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Stable carfilzomib pharmaceutical composition

A technology of carfilzomib and composition, which is applied in the direction of drug combination, antineoplastic drugs, and pharmaceutical formulations, 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 carfilzomib pharmaceutical composition, change the disadvantages of low dissolution rate and low bioavailability of carfilzomib, and improve the curative effect

Method used

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  • Stable carfilzomib pharmaceutical composition
  • Stable carfilzomib pharmaceutical composition
  • Stable carfilzomib pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0035] Carfilzomib 30g

[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) Carfilzomib, croscarmellose sodium and microcrystalline cellulose were dried, pulverized, and passed through a 100-mesh sieve to obtain carfilzomib powder, croscarmellose sodium and microcrystalline cellulose respectively. Cellulose powder;

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

[0043] 3) Dry the above-mentioned carfilzomib wet granules at 60°C until the water content is less than 5%, to obtain carfilzomi...

Embodiment 2

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

[0047] Carfilzomib 60g

[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) Carfilzomib, croscarmellose sodium and microcrystalline cellulose were dried, pulverized, and passed through a 100-mesh sieve to obtain carfilzomib powder and microcrystalline cellulose powder respectively;

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

[0055] 3) drying the above-mentioned carfilzomib wet granules at 60°C until the water content is less than 5%, to obtain carfilzomib dry granules;

[0056] 4) Pas...

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PUM

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Abstract

The present invention discloses a stable carfilzomib pharmaceutical composition, which is characterized in that the components in the formula for preparing 1000 tablets of the stable carfilzomib pharmaceutical compositions comprise 30-60 g of carfilzomib, 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 a carfilzomib tablet preparation method. According to the present invention, the carfilzomib 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 invention relates to a stable carfilzomib pharmaceutical composition and a preparation method thereof. Background technique [0002] On July 20, 2012, the US Food and Drug Administration (FDA) approved carfilzomib (carfilzomib) for the treatment of multiple myeloma who have previously received at least 2 drugs (including bortezomib and immunomodulators). (MM) patients. Carfilzomib is administered intravenously and its safety and efficacy were evaluated in a study of 266 patients who had received at least 2 prior therapies (including bortezomib and thalidomide). Evaluate the complete or partial disappearance of tumors in patients after treatment (overall response rate). The results showed that the overall effective rate of patients was 23%, and the median remission time was 7.8 months. Carfilzomib, chemical name (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxirane-2-yl )-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholineacetamido)-4-...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/20A61K47/38A61K47/36A61P35/00
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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