Controlled release pharmaceutical composition of venlafaxine hydrochloride, and process for preparation thereof

A technology of venlafaxine hydrochloride and controlled-release drug, which is applied in the field of novel compositions for controlled-release of venlafaxine hydrochloride, can solve problems such as large-scale preparation of unsuitable pharmaceutical compositions, and achieve good batch-to-batch repeatability. performance, good stability

Inactive Publication Date: 2008-09-03
VALPHARMA SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it should be said that these preparations are usually prepared by complicated and expensive methods, which are not suitable for large-scale preparation of uniform and stable pharmaceutical compositions

Method used

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  • Controlled release pharmaceutical composition of venlafaxine hydrochloride, and process for preparation thereof
  • Controlled release pharmaceutical composition of venlafaxine hydrochloride, and process for preparation thereof
  • Controlled release pharmaceutical composition of venlafaxine hydrochloride, and process for preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation of active ingredient core

[0030] 10Kg of neutral sugar pellets (composition: 80% by weight of sucrose, 20% of starch) with a particle size distribution of 710-1000 μm were loaded into HP / M025 automatic system GS.

[0031] These neutral pellets were coated with a solution of venlafaxine hydrochloride, which was prepared by dissolving 10 Kg of the active ingredient in 10 Kg of purified water.

[0032] Table 1 below records the operating conditions of the coating and the main operating parameter values ​​set for the equipment.

[0033] Table 1

[0034] Parameter

[0035] The pellets thus obtained were sieved using a 1200 μm mesh and dried at 60°C for 12 hours.

Embodiment 2

[0037] Preparation of controlled release coating

[0038] 290 g of ethyl cellulose and 29 g of stearic acid were added to 2.7 Kg of acetone and 2.7 Kg of 96% ethanol, and the mixture was left to completely dissolve under stirring.

[0039] The solution thus obtained was used to coat the retardation film on the pellets prepared as described in Example 1 above.

[0040] Talc was added in a small amount during the spraying of the solution, and the total amount of talc added was 40 g.

[0041] Table 2 below records the operating conditions of coating delay coating and the main operating parameter values ​​set for the equipment.

[0042] Table 2

[0043] Parameter

[0044] The pellets thus obtained were sieved using a 1340 μm mesh and dried at 60°C for 12 hours. At the end of the drying, the pellets were packed into "0" capsules, which included 150 mg of venlafaxine corresponding to 169.7 mg of venlafaxine hydrochloride.

Embodiment 3

[0046] Preparation of active ingredient core

[0047] The same type of neutral pellets of 2kg sugar spheres as described in Example 1 above were loaded into a GPCG 3 type Glatt fluidized bed, and 50% venlafaxine hydrochloride solution was coated on them.

[0048] At the end of coating the 4Kg solution, the pellets were sieved using a 1200 μm mesh and dried in the same fluidized bed at 60°C for 30 minutes.

[0049] Table 3 below records the operating conditions of the coating and the main operating parameter values ​​set for the equipment.

[0050] table 3

[0051] Parameter

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PUM

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Abstract

Herein is described a controlled release pharmaceutical composition of venlafaxine hydrochloride, an effective antidepressant, comprising an inert core, on which the active principle is uniformly layered, that in turn is coated with a layer comprising a hardening agent and a lipophilic agent; the process for the preparation of said pharmaceutical composition is also described.

Description

Technical field [0001] This application relates to the field of pharmaceutical compositions, in particular to a novel composition for the controlled release of venlafaxine hydrochloride. Background technique [0002] Venlafaxine, namely 1-[2-dimethylamino-1-(4-methoxyphenyl)-ethyl]cyclohexanol, is used in the treatment of depression and other neurological diseases such as epilepsy, par Products with recognized activity in the treatment of Kinsen's disease. [0003] The recommended daily dose range of the active ingredient is 75-350 mg per day, administered in 2 or 3 divided doses. This frequent dosing is particularly complicated, especially considering that the patient suffers from neurological diseases. Therefore, there is a clear need to design a controlled release composition of venlafaxine or its salt that allows avoiding frequent dosing and at the same time is suitable for the specific pharmacokinetics of venlafaxine salt. [0004] In fact, venlafaxine hydrochloride is a pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/137A61K9/48
CPCA61K9/167A61K9/5015A61K9/5042A61K9/5078A61K31/137A61P25/08A61P25/16A61P25/24A61K9/48
Inventor 罗伯托·瓦尔杜斯蒂兹亚诺·阿利基利塞若茨·阿万尼塞因
Owner VALPHARMA SA
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