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US4844907A
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Pharmaceutical composition comprising analgesic and anti-inflammatory agent
Assignee: Euro Celtique SA
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Filing: 1986-08-14
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Granted: 1989-07-04
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Expires: 2006-08-14
Abstract
Abstract A pharmaceutical composition in the form of a multiphase (especially a bilayered, optionally coated) tablet. The tablet has a narcotic analgesic phase containing a therapeutically effective quantity of a narcotic analgesic or an analgesically effective salt thereof (e.g. codeine phosphate) and a non-steroidal anti-inflammatory phase containing a therapeutically effective quantity of a non-steroidal anti-inflammatory carboxylic acid or an anti-inflammatory salt or ester thereof (e.g. ibuprofen). The narcotic analgesic phase is free from a non-steroidal anti-inflammatory carboxylic acid or salt or ester thereof, stearic acid and stearate salt, and the non-steroidal anti-inflammatory phase is free from a narcotic analgesic or salt thereof, stearic acid and a stearate salt. Further, both the narcotic analgesic phase and the non-steroidal anti-inflammatory phase contain a self-lubricating, compression aid, especially a self-lubricating, direct compression aid, such as microcrystalline cellulose.
Inventors
- 👤 Gordon A. Elger
- 👤 Stewart T. Leslie
- 👤 Sandra T. A. Malkowska
- 👤 Ronald B. Miller
- 👤 Philip J. Neale
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 19:40
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/185; A61K31/19; A61K31/33; A61K31/395; A61K31/435; A61K31/47; A61K31/485; A61K9/00; A61K9/20; A61K9/2072; A61K9/2086; A61K9/209; A61P; A61P25/00; A61P25/04
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
133 words
A pharmaceutical composition in the form of a multiphase tablet comprising at least one narcotic analgesic phase containing a therapeutically effective quantity of a narcotic analgesic or an analgesically effective salt thereof and at least one non-steroidal anti-inflammatory phase containing a therapeutically effective quantity of a non-steroidal anti-inflammatory carboxylic acid or an anti-inflammatory salt or ester thereof wherein the at least one narcotic analgesic phase is free from a non-steroidal anti-inflammatory carboxylic acid or salt or ester thereof, stearic acid and a stearate salt, and the at least one non-steroidal anti-inflammatory phase is free from a narcotic analgesic or salt thereof, stearic acid and a stearate salt, and further wherein both the at least one narcotic analgesic phase and the at least one non-steroidal anti-inflammatory phase contain at least one self-lubricating, compression aid.
Claim 2
Dependent Claim
133 words
A pharmaceutical composition in the form of a multiphase tablet comprising at least one narcotic analgesic phase containing a therapeutically effective quantity of a narcotic analgesic or an analgesically effective salt thereof and at least one non-steroidal anti-inflammatory phase containing a therapeutically effective quantity of a non-steroidal anti-inflammatory carboxylic acid or an anti-inflammatory salt or ester thereof wherein the at least one narcotic analgesic phase is free from a non-steroidal anti-inflammatory carboxylic acid or salt or ester thereof, stearic acid and a stearate salt, and the at least one non-steroidal anti-inflammatory phase is free from a narcotic analgesic or salt thereof, stearic acid and a stearate salt, and further wherein both the at least one narcotic analgesic phase and the at least one non-steroidal anti-inflammatory phase contain at least one self-lubricating, compression aid.
Claim 3
Dependent Claim
26 words
A composition according to claim 1 wherein the narcotic analgesic comprises a morphinan-6-ol or a morphinan-6-one derivative, selected from morphine, ethylmorphine, hydromorphone, hydrocodone, dihydrocodeine and codeine.
Claim 4
Dependent Claim
18 words
A composition according to claim 1 wherein the analgesically effective salt of the narcotic analgesic comprises codeine phosphate.
Claim 5
Dependent Claim
39 words
A composition according to claim 1 wherein the non-steroidal anti-inflammatory carboxylic acid comprises at least one of naproxen, a benzeneacetic acid, selected from alclofenac, diclofenac and fenclofenac, and a 2-phenylpropionic acid, selected from fenoprofen, flurbiprofen, indoprofen, ketoprofen and ibuprofen.
Claim 6
Dependent Claim
14 words
A composition according to claim 4 wherein the non-steroidal anti-inflammatory carboxylic acid comprises ibuprofen.
Claim 7
Dependent Claim
35 words
A composition according to claim 1 wherein the at least one self lubricating, compression aid comprises at least one self lubricating, direct compression aid, selected from microcrystalline cellulose and a free flowing, directly compressible starch.
Claim 8
Dependent Claim
28 words
A composition according to claim 1 wherein the concentration of the compression aid in the at least one non-steroidal anti-inflammatory phase is between 10% and 90% (by wt).
Claim 9
Dependent Claim
16 words
A composition according to claim 7 wherein the concentration is between 15% and 40% (by wt).
Claim 10
Dependent Claim
28 words
A composition according to claim 1 wherein the concentration of the compression aid in the at least one narcotic analgesic phase is between 50% and 99% (by wt).
Claim 11
Dependent Claim
16 words
A composition according to claim 9 wherein the concentration is between 70% and 95% (by wt).
Claim 12
Dependent Claim
13 words
A composition according to claim 1 in the form of a layered tablet.
Claim 13
Dependent Claim
13 words
A composition according to claim 11 in the form of a bilayered tablet.
Claim 14
Dependent Claim
83 words
A wet granulation process for the preparation of a pharmaceutical composition according to claim 1 comprising (a) granulating a narcotic analgesic or an analgesically effective salt thereof with at least one self-lubricating, compression aid to form narcotic analgesic granules, (b) granulating a non-steroidal anti-inflammatory carboxylic acid or an anti-inflammatory salt or ester thereof with at least one self lubricating, compression aid to form non-steroidal anti-inflammatory granules, and (c) compressing the narcotic analgesic granules and the non-steroidal anti-inflammatory granules to form a multiphase tablet.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-07-03 | 1993-01-02 | 1993-07-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-07-03 | 1997-01-02 | 1997-07-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-07-03 | 2001-01-02 | 2001-07-04 | $7700.00 | Window Closed / Lapsed |