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Freeze-drying process for paclitaxel liposome composition for injection

A technology of liposome composition and paclitaxel, which is applied in the field of freeze-drying technology, can solve the problems of long freeze-drying cycle, high input cost, and uneven product quality, so as to improve product quality and yield, reduce production cost, shorten Effects of freeze-drying cycles

Active Publication Date: 2017-07-07
NANJING LUYE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The freeze-drying cycle is long, which affects production capacity and requires high input costs. In addition, because the actual product temperature is mostly used as the main control temperature in the actual production process, there are large variables and it is difficult to achieve stable and controllable product quality in batches before and after, resulting in The product quality is not uniform between batches, which in turn affects the appearance, color, shape and encapsulation rate of the product, and the scrap rate is high in the production process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] First put 6.0g of paclitaxel, 72g of refined lecithin and 10.8g of cholesterol in a round bottom flask, add an appropriate amount of ethanol to the above mixture to completely dissolve into a clear solution, put it in a constant temperature water bath at 50°C and dry it under reduced pressure to form a film. 1.4g of lysine in 5% glucose solution to dissolve the membrane, use an ultrasonic instrument to ultrasonically pulverize or a high-pressure homogenizer pump to homogenate, then filter and sterilize with a 0.2μm filter membrane, pack in 30ml vials, and place in a freeze dryer , quickly drop the solution to -65°C within 1 hour, and keep it warm for 8 hours to obtain a frozen body, vacuum treatment to make the vacuum degree less than 10Pa, then raise the temperature of the frozen body to -5°C within 0.3 hours, and keep it warm for 4 hours, Then the frozen body was heated up to 30°C within 1 hour, kept warm for 4 hours, fed with nitrogen, helium or argon, to obtain a pac...

Embodiment 2

[0019] First, put 6.0g of paclitaxel, 72g of refined lecithin and 10.8g of cholesterol in a round bottom flask, add an appropriate amount of ethanol to the above mixture to completely dissolve into a clear solution, put it in a constant temperature water bath at 60°C and dry it under reduced pressure to form a film. 1.4g of lysine in 5% glucose solution to dissolve the membrane, use an ultrasonic instrument to ultrasonically pulverize or a high-pressure homogenizer pump to homogenate, then filter and sterilize with a 0.2μm filter membrane, pack in 30ml vials, and place in a freeze dryer , quickly drop the solution to -50°C within 0.5 hours, and keep it warm for 7 hours to obtain a frozen body, treat it with vacuum to make the vacuum degree less than 10pa, then raise the temperature of the frozen body to -5°C within 1.5 hours, and keep it warm for 3 hours. Then the frozen body was heated up to 35°C within 1 hour, kept warm for 4 hours, fed with nitrogen, helium or argon, to obta...

Embodiment 3

[0021] First, put 6.0g of paclitaxel, 72g of refined lecithin and 10.8g of cholesterol in a round bottom flask, add an appropriate amount of ethanol to the above mixture to completely dissolve into a clear solution, put it in a constant temperature water bath at 55°C and dry it under reduced pressure to form a film. 1.4g of lysine in 5% glucose solution to dissolve the membrane, use an ultrasonic instrument to ultrasonically pulverize or a high-pressure homogenizer pump to homogenate, then filter and sterilize with a 0.2μm filter membrane, pack in 30ml vials, and place in a freeze dryer , quickly drop the solution to -65°C within 1 hour, and keep it warm for 8 hours to obtain a frozen body, vacuum treatment to make the vacuum degree less than 10Pa, then raise the temperature of the frozen body to -5°C within 1 hour, and keep it warm for 2 hours, Then the frozen body was heated up to 30°C within 1 hour, kept warm for 4 hours, fed with nitrogen, helium or argon, to obtain a pacli...

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PUM

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Abstract

The invention provides a paclitaxel liposome composition for injection prepared through a novel freeze-drying method, and particularly relates to the paclitaxel liposome composition for injection, which is short in freeze-drying period, low in cost, stable and uniform in quality, excellent in product appearance and suitable for production. The process of the composition is simple, the preparation is stable after freeze-drying and is favorable for industrial production, the production cost is lowered, the fluctuation change of the grain size of the liposome is avoided, the pharmacological effects are guaranteed, and the safety of clinical medication is improved.

Description

technical field [0001] The invention relates to a freeze-drying process for shortening the freeze-drying cycle of a paclitaxel liposome composition for injection. Background technique [0002] Paclitaxel injection was approved by the U.S. FDA in 1992 as a first-line tumor treatment drug. However, paclitaxel is insoluble in water and many pharmaceutical solvents. A preparation made in a compound solvent with absolute ethanol. The polyoxyethylated castor oil in the compound solvent will promote the release of histamine in the body, causing allergic reactions in the human body. The incidence of moderate allergic reactions is as high as 50%, even life-threatening, and can aggravate the peripheral neurotoxicity of paclitaxel, produce Hepatotoxicity, side effects such as affecting the anti-tumor effect limit the clinical application of traditional paclitaxel injection. [0003] The advantages of liposomes such as targeting, low toxicity, and high efficiency are increasingly reco...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/127A61K31/337A61P35/00
CPCA61K9/0019A61K9/127A61K9/19A61K31/337
Inventor 陈文忠程光秦利利蔡德明
Owner NANJING LUYE PHARMA
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