Preparation of aqueous clear solution dosage forms with bile acids
First Claim
1. A method for treating gastritis and peptic ulcer disease comprising:
- (a) administration of an oral liquid dosage form comprising;
(i) 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;
(ii) a second material selected from the group consisting of an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide; and
(iii) water, wherein the first and second materials 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. The compositions of the invention 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 pH values and, according to one embodiment, remains in solution for 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. Non-limiting examples of pharmaceutical compounds include insulin, heparin, bismuth compounds, amantadine and rimantadine.
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Citations
87 Claims
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1. A method for treating gastritis and peptic ulcer disease comprising:
(a) administration of an oral liquid dosage form comprising;
(i) 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;
(ii) a second material selected from the group consisting of an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide; and
(iii) water, 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 (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for treating a liver disease comprising:
(a) administration of an oral liquid dosage form comprising;
(i) 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;
(ii) a second material selected from the group consisting of an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide; and
(iii) water, 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 (16, 17, 18, 19, 20, 21, 22)
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23. A method for treating gall stones comprising:
(a) administration of an oral liquid dosage form comprising;
(i) 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 and an aqueous soluble non-starch polysaccharide; and
(c) water, 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 (24, 25, 26, 27)
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28. A method for treating or preventing colorectal adenoma comprising:
(a) administration of an oral liquid dosage form comprising;
(i) 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;
(ii) a second material selected from the group consisting of an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide; and
(iii) water, 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 (29, 30, 31, 32, 33, 34, 35, 36)
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37. A method for treating hyperlipidemia comprising:
(a) administration of an oral liquid dosage form comprising;
(i) 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;
(ii) a second material selected from the group consisting of an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide; and
(iii) water, 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 (38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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48. A clear aqueous solution 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, and a bile acid conjugated with an amine by an amide linkage;
(b) an aqueous soluble non-starch polysaccharide; and
(c) water, wherein the first material and the polysaccharide both remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77)
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78. A method of preparing an aqueous solution wherein the solution forms no detectable precipitate at any pH value of the solution within a selected range of pH values comprising the steps of:
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(a) dissolving a bile acid, bile acid salt, or bile acid-amine conjugate in water to form a clear solution;
(b) adding at least one aqueous soluble non-starch polysaccharide to the clear solution and allowing it to dissolve to form a clear solution; and
(c) optionally adding a pharmaceutically effective amount of a pharmaceutical compound. - View Dependent Claims (79, 80)
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81. A clear aqueous solution 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, and a bile acid conjugated with an amine by an amide linkage;
(b) a polysaccharide having at least one reducing end and one at least one non-reducing end; and
(c) water, wherein the first material and the polysaccharide both remain in solution for all pH values of the solution within a selected range of pH values.
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82. A clear aqueous solution 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, and a bile acid conjugated with an amine by an amide linkage;
(b) a second material selected from the group consisting of an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide; and
(c) a third material comprising an aqueous soluble bismuth compound; and
(d) water, wherein the first, second, and third materials all remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (83, 84, 85, 86, 87)
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Specification