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Stable telaprevir capsule pharmaceutical composition

A technology of telaprevir and composition, which is applied in the field of telaprevir capsule pharmaceutical composition and preparation thereof, can solve the problems of poor fluidity, small difference in loading, low dissolution rate and the like, and achieves good fluidity, Fast dispersion and good dissolution

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

[0010] The present invention aims to overcome the problems of poor fluidity, low dissolution rate and obvious difference in loading capacity of the existing telaprevir pharmaceutical composition, changes the shortcomings of low dissolution rate and bioavailability of telaprevir capsules, and improves The curative effect is improved, and the provided telaprevir capsules have good fluidity and little difference in loading capacity

Method used

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  • Stable telaprevir capsule pharmaceutical composition
  • Stable telaprevir capsule pharmaceutical composition
  • Stable telaprevir capsule pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The formula composition of telaprevir capsules made into 1000 capsules is as follows:

[0043] Telaprevir 250g

[0044] Croscarmellose Sodium 50g

[0045] Microcrystalline cellulose 70g

[0046] Micropowder silica gel 0.5g

[0047] Appropriate amount of 10% pregelatinized starch solution

[0048] Preparation

[0049] 1) Telaprevir, croscarmellose sodium and microcrystalline cellulose were dried, pulverized, and passed through a 100-mesh sieve to obtain telaprevir powder, croscarmellose sodium and microcrystalline cellulose respectively. Cellulose powder;

[0050] 2) Take the prescribed amount of telaprevir, croscarmellose sodium and microcrystalline cellulose, mix evenly, then add an appropriate amount of 10% pregelatinized starch solution to make a soft material, pass through a 20-mesh sieve to granulate , to obtain telaprevir wet granules;

[0051] 3) Dry the above telaprevir wet granules at 60°C until the water content is less than 5%, to obtain telaprevir dry...

Embodiment 2

[0054] The formula composition of telaprevir capsules made into 1000 capsules is as follows:

[0055] Telaprevir 500g

[0056] Croscarmellose Sodium 100g

[0057] Microcrystalline cellulose 140g

[0058] Micropowder silica gel 1g

[0059] Appropriate amount of 10% pregelatinized starch solution

[0060] Preparation

[0061] 1) Telaprevir, croscarmellose sodium and microcrystalline cellulose were dried, pulverized, and passed through a 100-mesh sieve to obtain telaprevir powder and microcrystalline cellulose powder respectively;

[0062] 2) Take the prescribed amount of telaprevir, croscarmellose sodium and microcrystalline cellulose, mix evenly, then add an appropriate amount of 10% pregelatinized starch solution to make a soft material, pass through a 20-mesh sieve to granulate , to obtain telaprevir wet granules;

[0063] 3) drying the above telaprevir wet granules at 60°C until the water content is less than 5%, to obtain telaprevir dry granules;

[0064] 4) Pass the...

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Abstract

The present invention discloses a stable telaprevir capsule pharmaceutical composition, which is characterized in that the components in the formula for preparing 1000 stable telaprevir capsule pharmaceutical compositions comprise 375-700 g of telaprevir, 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 telaprevir capsule preparation method. According to the present invention, the telaprevir capsule prepared by using the formula and the preparation method has characteristics of good fluidity, good dissolution, low loading difference, high bioavailability, and good treatment effect.

Description

technical field [0001] The invention relates to a stable telaprevir capsule pharmaceutical composition and a preparation method thereof. Background technique [0002] telaprevir [0003] English name: Telaprevir; [0004] Structural formula: [0005] [0006] Molecular formula: C 36 h 53 N 7 o 6 ; [0007] Molecular weight: 679.85; [0008] Telaprevir is a reversible protease inhibitor, used in combination with pegylated α-interferon and ribavirin, can effectively inhibit the replication of HVC virus, and is used for the treatment of chronic hepatitis C. [0009] Through the research on the prior art, the low bioavailability of telaprevir in the human body is still a problem that plagues people and needs to be solved urgently. In addition, suitable preparation methods and process conditions, the type and amount of fillers are very important to the dissolution effect, fluidity and filling capacity of capsules. 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): A61K38/08A61K9/48A61K47/38A61P1/16A61P31/14
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH