Novel pharmaceutical composition and its use in a method for treatment of patients with upper respiratory mucosal congestion

a technology of upper respiratory mucosal congestion and composition, which is applied in the field of new pharmaceutical composition, can solve the problems of reducing the effect of end-of-dose dose, adverse effects, and higher incidence of adverse drug reactions of cetirizin

Inactive Publication Date: 2009-08-13
AFT PHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in comparison to loratadine, cetirizine has been reported to have a higher incidence of adverse drug reactions (ADRs), especially central nervous system ADRs.
However, there are adverse effects that can occur at peak concentration and also with end-of-dose diminution of effect.
However, products containing pseudoephedrine are now subject to abuse problems associated with illicit drug use in the community.
This has resulted in pharmacy hold-ups, stolen stock from warehouses and significant related crime.
The resulting crime, and its effects on the outlets which supply these medications to the market, means that some outlets are choosing not to stock these products, or at least restrict their availability.
This makes them less accessible to those with a genuine need for the medications.

Method used

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Examples

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Effect test

example

[0055]The components shown in Table 3 are combined into a single tablet and taken by either adults or children aged 12 years or older. The tablet may be taken up to 4 times a day giving a maximum dose of 10 mg of loratadine and 40 mg of phenylephrine per day.

TABLE 3Combination Composition FormulationQty. perReference toName of IngredienttabletFunctionspecificationsActive ingredient:Phenylephrine10.00mgActive ingredientPh. Eur.HydrochlorideLoratadine2.50mgActive ingredientIHSOther Ingredients:Lactose180.40mgDiluentPh. Eur.Maize starch140.00mgDiluent, binderPh. Eur.Pregelatinised starch10.365mgBinderPh. Eur.Lake of quinoline0.20mgColourantIHSyellowSodium metabisulphite0.40mgAntioxidantPh. Eur.Disodium EDTA0.14mgChelating agentPh. Eur.Talc3.00mgGlidantPh. Eur.Magnesium stearate3.00mgLubricantPh. Eur.

[0056]The formulation administered 4 times daily provides effective 24 hour treatment of the symptoms of upper respiratory mucosal congestion with reduced adverse effects and without using ...

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Abstract

The present invention relates to a pharmaceutical composition including loratadine or a pharmaceutically acceptable form thereof, and phenylephrine or a pharmaceutically acceptable form thereof, for treating upper respiratory / mucosal congestion, optionally by administering to a patient four times a day.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a divisional of U.S. Ser. No. 11 / 922,271 filed on 20 Dec. 2007 which is a national phase application from PCT / NZ2005 / 000132, with an international filing date and earliest priority date of 17 Jun. 2005.INTRODUCTION[0002]The present invention relates to a pharmaceutical composition including loratadine, its use in the treatment of upper respiratory mucosal congestion and a method of administration of the composition. Particularly, though not exclusively, the invention relates to a pharmaceutical composition including loratadine in an amount suitable for administration a maximum of 4 times a day, and a second active that is phenylephrine, or a salt thereof.BACKGROUND[0003]Upper respiratory mucosal congestion caused by infections such as the common cold and influenza, or allergic rhinitis, can lead to a number of nasal and ocular symptoms. These include rhinitis and sinusitis, nasal and sinus congestion or excessive secre...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/4545
CPCA61K31/137A61K31/4545A61K2300/00A61P11/02
Inventor ATKINSON, HARTLEY CAMPBELL
Owner AFT PHARM LTD
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