Stable ixabepilone pharmaceutical composition

A technology of ixabepilone and composition, applied in the field of ixabepilone pharmaceutical composition and its preparation

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

[0004] The present invention aims to overcome the problems of poor fluidity and low dissolution rate of the existing ixabepilone pharmaceutical composition, and changes the dissolution rate of ixabepilone And the shortcomings of low bioavailability, improve the curative effect

Method used

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  • Stable ixabepilone pharmaceutical composition
  • Stable ixabepilone pharmaceutical composition
  • Stable ixabepilone pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The formulation of ixabepilone made into 1000 tablets is as follows:

[0034] Ixabepilone 15g

[0035] Croscarmellose Sodium 50g

[0036] Microcrystalline cellulose 70g

[0037] Micropowder silica gel 0.5g

[0038] Appropriate amount of 10% pregelatinized starch solution

[0039] Preparation

[0040] 1) Ixabepilone, croscarmellose sodium and microcrystalline cellulose were dried, pulverized, and passed through a 100-mesh sieve to obtain ixabepilone powder, croscarmellose sodium and microcrystalline cellulose respectively. Cellulose powder;

[0041] 2) Take the prescribed amount of ixabepilone, 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 ixabepilone wet granules;

[0042] 3) Dry the above-mentioned ixabepilone wet granules at 60°C until the water content is less than 5%, to obtain ixabepilone dry granules

[0043] 4) Pass ...

Embodiment 2

[0045] The formulation of ixabepilone made into 1000 tablets is as follows:

[0046] Ixabepilone 45g

[0047] Croscarmellose Sodium 100g

[0048] Microcrystalline cellulose 140g

[0049] Micropowder silica gel 1g

[0050] Appropriate amount of 10% pregelatinized starch solution

[0051] Preparation

[0052] 1) Ixabepilone, croscarmellose sodium and microcrystalline cellulose were dried, pulverized, and passed through a 100-mesh sieve to obtain ixabepilone powder and microcrystalline cellulose powder respectively;

[0053] 2) Take the prescribed amount of ixabepilone, 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 ixabepilone wet granules;

[0054] 3) drying the above-mentioned ixabepilone wet granules at 60°C until the water content is less than 5%, to obtain ixabepilone dry granules;

[0055] 4) Pass the above-mentioned dry ixabepi...

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Abstract

The present invention discloses a stable ixabepilone pharmaceutical composition, which is characterized in that the components in the formula for preparing 1000 tablets of the stable ixabepilone pharmaceutical compositions comprise 15-45 g of ixabepilone, 70-140 g of microcrystalline cellulose, 0.5-1 g of micro-powder silica gel, 50-100 g of cross-linked sodium carboxymethyl cellulose, and a proper amount of a 10% pre-gelatinized starch solution. The present invention further relates to an ixabepilone tablet preparation method. According to the present invention, the ixabepilone prepared by using the formula and the preparation method has characteristics of good dissolution, high bioavailability, and good treatment effect.

Description

Technical field [0001] The present invention involves a stable Eshapron drug composition and its preparation methods. Background technique [0002] Esha Pelon is a new drug similar to the aggregate antitumoric chemotherapy of Embolinicin, which is similar to the polymerization of paclitaxel microtubules and inhibits microtubules.In October 2007, the FDA approved the IxEMPRA single medicine or was used with Koriebin to treat the incurable metastatic or local progress of the treatment of rings, pebane derivatives, and Koriebinbin.Esha Pelon is a semi -synthetic analogycin β -laidide analog. It belongs to the new generation of anti -silk divisions. Its mechanism is similar to paclitaxel drugs. It can be combined with microtubin protein that causes cancer cells to be divided smoothly, and then cancer makes cancer.Cells have apoptosis, and they are better than paclitaxel in terms of anti -tumor spectrum, anti -tumor activity, safety, water solution, and synthesis methods.Esha Pelon is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/427A61K47/38A61K47/36A61P35/00
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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