Pharmaceutical dosage form with multiple enteric polymer coating

Details Pharmaceutical dosage form with multiple enteric polymer coating Pharmaceutical dosage form with multiple enteric polymer coating

1995-05-17

1997-11-11

Nutter, Nathan M.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Capsules

424457, 424458, 424461, 424462, 424465, 424468, 424494, 424497, A01J 2100, A01J 2512, A21C 300, A23G 120

Patent

active

056861052

ABSTRACT:
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 a therapeutically active agent 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 therapeutically active agent 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.

REFERENCES:
patent: 4432966 (1984-02-01), Zeitoun et al.

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