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Daptomycin salt or salt-containing composition and preparation method thereof

A technology of daptomycin and composition, applied in the field of daptomycin metal salt or composition containing the salt and its preparation, can solve the problem of undisclosed daptomycin salt and undisclosed amorphous daptomycin Calcium salts, no disclosure of stability data, etc.

Inactive Publication Date: 2019-10-18
JIANGSU HENGRUI MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the prior art does not disclose amorphous daptomycin calcium salt, nor does it disclose how to prepare this amorphous daptomycin salt, nor disclose its stability data

Method used

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  • Daptomycin salt or salt-containing composition and preparation method thereof
  • Daptomycin salt or salt-containing composition and preparation method thereof
  • Daptomycin salt or salt-containing composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: Preparation of daptomycin calcium salt solid powder preparation

[0044] A. Preparation by spray drying method

[0045] (1) Preparation of solution

[0046] Dilute acetic acid solution: put 2.85mL of glacial acetic acid into a 50mL beaker, add about 30mL of purified water to dilute, transfer to a 50mL volumetric flask, and dilute with purified water.

[0047] Calcium hydroxide solution: Weigh 3.7g of calcium hydroxide into a 50mL beaker, add 50mL of water, and mix well before use.

[0048] tert-butanol / water solution (v / v=3:1): 150 mL tert-butanol + 50 mL water.

[0049] 20% daptomycin tert-butanol / water solution (v / v=3:1): Weigh about 10g daptomycin into a 100mL beaker, add about 24mL tert-butanol / water solution (v / v=3:1 ), keep stirring at low temperature until completely dissolved, transfer to a 50mL volumetric flask after dissolution, and dilute to volume with tert-butanol / water solution (v / v=3:1).

[0050]1M calcium acetate solution: Weigh 4.40g o...

Embodiment 2

[0090] Embodiment 2, add the daptomycin lyophilized preparation of lyoprotectant

[0091] (1) Preparation of solution

[0092] 20% daptomycin aqueous solution: Weigh about 5g of daptomycin into a 100mL beaker, add about 15mL of purified water, stir in an ice-water bath until dissolved (during the dissolution process, stir slowly with a magnet to avoid too much foam, do not Conducive to the later volume). Transfer to a 25mL volumetric flask, and make up to volume with purified water.

[0093] 4M NaOH solution: Weigh about 1.6g of sodium hydroxide into a 25mL beaker, add about 6mL of purified water and stir to dissolve, transfer to a 10mL volumetric flask, cool to room temperature, and dilute with purified water.

[0094] 1M NaOH solution: Weigh about 0.8g of sodium hydroxide into a 50mL beaker, add about 15mL of purified water and stir to dissolve, transfer to a 20mL volumetric flask, cool to room temperature, and dilute with purified water.

[0095] Phosphate buffer: Prepar...

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Abstract

The invention provides a Daptomycin salt or salt-containing composition and a preparation method thereof, belongs to the field of medicines, and particularly relates to Daptomycin metallic salt and asolid or powder preparation containing the Daptomycin metallic salt and a preparation method of the Daptomycin metallic salt and the solid or powder preparation containing the Daptomycin metallic salt. Compared with products in a non-salt manner, the Daptomycin salt and or the salt-containing composition, prepared by a spray drying method has the effect of improving chemical stability, and furthercan improve the antibacterial treatment effects.

Description

technical field [0001] The invention relates to the field of medicine and provides a daptomycin metal salt or a composition containing the salt and a preparation method thereof. Background technique [0002] Daptomycin is a cyclic lipopeptide antibiotic used in the treatment of complicated skin and skin structure infections and bacteremia. Daptomycin for injection can be administered intravenously, and is mainly stored in the form of solid dry powder, which is dissolved and reconstituted when used. [0003] In order to improve the storage stability of daptomycin in the form of solid dry powder, a protective agent needs to be added during the preparation of the dry powder. Patent WO2011063419 discloses the preparation of daptomycin in solid form by using glycine, sucrose, trehalose or mannitol as a protective agent The preparation improves the stability of the daptomycin solid preparation. [0004] Daptomycin itself has multiple free carboxyl groups and can form salts with ...

Claims

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Application Information

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IPC IPC(8): A61K38/12A61K9/14A61K9/19A61K47/02A61K47/26A61P31/04
CPCA61K9/143A61K9/145A61K9/19A61K38/12A61K47/02A61K47/26A61P31/04
Inventor 王立坤韩江彬鞠明珠
Owner JIANGSU HENGRUI MEDICINE CO LTD
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