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|Title:||Gelatin hard capsule containing crystalline hydrate of oral cephalosporin|
|Abstract:||An antibacterial, 7.beta.-[(Z)-2-(2-aminothiazol-4-yl)-4-carboxybut-2-enoylamino]-3-cephem-4 -carboxylic acid is stable in a (di or tri)-hydrate crystal form. A pharmacologically effective amount of this hydrate is filled in a gelatin hard capsule and sealed by a band of gelatin to make a stable composition for clinical use after storage for a long time.|
|Inventor(s):||Hamashima; Yoshio (Kyoto, JP), Minami; Kyoji (Nara, JP), Kawata; Kyozo (Osaka, JP), Sakamoto; Teruo (Osaka, JP), Takeda; Toyohiko (Hyogo, JP), Suzuki; Yusuke (Osaka, JP), Tujikawa; Masanori (Nara, JP)|
|Assignee:||Shionogi & Co., Ltd. (Osaka, JP)|
|Filing Date:||Feb 09, 1990|
|Claims:||1. A gelatin hard capsule containing a crystalline hydrate of 7.beta.-[(Z)-2-(2-aminothiazol-4-yl)-4-carboxybut-2-enoylamino]-3-cephem-4 -carboxylic acid having the X-ray diffraction pattern as follows: |
which is characterized by having a gelatin seal around the circumference at the joint of cap and body of the capsule.
2. A capsule as claimed in claim 1 additionally containing a bulking agent selected from glucose, fructose, lactose, corn starch, potato starch, crystalline cellulose, methylcellulose, and methylethylcellulose.
3. A capsule as claimed in claim 1 additionally containing a lubricant selected from purified talc, stearic acid, sodium stearate, magnesium stearate, calcium stearate, borax, liquid paraffin, sodium benzoate, polyethyleneglycol, carnauba wax, and hydrogenated oil.