US5326570A
Expired / Lapsed
US
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Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine
Assignee: Supernus Pharmaceuticals Inc
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Filing: 1991-07-23
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Granted: 1994-07-05
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Expires: 2011-07-23
Abstract
Abstract The present invention relates to a composition and method of treating a patient by administering carbamazepine in a pharmaceutical dosage form capable of maintaining the patient's blood concentration at from about 4 μg/ml to about 12 μg/ml over at least a 12 hour period, where the blood concentration of carbamazepine does not vary by more than 60 percent.
Inventors
- 👤 Edward M. Rudnic
- 👤 George W. Belendiuk
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 03:34
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K9/50; A61K9/5084; A61K31/00; A61K31/33; A61K31/395; A61K31/55
Claims Analysis
Total Claims: 27
Claim 1
Independent Claim
48 words
A drug delivery system for the oral administration of carbamazepine, comprising: (a) a sustained release unit containing carbamazepine; (b) an immediate release unit containing carbamazepine; and (c) an enteric release unit containing carbamazepine, said combination of components (a), (b), and (c) containing a therapeutically effective amount of carbamazepine.
Claim 2
Dependent Claim
48 words
A drug delivery system for the oral administration of carbamazepine, comprising: (a) a sustained release unit containing carbamazepine; (b) an immediate release unit containing carbamazepine; and (c) an enteric release unit containing carbamazepine, said combination of components (a), (b), and (c) containing a therapeutically effective amount of carbamazepine.
Claim 3
Dependent Claim
19 words
A method for treating a patient with carbamazepine, comprising: orally administering to the patient the system of claim 1.
Claim 4
Dependent Claim
17 words
The system of claim 1 wherein said components (a), (b) and (c) are present in a tablet.
Claim 5
Dependent Claim
17 words
The system of claim 1 wherein said components (a), (b) and (c) are present in a capsule.
Claim 6
Dependent Claim
19 words
The system of claim 1 wherein said components (a), (b) and (c) are present in a single dosage form.
Claim 7
Dependent Claim
25 words
The system of claim 1 wherein said components (a), (b), and (c) are in a pellet form and are present in a single dosage form.
Claim 8
Dependent Claim
13 words
The system of claim 6 wherein the single dosage form is a capsule.
Claim 9
Dependent Claim
18 words
The system of claim 1 wherein said system provides a therapeutically effective amount over a 12 hour period.
Claim 10
Dependent Claim
27 words
The system of claim 1 wherein said system comprising components (a), (b) and (c) contains carbamazepine in an amount from about 400 mg to about 600 mg.
Claim 11
Dependent Claim
27 words
The system of claim 1 wherein the system provides blood dosage levels of carbamazepine which do not vary by more than 60% over a 12 hour period.
Claim 12
Dependent Claim
21 words
The system of claim 10 wherein the blood dosage levels do not vary by more than 20% over a 12 period.
Claim 13
Dependent Claim
14 words
A system as in claim 1, wherein each of the units includes a surfactant.
Claim 14
Dependent Claim
29 words
A system as in claim 12, wherein the sustained release unit and the enteric release unit each contain an organic acid to maintain an acidic environment in the units.
Claim 15
Dependent Claim
13 words
A system as in claim 12, wherein said surfactant is sodium lauryl sulfate.
Claim 16
Dependent Claim
59 words
A system as in claim 1, wherein said sustained release unit is present in an amount ranging from about 5.0% to about 25.0% (w/w), said immediate release unit is present in an amount ranging from about 15.0% to about 70.0% (w/w) and said enteric release unit is present in an amount ranging from about 10.0% to about 50.0% (w/w).
Claim 17
Dependent Claim
50 words
A system as in claim 15, wherein said sustained release unit is coated with a coating material in an amount ranging from about 1.0% to about 25% (w/w) and said enteric release unit is coated with a coating material in an amount ranging from about 1.0% to about 15.0% (w/w).
Claim 18
Dependent Claim
29 words
A system as in claim 1, wherein the carbamazepine in said sustained release unit is released from said unit over a period from about 6 to about 10 hours.
Claim 19
Independent Claim
52 words
A method of treating a patient with carbamazepine comprising: orally administering to said patient a composition which contains, (a) an immediate release unit containing carbamazepine; (b) a sustained release unit containing carbamazepine; (c) an enteric release unit containing carbamazepine; said components (a), (b), and (c) containing a therapeutically effective amount of carbamazepine.
Claim 20
Independent Claim
52 words
A method of treating a patient with carbamazepine comprising: orally administering to said patient a composition which contains, (a) an immediate release unit containing carbamazepine; (b) a sustained release unit containing carbamazepine; (c) an enteric release unit containing carbamazepine; said components (a), (b), and (c) containing a therapeutically effective amount of carbamazepine.
Claim 21
Dependent Claim
46 words
A method as in claim 18, wherein said components (a), (b), (c) being administered in a combined amount to maintain a blood dosage level of carbamazepine within a range of from about 4 μg/ml to about 12 μg/ml for a period of at least 12 hours.
Claim 22
Dependent Claim
26 words
A method as in claim 18, wherein the components being administered contain a combined amount of carbamazepine of from about 400 mg to about 600 mg.
Claim 23
Dependent Claim
25 words
A method as in claim 19, wherein the blood dosage level of carbamazepine does not vary by more that 60 percent per 12 hour period.
Claim 24
Dependent Claim
28 words
A method as in claim 20, wherein the blood dosage level of carbamazepine within said range does not vary by more than 20 percent per 12 hour period.
Claim 25
Dependent Claim
14 words
A method as in claim 18, wherein each of the units includes a surfactant.
Claim 26
Dependent Claim
13 words
A method as in claim 22, wherein said surfactant is sodium lauryl sulfate.
Claim 27
Dependent Claim
29 words
A method as in claim 23, wherein said sustained release unit and said enteric release unit each contain an organic acid to maintain an acidic environment in the units.
References Cited (Backward Citations)
US4606909A
Cited
US4794001A
Cited
US4801460A
Cited
US4857336A
Cited
US5009894A
Cited
US4980170A
Cited
US4942182A
Cited
US5023272A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-07-04 | 1998-01-03 | 1998-07-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-07-04 | 2002-01-03 | 2002-07-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-07-04 | 2006-01-03 | 2006-07-05 | $7700.00 | Window Closed / Lapsed |