Invention Grant
- Patent Title: Method of evaluating evenness of suplatast tosilate crystal, even crystal, and process for producing the same
- Patent Title (中): 评价超晶体硅酸盐晶体,均匀晶体的均匀性及其制造方法
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Application No.: US11632075Application Date: 2005-07-13
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Publication No.: US07955607B2Publication Date: 2011-06-07
- Inventor: Takanori Ushio , Keiko Nagai
- Applicant: Takanori Ushio , Keiko Nagai
- Applicant Address: JP Tokyo
- Assignee: Taiho Pharmaceutical Co., Ltd.
- Current Assignee: Taiho Pharmaceutical Co., Ltd.
- Current Assignee Address: JP Tokyo
- Agency: Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.
- Priority: JP2004-206046 20040713
- International Application: PCT/JP2005/012893 WO 20050713
- International Announcement: WO2006/006616 WO 20060119
- Main IPC: A61K31/164
- IPC: A61K31/164 ; A61P37/08 ; C07C233/00 ; G01N21/84

Abstract:
Provided are a method for evaluating evenness of suplatast tosilate crystals; stable suplatast tosilate crystals exhibiting evenness in optical purity; and a method for producing the suplatast tosilate crystals.The method for evaluating evenness of suplatast tosilate crystals includes: (a) a step of adding a solvent to suplatast tosilate crystals to thereby dissolve 3% or less of the crystals in the solvent, and subjecting a portion of the supernatant of the resultant suspension to optical purity measurement, and (b) a step of adding a solvent to the remaining suspension to thereby dissolve the entirety of the suspension in the solvent, and subjecting a portion of the resultant solution to optical purity measurement, wherein the optical purity as measured in the step (a) is compared with the optical purity as measured in the step (b). The suplatast tosilate crystals exhibits excellent evenness and thermal stability. The method for producing the suplatast tosilate crystals is also provided.
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