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Medicine composition containing colesevelam hydrochloride and preparation method thereof

A technology of colesevelam hydrochloride and its composition, which is applied in the field of medicine, can solve the problems of many types and amounts of excipients, excessive main drug content, complicated preparation process, etc., and achieve good reproducibility, simple preparation process, batch-to-batch good reproducibility

Inactive Publication Date: 2014-02-19
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the disclosed prior art, there are mainly problems such as excessive main drug content, many types and amounts of excipients, complicated preparation process, high production cost, and poor patient compliance.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Plain Tablet Core Prescription (1000 Tablets)

[0037] Prescription 1 Colesevelam hydrochloride (g) 550 Silicified microcrystalline cellulose prosolv-50 (g) 300 Magnesium stearate (g) 1 production 851mg / tablet

[0038] Coating Solution Prescription

[0039] Opadry II (g) 50 water (g) 450 production 10% (w / w)

[0040] Preparation Process:

[0041] 1. Pretreatment: Both colesevelam hydrochloride and silicified microcrystalline cellulose are passed through a 20-mesh sieve;

[0042] 2. Pre-mixing: Weigh the prescribed amount of colesevelam hydrochloride and silicified microcrystalline cellulose prosolv-50 to pre-mix, add to the stirring mixer, and stir and mix for 15 minutes;

[0043] 3. Total blending: add lubricant magnesium stearate to the premixed materials and mix for 5 minutes;

[0044] 4. Tablet compression: Rotate the tablet press to compress the tablets, and test the friability of the plain t...

Embodiment 2

[0047] Plain Tablet Core Prescription (1000 Tablets)

[0048] Prescription 2 Colesevelam hydrochloride (g) 625 Silicified microcrystalline cellulose prosolv-90 (g) 250 Magnesium stearate (g) 5 production 880mg / tablet

[0049] Coating Solution Prescription

[0050] Opadry II (g) 50 water (g) 450 production 10% (w / w)

[0051] Preparation Process:

[0052] 1. Pretreatment: Both colesevelam hydrochloride and silicified microcrystalline cellulose are passed through a 20-mesh sieve;

[0053] 2. Pre-mixing: Weigh the prescribed amount of colesevelam hydrochloride and silicified microcrystalline cellulose prosolv-90 to pre-mix, add to the stirring mixer, and stir and mix for 15 minutes;

[0054] 3. Total blending: add lubricant magnesium stearate to the premixed materials and mix for 5 minutes;

[0055] 4. Tablet compression: Tablet compression with a rotary tablet press, and the friability of the plain tablets ...

Embodiment 3

[0058] Plain Tablet Core Prescription (1000 Tablets)

[0059] Prescription 3 Colesevelam hydrochloride (g) 600 Silicified microcrystalline cellulose prosolv-50 (g) 100 Silicified microcrystalline cellulose prosolv-90 (g) 200 Magnesium stearate (g) 10 production 910mg / tablet

[0060] Coating Solution Prescription

[0061] Opadry II (g) 50 water (g) 450 production 10% (w / w)

[0062] Preparation Process:

[0063] 1. Pretreatment: Both colesevelam hydrochloride and silicified microcrystalline cellulose are passed through a 20-mesh sieve;

[0064] 2. Pre-mixing: Weigh the prescribed amount of colesevelam hydrochloride and pre-mix silicified microcrystalline cellulose prosolv-50 and prosolv-90, add it to the stirring mixer, and stir and mix for 15 minutes;

[0065] 3. Total blending: add lubricant magnesium stearate to the premixed materials and mix for 5 minutes;

[0066] 4. Tablet compression: Rotate t...

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Abstract

The invention relates to a medicine composition containing colesevelam hydrochloride and a preparation method thereof. A prescription of the composition comprises a main medicine of colesevelam hydrochloride and two necessary auxiliaries of silicified microcrystalline cellulose and lubricant; the preparation method avoids the complex technique in the wet granulation or the dry granulation, and overcomes the defects of weak tablet fluidity, weak content uniformity, overgreat tablet weight and low compliance of patients of the large-dosage main medicine; the medicine composition can be prepared through the preparation technology of direct powder compression. The colesevelam hydrochloride tablet prescription of the invention has the advantages of rationality, simple and stable preparation technique, better effect on the selection of the auxiliaries and the ratio selection of the main material and the auxiliaries, lower production cost and convenience in industrial application.

Description

technical field [0001] The invention belongs to the technical field of medicine, relates to a pharmaceutical preparation and a preparation method thereof, in particular to a pharmaceutical composition containing colesevelam hydrochloride and a preparation method thereof. Background technique [0002] Colesevelam, English name: Colesevelam, colesevelam hydrochlorlde, trade name WelChol, chemical name: N,N,N-trimethyl-6-(2-propenylamino)-1-hexylammonium and (chloroform base) polymer of oxirane, 2-propen-1-amine and N-2-propenyl-1-decylamine hydrochloride, molecular formula: (C 13 h 27 N)n.(C 12 h 27 ClN 2 )n.(C 3 h 7 N)n.(C 3 h 5 ClO)n.xHCl is a non-absorbable bile acid sequestrant developed by GelTex Pharmaceuls Inc Center in the United States. It was approved by the FDA in 2000 for the treatment of hypercholesterolemia and was first listed in the United States in September 2000. [0003] Colesevelam is a bile acid sequestrant, which is a polymer that is not absorbed...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/20A61K31/785A61K47/38A61K47/12A61K47/04A61P3/06
Inventor 胡延臣高莹刘莱张伟强肖萱杨青松
Owner BEIJING TIDE PHARMA
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