Pharmaceutical compositions having novel scoring patterns and methods of using those compositions
OwnerLawrence Solomon, Allan S. Kaplaninventors
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Abstract
The invention provides novel scoring patterns for a wide variety of tablets that contain specific drugs or contain drugs in certain drug classes, and methods of treatment with layered tablets and fractional tablets derived from breaking said tablets.
Claims69
An improved pharmaceutically acceptable tablet containing at least one drug wherein said at least one drug is provided in a prior art dosage form as a capsule, an unscored tablet, a tablet having a bisecting score pattern, a tablet having a trisecting score pattern, or a tablet having a quadrisecting score pattern, said improvement comprising:
- a tablet when the prior art dosage form is not a tablet;
- a tablet having a score pattern selected from the group consisting of a bisecting, trisecting, quadrisecting, a pentasecting, and a score pattern more complex than a pentasecting score pattern, when the prior art tablet is limited to an unscored tablet;
- a tablet having a score pattern selected from the group consisting of a trisecting, quadrisecting, a pentasecting, and score pattern more complex than a pentasecting score pattern when the prior art tablet is limited to an unscored tablet or a bisected tablet;
- a tablet having a score pattern selected from the group consisting of a bisecting, quadrisecting, a pentasecting, and a score pattern more complex than a pentasecting score pattern, when the prior art dosage form is a trisected tablet;
- or
- a tablet having a score pattern selected from the group consisting of a bisecting, trisecting, and a pentasecting score pattern when the prior art dosage form is a quadrisected tablet;
- wherein said score pattern is formed by a debossed score or separation mark.
A method of treating, preventing or ameliorating a medical condition in a human or other animal using a dosing regimen comprising administration of different doses the human or other animal, said method comprising:
- providing a whole tablet comprising a dose of one or more drugs, said tablet being breakable to provide at least two portions of said tablet such that each portion comprises a predictable fractional dose of said one or more active drugs contained in the whole tablet, said fractional dose being more predictable than a fractional dose available from a prior art dosage form manufactured using known formulation technologies and having the same drug or drugs;
- prescribing or administering a fractional dose of said one or more active drugs, said fractional dose obtained by breaking the whole tablet into its one or more portions comprising a predictable fractional dose.
An article of manufacture or kit comprising:
- a whole dosage form comprising a medicament, said dosage form being accurately and predictably breakable into a plurality of fractional doses of a drug or drugs, and
- a separate instruction to create the fractional dose by breaking said whole dosage form or a fractional dose thereof into the plurality of fractional doses of said drug or drugs, wherein said dosage form and instruction are co-packaged as a single unit.
The method of claims 45-48 in which the tablet breaks into a fractional dose that is more predictable than a fractional dose provided by a known dosage form comprising the same drug or drugs.
The method of claims 45-49 in which the tablet is a segmented tablet comprising a scored drug-free segment and provides the more predictable fractional dose of the drug when broken through said score.
A method for treating hypertension comprising initial administration to a patient of an antihypertensive agent at a dose greater than a maximum starting dose previously recommended for said antihypertensive agent.
Dependencies are inferred from the claim text.