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Clear aqueous anaesthetic composition

A composition and transparent technology, applied in anesthetics, drug combinations, active ingredients of hydroxyl compounds, etc., can solve problems such as autoclave instability and achieve high sterility reliability

Inactive Publication Date: 2003-11-05
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 I

[0043] In this example two compositions were prepared using Process Runs A and B. Process test B is a comparative test rather than a test of the invention. The following ingredients were used in this example:

[0044]Ingredient A Ba) Propofol 1g 1gb) 2-Hydroxypropyl-β-cyclodextrin 30g 20gc) Glycerin 2.25g 2.25gd) Disodium EDTA 0.005g 0.005ge) Water enough to 100ml 100ml

[0045] step:

[0046] 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.

[0047] Glycerin and 0.5 ml of 1% w / v disodium edetate solution were added to the above solution with stirring at moderate speed. 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.

[0048] Composi...

Embodiment II

[0052] In this example two compositions were prepared using Process Runs C and D. Process test D is a comparative test rather than a test of the invention. The following ingredients were used in this example:

[0053] Ingredient C Da) Propofol 1g 1gb) 2-Hydroxypropyl-β-cyclodextrin 30g 20gc) Glycerin 2.25g 2.25gd) Disodium edetate 0.005g 0.005ge) Water enough to 100ml 100mlf) 5 % Glucose solution enough to 500ml 500ml

[0054] step:

[0055] 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.

[0056] The propofol content of the compositions was determined by the method specified in E...

Embodiment III

[0060] In this example two compositions were prepared using Process Runs E and F. Process Test F is a comparative test rather than an inventive test. The following ingredients were used in this example:

[0061] Ingredient E Fa) Propofol 0.2g 0.2gb) 2-Hydroxypropyl-β-cyclodextrin 6g 4gc) Glycerin 0.45g 0.45gd) Disodium edetate 0.001g 0.001ge) Glucose 5g 5gf) Water foot Measure to 100ml 100ml

[0062] step:

[0063] 2-Hydroxypropyl-β-cyclodextrin was dissolved in 55 ml of water at 25°C-30°C. Slowly add propofol into the HPBCD solution at 25°C-30°C under vigorous stirring.

[0064] Keeping the temperature at 25°C-30°C, the solution was stirred at moderate speed for 3 hours.

[0065] Glycerin and 0.1 ml of 1% w / v disodium edetate solution were added to the above solution under moderate stirring. Glucose was dissolved in 20 ml of water and added to the above solution with moderate stirring. The volume was made up to 100ml with water. The obtained transparent solution w...

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PUM

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Abstract

A sterile pharmaceutically stable autoclavable transparent aqueous composition of propofol (2,6-diisopropylphenol) suitable for parenteral administration is disclosed. The composition basically consists 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 Applications(China)
IPC IPC(8): A61K9/08A61K9/00A61K31/05A61K47/02A61K47/04A61K47/10A61K47/12A61K47/18A61K47/20A61K47/22A61K47/26A61K47/34A61K47/40A61K47/48A61P23/00
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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