Suplatast tosilate crystals

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form

Reexamination Certificate

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Reexamination Certificate

active

07138140

ABSTRACT:
Provided are a suplatast tosilate crystal showing characteristic peaks in powder X-ray diffraction diffraction angles (20±0.1°) of 5.6°, 9.0°, 11.0°, 15.3°, 16.5°, 17.2°, 17.9°, 19.2°, 19.9°, and 21.5°; and a preparation process of the crystal. Owing to merits such as fluctuation-free optically active substance ratio, low hygroscopicity and high storage stability, the suplatast tosilate crystal of the present invention can be mass-produced easily and, at the same time, is advantageous in drug preparation quality management. It is thus excellent as raw material for pharmaceuticals.

REFERENCES:
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patent: 5886045 (1999-03-01), Tokumochi et al.
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Takanori Ushio, Rui Tamura, Hiroki Takahashi, Nagao Azuma, and Keiji Yamamoto. Unusual Enantiomeric Resolution Phenomenon Observed Recrstallization of a Racemic Compound, 1996, VCH Verologsgesellschschaft mbh, Agnew.Chem. Int. Ed. Engl. 35 No. 20. pp. 2372-2374.
Brittain, H. G. Pharmaceutical Sciences: Polymorphism in Pharmaceutical Solids. vol. 95, 1995 Marcel Dekker, p. 236.
Takanori Ushio et al.: “Unusual enantiomeric resolution phenomenon observed upon recrystallization ofa racemic compound” Angew. Chem. Int. Ed. Engl., vol. 35, pp. 2372-2374 1996.
Kagaku, vol. 54, No. 6, pp. 47-54 1999 with English abstract.

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