US5520931A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Controlled release morphine preparation
Assignee: Gacell Laboratories AB
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Filing: 1995-01-04
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Granted: 1996-05-28
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Expires: 2015-01-04
Abstract
Abstract The present invention concerns an oral morphine preparation having essentially complete bioavailability and, for the major part of the dissolution, an essentially zero order and essentially pH independent release of morphine for a period of at least 8 hours, preferably at least 12 hours, during which a period less than 100% is dissolved. In the preparation, the morphine, in the form of an easily soluble salt, is present in a combination with a buffering agent in a preparation coated with a diffusion membrane.
Inventors
- 👤 Christiane Persson
- 👤 Staffan Waxegard
- 👤 Soren Kulstad
- 👤 Lennart Frigren
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 19:58
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/47; A61K31/485; A61K9/14; A61K9/16; A61K9/2004; A61K9/2013; A61K9/28; A61K9/2806; A61K9/282; A61K9/2826; A61K9/2833; A61K9/284; A61P; A61P25/00; A61P25/04
Claims Analysis
Total Claims: 28
Claim 1
Independent Claim
123 words
Oral morphine preparation, characterized by essentially complete bioavailability and an, for the major part of the dissolution, essentially zero order and essentially pH independent in vitro release of morphine for a period of at least 8 hours during which period less than 100%, and more than 50% of the total amount of morphine is dissolved, whereby the morphine is present in the form of an easily soluble salt in combination with a buffering agent, whereby the preparation is coated with a diffusion membrane comprising a polymer which is essentially insoluble in water and gastro-intestinal fluids, in which polymer a water soluble pore-creating agent is randomly dispersed, which preparation, in steady state, provides effective plasma levels for a period of at least 24 hours.
Claim 2
Dependent Claim
123 words
Oral morphine preparation, characterized by essentially complete bioavailability and an, for the major part of the dissolution, essentially zero order and essentially pH independent in vitro release of morphine for a period of at least 8 hours during which period less than 100%, and more than 50% of the total amount of morphine is dissolved, whereby the morphine is present in the form of an easily soluble salt in combination with a buffering agent, whereby the preparation is coated with a diffusion membrane comprising a polymer which is essentially insoluble in water and gastro-intestinal fluids, in which polymer a water soluble pore-creating agent is randomly dispersed, which preparation, in steady state, provides effective plasma levels for a period of at least 24 hours.
Claim 3
Dependent Claim
21 words
Preparation according to claim 1, characterized by an in vitro release of morphine after 8 hours in the range of 30-85%.
Claim 4
Dependent Claim
21 words
Preparation according to claim 1, characterized in an in vitro release of morphine after 12 hours in the range of 50-100%.
Claim 5
Dependent Claim
27 words
Preparation according to claim 1, characterized in that it is formulated as a tablet, wherein the morphine and the buffering agent are included in the tablet core.
Claim 6
Dependent Claim
27 words
Preparation according to claim 1, characterized in that the morphine salt is morphine sulphate or morphine chloride or any other water soluble salt acceptable for pharmaceutical use.
Claim 7
Dependent Claim
27 words
Preparation according to claim 1, characterized in that the buffering agent is succinic acid, tartaric acid, citric acid or any other organic acid acceptable for pharmaceutical use.
Claim 8
Dependent Claim
16 words
Preparation according to claim 1, characterized in that it is formulated as a multiple unit preparation.
Claim 9
Dependent Claim
11 words
Preparation according to claim 1 for administration with 24 hours intervals.
Claim 10
Dependent Claim
21 words
Preparation according to claim 2, characterized in an in vitro release of morphine after 12 hours in the range of 50-100%.
Claim 11
Dependent Claim
27 words
Preparation according to claim 2, characterized in that it is formulated as a tablet, wherein the morphine and the buffering agent are included in the tablet core.
Claim 12
Dependent Claim
27 words
Preparation according to claim 3, characterized in that it is formulated as a tablet, wherein the morphine and the buffering agent are included in the tablet core.
Claim 13
Dependent Claim
27 words
Preparation according to claim 9, characterized in that it is formulated as a tablet, wherein the morphine and the buffering agent are included in the tablet core.
Claim 14
Dependent Claim
27 words
Preparation according to claim 2, characterized in that the morphine salt is morphine sulphate or morphine chloride or any other water soluble salt acceptable for pharmaceutical use.
Claim 15
Dependent Claim
27 words
Preparation according to claim 3, characterized in that the morphine salt is morphine sulphate or morphine chloride or any other water soluble salt acceptable for pharmaceutical use.
Claim 16
Dependent Claim
27 words
Preparation according to claim 4, characterized in that the morphine salt is morphine sulphate or morphine chloride or any other water soluble salt acceptable for pharmaceutical use.
Claim 17
Dependent Claim
27 words
Preparation according to claim 2, characterized in that the buffering agent is succinic acid, tartaric acid, citric acid or any other organic acid acceptable for pharmaceutical use.
Claim 18
Dependent Claim
27 words
Preparation according to claim 3, characterized in that the buffering agent is succinic acid, tartaric acid, citric acid or any other organic acid acceptable for pharmaceutical use.
Claim 19
Dependent Claim
27 words
Preparation according to claim 4, characterized in that the buffering agent is succinic acid, tartaric acid, citric acid or any other organic acid acceptable for pharmaceutical use.
Claim 20
Dependent Claim
27 words
Preparation according to claim 5, characterized in that the buffering agent is succinic acid, tartaric acid, citric acid or any other organic acid acceptable for pharmaceutical use.
Claim 21
Dependent Claim
16 words
Preparation according to claim 5, characterized in that it is formulated as a multiple unit preparation.
Claim 22
Dependent Claim
28 words
Preparation according to claim 1 wherein said in vitro release of morphine for a period of at least 12 hours is less than 100% and more than 50%.
Claim 23
Dependent Claim
28 words
Preparation according to claim 1 wherein said in vitro release of morphine for a period of at least 12 hours is less than 100% and more than 60%.
Claim 24
Dependent Claim
21 words
Preparation according to claim 1 wherein said in vitro release of morphine after 8 hours is in the range of 40-80.
Claim 25
Dependent Claim
21 words
Preparation according to claim 1, wherein said in vitro release of morphine after 12 hours is in the range of 60-100%.
Claim 26
Dependent Claim
21 words
Preparation according to claim 1, wherein said in vitro release of morphine after 12 hours is in the range of 80-100%.
Claim 27
Dependent Claim
21 words
Preparation according to claim 2, wherein said in vitro release of morphine after 12 hours is in the range of 60-100%.
Claim 28
Dependent Claim
21 words
Preparation according to claim 2 wherein said in vitro release of morphine after 12 hours is in the range of 80-100%.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-05-28 | 1999-11-27 | 2000-05-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-05-28 | 2003-11-27 | 2004-05-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-05-28 | 2007-11-27 | 2008-05-28 | $7700.00 | Window Closed / Lapsed |