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Multi-layer tablet comprising non-steroidal anti-inflammatory drugs, decongestants and non-sedating antihist amines

A non-steroidal anti-inflammatory drug, multi-layer tablet technology, applied in the direction of anti-inflammatory agents, drug combinations, medical preparations containing active ingredients, etc., can solve the problem of decongestants and antihistamines that cannot alleviate the side effects of decongestants and antihistamines in sensitive individuals , can not provide a wide range of sleepless effects and other problems

Inactive Publication Date: 2007-10-31
WYETH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0022] [013] While these combination products provide effective symptomatic treatment of rhinitis caused by colds and allergies, they do not alleviate the side effects of decongestants and antihistamines in sensitive individuals
Furthermore, these combination products do not provide broad-spectrum sleepless relief when used to treat allergy and / or cold-associated rhinitis symptoms

Method used

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  • Multi-layer tablet comprising non-steroidal anti-inflammatory drugs, decongestants and non-sedating antihist amines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] [070] A bi-layer tablet is formulated for oral administration twice daily comprising an immediate release layer containing 5 mg loratadine and 220 mg naproxen sodium with suitable excipients, and an extended release layer containing 120 mg pseudoephedrine hydrochloride with appropriate excipients .

[0092] [071] The immediate release layer comprises loratadine and naproxen sodium, and is combined with various acceptable pharmaceutical excipients using wet granulation method. Additional excipients are used for extragranular mixing prior to compression. More specifically, the formulation of this example contained five intragranular ingredients: naproxen sodium, loratadine, povidone, talc, and croscarmellose sodium, which were mixed to form an immediate release wet pellets. Extragranular excipients are then blended into the immediate release granules prior to tablet compression. Extragranular excipients include glyceryl behenate, silicon dioxide, croscarmellose sodium,...

Embodiment 2

[0098] [074] The dosage forms of the pharmaceutical compositions of some embodiments of the invention are made up of the active ingredients in the dosages listed below.

[0099] NSAIDs

Embodiment 3

[0101] [075] Analgesic / decongestant / antihistamine capsule compositions containing effective amounts of ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate were evaluated and compared with pseudoephedrine and chlorpheniramine maleate in a study conducted The potency of the tablet combination of Namin. The study was a multi-center, outpatient, multiple-dose, placebo-controlled, double-blind, double-dummy, parallel-group, randomized trial.

[0102] [076] Patient Selection. The study involved 1070 appropriately selected patients aged at least 12 years, both male and female. Participants are required to have: (1) at least two years of history of seasonal allergic rhinitis (which includes one or more of the following symptoms: runny nose, itchy / fluid / red eyes, nasal congestion, sneezing, nasal / itchy throat / palate, allergy-related headache and facial pain / pressure / discomfort) and (2) experienced a history of at least moderate headache, and / or facial pain / pressure...

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Abstract

The present invention is directed to a pharmaceutical composition and method for treatment of rhinitis and cold like symptoms, the composition includes a non-steroidal anti-inflammatory drug (NSAID), a decongestant and an antihistamine preferably in a multi-layer tablet comprising an immediate release layer and an extended release layer to optimize the delivery profile and match the duration of biological action of the multiple active agents.

Description

[0001] Cross References to Related Applications [0002] [001] This application claims priority to U.S. Application 10 / 859,256, filed June 2, 2004, entitled "Compositions of Non-Steroidal Anti-Inflammatory Drugs, Decongestants, and Antihistamines," which is hereby incorporated The entire content is for reference only. [0003] [002] This application also claims priority to U.S. Patent Application 10 / 740,386, a continuation-in-part, filed on December 17, 2003, which claims the benefit of U.S. Provisional Application 60 / 434,342, filed on December 18, 2002, at Both are incorporated herein by reference. technical field [0004] [003] The present invention relates to improved dosage forms of medicines for the treatment of allergy and cold-related rhinitis. Background technique [0005] Decongestants and antihistamines [0006] [004] Rhinitis refers to an inflammatory disorder of the nasal passages. Symptoms of rhinitis usually include sneezing, runny nose, nasal congestion, a...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/22A61K9/28A61K9/24A61K31/137A61K31/192A61K31/495A61K31/55
CPCA61K31/495A61K31/192A61K9/209A61K31/55A61P11/02A61P29/00A61P37/08A61P43/00A61P9/00
Inventor R·伯林P·拉姆西A·乌萨亚潘特J·福巴拉S·波克松W·布布尼斯D·加马尔瓦J·斯特罗德J·巴彻特M·威廉斯
Owner WYETH LLC
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