Titration dosing regimen for controlled release tramadol

• US 7,413,749 B2
• Filed: 03/10/2004
• Issued: 08/19/2008
• Est. Priority Date: 03/11/2003
• Status: Active Grant

• Current Assignee: Purdue Pharma L.P.
• Original Assignee: Purdue Pharma L.P.
• Inventors: Wright, Curtis, Sanchez, Raymond, Colucci, Robert
• Primary Examiner(s): Monshipouri; Maryam
• Application Number:
  US10/800,254
• Publication Number:
  US 20040259956A1
• Time in Patent Office: 1,623 Days
• Field of Search: 424/468, 424/469, 424/484, 424/485, 424/400
• 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 comprising administering:

about 75 mg to about 125 mg of tramadol in a controlled release dosage form once-a-day for about 4 to about 10 days;

then 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.

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 a form selected from the group consisting of a free form of tramadol, a pharmaceutically acceptable salt of tramadol, a base form of tramadol, an optically active isomer of tramadol and a stereoisomer of tramadol.

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

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

6. The dosage regimen of claim 1 comprising administering about 275 mg to about 325 mg of tramadol in a controlled release dosage form once-a-day for at least 7 days and optionally thereafter.

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

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