Stable fidaxomicin medicine composition

A technology of fidaxomicin and its composition, which is applied in the field of fidaxomicin pharmaceutical composition and its preparation, and can solve problems such as low dissolution rate and poor fluidity

Inactive Publication Date: 2016-06-08
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention aims to overcome the problems of poor fluidity and low dissolution rate of the existing fidaxomicin pharmaceutical composition, change the disadvantages of low dissolution rate and low bioavailability of fidaxomicin, and improve the curative effect

Method used

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  • Stable fidaxomicin medicine composition
  • Stable fidaxomicin medicine composition
  • Stable fidaxomicin medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The formula composition of Fidaxomycin made into 1000 tablets is as follows:

[0035] Fidaxomycin 200g

[0036] Croscarmellose Sodium 50g

[0037] Microcrystalline cellulose 70g

[0038] Micropowder silica gel 0.5g

[0039] Appropriate amount of 10% pregelatinized starch solution

[0040] Preparation

[0041] 1) Fidaxomycin, croscarmellose sodium and microcrystalline cellulose were dried, pulverized, and passed through a 100-mesh sieve to obtain fidaxomicin powder, croscarmellose sodium and microcrystalline cellulose respectively. Cellulose powder;

[0042] 2) Take the prescribed amount of fidaxomicin, croscarmellose sodium and microcrystalline cellulose, mix well, then add 10% pregelatinized starch solution to make a soft material, pass through a 40-mesh sieve to granulate , to obtain wet granules of Fidaxomycin;

[0043] 3) Dry the above wet granules of Fidaxomycin at 60°C until the water content is less than 5%, to obtain dry granules of Fidaxomicin

[0044] ...

Embodiment 2

[0046] The formula composition of Fidaxomycin made into 1000 tablets is as follows:

[0047] Fidaxomycin 400g

[0048] Croscarmellose Sodium 100g

[0049] Microcrystalline cellulose 140g

[0050] Micropowder silica gel 1g

[0051] Appropriate amount of 10% pregelatinized starch solution

[0052] Preparation

[0053] 1) drying Fidaxomycin, croscarmellose sodium and microcrystalline cellulose respectively, pulverizing and passing through a 100-mesh sieve to obtain fidaxomicin powder and microcrystalline cellulose powder;

[0054] 2) Take the prescribed amount of fidaxomicin, croscarmellose sodium and microcrystalline cellulose, mix well, then add 10% pregelatinized starch solution to make a soft material, pass through a 40-mesh sieve to granulate , to obtain wet granules of Fidaxomycin;

[0055] 3) drying the wet granules of Fidaxomycin at 60°C until the water content is less than 5%, to obtain dry granules of Fidaxomicin;

[0056] 4) Pass the above-mentioned fidaxomicin ...

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Abstract

The invention discloses a stable fidaxomicin medicine composition, which is characterized in that a recipe for preparing 1000 tablets comprises the following ingredients including 200 to 400g of fidaxomicin, 70 to 140g of microcrystalline cellulose, 0.5 to 1g of superfine silica gel powder, 50 to 100g of croscarmellose sodium and a proper amount of 10-percent amylum pregelatinisatum solution. The invention also relates to a preparation method of the stable fidaxomicin medicine composition. The fidaxomicin prepared by the recipe and the preparation method has the advantages of high dissolution rate, high bioavailability and good curative effect.

Description

technical field [0001] The invention relates to a stable fidaxomicin pharmaceutical composition and a preparation method thereof. Background technique [0002] Fidaxomicin is a new narrow-spectrum macrolide antibacterial drug developed by Op-timer Pharmaceutical Company in recent years. On May 27, 2011, it was approved by the FDA to go on the market in the United States under the trade name Dificid. The drug is mainly used to treat Clostridium difficile (Clostridium difficile, also known as Clostridium difficile) associated diarrhea (CDAD) [0003] Structural formula: [0004] [0005] Through the research on the prior art, the low bioavailability of fidaxomicin in the human body is still a problem that bothers people and needs to be solved urgently. In addition, the appropriate preparation method and process conditions, the type and amount of filler are crucial to the dissolution effect and fluidity of the tablet. Commonly used fillers are lactose, microcrystalline c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K9/20A61K47/38A61P1/12A61P31/04
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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