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Pharmaceutical composition of freeze-dried powder injection containing caspofungin

A freeze-dried powder injection, caspofungin technology, applied in freeze-drying transportation, drying solid materials, drying and other directions, can solve the problems of unfreeze-dried process comparison, low production efficiency, high energy consumption, and shorten the freeze-dried process. Dry cycle, improve production efficiency, good stability

Inactive Publication Date: 2014-10-29
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Secondly, the relevant technical materials that have been queried all use similar excipients (fillers) and buffer formulations to effectively improve product stability, but none of them have studied the correlation between the formulation and the freeze-drying process
Chinese patent ZL97195514 mentions a composition containing antifungal agent and acetate buffer, and the stability is effectively improved after using acetate buffer, but there is no data provided in the patent, and its stability cannot be confirmed; at the same time, from According to its disclosed technical background, the complete cycle of freeze-drying is as long as 2 days, with low production efficiency and high energy consumption
Patent applications CN103118663A, CN102166186A, and CN101516387A all mentioned that using different buffer systems or using an appropriate amount of specific pH regulators can help improve the stability of the composition system, and use different technical means to confirm the stability and safety results, but all Freeze-drying process was not compared

Method used

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  • Pharmaceutical composition of freeze-dried powder injection containing caspofungin
  • Pharmaceutical composition of freeze-dried powder injection containing caspofungin
  • Pharmaceutical composition of freeze-dried powder injection containing caspofungin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] prescription:

[0048]

[0049] Preparation process: Weigh 90% of the total amount of water for injection and cool to room temperature, add L-lactic acid, stir well, adjust the pH value to 3.0-5.5 with sodium hydroxide solution; add sucrose and mannitol, stir to dissolve, add medicinal Charcoal, stirred and adsorbed, decarbonized and filtered. Cool the filtrate to below 15°C, add the prescribed amount of caspofungin acetate, stir to dissolve, and add water for injection to the full amount. Sterilization and filtration, filling, half-stoppering, putting into the box of a freeze dryer, freeze-drying, corking out of the box, and capping to obtain composition 1.

[0050] Freeze-drying process: cool down to -40°C to freeze, heat up to about -20°C for 20 minutes, continue to cool down to -40°C to freeze solid; vacuumize to 10Pa, heat up to -10°C for sublimation and drying; continue to heat up to 20°C to complete analysis dry.

Embodiment 2

[0052] prescription:

[0053]

[0054]

[0055] Preparation process: Weigh 90% of the total amount of water for injection and cool to room temperature, add L-lactic acid, stir well, adjust the pH value to 3.0-5.5 with sodium hydroxide solution; add sucrose and mannitol, stir to dissolve, add medicinal Charcoal, stirred and adsorbed, decarbonized and filtered. Cool the filtrate to below 15°C, add the prescribed amount of caspofungin acetate, stir to dissolve, and add water for injection to the full amount. Sterilization and filtration, filling, half-stoppering, putting into the box of a freeze dryer, freeze-drying, corking out of the box, and capping to obtain composition 2.

[0056] Freeze-drying process: cool down to -35°C for freezing, heat up to about -20°C for 30 minutes, continue to cool down to -35°C for freezing; vacuumize to 15Pa, heat up to -15°C for sublimation and drying; continue to heat up to 20°C to complete analysis dry.

Embodiment 3

[0058] prescription:

[0059]

[0060] Preparation process: Weigh 90% of the total amount of water for injection and cool to room temperature, add L-lactic acid, stir well, adjust the pH value to 3.0-5.5 with sodium hydroxide solution; add sucrose and mannitol, stir to dissolve, add medicinal Charcoal, stirred and adsorbed, decarbonized and filtered. Cool the filtrate to below 15°C, add the prescribed amount of caspofungin acetate, stir to dissolve, and add water for injection to the full amount. Sterilization and filtration, filling, half-stoppering, putting into the box of a freeze dryer, freeze-drying, corking out of the box, and capping to obtain composition 3.

[0061] Freeze-drying process: cool down to -32°C for freezing, heat up to about -20°C for 60 minutes, continue to cool down to -32°C for freezing; vacuumize to 20Pa, heat up to -5°C for sublimation and drying; continue to heat up to 20°C to complete analysis dry.

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PUM

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Abstract

The invention provides a pharmaceutical composition of a freeze-dried powder injection containing caspofungin or pharmaceutically acceptable salts of the caspofungin, and a preparation method of the pharmaceutical composition. The composition contains caspofungin or pharmaceutically acceptable salts of the caspofungin, a pH modifier and pharmaceutically acceptable auxiliary materials, wherein the pharmaceutically acceptable auxiliary materials are one or more of cane sugar, mannitol, newtol and sorbitol; and the pH modifier is one or more of appropriate lactic acid, sodium hydroxide and potassium hydroxide, so that the pH value of the pharmaceutical composition is kept within an acceptable range.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a caspofungin-containing freeze-dried powder injection pharmaceutical composition. Background technique [0002] Caspofungin acetate is the diacetate salt of caspofungin, which is a semi-synthetic lipopeptide (echinocandin) compound synthesized from the fermentation product of Glarea Lozoyensis. Caspofungin can inhibit the synthesis of β(1,3)-D-glucan, a basic component of the cell wall of many filamentous fungi and yeasts. P(1,3)-D-glucan does not exist in mammalian cells. [0003] In vitro pharmacological studies have shown that caspofungin acetate has antibacterial activity against many pathogenic Aspergillus and Candida fungi. A standard drug susceptibility test method for the detection of P(1,3)-D-glucan synthesis inhibitors has not been established yet. Moreover, the results of drug susceptibility tests do not necessarily have a necessary relationship with c...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/12A61P31/10F26B5/06
Inventor 余悦东冯卫
Owner SICHUAN HAISCO PHARMA CO LTD
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