2-(4-isobutylphenyl) propionic acid medicinal composition

A kind of composition and medicine technology, applied in the pharmaceutical composition of aqueous solution, the pharmaceutical composition of amino acid is arginine, the field of manufacture of pharmaceutical composition containing arginine and ibuprofen aqueous solution

Inactive Publication Date: 2005-02-23
CUMBERLAND PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0011] However the method described in the aforementioned patent has the disadvantage that it needs to be formulated into a salt and then dissolved, but the salt must be isolated and tested before the dosage form can be produced

Method used

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  • 2-(4-isobutylphenyl) propionic acid medicinal composition
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  • 2-(4-isobutylphenyl) propionic acid medicinal composition

Examples

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Embodiment 1

[0020] Add 8.2 kg of arginine to approximately 80 liters of water for injection and mix until dissolved. Add 10.0 kg of ibuprofen to the arginine solution and mix until dissolved. Sufficient water was added to bring up to 100 liters to produce a 100 mg / ml solution with a molar ratio (arginine: ibuprofen) of 0.92:1. The resulting product was a clear, colorless solution that readily passed through a 0.2 micron filter. The pH of the resulting solution was about 7.4 and could be adjusted to slightly higher or lower pH as needed. The solution can be further sterilized at the end to minimize the possibility of the product not being sterilized.

Embodiment 2

[0022] Lower concentrations of ibuprofen can be prepared using lower amounts of arginine and ibuprofen. Add 41 g of arginine to approximately 80 liters of water for injection and mix until dissolved. Add 50 g of ibuprofen to the arginine solution and mix until dissolved. Sufficient water was added to bring up to 100 liters to produce a 0.5 mg / ml solution with a molar ratio (arginine:ibuprofen) of 0.92:1. The resulting product was a clear, colorless solution that readily passed through a 0.2 micron filter. The pH of the resulting solution can be adjusted to achieve the desired pH.

Embodiment 3

[0024] Lower concentrations of arginine can be used to prepare ibuprofen solutions. Add 3.8 kg of arginine to approximately 80 liters of water for injection and mix until dissolved. Add 7.5 kg of ibuprofen to the arginine solution and mix until dissolved. Sufficient water was added to bring up to 100 liters to produce a 75 mg / ml solution with a molar ratio (arginine:ibuprofen) of 0.60:1. The product can be passed through a 0.2 micron filter to give a clear colorless solution. The pH of the resulting solution can be adjusted to achieve the desired pH.

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Abstract

The present invention provides a pharmaceutical composition comprising an aqueous solution of arginine and ibuprofen, wherein the molar ratio of arginine to ibuprofen is less than 1:1, as well as a method of making the same. The present invention also provides a method of treating a condition chosen from pain, inflammation, fever, and / or other conditions alleviated by ibuprofen comprising administering a pharmaceutical composition comprising an aqueous solution of arginine and ibuprofen, wherein the molar ratio of arginine to ibuprofen is less than 1:1.

Description

[0001] The present invention relates to a pharmaceutical composition containing 2-(4-isobutylphenyl)propionic acid and basic amino acid, more specifically arginine, for oral or injection (parenteral). Background of the invention [0002] 2-(4-isobutylphenyl) propionic acid, its international non-patent trade name is ibuprofen (ibuprofen), is a kind of well-known anti-inflammatory substance, molecular weight is 206.28, has following chemical structural formula: [0003] [0004] (Merck Index 12th ed., n4925, p 839). Since originally patented in the 1960's, ibuprofen is now marketed generically under the trade names Motrin(R), Advil(R), Advil(R), and Nuprin(R) for the treatment of pain, inflammation and fever. [0005] Ibuprofen is readily available as a racemic mixture of two enantiomers, (R) ibuprofen and (S) ibuprofen (RS-ibuprofen). Even though only the (S) enantiomer is the biologically active form, most preparations contain this racemic mixture because the (R) enantiom...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/00A61K9/19A61K31/192A61K47/18A61P25/04A61P29/00
CPCA61K9/0019A61K47/183A61K9/19A61K9/0095A61P25/04A61P29/00A61K31/192A61K31/198
Inventor L·帕维利夫
Owner CUMBERLAND PHARM INC
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