Room temperature stable aqueous liquid pharmaceutical composition
First Claim
1. A liquid pharmaceutical composition comprising a pharmaceutically effective amount of a drug dissolved or dispersed in an aqueous medium, said aqueous medium comprising:
- water;
about 3% to about 10% w/v polyvinylpyrrolidone (PVP);
about 55% to about 75% w/v of C3-C6 polyol, wherein at least 55% w/v of the total composition is a non-reducing disaccharide, trisaccharide, or tetrasaccharide;
about 0.01% to about 0.5% w/v of a glycyrrhetic acid, glycyrrhizinate derivative, or salt thereof; and
one or more flavorants, said composition being stable at room temperature.
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Accused Products
Abstract
A liquid pharmaceutical composition is contemplated that comprises a pharmaceutically effective amount of a drug dissolved or dispersed in an aqueous medium. The aqueous medium consists essentially of water, about 3% to about 10% w/v polyvinylpyrrolidone, about 60% to about 75% w/v of C3-C6 polyol that includes more than 55% w/v of a non-reducing disaccharide, trisaccharide or tetrasaccharide such as sucrose, optionally about 0.01% to about 0.5% w/v of a glycyrrhetic acid, glycyrrhizinate derivative or salt thereof, and one or more flavorants, and preferably includes one or more preservatives. The liquid composition is room temperature stable, and may have a pleasant taste.
32 Citations
21 Claims
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1. A liquid pharmaceutical composition comprising a pharmaceutically effective amount of a drug dissolved or dispersed in an aqueous medium, said aqueous medium comprising:
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water;
about 3% to about 10% w/v polyvinylpyrrolidone (PVP);
about 55% to about 75% w/v of C3-C6 polyol, wherein at least 55% w/v of the total composition is a non-reducing disaccharide, trisaccharide, or tetrasaccharide;
about 0.01% to about 0.5% w/v of a glycyrrhetic acid, glycyrrhizinate derivative, or salt thereof; and
one or more flavorants, said composition being stable at room temperature. - View Dependent Claims (2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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8. The liquid pharmaceutical composition according to claim I wherein said PVP is present at about 5% w/v of the total composition.
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18. A liquid pharmaceutical composition comprising a pharmaceutically effective amount of prednisolone sodium phosphate present in an amount of less than about 1.0% w/v dissolved or dispersed in an aqueous medium buffered at a pH value of about 6 to about 8, said aqueous medium comprising water, buffer salts, about 3% to about 10% w/v PVP, a mixture of one or more C3 polyols and one or more C6 polyol that is present in an amount of about 55% to about 75% w/v in which the weight ratio of said C3 polyol to said C6 polyol is about 1:
- 6 to about 1;
70, said mixture of C3 polyol and C6 polyol includes more than 55% w/v of the total composition of sucrose, about 0.01% to about 0.5% w/v of glycyrrhetic acid, derivative or salt thereof, and one or more flavorants, said composition being stable at room temperature and having a pleasant taste. - View Dependent Claims (19, 20, 21)
- 6 to about 1;
Specification
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- Resources
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Current AssigneeShionogi Pharma Incorporated (Shionogi & Co., Ltd.)
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Original AssigneeMedicis Pediatrics Incorporated
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InventorsPatel, Bhiku, Kakkis, Emil D., Bhatia, Kuljit, Sorgi, Frank L., Clemente, Emmett
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Application NumberUS11/066,113Publication NumberTime in Patent OfficeDaysField of SearchUS Class Current424/400CPC Class CodesA61K 31/573 substituted in position 21,...A61K 31/66 Phosphorus compoundsA61K 47/10 Alcohols; Phenols; Salts th...A61K 47/26 Carbohydrates, e.g. sugar a...A61K 47/28 Steroids, e.g. cholesterol,...A61K 47/32 Macromolecular compounds ob...A61K 9/0095 Drinks; Beverages; Syrups; ...
