Segmented pharmaceutical dosage forms
A pharmaceutical tablet adapted for accurate division of a dose of a drug into two or more smaller doses, which tablet has two or more segments.
1. A compressed, layered pharmaceutical dosage form comprising
a first bottom segment comprising a composition containing an effective amount of one or more drugs, said segment comprising a score greater than 50% through the maximum height of said first segment and
a second, unscored, top segment contacting said first segment, said second segment comprising a composition substantially free of drug, said second segment forming an outer segment of said dosage form and providing a breaking segment for breaking through said second segment without substantial consequent breakage of the first segment, wherein said tablet is compressed in a tablet compression die using an embossed bottom punch and an unembossed top punch to allow tamping of the first bottom segment by the unembossed top punch, and
wherein the terms “upper,” “lower,” “top” and “bottom” refer to orientation of the segments or tablet in a tablet die during compression.
2. The dosage form of claim 1 wherein said composition containing a drug or drugs is a controlled release composition selected from the group consisting of delayed release, modified release, sustained-release, and quick dissolve oral or buccal release.
3. The pharmaceutical tablet of claim 1 comprising in at least one segment a colorant for visually distinguishing said segment from another segment.
4. The dosage form of claim 1 wherein said tablet is further covered with an inert or pharmaceutically inactive composition.
5. The dosage form of claim 4 wherein the inert or pharmaceutically inactive composition is a capsule.