Claims for Patent: 5,407,688

Summary for Patent: 5,407,688

Title:	Compositions and methods for treating gastrointestinal disorders
Abstract:	The present invention relates to pharmaceutical compositions useful for treating or preventing gastrointestinal disorders. These compositions comprise a campylobacter-inhibiting antimicrobial agent such as nitrofurantoin and bismuth subsalicylate, and a histamine-2 receptor blocking anti-secretory agent such as cimetidine. The present invention further relates to methods for treating or preventing gastrointestinal disorders in humans or lower animals by administering a campylobacter-inhibiting antimicrobial agent and a histamine-2 receptor blocking anti-secretory agent.
Inventor(s):	Place; Geoffrey (Cincinnati, OH)
Assignee:	The Procter & Gamble Company (Cincinnati, OH)
Application Number:	07/970,595
Patent Claims:	1. Pharmaceutical compositions useful for treating or preventing gastrointestinal disorders, said compositions comprising: (a) a safe and therapeutically effective amount of a campylobacter-inhibiting antimicrobial agent; (b) a safe and therapeutically effective amount of an H.sub.2 receptor blocking anti-secretory agent; and (c) a pharmaceutically-acceptable carrier. 2. Pharmaceutical compositions useful for treating or preventing gastrointestinal disorders, according to claim 1, wherein the campylobacter-inhibiting antimicrobial agent is selected from the group consisting of antibacterial nitrofurans and antibiotics. 3. Pharmaceutical compositions useful for treating or preventing gastrointestinal disorders, according to claim 2, wherein the campylobacter-inhibiting antimicrobial agent is nitrofurantoin. 4. Pharmaceutical compositions useful for treating or preventing gastrointestinal disorders, according to claim 2, wherein the H.sub.2 receptor blocking anti-secretory agent is selected from the group consisting of cimetidine, ranitidine, and mixtures thereof. 5. Pharmaceutical compositions useful for treating or preventing gastrointestinal disorders, said compositions comprising: (a) a safe and therapeutically effective amount of nitro-furantoin; (b) a safe and therapeutically effective amount of an H.sub.2 receptor blocking anti-secretory agent selected from the group consisting of cimetidine, ranitidine, and mixtures thereof; and (c) a pharmaceutically-acceptable carrier. 6. Pharmaceutical compositions useful for treating or preventing gastrointestinal disorders, according to claim 5, wherein the H.sub.2 receptor blocking anti-secretory agent is cimetidine. 7. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, said methods comprising administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a campylobacter-inhibiting antimicrobial agent and a safe and therapeutically effective amount of an H.sub.2 receptor blocking anti-secretory agent, except that when said methods are methods whereby only a bismuth-containing campylobacter-inhibiting antimicrobial agent is administered with an H.sub.2 receptor blocking anti-secretory agent, then said methods further comprise administering the bismuth-containing campylobacter-inhibiting antimicrobial agent and an H2 receptor blocking anti-secretory agent within about one hour of each other. 8. A method for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 7, wherein the campylobacter-inhibiting antimicrobial agent and the H.sub.2 receptor blocking anti-secretory agent are both administered orally and concurrently. 9. A method for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 8, wherein the campylobacter-inhibiting antimicrobial agent and the H.sub.2 receptor blocking anti-secretory agent are administered concurrently. 10. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 9, wherein the campylobacter-inhibiting antimicrobial agent is selected from the group consisting of antibacterial nitrofurans and antibiotics. 11. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 10, wherein the campylobacter-inhibiting antimicrobial agent is nitrofurantoin; and wherein further the H.sub.2 receptor-blocking anti-secretory agent is selected from the group consisting of cimetidine, ranitidine, and mixtures thereof. 12. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 11, wherein the campylobacter-inhibiting antimicrobial agent is nitrofurantoin, and the H.sub.2 receptor blocking anti-secretory agent is cimetidine. 13. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 8, wherein the campylobacter-inhibiting antimicrobial agent and the H.sub.2 receptor blocking anti-secretory agent are administered non-concurrently. 14. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 13, wherein the campylobacter-inhibiting antimicrobial agent is selected from the group consisting of antibacterial nitrofurans and antibiotics. 15. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 14, wherein the campylobacter-inhibiting antimicrobial agent is nitrofurantoin; and wherein further the H.sub.2 receptor blocking anti-secretory agent is selected from the group of cimetidine, ranitidine, and mixtures thereof. 16. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, according to claim 15, wherein the campylobacter-inhibiting antimicrobial agent is nitrofurantoin, and the H.sub.2 receptor blocking anti-secretory agent is cimetidine. 17. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, said methods comprising administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 1. 18. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, said methods comprising administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 3. 19. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, said methods comprising administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 5. 20. Methods for treating or preventing gastrointestinal disorders in humans or lower animals, said methods comprising administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 6. 21. Pharmaceutical compositions useful for treating or preventing gastrointestinal disorders, said compositions comprising: (a) a safe and therapeutically effective amount of a campylobacter-inhibiting antimicrobial agent; and (b) a safe and therapeutically effective amount of a pharmaceutically-acceptable salt suitable for oral co-administration of a bismuth-containing agent and an H.sub.2 receptor blocking anti-secretory agent, said salt comprising bismuth, an organic acid, and an H.sub.2 receptor blocking anti-secretory agent selected from the group consisting of ranitidine and cimetidine. 