FORMULATIONS OF DEOXYCHOLIC ACID AND SALTS THEREOF
First Claim
1. A composition consisting essentially of about 0.5% of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5 and, when so maintained, said composition does not form a precipitate.
3 Assignments
0 Petitions
Accused Products
Abstract
The present application is directed to an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid, wherein the composition is maintained at a pH from about 8.1 to about 8.5 such that the composition is stabilized against precipitation. Also disclosed herein, are methods for stabilizing an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid against precipitation, said method comprising maintaining pH of the solution from about 8.1 to about 8.5.
12 Citations
16 Claims
- 1. A composition consisting essentially of about 0.5% of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5 and, when so maintained, said composition does not form a precipitate.
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2. A composition consisting essentially of about 1% of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5 and, when so maintained, said composition does not form a precipitate.
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10. A composition consisting essentially of:
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a sterile aqueous solution buffered to a pH of about 8.3; about 0.5% w/v of sodium deoxycholate; about 0.9% w/v benzyl alcohol; and about 1% w/v of sodium chloride, wherein the composition is stable against precipitation.
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11. A composition consisting essentially of:
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an aqueous solution buffered to a pH of about 8.3; about 1% w/v of sodium deoxycholate; about 0.9% w/v benzyl alcohol; and about 1% w/v of sodium chloride, wherein the composition is stable against precipitation.
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15. A composition consisting essentially of:
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a sterile aqueous solution buffered to a pH of about 8.3; about 1% w/v of sodium deoxycholate; about 10 mM sodium phosphate; about 0.9% w/v benzyl alcohol; and about 75 mM of sodium chloride, wherein the composition is stable against precipitation.
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16. A composition consisting essentially of:
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a sterile aqueous solution buffered to a pH of about 8.3; about 1% w/v of sodium deoxycholate; about 10 mM sodium phosphate; and about 0.86% w/v of sodium chloride, wherein the composition is stable against precipitation.
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Specification
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- Resources
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Current AssigneeAllergan Sales LLC (Abbvie Incorporated)
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Original AssigneeKythera Biopharmaceuticals, Inc. (Abbvie Incorporated)
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InventorsHodge, Robert Emil, Webster, Jeffrey Douglas, Moriarty, Robert M.
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current514/182
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CPC Class CodesA61K 31/575 substituted in position 17 ...A61K 47/02 Inorganic compoundsA61K 47/10 Alcohols; Phenols; Salts th...A61K 9/0019 Injectable compositions; In...A61P 3/04 Anorexiants; Antiobesity ag...
