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Stable pharmaceutical composition of fluoroether compound for anesthetic use, method for stabilizing a fluoroether compound, use of stabilizer agent for precluding the degradation of a fluoroether com

A stabilizer and composition technology, applied in the field of preventing the degradation of fluoroether compounds and sevoflurane, can solve the problems of unproven and insufficient inhibition

Inactive Publication Date: 2007-07-11
CRISTALIA PROD QUI FARM LTDA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] The method described in document WO 98 / 32430, which proposes water as an inhibitor of sevoflurane degradation, has not been shown to ensure adequate inhibition of the degradation of this compound, since the observed HFIP (1, 1, 1, 3, 3, 3-hexafluoroisopropanol) is convincing evidence that this mechanism cannot be inhibited sufficiently to ensure that no other degradation by-product, i.e. hydrofluoric acid, is formed

Method used

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  • Stable pharmaceutical composition of fluoroether compound for anesthetic use, method for stabilizing a fluoroether compound, use of stabilizer agent for precluding the degradation of a fluoroether com
  • Stable pharmaceutical composition of fluoroether compound for anesthetic use, method for stabilizing a fluoroether compound, use of stabilizer agent for precluding the degradation of a fluoroether com
  • Stable pharmaceutical composition of fluoroether compound for anesthetic use, method for stabilizing a fluoroether compound, use of stabilizer agent for precluding the degradation of a fluoroether com

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Example 1. Degradation of sevoflurane by acidic substances.

[0075] The purpose of this pilot study was to select stress conditions for the following studies using stabilizer substances.

[0076] For example, when the anhydrous sevoflurane sample was mixed with alumina (Al 2 o 3 ) and heated at 60°C for 22 hours, the degradation of sevoflurane by acidic substances can be observed.

[0077] The sevoflurane used for this test was previously dried over molecular sieves to a moisture content of 20 ppm. Add 20 mL of anhydrous sevoflurane to two type III glass bottles with a capacity of 100 mL, and add 20 mg of aluminum oxide to one of the bottles, finally reaching 1.0 mg Al per mL of sevoflurane 2 o 3 . Both bottles were sealed with stoppers and screw metal caps and heated in an oven at 60°C for 22 hours. After this period, samples were analyzed in duplicate by gas chromatography using internal standard addition (toluene). Figure 3 shows the chromatogram of an anhydr...

Embodiment 2

[0080] Example 2. Effect of water on the stability of sevoflurane.

[0081] This example shows a study on the effect of water on the stability of sevoflurane. According to document WO 98 / 32430, a water content of 150 ppm to 1400 ppm present in sevoflurane will ensure its stability against the formation of degradation products.

[0082] The study was performed using sevoflurane dried with molecular sieves to achieve an initial moisture content of 20 ppm. In the presence of water, the degree of protection or degradation of sevoflurane was evaluated from sevoflurane samples containing different water contents, treated with or without alumina, where the treatment was carried out at 1 mg alumina per ml sevoflurane ratio is carried out. Samples were prepared and placed in Type III glass vials, and the vials were sealed with stoppers and screw metal caps.

[0083] The samples were placed under two stress conditions, one cycle of heating in an oven at 60°C for 22 hours, and another...

Embodiment 3

[0090] Example 3. Adding polyols or saturated cyclic alcohols to stabilize sevoflurane against the degradation of aluminum oxide.

[0091] In this example, polyols and saturated cyclic alcohols were used to prevent the degradation of sevoflurane by alumina. The substances selected in each group were propylene glycol and menthol, respectively.

[0092] Samples were prepared containing 0, 50, 200, 600, 1000 and 1400 ppm stabilizer. The sevoflurane used to prepare these samples was previously dried over molecular sieves to obtain a water content of 20 ppm. The study consisted of exposing sevoflurane to an acidic substance, subjecting the samples to stress by heating at 60 °C for 22 h, and evaluating the chromatographic purity of sevoflurane after stress by comparison. Activated alumina was used as the acidic substance at a constant dosage of 1 mg activated alumina per ml of sevoflurane.

[0093] 20 mL of test sevoflurane containing defined amounts of stabilizers (0, 50, 200, 6...

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Abstract

The present invention has as objective the stabilization of a fluoroether compound against degradation by acid substances. The stabilizers proposed are selected among appropriate pharmaceutical compounds selected from the group constituted of propylene glycol, polyethylene glycol, hexylene glycol and 1,3-butileneglicol, or a saturated cyclic alcohol preferably menthol, and are used for preparing stable pharmaceutical compositions of a fluoroether compound. Method for stabilizing a fluoroether compound and use of stabilizers agents for precluding the degradation of a fluoroether are also described.

Description

field of invention [0001] The object of the present invention is to stabilize fluoroether compounds against degradation by acidic substances. [0002] In particular, the present invention relates to stabilizing fluoroether compounds having anesthetic properties, and stable pharmaceutical compositions of fluoroether compounds for anesthetic use. Stabilizers used are selected from suitable pharmaceutical compounds and are used to prepare stable pharmaceutical compositions. The invention also describes a method for preventing the degradation of fluoroether compounds, and the use of a stabilizer for preventing the degradation of fluoroether compounds, said degradation being caused by acidic substances. [0003] The fluoroether compounds with anesthetic properties involved in the present invention include sevoflurane, desflurane, isoflurane, enflurane and methoxyflurane. Among these fluoroether compounds, the present invention is particularly applicable to sevoflurane. [0004] ...

Claims

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Application Information

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IPC IPC(8): A61K31/075A61K9/00A61K33/16A61P23/00
Inventor O·帕切克E·鲁索V·鲁索J·A·马丁斯M·A·伯克曼S·罗萨托
Owner CRISTALIA PROD QUI FARM LTDA
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