发明名称 |
Bisacodyl dosage form with multiple enteric polymer coatings for colonic delivery |
摘要 |
The present invention relates to a pharmaceutical composition in a unit dosage form for peroral administration in a human or lower animal, having a gastrointestinal tract comprising a small intestine and a colon with a lumen therethrough having an inlet to the colon from the small intestine, comprising: a. a safe and effective amount of rapidly dissolving bisacodyl incorporated into or coated on the surface of a dosage form selected from the group consisting of a spherical substrate, an elliptical substrate, a hard capsule, or a compressed tablet, with a maximum diameter of about 3 mm to about 10 mm; and b. an enteric polymer coating material comprising at least one inner coating layer and one outer coating layer; wherein the dosage form has a smooth surface free from edges or sharp curves; the elliptical substrate and the hard capsule have a ratio of the long to short diameters of no greater than about 1.5; the rapidly dissolving bisacodyl is released at a point near the inlet to, or within the colon; each of the inner coating layer(s) is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 5 to about 6.3; and the outer coating layer is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 6.8 to about 7.2.
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申请公布号 |
US5656290(A) |
申请公布日期 |
1997.08.12 |
申请号 |
US19950442914 |
申请日期 |
1995.05.17 |
申请人 |
THE PROCTER & GAMBLE COMPANY |
发明人 |
KELM, GARY ROBERT;MANRING, GARY LEE;DAVIS, PAULA DENISE;DOBROZSI, DOUGLAS JOSEPH;MANDEL, KENNETH GARY |
分类号 |
A61K9/00;A61K9/14;A61K9/22;A61K9/28;A61K9/30;A61K9/48;A61K9/50;A61K31/44;A61K31/4402;A61K47/48;(IPC1-7):A61K9/48;A61K9/32;A61K9/36;A61K9/58 |
主分类号 |
A61K9/00 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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