Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2005-08-09
2005-08-09
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S457000, C424S463000, C424S468000, C424S474000, C424S480000, C424S482000
Reexamination Certificate
active
06926907
ABSTRACT:
The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.
REFERENCES:
patent: 4255431 (1981-03-01), Junggren et al.
patent: 4508905 (1985-04-01), Junggren et al.
patent: 4554276 (1985-11-01), LaMattina
patent: 4562261 (1985-12-01), Hirata et al.
patent: 4619934 (1986-10-01), Sunshine et al.
patent: 4676984 (1987-06-01), Wu et al.
patent: 4704278 (1987-11-01), Wu et al.
patent: 4757060 (1988-07-01), Lukacsko et al.
patent: 4766117 (1988-08-01), Crawford et al.
patent: 4786505 (1988-11-01), Lovgren et al.
patent: 4965065 (1990-10-01), Lukacsko et al.
patent: 5037815 (1991-08-01), Lukacsko et al.
patent: 5043358 (1991-08-01), Lukacsko et al.
patent: 5204118 (1993-04-01), Goldman et al.
patent: 5260333 (1993-11-01), Lukacsko et al.
patent: 5364616 (1994-11-01), Singer et al.
patent: 5373022 (1994-12-01), Fawzi et al.
patent: 5417980 (1995-05-01), Goldman et al.
patent: 5466436 (1995-11-01), Stables
patent: 5514663 (1996-05-01), Mandel
patent: 5631022 (1997-05-01), Mandel et al.
patent: 5643960 (1997-07-01), Breitner et al.
patent: 5686105 (1997-11-01), Kelm et al.
patent: 5716648 (1998-02-01), Halskov et al.
patent: 5955451 (1999-09-01), Lichtenberger et al.
patent: 6013281 (2000-01-01), Lundberg et al.
patent: 6025395 (2000-02-01), Breitner et al.
patent: 6160020 (2000-12-01), Ohannesian et al.
patent: 6162816 (2000-12-01), Bohlin et al.
patent: 6207188 (2001-03-01), Gustavsson et al.
patent: 6365184 (2002-04-01), Depui et al.
patent: 6395298 (2002-05-01), Flanagan et al.
patent: 6485747 (2002-11-01), Flanagan et al.
patent: 6544556 (2003-04-01), Chen et al.
patent: 2001/0025107 (2001-09-01), Barberich et al.
patent: 2001/0036473 (2001-11-01), Scott et al.
patent: 2001/0044410 (2001-11-01), Gelber et al.
patent: 2002/0012676 (2002-01-01), Lundeberg et al.
patent: 2002/0042433 (2002-04-01), Yelle et al.
patent: 2002/0044962 (2002-04-01), Cherukuri et al.
patent: 2002/0045184 (2002-04-01), Chen
patent: 2002/0086029 (2002-07-01), Lundberg et al.
patent: 2002/0111370 (2002-08-01), Bergman et al.
patent: 2002/0155153 (2002-10-01), Depui et al.
patent: 2003/0008903 (2003-01-01), Barberich et al.
patent: 2003/0113375 (2003-06-01), Lundberg et al.
patent: 2003/0129235 (2003-07-01), Chen et al.
patent: 198 01 811 (1998-01-01), None
patent: 0 320 550 (1989-06-01), None
patent: 0 426 479 (1991-05-01), None
patent: 0 426 479 (1991-05-01), None
patent: 0 550 083 (1993-07-01), None
patent: 2 105 193 (1983-03-01), None
patent: WO 85/03443 (1985-08-01), None
patent: WO 93/12817 (1993-07-01), None
patent: WO 94/07541 (1994-04-01), None
patent: WO 98/22117 (1998-05-01), None
patent: WO 99/00380 (1999-01-01), None
patent: WO 99/12524 (1999-03-01), None
patent: WO 00/71122 (2000-11-01), None
patent: WO 00/72838 (2000-12-01), None
patent: WO 03/017980 (2003-03-01), None
Howden, “Clinical Pharmacology of Omeprazole,”Clin. Pharmacokinet. 20(1):38-49 (1991) abstract.
Pilbrant, et al., “Development of an Oral Formulation of Omeprazole,”Scand. J. Gastroenterol. 20(Suppl. 108):113-120 (1985).
Sharma, “Comparison of 24-Hour Intragastric pH Using Four Liquid Formulations of Lansoprazole and Omeprazole,”Am. J. Health-Syst. Pharm. 56(Supp. 4):S18-S21 (1999).
Bigard, et al., “Complete Prevention by Omeprazole of Aspirin Induced Gastric Lesions in Healthy Subjects,”GUT 29(5):A712, T49 (1988).
Bombardier, et al., “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,”N. Engl. J. Med. 343:1520-1528 (2000).
