzaris et al., “Budesonide Versus Mesalamine for Maintaining Remission in Patients Refusing Other Immunomodulators for Steroid-Dependent Crohn's Disease,” Clinical Gastroenterology and Hepatology , vol. 1, pp. 122-128, (2003).
S. Davaran 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).
Zambito et al., “Preparation and In Vitro Evaluation of Chitosan Matrices for Colonic Controlled Drug Delivery”, J Pharm Pharmaceut Sci, vol. 6 (2), pp. 274-281, (2003).
L. Sutherland et al., “Oral 5-Aminosalicylic Acid for Induction of Remission in Ulcerative Colitis (Review)”, Cochrane Database of Systematic Reviews 2006, Issue 2, Art. No. CD 000543.
M. Campieri et al., “Oral Beclometasone Dipropionate in the Treatment of Extensive and Left-Sided Active Ulcerative Colitis: A Multicentre Randomised Study,” Aliment Pharmacol Ther. vol. 17, pp. 1471-1480 (2003).
A. Forbes et al., “Review Article: Oral, Modified-Release Mesalazine Formulations-Proprietary Versus Generic,” Aliment Pharmacol Ther, vol. 17, pp. 1207-1214 (2003).
M. K. Chourasia et al., “Phamaceutical Approaches to Colon Targeted Drug Delivery Systems,” J. Pharm Pharmaceut Sci, vol. 6(1) pp. 33-66, (2003).
M. Brunner et al., “Gastrointestinal Transit and Release of 5-Aminosalicylic Acid From153Sm-Labelled Mesalazine Pellets vs. Tablets in Male Healthy Volunteers,” Aliment Pharmacol Ther, vol. 17 pp. 1163-1169, (2003).
I. R. Wilding et al., “Combined Scintigraphic and Pharmacokinetic Investigation of Enteric-Coated Mesalazine Micropellets in Heathy Subjects,” Aliment Pharmacol Ther, vol. 17, pp. 1153-1162, (2003).
Rogozina et al., “Comparative Efficacy of Mezakol and Sulfasalazine in Treating Chronic Relapsing Ulcerative Colitis,” Eksp Klin Gatroenterol, vol. 1, 58-9, 183 (2003).
Fernandez-Banares et al., “Collagenous and Lymphocytic Colitis: Evaluation of Clinical and Histological Features, Response to Treatment, and Long-Term Follow-Up,” American Journal of Gastroenterology, vol. 98, No. 2, pp. 395-402, (2003).
M. Brunner et al., “Gastrointestinal Transit and 5-ASA Release From A New Mesalazine Extended-Release Formulation,” Aliment Pharmacol Ther, vol. 17, pp. 395-402, (2003).
Nigovic et al., “Determination of 5-Aminosalicylic Acid in Pharmaceutical Formulation by Differential Pulse Voltammetry,” Journal of Pharmaceutical and Biomedical Analysis, vol. 31, pp. 169-174, (2003).
Tursi et al., “Assessment of Orocaecal Transit Time in Different Localization of Crohn's Disease and its Possbile Influence on Clinical Response to Therapy,” European Journal of Gastrenterology & Hepatology, vol. 15, No. 1, pp. 69-74, (2003).
L. Sutherland et al., “Oral 5-Aminosalicylic Acid for Maintenance of Remission in Ulcerative Colitis (Review),” Cochrane Database of Systematic Reviews 2006, issue2, At. No. CD 000544.
W. J. Sandborn et al., “Systematic Review: the Pharmacokinetic Profiles
Butler Jackie
Devane John
AGI Therapeutics Ltd.
Anderson Rebecca L
Finnegan Henderson Farabow Garrett & Dunner L.L.P.
Nolan Jason M
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