| 摘要 |
1. A pharmaceutical composition which comprises: an essentially nonaqueous, liquid concentrate for oral administration comprising an amount of sertraline or a pharmaceutically acceptable salt thereof and one or more essentially nonaqueous pharmaceutically acceptable excipients; wherein at least one of the excipients is liquid. 2. The composition of claim 1 wherein the pharmaceutically acceptable salt of sertraline is the hydrochloride salt or the mesylate salt. 3. The composition of claim 1 wherein the excipients are selected from the group consisting of ethanol, glycerin, polyethylene glycol and propylene glycols. 4. The composition of claim 3 wherein the excipients are ethanol and glycerin. 5. The composition of claim 1 wherein the concentrate comprises sertraline hydrochloride in an amount of about 15 to about 30 mg/ml and wherein the excipients are ethanol and glycerin in an amount of about 8 to about 20% ethanol (by weight) in glycerin. 6. The composition of claim 5 wherein the concentrate further comprises one or more flavoring agents and one or more pharmaceutically acceptable preservatives. 7. The composition of claim 6 wherein the flavoring agents are selected from the group consisting of peppermint, spearmint and menthol; and wherein the preservatives are selected from the group consisting of butylhydroxytoluene, butylated hydroxyanisole, propyl gallate, ascorbic acid, ascorbyl palmitate, sodium metabisulite, sodium bisulfate, sodium thiosulfate, sodium hydroxide, cystiene, ethylenediamine tetraacetic acid or salts thereof, citric acid, triethanolamine, thioglycerol, methylparaben and propylparaben. 8. The composition of claim 7 wherein the flavoring agent is menthol and wherein the preservative is butylhydroxytoluene. 9. The composition of claim 8 wherein each ml of the concentrate comprises about 22.4 mg of sertraline hydrochloride, about 151 mg of ethanol, about 0.50 mg of menthol, about 0.10 mg of butylhydroxytoluene, and about 1011 mg of glycerin. 10. Use of an essentially nonaqueous, liquid concentrate of sertraline or a pharmaceutically acceptable salt thereof of claim 1 to prepare an aqueous solution of sertraline which comprises diluting the concentrate in an aqueous diluent prior to oral administration. 11. The use of claim 10 wherein the pharmaceutically acceptable salt of sertraline is the hydrochloride salt or the mesylate salt. 12. The use of claim 10 wherein the diluent is selected from the group consisting of water, orange juice, ginger ale, lemon-lime soda and lemonade.
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