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Pharmaceutical composition of ibuprofen for injection

A composition and drug technology, applied in the direction of drug combination, drug delivery, antipyretics, etc., can solve the problems of endangering the solubility of ibuprofen, no prompt, unsuitable for sterilization, etc.

Inactive Publication Date: 2013-01-23
HANNFAMA LAB LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this document neither describes nor suggests preparations with other concentration values ​​of said ingredients or with pH values ​​outside said ranges
In addition, the relatively high content of ibuprofen in the compositions disclosed in this document can compromise the solubility of ibuprofen at the pH of the composition, and the fact that these compositions are sterilized by sterile Filtration suggests that these compositions may not be suitable for sterilization in an autoclave

Method used

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  • Pharmaceutical composition of ibuprofen for injection
  • Pharmaceutical composition of ibuprofen for injection
  • Pharmaceutical composition of ibuprofen for injection

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Embodiment Construction

[0014] Therefore, the liquid pharmaceutical composition of the present invention comprises ibuprofen at a concentration of 2-6 mg / mL and preferably about 4 mg / mL, tromethamine at a concentration of 1.8-5.8 mg / ml and preferably about 3.8 mg / ml, and The NaCl is necessary to provide suitable isotonicity, that is, usually about 300 mOsm / kg, which requires a NaCl concentration of preferably about 7.7 mg / ml. It is believed that tromethamine helps to increase the dissolution rate of ibuprofen in aqueous solvents and also helps maintain the stability of ibuprofen in solution. In the composition of the present invention, tromethamine is added at a concentration of 1.5-5.8 mg / ml, and preferably about 3.8 mg / ml. The pH of the compositions of the present invention is 7.0-12, preferably 7.0-9.5, more preferably 7.5-9.0, even more preferably 8.0-9.0, and most preferably about 8.5, depending on the container in which they are placed. The adjustment of the pH can be carried out by any means k...

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Abstract

Pharmaceutical composition of ibuprofen for injection that comprises an aqueous solution of ibuprofen and trometamol. These compositions display a minimal loss of active principle and acceptable increase of impurities after autoclaving, properties that have been demonstrated in various types of containers, such as containers made of plastics such as polypropylene, PVC and polyethylene, as well as in glass containers. These compositions, after undergoing autoclaving, still comply with all the relevant technical specifications of the European Pharmacopoeia and of the USP.

Description

Invention field [0001] The present invention relates to a pharmaceutical composition for intravenous application, which comprises 2-(4-isobutylphenyl)-propionic acid (ibuprofen), trometamol and NaCl. Background of the invention [0002] 2-(4-Isobutylphenyl)-propionic acid (ibuprofen) is an analgesic, antipyretic, and anti-inflammatory drug, which has the following chemical formula: [0003] [0004] Ibuprofen has become a very famous drug since its invention in the 1960s, and it is currently sold under various trade names in the form of drugs for oral administration for the treatment of pain, inflammation and fever. [0005] Ibuprofen can take the form of (R) or (S) enantiomer, and although it is the biologically active (S) enantiomer, most formulations contain a racemic mixture because the (R) enantiomer is Converted into the active form (S) in the body. In the following, "ibuprofen" means either of these two enantiomers, (R) or (S), or racemate. [0006] Despite its many advantag...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/19A61K47/18
CPCA61K9/0019A61K47/18A61K31/19A61K31/192A61P29/00
Inventor 伊格纳西奥·奥图萨尔安德查加马里奥·奥图萨尔古铁雷斯
Owner HANNFAMA LAB LLC
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