22. Pharmaceutical compositions according to claim 21 wherein said organic acid is selected from the group consisting of citrate and tartrate. 23. Pharmaceutical compositions according to claim 22 wherein said pharmaceutically-acceptable salt comprises bismuth, citrate and ranitidine. 24. Pharmaceutical compositions according to claim 22 wherein said pharmaceutically-acceptable salt comprises bismuth, citrate and cimetidine. 25. Pharmaceutical compositions according to claim 22 wherein said pharmaceutically-acceptable salt comprises bismuth, tartrate and ranitidine. 26. Pharmaceutical compositions according to claim 22 wherein said pharmaceutically-acceptable salt comprises bismuth, tartrate and cimetidine. 27. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising orally administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 21. 28. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising orally administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 22. 29. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising orally administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 23. 30. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising orally administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 24. 31. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising orally administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 25. 32. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising orally administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a pharmaceutical composition according to claim 26. 33. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising dosing the gastrointestinal tract of the human or lower animal in need of such treatment or prevention with safe and therapeutically effective amounts of bismuth, ranitidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 34. A method for treating or preventing gastrointestinal disorders according to claim 33 wherein the bismuth, ranitidine, and non-bismuth campylobacter-inhibiting antimicrobial agent are administered concurrently. 35. A method for treating or preventing gastrointestinal disorders according to claim 33 wherein at least one of the bismuth, ranitidine and non-bismuth campylobacter-inhibiting antimicrobial agent are administered non-concurrently. 36. A method for treating or preventing gastrointestinal disorders in humans or lower animals, said method comprising dosing the gastrointestinal tract of the human or lower animal in need of such treatment or prevention with safe and therapeutically effective amounts of bismuth, cimetidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 37. A method for treating or preventing gastrointestinal disorders according to claim 36 wherein the bismuth, cimetidine, and non-bismuth campylobacter-inhibiting antimicrobial agent are administered concurrently. 38. A method for treating or preventing gastrointestinal disorders according to claim 36 wherein at least one of the bismuth, cimetidine and non-bismuth campylobacter-inhibiting antimicrobial agent are administered non-concurrently. 39. A method for treating ulcers of the upper gastrointestinal tract in humans or lower animals, said method comprising concurrently treating the upper gastrointestinal tract of the human or lower animal in need of such treatment with safe and therapeutically effective amounts of bismuth, ranitidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 40. A method for treating ulcers of the upper gastrointestinal tract in humans or lower animals, said method comprising concurrently treating the upper gastrointestinal tract of the human or lower animal in need of such treatment with safe and therapeutically effective amounts of bismuth, cimetidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 41. A method for treating non-ulcerative gastrointestinal disorders in humans or lower animals, said method comprising concurrently treating the upper gastrointestinal tract of the human or lower animal in need of such treatment with safe and therapeutically effective amounts of bismuth, ranitidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 42. A method for treating non-ulcerative gastrointestinal disorders in humans or lower animals, said method comprising concurrently treating the upper gastrointestinal tract of the human or lower animal in need of such treatment with safe and therapeutically effective amounts of bismuth, cimetidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 43. A method for treating Campylobacter pyloridis infection of the upper gastrointestinal tract in humans or lower animals, said method comprising concurrently treating the upper gastrointestinal tract of the human or lower animal infected with Campylobacter pyloridis with safe and therapeutically effective amounts of bismuth, ranitidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 44. A method for treating Campylobacter pyloridis infection of the upper gastrointestinal tract in humans or lower animals, said method comprising concurrently treating the upper gastrointestinal tract of the human or lower animal infected with Campylobacter pyloridis with safe and therapeutically effective amounts of bismuth, cimetidine, and a non-bismuth campylobacter-inhibiting antimicrobial agent. 45. Methods for treating or preventing gastrointestinal disorders in human or lower animals, said methods comprising administering to a human or lower animal in need of such treatment or prevention a safe and therapeutically effective amount of a campylobacter-inhibiting antimicrobial agent and a safe and therapeutically effective amount of an H.sub.2 receptor blocking anti-secretory agent, except that when said methods are methods whereby only a bismuth-containing campylobacter-inhibiting antimocrobial agent is administered with an H.sub.2 receptor blocking anti-secretory agent, then said methods further comprise administering the bismuth-containing campylobacter-inhibiting antimicrobial agent and an H.sub.2 receptor blocking anti-secretory agent within about five minutes of each other.