US4601894A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Controlled release dosage form comprising acetaminophen, pseudoephedrine sulfate and dexbrompheniramine maleate
Assignee: Merck Sharp & Dohme LLC
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Filing: 1985-03-29
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Granted: 1986-07-22
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Expires: 2005-03-29
Abstract
Abstract The invention relates to a controlled release dosage form comprising three actives: acetaminophen, psueudoephedrine sulfate and dexbrompheniramine maleate.
Inventors
- 👤 Gayda Hanna
- 👤 Winston A. Vadino
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 15:50
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2054; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/44; A61K9/2009
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
67 words
An oral dosage form comprising an analgesic-effective amount of acetaminophen, an amount of pseudoephedrine or a pharmaceutically acceptable salt thereof effective in reducing nasal congestion, and an antihistaminic-effective amount of dexbrompheniramine or a pharmaceutically acceptable salt thereof in a uniform matrix comprising a controlled release carrier comprised of a polymer selected from hydroxypropyl methylcellulose ethers or a combination of polymers selected from hydroxypropyl methylcellulose ethers and ethylcellulose.
Claim 2
Dependent Claim
67 words
An oral dosage form comprising an analgesic-effective amount of acetaminophen, an amount of pseudoephedrine or a pharmaceutically acceptable salt thereof effective in reducing nasal congestion, and an antihistaminic-effective amount of dexbrompheniramine or a pharmaceutically acceptable salt thereof in a uniform matrix comprising a controlled release carrier comprised of a polymer selected from hydroxypropyl methylcellulose ethers or a combination of polymers selected from hydroxypropyl methylcellulose ethers and ethylcellulose.
Claim 3
Dependent Claim
28 words
A dosage form of claim 1 comprising 400 to 750 mg of acetaminophen, 15 to 75 mg of pseudoephedrine sulfate, and 1 to 5 mg of dexbrompheniramine maleate.
Claim 4
Dependent Claim
19 words
A dosage form of claim 2 comprising 500 mg acetaminophen, 60 mg pseudoephedrine sulfate and 3 mg dexbrompheniramine maleate.
Claim 5
Dependent Claim
61 words
A dosage form of claim 1 wherein the carrier comprises a polymer, wherein the polymer is comprised of 100-60% hydroxypropyl methylcellulose ethers and 0-40% ethylcellulose, one or more lubricants selected from stearic acid, magnesium stearate, calcium stearate, waxes, polyethylene glycol and magnesium lauryl sulfate, and one or more fillers selected from the group consisting of dibasic calcium phosphate dihydrate and lactose.
Claim 6
Dependent Claim
44 words
A dosage form of claim 4 wherein the total polymer weight represents 1-8% of the total dosage form weight, the total binder weight represents 11-13% of the total dosage form weight, and the total lubricant weight represents 1-3% of the total dosage form weight.
Claim 7
Dependent Claim
13 words
A dosage form of claim 5 wherein the polymer is 100% hydroxypropyl methylcellulose.
Claim 8
Dependent Claim
15 words
A dosage form of claim 5 wherein the polymer is 100% hydroxypropyl methylcellulose USP 2208.
Claim 9
Dependent Claim
14 words
A dosage form of claim 5 wherein the filler is dibasic calcium phosphate dihydrate.
Claim 10
Dependent Claim
15 words
A dosage form of claim 5 wherein the lubricants are stearic acid and magnesium stearate.
Claim 11
Dependent Claim
26 words
A dosage form of claim 5 comprising 1-8% hydroxypropyl methylcellulose, 10-13% dibasic calcium phosphate dihydrate and 1-3% of a combination of stearic acid and magnesium stearate.
Claim 12
Dependent Claim
12 words
A dosage form of claim 10 comprising 1-8% hydroxypropyl methylcellulose USP 2208.
Claim 13
Dependent Claim
25 words
A dosage form of claim 11 comprising 400 to 750 mg acetaminophen, 15 to 75 mg pseudoephedrine sulfate and 1 to 5 mg dexbrompheniramine maleate.
Claim 14
Dependent Claim
40 words
A dosage form comprising 500 mg acetaminophen, 60 mg pseudoephedrine sulfate, 3 mg dexbrompheniramine maleate, 48 mg hydroxypropyl methylcellulose USP 2208, 95 mg dibasic calcium phosphate dihydrate, 10 mg stearic acid and 4 mg magnesium stearate in a uniform matrix.
Claim 15
Dependent Claim
40 words
A dosage form comprising 500 mg acetaminophen, 60 mg pseudoephedrine sulfate, 3 mg dexbrompheniramine maleate, 48 mg hydroxypropyl methylcellulose USP 2208, 95 mg dibasic calcium phosphate dihydrate, 10 mg stearic acid and 4 mg magnesium stearate in a uniform matrix.
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1989-07-21 | 1990-01-20 | 1990-07-22 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1993-07-21 | 1994-01-20 | 1994-07-22 | $3760.00 | Window Closed / Lapsed |
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