Pharmaceutical Tablets Comprising Two or More Unitary Segments

• US 20080233189A1
• Filed: 05/23/2005
• Published: 09/25/2008
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Accu-Break Technologies, Inc.
• Original Assignee: Accu-Break Technologies, Inc.
• Inventors: Kaplan, Allan S., Solomon, Lawrence
• Granted Patent: US 8,158,148 B2
• Time in Patent Office: Days
• US Class Current: 424/467
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 5/14 of the thyroid hormones, e.g. T3, T4
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Accurate means of dosing with a compressed, segmented pharmaceutical tablet, and tablettes formed from said tablets, is disclosed.

Claims

1. A pharmaceutical tablet comprising a first segment one face of which is contiguous with a plurality of compositionally substantially identical unitary segments that contain a drug or drugs.

2. A pharmaceutical tablet as defined in claim 1 including two or more compositionally identical unitary segments comprising a first unitary segment and a second unitary segment, said first unitary segment and said second unitary segment each containing a drug or drugs, said first unitary segment and said second unitary segment being derived from the same divided layer or layers;

said first segment optionally having a score on its surface positioned between said first and said second unitary segments;

said tablet optionally having additional unitary segments.

3. A pharmaceutical tablet as defined in claim 1 in which one or more additional unitary segments in addition to said first and second unitary segments are optionally present and are derived from the same layer or layers as said first unitary segment.

4. A pharmaceutical tablet as defined in claim 1 in which said first unitary segment and said second unitary segment contain a drug or drugs, where said first segment contains either an undetectable amount of a drug, a pharmacologically ineffective amount of drug, or a pharmacologically effective quantity of said drug or drugs present in said second segment, hut has fewer milligrams of said drug or drugs relative to the excipients in each segment than does said second segment.

5. A pharmaceutical tablet as defined in claim 4 in which said first unitary segment and said second unitary segment each contain a pharmacologically effective dose of said drug or drugs.

6. A pharmaceutical tablet as defined in claim 4 in which the first segment has from an undetectable amount of drug up to 80% of the concentration of the drug or drugs in said first unitary segment or said second unitary segment.

7. A pharmaceutical tablet as defined in claim 4 in which the first segment contains no more than 10 parts per million of the concentration of the drug or drugs present in said first unitary segment and said second unitary segment.

8. A pharmaceutical tablet as defined in claim 4 in which the first segment contains no more than 10% of the concentration of drug or drugs present in the first unitary segment and said second unitary segment.

9. A pharmaceutical tablet as defined in claim 1 in which the first segment contains no more than 2% the concentration of drug present in the first unitary segment and said second unitary segment.

10. A pharmaceutical tablet as defined in claim 1 in which said first segment is derived from a granulation that does not contain a drug.

11. A pharmaceutical tablet as defined in claim 1 in which additional unitary segments are contained in said tablet which are compositionally different from the composition of said first unitary segment and said second unitary segment and are derived from a granulation containing a drug.

12. A pharmaceutical tablet as defined in claim 1 in which said first unitary and said second unitary segments are outer segments.

13. A pharmaceutical tablet as defined in claim 1 in which said first unitary segment and said second unitary segment adjoins other unitary segments that are outer segments.

14. A pharmaceutical tablet as defined in claim 12 in which there are interposed unitary segments between said first unitary segment and said first segment.

15. A pharmaceutical tablet as defined in claim 1 in which there is a substantially vertical score in said first segment, said score being vertically aligned with the center of the space between said first unitary segment and said second unitary segment.

16. A pharmaceutical tablet as defined in claim 1 in which in addition to said first unitary segment and said second unitary segment, there are two additional unitary segments which are compositionally identical.

17. A pharmaceutical tablet as defined in claim 1 in which said drug or drugs is or are pharmacologically effective in the treatment of cardiovascular conditions, psychiatric conditions, diabetes, thyroid disorders, pain or thrombotic disorders.

18. A pharmaceutical tablet as defined in claim 17 in which said drug is warfarin.

19. A pharmaceutical tablet as defined in claim 17 in which said drug is digoxin.

20. A pharmaceutical tablet as defined in claim 17 in which said drug is levothroxine.

21. A pharmaceutical tablet as defined in claim 1 in which said first segment adjoins a plurality of unitary segments on the side of said first segment that is opposite the surface adjoining said first and second unitary segments.

22. A pharmaceutical tablet as defined in claim 1 in which a second segment which contains a drug adjoins said first segment on the side opposite the side where said first and said second unitary segments are located.

23. A method of breaking a pharmaceutical tablet as defined in claim 1 wherein said tablet is broken by applying force to said first and said second unitary segments to cause the tablet to break substantially through said first segment and substantially not through any unitary segment.

24. A method of breaking a tablet as in claim 22 that comprises first breaking said tablet through said first segment to obtain a tablette that contains part of said first segment plus unitary segments and thereafter breaking said tablet between said first and said second unitary segments so that the tablet breaks substantially completely within said first segment.

25. A method of administering a partial dose of a drug contained in a pharmaceutical tablet, said method comprising breaking a pharmaceutical tablet as defined in claim 1 by breaking said tablet substantially only through said first segment to form two or more tablettes each containing a unitary segment and having a patient, other person, or other animal in need thereof ingest a tablette containing a unitary segment.

26. A method of administering a partial dose of a drug contained in a pharmaceutical tablet, said method comprising breaking a pharmaceutical tablet according to the method of claim 24 and having a patient, other person, or other animal in need thereof ingest a tablette formed by said breaking.

33. A pharmaceutical tablet as defined in claim 1 in which said drug or drugs is or are pharmacologically effective in the treatment of cardiovascular conditions, psychiatric conditions, diabetes, thyroid disorders, pain or thrombotic disorders.

27. A compressed pharmaceutical tablet having a first segment that contains a drug and that is scored from 95-99.5% of the distance between said segment and an adjoining second segment.

29. A compressed pharmaceutical tablet which comprises the tablet of claim 27 as a core structure in a tablet with an additional segment.

30. A compressed pharmaceutical tablet which comprises the tablet of claim 27 as a core structure in a tablet with two or more additional segments.

31. A method of breaking a pharmaceutical tablet as defined in claim 27 wherein said tablet is broken by applying force to cause the tablet to break substantially through said first segment but not through a unitary segment.

32. A method of administering a precise partial dose of a drug contained in a pharmaceutical tablet, said method comprising breaking a pharmaceutical tablet according to claim 27 by breaking said tablet through said first segment to form two or more tablettes and administering at least one of said tablettes to a patient, other person, or other animal in need thereof who ingests said tablette.

28. A compressed pharmaceutical tablet having a scored first segment that adjoins a second segment, in which less than 5% of the quantity of drug contained in said first segment is present between said score and said second segment.