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| Title: | Pleasant-tasting aqueous liquid composition of a bitter-tasting drug |
| Abstract: | A liquid pharmaceutical composition is contemplated that comprises a pharmaceutically effective amount of a bitter tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol. That aqueous medium consists essentially of water, about 5 to about 30 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants. The liquid composition is transparent and has a pleasant taste. |
| Inventor(s): | Anaebonam; Aloysius O. (Burlington, MA), Clemente; Emmett (Manchester, MA), Fawzy; Abdel A. (Groton, MA) |
| Assignee: | Ascent Pediatrics, Inc. (Wilmington, MA) |
| Application Number: | 08/692,081 |
| Patent Claims: | 1. A liquid pharmaceutical composition comprising a pharmaceutically effective amount of a bitter-tasting drug dissolved or dispersed in an aqueous medium that is free of
ethanol, said aqueous medium consisting essentially of water, about 5 to about 30 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and
one or more flavorants, said liquid composition being transparent and having a pleasant taste when administered orally.
2. The liquid pharmaceutical composition according to claim 1 wherein said polyvinylpyrrolidone is present at about 7 to about 15 weight percent. 3. The liquid pharmaceutical composition according to claim 1 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols. 4. The liquid pharmaceutical composition according to claim 1 wherein said ammonium glycyrrhizinate is present at a weight ratio to said drug of about 1:50 to 1:10. 5. The liquid pharmaceutical composition according to claim 1 wherein said drug is present in an amount of about 0.5 to about 5 weight percent. 6. A liquid pharmaceutical composition comprising about 0.5 to about 5 weight percent of a bitter-tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol, said aqueous medium consisting essentially of water, about 7 to about 15 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants, said ammonium glycyrrhizinate being present at a weight ratio to said drug of about 1:50 to about 1:10 and said liquid composition being transparent and having a pleasant taste when administered orally. 7. The liquid pharmaceutical composition according to claim 6 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols. 8. The liquid pharmaceutical composition according to claim 7 wherein the weight ratio of said C.sub.3 polyol to said C.sub.6 polyol is about 1:4 to about 3:5. 9. The liquid pharmaceutical composition according to claim 6 wherein polyol other than a C.sub.6 polyol constitutes less than about 5 weight percent of said composition. 10. The liquid pharmaceutical composition according to claim 6 wherein said drug is present in an amount of about one to about 3 weight percent. 11. The liquid pharmaceutical composition according to claim 6 wherein said bitter tasting drug is selected from the group consisting of acetaminophen, terfenadine, guaifenesin, trimethoprim, prednisolone, ibuprofen, prednisolone sodium phosphate, methacholine, neostigmine, epinephrine, albuterol, pseudoephedrine hydrochloride, diphenhydramine, chlorpheniramine maleate, phenothiazine, chlorpromazine, chlordiazepoxide, amitriptyline, barbiturates, diphenylhydantoin, caffeine, morphine, demerol, codeine, lomotil, lidocaine, salicylic acid, sulfonamides, chloroquine and penicillins. 12. The liquid pharmaceutical composition according to claim 6 wherein said bitter tasting drug is guaifenesin. 13. The liquid pharmaceutical composition according to claim 6 wherein said bitter tasting drug is trimethoprim. |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Product | Substance | Delist_Flag | Patent Expiration | Patented / Exclusive Use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Fsc | PRIMSOL | trimethoprim hydrochloride | SOLUTION; ORAL | 074973 | Jan 24, 2000 | RX | Yes | 5,763,449 | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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