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Claims for Patent: 8,980,931

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Claims for Patent: 8,980,931

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)
Application Number:14/263,293
Patent Claims: 1. A pharmaceutical medicament preparation, comprising: 1) luliconazole; and 2) polyhydric alcohol or ether thereof and dibasic acid ester, wherein upon measurement of 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) by storage under a severe condition and an accelerated condition, 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 mass with respect to a compounded amount of luliconazole. ##STR00008##

2. The pharmaceutical medicament preparation 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 after storage under the severe condition and the accelerated condition is not more than 0.5% by mass with respect to the compounded amount of luliconazole.

3. The pharmaceutical medicament preparation according to claim 1, wherein polyhydric alcohol or ether thereof is selected from propylene glycol, polyethylene glycol, 1,3-butanediol, diethylene glycol monoethyl ether, diethylene glycol diethyl ether and polypropylene glycol; and dibasic acid ester is selected from diethyl adipate, diisopropyl adipate and propylene carbonate.
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