Preparation of aqueous clear solution dosage forms with bile acids
First Claim
1. A method for achieving a Cmax (μ
- g UDCA/mL) of from about 4.5 to about 20.4 with a Tmax of less than about 30 minutes comprising;
(a) administration of a clear 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/or an aqueous soluble non-starch polysaccharide; and
(iii) sodium hydroxide, and,(iv) 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 and wherein the molar ratio of the sodium hydroxide to the first material is from about 0.6 to about 1.2.
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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
24 Claims
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1. A method for achieving a Cmax (μ
- g UDCA/mL) of from about 4.5 to about 20.4 with a Tmax of less than about 30 minutes comprising;
(a) administration of a clear 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/or an aqueous soluble non-starch polysaccharide; and (iii) sodium hydroxide, and, (iv) 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 and wherein the molar ratio of the sodium hydroxide to the first material is from about 0.6 to about 1.2. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 19, 20, 21)
- g UDCA/mL) of from about 4.5 to about 20.4 with a Tmax of less than about 30 minutes comprising;
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10. A method for achieving a Cmax (μ
- g GUDCA/mL) of from about 0.3 to about 1.6 with a Tmax of less than about 3.5 hours comprising;
(a) administration of a clear 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/or an aqueous soluble non-starch polysaccharide; (iii) sodium hydroxide, and, (iv) 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 and wherein the molar ratio of the sodium hydroxide to the first material is from about 0.6 to about 1.2. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 22, 23, 24)
- g GUDCA/mL) of from about 0.3 to about 1.6 with a Tmax of less than about 3.5 hours comprising;
Specification