Brown, et al., “Prevention of the Gastrointestinal Adverse Effects of Nonsteroidal Anti-Inflammatory Drugs,”Pract. Drug Safety 21:503-512 (1999).
Cullen, et al., “Primary Gastroduodenal Prophylaxis with Omeprazole for Non-Steroidal Anti-Inflammatory Drug Users,”Aliment. Pharmacol. Ther. 12:135-140 (1998).
Hawkey, “Progress in Prophylaxis Against Nonsteroidal Anti-Inflammatory Drug-Associated Ulcers and Erosions,”Am. J. Med. 104:67S-74S (1998).
Hawkey, et al., “Omeprazole Compared with Misoprostol for Ulcers Associated with Nonsteroidal Anti-Inflammatory Drugs,”N. Engl. J. Med. 338:727-734 (1998).
Katz, et al., “Gastric Acidity and Acid Breakthrough with Twice-Daily Omeprazole or Iansoprazole,”Aliment. Pharmacol. Ther 14:709-714 (2000).
Kephart, et al., “Coprescribing of Nonsteroidal Anti-Inflammatory Drugs and Cytoprotective and Antiulcer Drugs in Nova Scotia's Senior Population,”Clin. Ther. 17:1159-1173 (1995).
Lad, et al., “Management of Nonsteroidal Anti-Inflammatory Drug-Induced Gastroduodenal Disease by Acid Suppression,”Can. J. Gastroenterol 13:135-142 (1999).
Mattsson, et al., “Omeprazole Provides Protection Against Experimentally Induced Gastric Mucosal Lesions,”Eur. J. Pharmacol. 91:111-114 (1983).
Oddsson, et al., “Endoscopic Findings in the Stomach and Duodenum after Treatment with Enteric-Coated and Plain Naproxen Tablets in Healthy Subjects,”Scand. J. Gastroenterol. 25:231-234 (1990).
Scheiman, “NSAID-Induced Peptic Ulcer Disease: A Critical Rview of Pathogenesis and Management,”Dig. Dis. 12:210-222 (1994).
Selway, “Potential Hazards of Long-Term Acid Suppression,”Scand. J. Gasatroenterol. 25(Supp. 178):85-92 (1990).
Silverstein, et al., “Gastrointestinal Toxicity with Celecoxib vs. Nonsteroidal Anti-Inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis; The CLASS Study: A Randomized Controlled Trial,”JAMA 284:1247-1255 (2000).
Tronstad, et al., “Gastroscopic Findings after Treatment with Enteric-Coated and Plain Naproxen Tablets in Healthy Subjects,”Scand. J. Gastroenterol. 20:239-242 (1985).
Wolfe, et al., “Gastrointestinal Toxicity of Nonsteroidal Anti-Inflammatory Drugs,”N. Engl. J. Med. 340:1888-1899 (1999).
Yeomans, et al., “A Comparison of Omeprazole with Ranitidine for Ulcers Associated with Nonsteroidal Anti-Inflammatory Drugs,”N. Engl. J. Med. 338:719-726 (1998).
Yeomans, et al., “New Data on Healing of Nonsteroidal Anti-Inflammatory Drug-Associated Ulcers and Erosions,”Am. J. Med. 104:56S-61S (1998).
English language abstract for DE 198 01 811, Reference B13 above.
Dent, “Why Proton Pump Inhibition Should Heal and Protect Against Nonsteroidal Anti-Inflammatory Drug Ulcers,”Am. J. Med. 104:52S-55S (1998).
Kimmey, et al., “Role of H2-Receptor Blockers in the Prevention of Gastric Injury Resulting from Nonsteroidal Anti-inflammatory Agents,”Am. J. Med. 84:49-52 (1988).
Lee, et al., “Omeprazole Prevents Indomethacin-Induced Gastric Ulcers in Rabbits,”Aliment. Pharmacol. Ther. 10:571-576 (1996).
Lichtenbergetr, et al., “Nonsteroidal Anti-inflammatory Drug and Phospholipid Prodrugs: Combination Therapy with Antisecretory Agents in Rats,”Gastroenterology 111:990-995 (1996).
Savarino, et al., “Effect of One-Month Treatment with Nonsteroidal Antiinflammatory Drugs (NSAIDs) on Gastric pH of Rheumatoid Arthritis Patients,”Digestive Diseases and Sciences 43:459-463 (1998).
Wagner, et al., “Effects of Nonsteroidal Antiinflammatory Drugs on Ulcerogenesis and Gastric Secretion in Pylorus-Ligated Rat,”Digestive Diseases and Sciences 40:134-140 (1995).
Fitch Even Tabin & Flannery
Pozen Inc.
Sanzo Michael A.
Spear James M.
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