US5672360A
Expired / Lapsed
US
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Method of treating pain by administering 24 hour oral opioid formulations
Assignee: Purdue Pharma LP
•
Filing: 1994-11-22
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Granted: 1997-09-30
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Expires: 2014-11-22
Abstract
Abstract PCT No. PCT/US94/13606 Sec. 371 Date Jul. 22, 1996 Sec. 102(e) Date Jul. 22, 1996 PCT Filed Nov. 22, 1994 PCT Pub. No. WO95/14460 PCT Pub. Date Jun. 1, 1995Patients are treated with 24-hour oral sustained release opioid formulations which, upon administration, provide an initially rapid opioid absorption such that the minimum effective analgesic concentration of the opioid is more quickly achieved. These sustained release opioid formulations include an effective amount of at least one retardant material to cause said opioid analgesic to be released at a such a rate as to provide an analgesic effect after oral administration to a human patient for at least about 24 hours, and are characterized by providing an absorption half-life from 1 to about 8 hours. A method of titrating a human patient utilizing these sustained release opioid formulations is also disclosed.
Inventors
- 👤 Richard S. Sackler
- 👤 Robert F. Kaiko
- 👤 Paul Goldenheim
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 18:49
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/13; A61K31/135; A61K31/137; A61K9/00; A61K9/14; A61K9/48; A61K9/50; A61K9/5073; A61K9/5078; A61K31/33; A61K31/395; A61K31/435; A61K31/47; A61K31/485; A61K9/16; A61K9/20; A61K9/2072; A61K9/2077; A61K9/2081; A61K9/4808; A61K9/5005; A61K9/5021; A61K9/5026; A61P; A61P25/00; A61P25/04; A61P29/00
Claims Analysis
Total Claims: 18
Claim 1
Independent Claim
104 words
A method of effectively treating pain in humans, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which upon administration provides a time to maximum plasma concentration (T max ) of said opioid in about 2 to about 10 hours and a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which dosage form provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 2
Independent Claim
104 words
A method of effectively treating pain in humans, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which upon administration provides a time to maximum plasma concentration (T max ) of said opioid in about 2 to about 10 hours and a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which dosage form provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 3
Dependent Claim
24 words
The method of claim 1, wherein the T max occurs in about 2 to about 8 hours after oral administration of said dosage form.
Claim 4
Dependent Claim
24 words
The method of claim 1, wherein the T max occurs in about 6 to about 8 hours after oral administration of said dosage form.
Claim 5
Dependent Claim
12 words
The method of claim 1, wherein said opioid analgesic is morphine sulfate.
Claim 6
Dependent Claim
19 words
The method of claim 1, wherein said dosage form contains from about 5 mg to about 800 mg morphine.
Claim 7
Independent Claim
82 words
A method of effectively treating pain in a human patient, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which provides a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 8
Independent Claim
82 words
A method of effectively treating pain in a human patient, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which provides a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 9
Dependent Claim
12 words
The method of claim 6, wherein said opioid analgesic is morphine sulfate.
Claim 10
Dependent Claim
19 words
The method of claim 6, wherein said dosage form contains from about 5 mg to about 800 mg morphine.
Claim 11
Independent Claim
104 words
A method of effectively treating pain in humans, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which at steady-state provides a time to maximum plasma concentration (T max ) of said opioid in about 2 to about 10 hours and a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which dosage form provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 12
Independent Claim
104 words
A method of effectively treating pain in humans, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which at steady-state provides a time to maximum plasma concentration (T max ) of said opioid in about 2 to about 10 hours and a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which dosage form provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 13
Dependent Claim
24 words
The method of claim 9, wherein the T max occurs from about 6 to about 8 hours after oral administration of said dosage form.
Claim 14
Dependent Claim
12 words
The method of claim 9, wherein said opioid analgesic is morphine sulfate.
Claim 15
Independent Claim
82 words
A method of effectively treating pain in a human patient,comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage containing an opioid analgesic or salt thereof which at steady-state provides a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 16
Independent Claim
82 words
A method of effectively treating pain in a human patient,comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage containing an opioid analgesic or salt thereof which at steady-state provides a maximum plasma concentration (C max ) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which provides effective treatment of pain for about 24 hours or more after administration to the patient.
Claim 17
Dependent Claim
12 words
The method of claim 12, wherein said opioid analgesic is morphine sulfate.
Claim 18
Dependent Claim
19 words
The method of claim 12, wherein said dosage form contains from about 5 mg to about 800 mg morphine.
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| 3.5 Years (Year 4) | 2000-09-29 | 2001-03-31 | 2001-09-30 | $2000.00 | Window Closed / Lapsed |
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