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Anti-ulcer composition
| Details |
Inventors: Harwood, Richard J.; Henry, Edward V.; Sonk, Joseph S.; Foo, Luke T. H.; Rheingold, Jay L.; deGroof, Robert C.;
Assignee: E. R. Squibb & Sons, Inc. (Princeton, NJ)
Primary Examiner: Cashion, Jr.; Merrell C.
Assistant Examiner: Prater; P. L.
Attorney, Agent or Firm: Furman, Jr.; Theodore R.
In accordance with the present invention a novel oral composition and method of using same for the treatment of ulcers and other gastrointestinal disorders is disclosed. The composition comprises an agent capable of forming an ulcer-adherent protective complex in an acid environment combined with one or more alkaline materials in a total amount sufficient to substantially prevent the formation of such a complex in the mouth and adherence of such a complex to the buccal mucosa. |
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DETAILED DESCRIPTION OF THE INVENTION The present invention provides an improved composition for ulcer curative/ulcer therapy agents capable of forming an ulcer-adherent protective complex, such as sucralfate. Sucralfate, an aluminum salt of sucrose sulfate ester, is an excellent duodenal ulcer curative agent. Although sucralfate has negligible acid neutralizing capacity, its anti-ulcer activity is apparently the result of the formation of an ulcer-adherent complex that covers the ulcer site and protects it from further attack by acid, pepsin and bile salts. This complex is a gummy, gel-like bioadhesive which forms in acidic environments, e. g. , the stomach, and which binds bile salts and inhibits pepsin activity in gastric juices. The complex actually favors adherence to ulcerated or inflamed mucosa. In a preferred embodiment, the composition of the present invention is in the form of a chewable tablet. The present composition in chewable tablet form is not of a gritty, uncomfortable consistency but rather is of a soft, freely flowing powder when broken up by chewing. This renders the present chewable composition easy to swallow and provides adherence of the preparation to inflammatory sites caused by regurgitational esophagitis, as well as to the duodenal ulcer sites, ulcer sites in the stomach and other ulcer sites. Therefore, the compositions of the present invention, especially the chewable tablet formulation, is useful in the treatment of stomach ulcers, duodenal ulcers, regurgitational esophagitis, hiatal hernia, and symptoms of upset stomach or dyspepsia, e. g. , indigestion, "acid stomach", "sour stomach", "full stomach", heartburns, "burning" and the like. A potential disadvantage with taking an agent such as sucralfate by mouth is premature formation of the gummy complex in the mouth. Although the mouth is generally pH neutral, this premature gumming and adherence of the complex to the buccal mucosa can take place when the pH of the mouth is slightly acidic and/or when the mouth is ulcerated
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