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Tedizolid phosphate for injection

A technology for tedizolid phosphate and injection, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, freeze-dried delivery, etc. It can solve the problems of high moisture content, unqualified product quality, and drug stability. Not advanced question

Active Publication Date: 2016-02-03
NANJING CHIA TAI TIANQING PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent 201080014363.0 discloses the prescription of tedizolid tablets and freeze-dried preparations, but the finished products prepared according to this preparation process have high moisture content and low drug stability
[0005] The moisture in the tedizolid phosphate product for injection is difficult to remove during the freeze-drying process, and the residual moisture will affect the stability of the product, such as the decrease in the clarity of the reconstituted solution and the increase of related substances in the product, resulting in poor product quality. Qualified, and brings drug safety issues

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The tedizolid phosphate for injection of the present invention has a prescription composition as follows:

[0034] Composition

Dosage

effect

Tedizolid Phosphate

210mg

Active ingredients

lactose

70mg

Protective agent

Trehalose

35mg

Protective agent

Sodium Hydroxide and Hydrochloric Acid

Adjust pH to 7.0-8.0

pH regulator

Water for Injection

2.1ml

solvent

[0035] Its preparation method comprises the following steps:

[0036] Add 60% of the prescribed amount of water for injection to the liquid preparation tank, and cool to 30°C; add the prescribed amount of tedizolid phosphate, and add sodium hydroxide solution dropwise under stirring until the liquid medicine is clear. Add the prescribed amount of lactose and trehalose, stir to dissolve, adjust the pH value to 7.0-8.0 with sodium hydroxide solution or hydrochloric acid solution; add water for injection to make up to th...

Embodiment 2

[0039] The tedizolid phosphate for injection of the present invention has a prescription composition as follows:

[0040] Composition

Dosage

effect

Tedizolid Phosphate

210mg

Active ingredients

lactose

70mg

Protective agent

Trehalose

35mg

Protective agent

Sodium Hydroxide and Hydrochloric Acid

Adjust pH to 7.0-8.0

pH regulator

Water for Injection

2.1ml

solvent

[0041] Its preparation method comprises the following steps:

[0042]Add 60% of the prescribed amount of water for injection to the liquid preparation tank, and adjust the temperature to 40°C; add the prescribed amount of tedizolid phosphate, and add sodium hydroxide solution dropwise under stirring until the liquid medicine is clear. Add the prescribed amount of lactose and trehalose, stir to dissolve, adjust the pH value to 7.0-8.0 with sodium hydroxide solution or hydrochloric acid solution; add water for injection...

Embodiment 3

[0045] The tedizolid phosphate for injection of the present invention has a prescription composition as follows:

[0046] Composition

Dosage

effect

[0047] Tedizolid Phosphate

200mg

Active ingredients

lactose

50mg

Protective agent

Trehalose

50mg

Protective agent

Sodium Hydroxide and Hydrochloric Acid

Adjust pH to 7.0-8.0

pH regulator

Water for Injection

2ml

solvent

[0048] The specific preparation method comprises the following steps: adding 70% of the prescribed amount of water for injection to the liquid preparation tank, cooling to 20° C.; adding the prescribed amount of tedizolid phosphate, and adding sodium hydroxide solution dropwise under the condition of stirring until the medicinal liquid is clear. Add the prescribed amount of lactose and trehalose, stir to dissolve, adjust the pH value to 7.0-8.0 with sodium hydroxide solution or hydrochloric acid soluti...

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations, and relates to tedizolid phosphate for injection. The freeze-drying preparation for injection is prepared by the steps of taking tedizolid phosphate as an effective ingredient, adding a freeze-drying protective agent and a pH regulator, and carrying out medical solution preparation, filling and freeze-drying to obtain the tedizolid phosphate powder injection for injection. The freeze-drying process provided by the invention is designed according to the tedizolid phosphate property characteristics; the process is simple and convenient to operate and short in production cycle, and adapts to industrialized mass production; and besides, low-moisture products can be provided, the problem that tedizolid phosphate for injection is hydrolyzed in the storage process is overcome, and the product quality and stability are increased.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a freeze-drying process for preparing tedizolid phosphate for injection. Background technique [0002] Acute bacterial skin and skin tissue infections (ABSSSI), including cellulitis or erysipelas, skin abscesses, and wound infections, are life-threatening requiring surgery or hospitalization. Studies have found that more and more ABSSSIs are caused by drug-resistant pathogens, and some antibacterial agents limit their use due to their side effects. Gram-positive bacteria (mostly Staphylococcus aureus and β-hemolytic streptococcus) are the main pathogens of infection, among which methicillin-resistant Staphylococcus aureus (MRSA) is now spreading in some European countries, the United States and other places . Community-acquired MRSA (CA-MRSA) has become the main pathogen causing skin and soft tissue infections. The treatment failure rate and recurrence rate ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K31/675A61P31/04
Inventor 陆洁章晓骅徐丹朱春霞田舟山谢军李惠
Owner NANJING CHIA TAI TIANQING PHARMA
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