Titration dosing regimen for controlled release tramadol

• US 8,722,087 B2
• Filed: 08/18/2008
• Issued: 05/13/2014
• Est. Priority Date: 03/11/2003
• Status: Active Grant

• Current Assignee: Purdue Pharma L.P.
• Original Assignee: Purdue Pharma L.P.
• Inventors: Wright, Curtis, Colucci, Robert, Sanchez, Raymond
• Primary Examiner(s): Monshipouri, Maryam
• Application Number:
  US12/193,329
• Publication Number:
  US 20080319085A1
• Time in Patent Office: 2,094 Days
• Field of Search: 424/400, 424/468
• US Class Current: 424/468
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• 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 29/02 without antiinflammatory effect

Abstract

A titration dosing regimen for the administration of controlled release tramadol analgesic to patients. The titration dosing regimen provides a significant reduction in the occurrence of adverse effects from the introduction of controlled released tramadol dosing, thus increasing patient compliance and medication tolerability.

Claims

1. A dosage regimen for administering tramadol to a patient for the treatment of pain comprising administering:

about 100 mg of tramadol in a controlled release dosage form once-a-day on days 1 through 7;

then about 200 mg of tramadol in a controlled release dosage form once-a-day on days 8 through 14;

then about 300 mg of tramadol in a controlled release dosage form once-a-day on day 15 and optionally thereafter.

2. The dosage regimen of claim 1 wherein the controlled release dosage forms are each oral dosage forms.

3. The dosage regimen of claim 2 wherein the tramadol is present in each oral dosage form in the form of tramadol hydrochloride.

4. The dosage regimen of claim 3 each oral dosage form provides in vitro release of tramadol hydrochloride for about 24 hours or longer.

5. The dosage regimen of claim 1 further comprising administering about 300 mg of tramadol in a controlled release dosage form once-a-day on days 15 through 21 and optionally thereafter.

6. The dosage regimen of claim 5 wherein 100 mg of tramadol is administered in a controlled release dosage form on days 1 through 7;

200 mg of tramadol is administered in a controlled release dosage form on days 8 through 14; and

300 mg of tramadol is administered in a controlled release dosage form on days 15 through 21 and optionally thereafter.

7. The dosage regimen method of claim 6 wherein the tramadol is present in each oral dosage form in the form of tramadol hydrochloride.

8. The dosage regimen method of claim 7 wherein each oral dosage form provides an in vitro release of tramadol hydrochloride of about 24 hours or more.

9. A dosage regimen for administering tramadol to a patient for the treatment of pain comprising administering:

about 175 mg to about 225 mg of tramadol in a controlled release dosage form once-a-day for about 4 to about 10 days;

then about 275 mg to about 325 mg of tramadol in a controlled release dosage form once-a-day for at least 1 day and optionally thereafter.

10. The dosage regimen of claim 9 wherein the controlled release dosage forms are each oral dosage forms.

11. The dosage regimen of claim 10 wherein the tramadol is present in each oral dosage form in the form of tramadol hydrochloride.

12. The dosage regimen of claim 11 wherein each oral dosage form provides an in vitro release of tramadol hydrochloride of about 24 hours or more.

13. The dosage regimen of claim 9 comprising administering about 275 mg to about 325 mg of tramadol in a controlled release dosage form once-a-day for at least 6 days and optionally thereafter.

14. A dosage regimen for administering tramadol to a patient for the treatment of pain comprising administering:

about 200 mg of tramadol in a controlled release dosage form once-a-day for days 1 through 7;

then about 300 mg of tramadol in a controlled release dosage form once-a-day for at least 1 day and optionally thereafter.

15. The dosage regimen of claim 14 wherein the controlled release dosage forms are each oral dosage forms.

16. The dosage regimen of claim 15 wherein the tramadol is present in each oral dosage form in the form of tramadol hydrochloride.

17. The dosage regimen of claim 16 wherein each oral dosage form provides an in vitro release of tramadol hydrochloride of about 24 hours or more.

18. The dosage regimen of claim 14 comprising administering about 300 mg of tramadol in a controlled release dosage form once-a-day for at least 7 days and optionally thereafter.

19. A kit for the administration of a dosage regimen of tramadol comprising:

instructions to administer the following amounts of tramadol in controlled release oral dosage forms according to the following dosage regimen;

100 mg of tramadol once-a-day on days 1 through 7;

200 mg of tramadol once-a-day on about days 8 through 14; and

300 mg of tramadol once-a-day on about days 15 through 21, and optionally thereafter; and

a sufficient quantity of controlled release oral dosage forms of tramadol to administer tramadol according to the dosage regimen.

20. A kit for the administration of a dosage regimen of tramadol comprising:

instructions to administer the following amounts of tramadol in controlled release oral dosage forms according to the following dosage regimen;

200 mg of tramadol once-a-day on days 1 through 7; and

300 mg of tramadol once-a-day on about days 8 through 14, and optionally thereafter; and

a sufficient quantity of controlled release oral dosage forms of tramadol to administer tramadol according to the dosage regimen.