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Pharmaceutical composition of ibuprofen and paracetamol and methods of using the same

a technology of ibuprofen and paracetamol, which is applied in the field of combination compositions for pain treatment, can solve the problems of reducing the efficacy of pain relief, still associated with side effects in some individuals, and affecting the health of patients,

Inactive Publication Date: 2008-08-21
AFT PHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ibuprofen is generally well tolerated in divided self medicated doses of up to 1.2 g / day, but it is still associated with side effects in some individuals, such as gastro-intestinal damage.
However, it is a concern that using a lower dose of ibuprofen would result in less pain relief due to a lower peak drug concentration with the result that the efficacy of the pain relief is reduced.

Method used

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  • Pharmaceutical composition of ibuprofen and paracetamol and methods of using the same
  • Pharmaceutical composition of ibuprofen and paracetamol and methods of using the same
  • Pharmaceutical composition of ibuprofen and paracetamol and methods of using the same

Examples

Experimental program
Comparison scheme
Effect test

example 1

Tablets for Oral Use

[0097]

Core:Paracetamol500.0mgIbuprofen150.0mgMaize Starch (dry mix)14.83mgColloidal Silicon Dioxide1.70mgMaize Starch (for paste)22.5mgDisodium EDTA0.50mgPolyvinyl Pyrrolidone7.54mgSodium Benzoate1.00mgMaize Starch (Lubrication)12.50mgColloidal Silicon Dioxide12.00mgMagnesium Stearate2.45mgSodium Starch Glycolate25.00mgPurified Water q.s.Coating:Hydroxypropylmethyl Cellulose7.20mgPolyethylene Glycol 60000.80mgTitanium Dioxide (Colorant)0.21mgMethylhydroxybenzoate0.20mgPropylhydroxybenzoate0.02mgPurified Water q.s.Total:758.45mg

example 2

Preparation of Tablets

[0098]A Preparation of a Granulation Mixture

[0099]1. Weigh paracetamol and ibuprofen and sift using a suitable vibrosifter and transfer to mixer. Discard any material not passing through #12 sieve.

[0100]2. Weigh and sift maize starch using a suitable vibrosifter (#40 sieve) and transfer to mixer.

[0101]3. Weigh and sift colloidal silicon dioxide using a suitable vibrosifter (#100 sieve) and transfer to mixer.

[0102]4. Mix for 10-11 minutes at slow speed.

[0103]B. Wet Granulation and Drying

[0104]1. Add purified water (0.03 ml / tablet) to stainless steel container

[0105]2. Sift maize starch (for paste) using suitable sieve (for example #60) and stir until slurry is formed.

[0106]3. Add purified water (0.18 ml / tablet) to a suitable jacketed planetary mixer and heat to boiling.

[0107]4. Add disodium EDTA, polyvinyl pyrrolidine and sodium benzoate. Dissolve and stir for 5-6 minutes until a clear solution is obtained.

[0108]5. Add starch slurry under continuous stirring unti...

example 3

Tablets for Oral Use

[0122]

Part I (Dry Mixing)Paracetamol500.0 mgIbuprofen150.0 mgMaize Starch (dry mix)25.32 mgMicrocrystalline Cellulose30.00 mgPregelatanized starch32.00 mgCroscarmellose sodium 2.50 mgPart II (Granulation)Maize starch (paste)50.00 mgMethyl parahydoxybenzoate 0.30 mgPropyl parahydroxybenzoate 0.03 mgPurified Water q.s.Part III (Lubrication)Maize starch10.00 mgCroscarmellose sodium10.00 mgMagnesium stearate 4.85 mgTalc10.00 mgFilm CoatingOpadry white OYLS 5890014.00 mgTalc 1.00 mgPurified Water q.s.

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PUM

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Abstract

A combination pharmaceutical composition for the treatment of pain comprising between about 125 mg and about 150 mg ibuprofen and between about 475 mg and about 500 mg paracetamol, and a method for alleviating pain in a patient comprising administering to the patient a pharmaceutical composition comprising between about 125 mg and about 150 mg ibuprofen and between about 475 mg and about 500 mg paracetamol.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation in part of U.S. Ser. No. 11 / 570,887, now pending, which is a National Stage Application of International Patent Application No. PCT / NZ2005 / 000168, with an international filing date of Jul. 7, 2005, which is based on New Zealand Patent Application No. 533982, filed Jul. 7, 2004. The contents of all of these specifications are incorporated herein by referenceBACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The invention relates to a method and combination composition for the treatment of pain. In particular, the invention relates to a pharmaceutical composition comprising ibuprofen and paracetamol for the treatment of pain.[0004]2. Description of the Related Art[0005]Without a medical practitioner's prescription (i.e., over the counter (“OTC”)), a full therapeutic dose of paracetamol (acetaminophen) is 1000 mg, and a full therapeutic dose of ibuprofen is 400 mg to relieve pain. The total dai...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/192A61K31/215A61K31/16
CPCA61K31/16A61K31/167A61K31/192A61K31/215A61K9/2059A61K2300/00A61P25/04A61P29/00A61K31/216A61K31/44A61K31/165A61K31/19
Inventor ATKINSON, HARTLEY CAMPBELL
Owner AFT PHARM LTD
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