Pharmaceutical tablets comprising two or more unitary segments

• US 8,158,148 B2
• Filed: 05/23/2005
• Issued: 04/17/2012
• Est. Priority Date: 05/21/2004
• Status: Expired due to Fees

• Current Assignee: Accu-Break Technologies, Inc.
• Original Assignee: Accu-Break Technologies, Inc.
• Inventors: Solomon, Lawrence, Kaplan, Allan S.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Sasan, Aradhana
• Application Number:
  US10/598,315
• Publication Number:
  US 20080233189A1
• Time in Patent Office: 2,521 Days
• Field of Search: 424/467, 424/464, 514/457, 514/175, 514/567
• 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 compressed, layered pharmaceutical tablet formed in a tablet die having an embossed bottom tablet punch and a top tablet punch, said tablet comprising

one or more layers of a powder or granulation composition containing an effective amount of one or more active drugs, wherein said active drug-containing composition is filled into the tablet die wherein the embossed bottom tablet punch forms a divided active bottom layer or layers, said bottom layer or layers being tamped using the top tablet punch to provide first and second unitary segments each having a level top surface following said tamping;

and

one or more layers of a second powder or granulation composition containing either an undetectable amount of drug or a pharmacologically ineffective amount of drug, wherein said second composition is filled onto the level top surface of said first and second unitary segments in the tablet die, said second composition forming an undivided, non-unitary inactive top segment having a bottom and top surface, wherein only the bottom surface contacts said level top surfaces of said first and second unitary active segments,

wherein the bottom active unitary segments and top inactive non-unitary segment are compressed to form a whole tablet, said tablet being divisible by breaking through the inactive non-unitary segment, without breaking of the first and second unitary segments,

wherein the terms “

bottom” and

“

top”

refer to the orientation of the tablet in the tablet die during compression.

2. 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.

3. A pharmaceutical tablet as defined in claim 1 in which the top inactive segment contains no more than 10 parts per million of the concentration of the drug or drugs present in said first unitary and said second unitary active segments.

4. A pharmaceutical tablet as defined in claim 1 in which the top inactive segment contains no more than 10% of the concentration of drug or drugs present in the first unitary segment and said second unitary segment.

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

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

7. A pharmaceutical tablet as defined in claim 1 in which additional unitary segments 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.

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

9. 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.

10. A pharmaceutical tablet as defined in claim 1 in which said drug is warfarin.

11. A pharmaceutical tablet as defined in claim 1 in which said drug is digoxin.

12. A pharmaceutical tablet as defined in claim 1 in which said drug is levothyroxine.

13. 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.

14. 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.

15. A method of breaking a pharmaceutical tablet as defined in claim 1 wherein said tablet is broken by applying force to said top inactive non-unitary segment to cause the tablet to break through said first segment.

16. A method of breaking a tablet as in claim 15 that comprises first breaking said tablet through said top inactive non-unitary 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.

17. A method of administering a partial dose of a drug contained in a pharmaceutical tablet, said method comprising breaking a pharmaceutical tablet according to claim 1 by breaking said tablet through said top inactive non-unitary 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.

18. 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 15 and having a patient, other person, or other animal in need thereof ingest a tablette formed by said breaking.