Bile preparations for gastrointestinal disorders
First Claim
1. A method of ameliorating or eliminating in a subject at least one adverse gastrointestinal effect of a composition, said method comprising:
- administering the composition to the subject; and
administering to the subject an aqueous solution substantially free of precipitates or particles comprising;
(a) a first material selected from the group consisting of a bile acid, a bile acid salt, and a bile acid conjugated with an amine by an amide linkage;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product or an aqueous soluble non-starch polysaccharide; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values obtainable in an aqueous system;
wherein the composition comprises over about 20% ethanol (w/w).
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Accused Products
Abstract
The present disclosure relates to methods and compositions to offset, ameliorate and/or alleviate one or more unwanted and/or adverse gastrointestinal effects. For example, in some embodiments, the present disclosure relates to compositions that include a bile acid, a carbohydrate and/or a pharmaceutical compound, wherein the pharmaceutical is associated with an adverse gastrointestinal effect in a subject (e.g., mammal or human). Non-limiting examples of pharmaceutical compounds may include a nonsteroidal anti-inflammatory drug, a gastric irritating drug (e.g., an antibiotic, an adrenal cortocoid steroid and an anti-cancer drug) and combinations thereof. The disclosure further relates to methods of ameliorating or eliminating at least one adverse gastrointestinal effects of a composition, comprising administering to a subject an aqueous solution comprising a bile acid and a carbohydrate.
65 Citations
29 Claims
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1. A method of ameliorating or eliminating in a subject at least one adverse gastrointestinal effect of a composition, said method comprising:
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administering the composition to the subject; and administering to the subject an aqueous solution substantially free of precipitates or particles comprising; (a) a first material selected from the group consisting of a bile acid, a bile acid salt, and a bile acid conjugated with an amine by an amide linkage; (b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product or an aqueous soluble non-starch polysaccharide; and (c) water, wherein the first material and the carbohydrate both remain in solution for all pH values obtainable in an aqueous system; wherein the composition comprises over about 20% ethanol (w/w). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method of ameliorating or eliminating in a subject at least one adverse gastrointestinal effect of a composition, said method comprising:
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administering the composition to the subject; and administering to the subject an aqueous solution substantially free of precipitates or particles comprising; (a) a first material selected from the group consisting of a bile acid, a bile acid salt, and a bile acid conjugated with an amine by an amide linkage; (b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product or an aqueous soluble non-starch polysaccharide; and (c) water, wherein the first material and the carbohydrate both remain in solution for all pH values obtainable in an aqueous system; wherein the composition comprises up to 100% ethanol (w/w). - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method of ameliorating or eliminating in a subject at least one adverse gastrointestinal effect induced by a composition having mechanisms of gastrointestinal irritation identical to acidified ethanol, said method comprising:
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administering the composition having a mechanism of gastrointestinal irritation identical to acidified ethanol to the subject; administering to the subject an aqueous solution substantially free of precipitates or particles comprising; (a) a first material selected from the group consisting of a bile acid, a bile acid salt, and a bile acid conjugated with an amine by an amide linkage; (b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product or an aqueous soluble non-starch polysaccharide; and (c) water, wherein the first material and the carbohydrate both remain in solution for all pH values obtainable in an aqueous system; wherein the adverse gastrointestinal effect is selected from the group consisting of gastroduodenal mucosal cell death, gastrointestinal necrosis, gastrointestinal apoptosis, gastroduodenal mucosal lesion, gastroduodenal mucosal erosion, gastroduodenal ulcer, gastrointestinal cancer, gastrointestinal bleeding, epigastralgia, gastritis, gastrointestinal redness, gastrointestinal edema, and combinations thereof.
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Specification