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Details for Patent: 9,085,554

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Details for Patent: 9,085,554

Title:Method of evaluating pharmaceutical preparation containing luliconazole and index substance
Abstract: Disclosed is a method of evaluating stability of a pharmaceutical preparation containing luliconazole. The method includes measuring an amount of production of an SE form of luliconazole represented by following formula (2), an amount of production of a Z form of luliconazole represented by following formula (3) and an amount of production of an amide form of luliconazole represented by following formula (1) after storage under a severe condition or an accelerated condition, and judging that the stability of the pharmaceutical preparation is high if each of the amount of production of the SE form, the amount of production of the Z form and the amount of production of the amide form is not more than 5% by weight with respect to a compounded amount of luliconazole. ##STR00001##
Inventor(s): Masuda; Takaaki (Kanagawa, JP), Yamaguchi; Hiroshi (Tokyo, JP)
Assignee: POLA PHARMA INC. (Tokyo, JP) NIHON NOHYAKU CO., LTD. (Tokyo, JP)
Filing Date:Jan 08, 2015
Application Number:14/592,695
Claims:1. A method of evaluating stability of a pharmaceutical preparation comprising luliconazole, comprising: storing the pharmaceutical preparation under condition at 60.degree. C. for 3 weeks or at 40.degree. C. for 6 months, measuring an amount of production of an SE form of luliconazole represented by following formula (2), an amount of production of a Z form of luliconazole represented by following formula (3) and an amount of production of an amide form of luliconazole represented by following formula (1) after storage, and judging that the pharmaceutical preparation is stable if each of the amount of production of the SE form, the amount of production of the Z form and the amount of production of the amide form is not more than 5% by weight with respect to a compounded amount of luliconazole ##STR00008##

2. The evaluation method according to claim 1, wherein each of the amount of production of the SE form, the amount of production of the Z form and the amount of production of the amide form is not more than 0.2% by weight with respect to the compounded amount of luliconazole.

3. The evaluation method according to claim 1, wherein the pharmaceutical preparation comprising luliconazole comprises one or more of a component selected from polyhydric alcohol or ether thereof, dibasic acid ester, aromatic alcohol, ketone, triglyceride and heterocyclic solvent.

4. The evaluation method according to claim 3, wherein the polyhydric alcohol or the ether thereof is selected from propylene glycol, polyethylene glycol, 1,3-butanediol, diethylene glycol monoethyl ether, diethylene glycol diethyl ether and polypropylene glycol; the dibasic acid ester is selected from diethyl adipate, diisopropyl adipate and propylene carbonate; the aromatic alcohol is benzyl alcohol; the ketone is acetone or methyl ethyl ketone; the triglyceride is medium chain fatty acid triglyceride or olive oil; and the heterocyclic solvent is N-methyl-2-pyrrolidone or N-ethyl-2-pyrrolidone.
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