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Combination Composition

a combination composition and pain treatment technology, applied in the field of pain treatment methods and combination compositions, can solve the problems of gastrointestinal damage, still associated with side effects in some individuals, and reduce the effect of pain reli

Inactive Publication Date: 2008-11-06
AFT PHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The combination provides effective pain relief with reduced incidence of adverse side effects, achieving equivalent or improved efficacy compared to higher doses of ibuprofen alone, allowing for convenient and effective self-medication for short-term, intermittent pain.

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 gastrointestinal 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 concentrations with the result that the efficacy of the pain relief is reduced.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Tablets for Oral Use

[0052]

CoreParacetamol500.0mgIbuprofen150.0mgMaize 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 Glycollate25.00mgPurified Water q.s.CoatingHydroxypropylmethyl cellulose7.20mgPolyethylene Glycol 60000.80mgTitanium Dioxide (Colourant)0.21mgMethylhydroxybenzoate0.20mgPropylhydroxybenzoate0.02mgPurified Waterq.s.Total758.45mg

example 2

Preparation of Tablets

A. Preparation of a Granulation Mixture

[0053]1. Weigh paracetamol and ibuprofen and sift using a suitable vibrosifter and transfer to mixer. Discard any material not passing through #12 sieve.[0054]2. Weigh and sift maize starch using a suitable vibrosifter (#40 sieve) and transfer to mixer.[0055]3. Weigh and sift colloidal silicon dioxide using a suitable vibrosifter (#100 sieve) and transfer to mixer.[0056]4. Mix for 10-11 minutes at slow speed.

B. Wet Granulation and Drying

[0057]1. Add purified water (0.03 ml / tablet) to stainless steel container[0058]2. Sift maize starch (for paste) using suitable sieve (for example #60) and stir until slurry is formed.[0059]3. Add purified water (0.18 ml / tablet) to a suitable jacketed planetary mixer and heat to boiling.[0060]4. Add disodium EDTA, polyvinyl pyrrolidine and sodium benzoate. Dissolve and stir for 5-6 minutes until a clear solution is obtained.[0061]5. Add starch slurry under continuous stirring until a translu...

example 3

Tablets for Oral Use

[0074]

Part 1 (Dry Mixing)Paracetamol500.0mgIbuprofen150.0mgMaize Starch (dry mix)25.32mgMicrocrystalline Cellulose30.00mgPregelatanised starch32.00mgCroscarmellose sodium2.50mg

Part II (Granulation)Maize starch (paste)50.00mgMethyl parahydoxybenzoate0.30mgPropyl parahydroxybenzoate0.03mgPurified Waterq.s.

Part III (Lubrication)Maize starch10.00mgCroscarmellose sodium10.00mgMagnesium stearate4.85mgTalc10.00mg

Film CoatingOpadry white OYLS 5890014.00mgTalc1.00mgPurified Waterq.s.

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Abstract

A combination pharmaceutical composition for the treatment of pain including about 125 mg to about 150 mg ibuprofen and about 475 mg to about 500 mg paracetamol.

Description

TECHNICAL FIELD[0001]The invention relates to a method and combination composition for the treatment of pain. In particular, the invention relates to a composition containing ibuprofen and paracetamol for the treatment of pain.BACKGROUND TO THE INVENTION[0002]Without a medical practitioner's prescription (ie over the counter (“OTC”)), a full therapeutic dose of paracetamol (acetaminophen) is 1000 mg, a full therapeutic dose of ibuprofen is 400 mg to relieve pain. The total daily amount is also limited to 4000 mg of paracetamol and 1200 mg of ibuprofen, per day in divided doses.[0003]Dosing regimes for each of paracetamol and ibuprofen, when given individually to patients, are often maximised to give the full individual therapeutic dose. Care needs to be taken that the maximum daily dose is met but not exceeded for each medication.[0004]Pharmaceutical combinations such as paracetamol and codeine (500 mg / 8 mg) and ibuprofen and codeine (200 mg / 12.8 mg) in single dose forms are known. ...

Claims

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Application Information

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