Clear aqueous anaesthetic composition

A composition and transparent technology, which is applied in the direction of anesthetics, drug combinations, active ingredients of hydroxyl compounds, etc., can solve the problems of high pressure sterilization instability and achieve high sterility reliability

Inactive Publication Date: 2006-05-03
BHARAT SERUMS & VACCINES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, we found that this solution was not stable to autoclaving

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0040] The invention will now be illustrated by way of examples. The examples are only used to illustrate the present invention, but not to limit the scope of the present invention.

[0041] All raw materials used in the examples are of pharmaceutical grade. The equipment used is conventional equipment. The entire processing takes place in an area of ​​controlled environment.

Embodiment I

[0044] step:

[0045] 2-Hydroxypropyl-β-cyclodextrin was dissolved in 55 ml of water at 25°C-30°C. Propofol was slowly added to the HPBCD solution under vigorous stirring at 25°C-30°C. Keeping the temperature at 25°C-30°C, the solution was stirred at moderate speed for 3 hours.

[0046] Glycerin and 0.5 ml of 1% w / v disodium edetate solution were added to the above solution under moderate stirring. The volume was made up to 100ml with water. The obtained clear solution was filtered through a 0.2 μ filter, filled into glass vials under nitrogen atmosphere, sealed and autoclaved.

[0047] Composition A remained clear after autoclaving, while composition B became cloudy. This example shows that the ratio of propofol to HPBCD is important for the stability of the composition when subjected to autoclaving.

[0048]The propofol content of the composition was determined by HPLC using a 270 nm detector and a 4.6 mm x 25 cm column containing packing L1. The flow rate was a...

Embodiment II

[0052] step:

[0053] Operate with the method of embodiment 1. However, after the volume was made up to 100 ml with water, it was further diluted to 500 ml with 5% glucose solution so that the concentration of propofol was 2 mg / ml. Then filter through a 0.2 μ filter according to the steps of Example 1, pack into a glass vial under a nitrogen atmosphere, seal and autoclave. Composition (C) remained clear after autoclaving, while composition (D) became cloudy.

[0054] The propofol content of the compositions was determined by the method specified in Example 1.

[0055] Process Test A to produce a composition with a propofol content of 2 mg / ml was repeated using a larger batch size and used for stability studies. The results of the stability study are listed in Table I.

[0056] The composition of Example II(c) was used in animal studies, the results of which are listed in Table II.

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PUM

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Abstract

Sterile, pharmaceutically stable, autoclavable clear aqueous compositions of propofol (2,6-diisopropylphenol) suitable for parenteral administration are disclosed. The composition consists essentially of a complex of propofol and 2-hydroxypropyl-β-cyclodextrin in a weight ratio of 1:30 to 1:60. This complex of propofol with 2-hydroxypropyl-β-cyclodextrin produces a clear aqueous composition that is stable to autoclaving. The composition is effective as an anesthetic. Methods of making these synergistic compositions are also described.

Description

field of invention [0001] The present invention relates to a pharmaceutical composition of propofol (2,6-diisopropylphenol) for parenteral administration. In particular, the present invention relates to compositions wherein propofol is complexed with 2-hydroxypropyl-beta-cyclodextrin (hereinafter "HPBCD"). More particularly the present invention relates to clear aqueous compositions of propofol-HPBCD complexes which are stable to autoclaving and methods for their preparation. Background of the invention [0002] Propofol is an intravenous anesthetic characterized by a short recovery time. It has the desirable characteristics of rapid onset and resolution of anesthesia after intravenous administration and minimal accumulation in chronic administration. [0003] Although propofol is a preferred anesthetic, it has presented great challenges to the pharmacist since its invention due to its water insolubility. Initially it was formulated as a 1% aqueous solution containing the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/05A61K47/48A61K9/08A61P23/00A61K9/00A61K47/02A61K47/04A61K47/10A61K47/12A61K47/18A61K47/20A61K47/22A61K47/26A61K47/34A61K47/40
CPCA61K9/0019A61K47/10B82Y5/00A61K47/6951A61P23/00A61K47/40
Inventor S·佩S·里范卡S·科查雷卡
Owner BHARAT SERUMS & VACCINES
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