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Details for Patent: 8,883,825

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Details for Patent: 8,883,825

Title:Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Abstract: An aqueous liquid preparation containing (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof, which is stabilized with a water-soluble metal chloride, is provided.
Inventor(s): Higashiyama; Masayo (Kobe, JP)
Assignee: Senju Pharmaceutical Co., Ltd. (Osaka, JP)
Filing Date:Aug 30, 2012
Application Number:13/599,212
Claims:1. A method of light-stabilizing (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid in an aqueous solution, which consists of preparing a solution consisting of water; a water-soluble metal chloride; (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof, thereof; and optionally at least one material selected from the group consisting of a buffer, a preservative, a chelating agent, and a flavor; wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.2 w/v % and an upper limit concentration of 1.2 w/v %; and wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt in the aqueous solution is light-stabilized by the water-soluble metal chloride.

2. The method of claim 1, wherein the metal chloride is at least one kind selected from sodium chloride, potassium chloride and calcium chloride.

3. The method of claim 1, wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof is an acid addition salt of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid.

4. The method of claim 3, wherein the acid addition salt is monobenzenesulfonate.

5. The method of claim 1, wherein the aqueous liquid preparation has a pH in the range of 4-8.5.

6. The method of claim 1, wherein the aqueous liquid preparation is an eye drop.

7. The method of claim 1, wherein the aqueous liquid preparation is a nasal drop.

8. The method of claim 1, wherein the (+) (S)-4-[4-[4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt is (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid monobenzenesulfonate; the metal chloride is sodium chloride; and the concentration of the sodium chloride is 0.2 to 0.8 w/v %.

9. The method of claim 1, wherein the metal chloride is at least one kind selected from alkali metal chlorides and alkaline earth metal chlorides.

10. The method of claim 1, wherein the light-stabilized preparation suppresses precipitation of a precipitate.

11. A method of light-stabilizing (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid in an aqueous solution, which consists of preparing a solution consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof, a water-soluble metal chloride in a light-stabilizing effective amount, wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.2 w/v % and an upper limit concentration of 1.2 w/v %, benzalkonium chloride, sodium dihydrogenphosphate dihydrate, sodium hydroxide and water, to obtain an aqueous liquid preparation consisting of the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt which is light-stabilized, the water-soluble metal chloride, the benzalkonium chloride, the sodium dihydrogenphosphate dihydrate, the sodium hydroxide and the water.

12. A method of suppressing coloration of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid in an aqueous solution, which consists of preparing a solution consisting of water; a water-soluble metal chloride; (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof; and optionally at least one material selected from the group consisting of a buffer, a preservative, a chelating agent, and a flavor; wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.2 w/v % and an upper limit concentration of 1.2 w/v %; and wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt in the aqueous solution is light-stabilized by the water-soluble metal chloride.

13. A method of light-stabilizing (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid in an aqueous solution, which consists of preparing a solution consisting of water; a water-soluble metal chloride; (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof; benzalkonium chloride, sodium dihydrogenphosphate dihydrate, sodium hydroxide and water; wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.2 w/v % and an upper limit concentration of 1.2 w/v %; and wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt in the aqueous solution is light-stabilized by the water-soluble metal chloride.
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