Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Hydrolases
Reexamination Certificate
1998-12-21
2003-12-02
Saucier, Sandra E. (Department: 1651)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Hydrolases
C424S009100, C435S198000
Reexamination Certificate
active
06656464
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to compositions having an effect of promoting the gastric emptying. More particularly, it relates to medicaments containing a lipase preparation which is a digestive enzyme. The medicaments of the present invention are efficaciously used in ameliorating or treating chronic gastrointestinal symptoms such as sinking feelings, heartburn and heaviness in the stomach, i.e., complaints about the digestive tracts.
BACKGROUND OF THE INVENTION
Even healthy people often notice subjective gastric symptoms (sinking feelings, heartburn, anorexia, etc.) in the everyday life. These symptoms are caused by stress, overeating, excessive intake of alcoholic drinks and intake of drugs. Moreover, it is frequently observed that the stress of the complicated current social structure or side effects of medicaments result in chronic gastrointestinal symptoms such as sinking feelings and heaviness in the stomach, i.e., complaints about the digestive tracts, which is now a serious social problem.
In the present aging society, furthermore, the aged are largely affected by the above-mentioned problem.
Additional major causes of the complaints about the digestive tracts include maldigestion, chronic gastritis, delayed gastric emptying after meals, gastric hyperacidity and peptic ulcers which bring about subjective symptoms such as abdominal swelling feelings, unpleasantness in the upper abdomen, anorexia, heartburn and belching (eructation). To ameliorate these symptoms, there have been employed various agents adequate for the respective symptoms. To treat delayed gastric emptying, there have been developed and employed acetylcholine agonists (aclatonium napadisilate preparations), antidopamine agents (domperidone preparations), serotonin antagonists (cisapride preparations), opiate agonists (trimebutine maleate preparations) and ursodeoxycholic acid preparations.
To treat gastric hyperacidity, use has been made of antacid agents, pepsin inhibitors, gastric mucosa protective agents, anticholine agents for suppressing the secretion of gastric hydrochloric acid, parasympathetic blocking agents, histamine H
2
receptor antagonists (hereinafter referred to as “H
2
blockers”), proton pump inhibitors, etc. Examples of the H
2
blockers include cimetidine, ranitidine and famotidine, while examples of the proton pump inhibitors include omeprazole, lansoprazole and raveprazole.
However, acetylcholine agonists, etc. have only less selective pharmacological actions. Moreover, there is a large problem regarding the side effects of these agents, i.e., acting on the central nervous system. Other agents might also cause diarrhea, loose stool, abdominal pain, retching, vomiting, etc. as side effects thereof. In these cases, it is needed to stop the administration of the agents or reduce the dose thereof. These agents are administered so frequently in many cases that they should have high safety.
In general, aged persons are liable to have abdominal swelling feelings after taking fat-rich meals. Also, the food intake of aged persons goes down day by day. These phenomena are seemingly caused by the delayed gastric emptying. In the case of these aged, in particular, it is feared that the above-mentioned side effects of agents might result in serious problems. Therefore, these agents should be administered to them very cautiously.
SUMMARY OF THE INVENTION
Based on the above consideration, the present inventor has conducted extensive studies. As a result, it has been found that lipase (i.e., a kind of digestive enzyme) exhibits not only a direct effect on foods to accelerate the digestion but also an unexpected effect of promoting the gastric emptying, thus completing the present invention.
It is said that the gastric emptying action is fed back by fatty acids, which are formed by the hydrolysis of lipids, and thus the discharge of the gastric contents is delayed. However, it has been found out that a lipase preparation unexpectedly promotes the gastric emptying action when taken together with foods containing lipids.
Accordingly, the present invention relates to gastric emptying-promoting agents comprising lipase as the active ingredient; a method for promoting gastric emptying by administering lipase; and use of lipase for the manufacture of a medicament for promoting gastric emptying. It is expected that the compositions containing a lipase preparation according to the present invention not only accelerate the digestion of foods but also promote the gastric emptying to thereby ameliorate various subjective symptoms. Thus, these compositions are useful in treating the pathological conditions as cited above.
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Afremova Vera
Amano Pharmaceutical Co. Ltd.
Saucier Sandra E.
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