Compositions of non-steroidal anti-inflammatory drugs decongestants and anti-histamines

Abstract

The present invention is directed to a pharmaceutical composition and a method for the treatment of rhinitis and cold-like symptoms which includes a non-steroidal anti-inflammatory drug (NSAID), a decongestant, and an antihistamine. It has been found that the NSAID enhances the activity of a decongestant and an anti-histamine, thus permitting a reduction in either or both in administration of separate dosage forms. The same enhancement can also occur with an anti-tussitive. Thus, the effective amount of the decongestant or the antihistamine or both is less than about 75 % of an amount presentin an approved dose of the decongestant or the antihistamine, or both, relative to an amount of the NSAID corresponding to about 100% of the amount present in a normal strength dosage form of the NSAID.

Description

[0001] This application is a divisional application of the Chinese patent application 200380106488.6 with the filing date of December 18, 2003 and the title of the invention being "composition of non-steroidal anti-inflammatory drugs, decongestants and antihistamines".

[0002] This application claims priority to US Provisional Application No. 60 / 434,342, filed December 18, 2002, which is hereby incorporated by reference in its entirety. field of invention

[0003] The present invention relates to improved dosage forms of medicaments for the treatment of rhinitis associated with allergies and colds Background of the invention

[0004] Decongestants and antihistamines

[0005] Rhinitis is an inflammatory disease of the nasal passages. Symptoms of rhinitis usually include sneezing, runny nose, nasal congestion, and increased nasal discharge. Untreated rhinitis can lead to other conditions, including infections of the sinuses, ears, and lower respiratory tract.

[0006] Two...

Examples

Embodiment 1

[0065] The dosage form of the pharmaceutical composition of the present invention is made of the following active ingredients in the following doses and dosages.

[0066] Table 1

[0067] NSAIDs

Embodiment 2

[0069] A study was conducted to evaluate and compare the analgesic / decongestant / anti-inflammatory effects of ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate in small capsule compositions with the combination of pseudoephedrine and chlorpheniramine in tablets. Potency of histamine. The study was a multicenter, outpatient, multiple-dose, placebo-controlled, double-blind, double-dummy, parallel group, randomized trial.

[0070] Patient Selection The study involved 1070 appropriately selected patients, aged at least 12 years, both male and female. Study participants were required to have: (1) A history of at least two years of seasonal allergic rhinitis (including one or more of the following symptoms: runny nose, itchy / fluid / red eyes, nasal congestion, sneezing, nasal / throat / palate itching, allergy-related headache and facial pain / pressure / discomfort) and (2) history of at least moderate headache, and / or facial pain / pressure / discomfort Exacerbated during ...

[0001] This application is a divisional application of the Chinese patent application 200380106488.6 with the filing date of December 18, 2003 and the title of the invention being "composition of non-steroidal anti-inflammatory drugs, decongestants and antihistamines".

[0002] This application claims priority to US Provisional Application No. 60 / 434,342, filed December 18, 2002, which is hereby incorporated by reference in its entirety. field of invention

[0003] The present invention relates to improved dosage forms of medicaments for the treatment of rhinitis associated with allergies and colds Background of the invention

[0004] Decongestants and antihistamines

[0005] Rhinitis is an inflammatory disease of the nasal passages. Symptoms of rhinitis usually include sneezing, runny nose, nasal congestion, and increased nasal discharge. Untreated rhinitis can lead to other conditions, including infections of the sinuses, ears, and lower respiratory tract.

[0006] Two...

Examples

Embodiment 1

[0065] The dosage form of the pharmaceutical composition of the present invention is made of the following active ingredients in the following doses and dosages.

[0066] Table 1

[0067] NSAIDs

Embodiment 2

[0069] A study was conducted to evaluate and compare the analgesic / decongestant / anti-inflammatory effects of ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate in small capsule compositions with the combination of pseudoephedrine and chlorpheniramine in tablets. Potency of histamine. The study was a multicenter, outpatient, multiple-dose, placebo-controlled, double-blind, double-dummy, parallel group, randomized trial.

[0070] Patient Selection The study involved 1070 appropriately selected patients, aged at least 12 years, both male and female. Study participants were required to have: (1) A history of at least two years of seasonal allergic rhinitis (including one or more of the following symptoms: runny nose, itchy / fluid / red eyes, nasal congestion, sneezing, nasal / throat / palate itching, allergy-related headache and facial pain / pressure / discomfort) and (2) history of at least moderate headache, and / or facial pain / pressure / discomfort Exacerbated during ...