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Last Updated: March 28, 2024

Claims for Patent: 9,453,006


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Summary for Patent: 9,453,006
Title:Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient
Abstract: Means for improving the solubility of luliconazole is provided. A crystal of luliconazole represented by the following formula is provided, wherein the crystal has such a crystal habit that (011) plane is a specific crystal growth plane. The crystal is characterized in that I.sub.(011) with respect to a sum total of I.sub.(001), I.sub.(100), I.sub.(10-1), I.sub.(011), I.sub.(110), I.sub.(11-1), I.sub.(10-2), I.sub.(11-2), I.sub.(020), I.sub.(021), I.sub.(20-2), I.sub.(121), I.sub.(013), I.sub.(11-3), and I.sub.(221) is not less than 25%, provided that integrated intensities of diffraction peaks, which correspond to the (001), (100), (10-1), (011), (110), (11-1), (10-2), (11-2), (020), (021), (20-2), (121), (013), (11-3), and (221) planes, are designated as I.sub.(001), I.sub.(100), I.sub.(10-1), I.sub.(011), I.sub.(110), I.sub.(11-1), I.sub.(10-2), I.sub.(11-2), I.sub.(020), I.sub.(021), I.sub.(20-2), I.sub.(121), I.sub.(013), I.sub.(11-3), and I.sub.(221) respectively in relation to the diffraction peaks detected in a range of 2.theta.=5 to 35.degree. in a powder X-ray diffractometry using CuK.alpha. radiation. ##STR00001##
Inventor(s): Masuda; Takaaki (Kanagawa, JP), Miyata; Yoshiyuki (Tokyo, JP), Kaneda; Hideo (Tokyo, JP)
Assignee: POLA PHARMA INC. (Tokyo, JP) NIHON NOHYAKU CO., LTD. (Tokyo, JP)
Application Number:14/388,218
Patent Claims: 1. A crystal of luliconazole represented by the following formula, wherein the crystal is recrystallized from alcohol which may contain water, and the crystal has such a crystal habit that (011) plane is a specific crystal growth plane, and the crystal is characterized by crystal system of monoclinic crystal, space group of P2.sub.1 ,lattice constant of a =9.0171(9) .ANG., b =8.167(1) .ANG., c =10.878(1) .ANG., .beta.=95.917(9) .degree., R factor of R =0.046, R.sub.w =0.047: ##STR00004##

2. The crystal according to claim 1, wherein I.sub.(011) with respect to a sum total of I.sub.(001), I.sub.(100), I.sub.(l0-1), I.sub.(011), I.sub.(110), I.sub.(11-1), I.sub.(10-2), I.sub.(11-2), I.sub.(020), I.sub.(021), I.sub.(20-2), I.sub.(121), I.sub.(013), I.sub.(11-3), and I.sub.(221) is not less than 25%, provided that integrated intensities of diffraction peaks, which correspond to the (001), (100), (10-1), (011), (110), (11-1), (10-2), (11-2), (020), (021), (20-2), (121), (013), (11-3), and (221) planes, are designated as I.sub.(001), I.sub.(100), I.sub.(10-1), I.sub.(011), I.sub.(110), I.sub.(11-1), I.sub.(10-2), I.sub.(11-2), I.sub.(020), I.sub.(021), I.sub.(20-2),I.sub.(121), I.sub.(013), I.sub.(11-3), and I.sub.(221) respectively in relation to the diffraction peaks detected in a range of 2.theta.=5 to 35.degree. in a powder X-ray diffractometry using CuK.alpha. radiation.

3. The crystal according to claim 1, wherein the crystal has such a crystal habit that sulfur atom is arranged on a specific crystal growth plane.

4. An active pharmaceutical ingredient, containing the crystal as defined in claim 1.

5. A method for producing a pharmaceutical composition, comprising a step of dissolving, in a solvent, the crystal as defined in claim 1, followed by being filtrated through a sterilizing filter.

6. The method according to claim 5, wherein the sterilizing filter is a filter which has a pore size of 0.2 .mu.m to 0.5 .mu.m.

7. The method according to claim 5, wherein the pharmaceutical composition is a pharmaceutical composition which is usable for vaginitis or pneumonia.

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