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Preparation of sevoflurane with negligible water content

A technology of sevoflurane and water content, applied in the field of inhalation anesthetics, can solve problems such as limited commercial application value

Inactive Publication Date: 2008-05-14
PIRAMAL CRITICAL CARE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] A number of methods for the preparation of sevoflurane have been described, many of which have limited commercial application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The following experiments illustrate the preparation of low water content sevoflurane and its subsequent stability. In an experiment initiated in August 2000, sevoflurane (Abbott Laboratories, Lot #61-339-DK, expiry date 8 / 1 / 2001) was dried to a moisture content of 0 ppm using a type 3A molecular sieve. Drying is performed by mixing sevoflurane with molecular sieves and then keeping these substances together for several hours. Moisture content was determined by Karl Fischer analysis. The dried sevoflurane samples were placed in new type I11 amber glass vials that had been dried at 100°C for 2 hours. The bottles were sealed with black phenolic / urea resin caps with polyethylene resin polyseal liners and shrink-wrapped, or wrapped with Teflon(R) tape and shrink-wrapped. The samples were then stored at room temperature (25-27°C) and ambient relative humidity. At the end of the four-week stability test, the water content of the sample (Karl Fischer analysis) and the purit...

Embodiment 2

[0037] A batch of undried sevoflurane from Abbott Laboratories (Lot #0 335 70 K, expiry date 4 / 01 / 97, stored in Type III bottles) was assayed in May and October 2000. The water content of the sevoflurane was determined by gas chromatography to be 97 ppm, and the purity of the sevoflurane was 99.9916%. The sample has an expiration date of 1997 and a shelf life of 2 years, indicating that it was probably packaged in 1995 and stored for about 5 years without degradation at the environmental stability of the test period.

Embodiment 3

[0039] Additional data on the stability of sevoflurane comes from the US government, listing the water content of 71 lots of sevoflurane manufactured by Abbott Laboratories prior to January 27, 1997. The moisture content of these batches ranged from 0.0008 to 0.0131% by weight (ie 8 ppm to 131 ppm). A subset of lots on this list have been recalled due to instability; this information was obtained from FDA through the Freedom of Information Act. In fact, 19 of the 71 lots were recalled for instability and / or decomposition. The moisture content of the 19 recalled batches (average 0.0036% or 36 ppm) was similar to the moisture content of the 52 non-recalled batches (average 0.0036% or 36 ppm). The batches are listed in chronological order, and the recalled batches are not evenly distributed among them, and most unstable batches are located in the later part of the sequence. Abbott speculates in the related literature that the root cause of the degradation is caused by sevoflura...

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Abstract

Provided is a sevoflurane anesthetic product which can remain substantially undegraded after long periods of storage, as well as a method for preparing the product. The product comprises sevoflurane in a glass container having a water content of less than 130 ppm. The method comprises drying sevoflurane having a water content of greater than 130 ppm to a water content les than 130 ppm. A preferred method of drying comprises contacting a sevoflurane composition having a water content of greater than 130 ppm with alumina-containing molecular sieves such that the water content is reduced to lessthan 130 ppm.

Description

[0001] Related Application Cross Reference [0002] Applicants claim priority to US Patent Provisional Application 60 / 672,334, filed April 18, 2005 and entitled "Preparation of Sevoflurane With Negligible Water Content," the contents of which are incorporated herein by reference. technical field [0003] The invention relates to the field of inhalation anesthetics, and more particularly, the invention relates to a preparation method of sevoflurane with negligible water content. Background technique [0004] The compound sevoflurane (1,1,1,3,3,3-hexafluoroisopropyl fluoromethyl ether or hexafluoroisopropyl fluoromethyl ether or (CF 3 ) 2 CHOCH 2 F) is a widely used inhalational anesthetic, especially for outpatient surgery. Therefore, a cost-effective method for the preparation of stable sevoflurane is highly desired. [0005] A number of methods for the preparation of sevoflurane have been described, many of which have limited commercial application. U.S. Patent 3,683,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C41/00
CPCA61K31/075C07C41/36A61P23/00C07C43/123
Inventor R·C·特雷尔J·A·乐文森J·C·麦克那尼
Owner PIRAMAL CRITICAL CARE
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