Dried forms of aqueous solubilized bile acid dosage formulation: preparation and uses thereof
First Claim
1. A dried form of a primary aqueous solubilized bile acid formulation comprising:
- (a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and combinations thereof; and
(b) an aqueous soluble starch conversion product;
wherein the first material and the aqueous soluble starch conversion product both remain in solution for all pH values of the solution within a selected range of pH values.
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Abstract
Compositions for pharmaceutical and other uses comprising clear aqueous solutions of bile acids which do not form any detectable precipitates over selected ranges of pH values of the aqueous solution and methods of making such solutions are disclosed. Compositions of the disclosure may comprise water; a bile acid in the form of a bile acid, bile acid salt, or a bile acid conjugated with an amine by an amide linkage; and either or both an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide. The composition remains in solution without forming a precipitate over a range of all pH values obtainable in an aqueous system. The composition, according to some embodiments, may further contain a pharmaceutical compound in a pharmaceutically effective amount. The disclosure further provides dried forms of primary aqueous solubilized bile acid formulations and methods of preparing such dried forms.
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Citations
42 Claims
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1. A dried form of a primary aqueous solubilized bile acid formulation comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and combinations thereof; and
(b) an aqueous soluble starch conversion product;
wherein the first material and the aqueous soluble starch conversion product both remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (10, 11, 12)
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2. A dried form of a primary aqueous solubilized bile acid formulation comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and combinations thereof; and
(b) an aqueous soluble starch conversion product having a Dextrose Equivalency of from about 5 to about 10;
wherein the first material and the aqueous soluble starch conversion product both remain in solution for all pH values within the range of pH 6.5 to pH 8.
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3. A dried form of a primary aqueous solubilized bile acid formulation comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and combinations thereof;
(b) a second material consisting of an aqueous soluble starch conversion product; and
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(c) a third material selected from the group consisting of a resistant maltodextrin and an aqueous soluble non-starch polysaccharide;
wherein the first, second, and third materials remain in solution for all pH values of the solution within a selected range of pH values.
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4. A dried form of a primary aqueous solubilized bile acid formulation comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and, combinations thereof;
(b) a second material selected from the group consisting of an aqueous soluble starch conversion product, a resistant maltodextrin, an aqueous soluble non-starch polysaccharide, and combinations thereof; and
,(c) a third material selected from aqueous soluble ginseng extract, aqueous soluble red ginseng extract, and combinations thereof;
wherein the first, second materials, and third material remain in solution for all pH values of the solution within a selected range of pH values.
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5. A dried form of a primary aqueous solubilized bile acid formulation comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and combinations thereof; and
(b) a second material selected from the group consisting of an aqueous soluble starch conversion product, a non-starch polysaccharide, and combinations thereof, wherein the first and second materials both remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (6, 7, 8, 9, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method of preparing a dried form of a primary aqueous solubilized bile acid formulation comprising:
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preparing an primary aqueous solubilized bile acid formulation comprising;
a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and combinations thereof; and
a second material selected from the group consisting of an aqueous soluble starch conversion product, a non-starch polysaccharide, and combinations thereof, wherein the first and second materials both remain in solution for all pH values of the solution within a selected range of pH values. removing water from the primary aqueous solubilized bile acid formulation by a granulation method selected from the group consisting of wet granulation, fluid-bed granulation, dry granulation, spheronization, spray-drying, evaporation, lyophilization, and combinations thereof, wherein a dry form is produced. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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Specification