Sustained-release pharmaceutical composition containing venlafaxine hydrochloride as well as preparation method thereof

A technology of venlafaxine hydrochloride and a composition is applied in a new pharmaceutical composition and the field of preparation thereof, which can solve the problems of consuming manpower, material resources and time, achieve stable drug release, solve the problem of high solubility, and improve the preparation process simple effect

Inactive Publication Date: 2018-06-29
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Wet granulation requires the addition of binders and the drying of the obtained granules, which requires a certain amount of manpower, material resources and time

Method used

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  • Sustained-release pharmaceutical composition containing venlafaxine hydrochloride as well as preparation method thereof
  • Sustained-release pharmaceutical composition containing venlafaxine hydrochloride as well as preparation method thereof
  • Sustained-release pharmaceutical composition containing venlafaxine hydrochloride as well as preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The preparation of venlafaxine hydrochloride sustained-release tablet, tablet composition is as follows:

[0027] prescription

Dosage per tablet (mg)

Venlafaxine Hydrochloride

75

Glyceryl behenate

40

HPMC K4M

120

Calcium hydrogen phosphate anhydrous

115

silica

3.6

Magnesium stearate

6.4

[0028] Preparation:

[0029] (1) Preparation of Venlafaxine Hydrochloride Sustained-release Granules: Weigh the prescription amount of Venlafaxine Hydrochloride, Glyceryl Behenate, Hypromellose and Anhydrous Dibasic Calcium Phosphate and mix them evenly, then place in a high-shear mixing system In the granulator, turn on the stirring paddle and the shearing paddle, the speeds are 600r / min and 1000r / min respectively, heat to 80°C to melt the glyceryl behenate, continue stirring for 5min, and adjust the speed of the stirring paddle and the shearing paddle to 1000r / min respectively / min and 2000r / min, turn on t...

Embodiment 2

[0032] The preparation of venlafaxine hydrochloride sustained-release tablet, tablet composition is as follows:

[0033] prescription

Dosage per tablet (mg)

Venlafaxine Hydrochloride

75

Glyceryl behenate

75

HPMC K15M

100

Calcium hydrogen phosphate anhydrous

100

silica

5

Magnesium stearate

5

[0034] Preparation:

[0035](1) Preparation of Venlafaxine Hydrochloride Sustained-release Granules: Weigh the prescription amount of Venlafaxine Hydrochloride, Glyceryl Behenate, Hypromellose and Anhydrous Dibasic Calcium Phosphate and mix them evenly, then place in a high-shear mixing system In the granulator, turn on the stirring paddle and the shearing paddle, the speeds are 600r / min and 1000r / min respectively, heat to 85°C to melt the glyceryl behenate, continue stirring for 5min, and adjust the speed of the stirring paddle and the shearing paddle to 1000r / min respectively / min and 2000r / min, turn on the c...

Embodiment 3

[0038] The preparation of venlafaxine hydrochloride sustained-release tablet, tablet composition is as follows:

[0039] prescription

Dosage per tablet (mg)

Venlafaxine Hydrochloride

75

Glyceryl behenate

150

HPMC K100M

80

Calcium hydrogen phosphate anhydrous

45

silica

6.4

Magnesium stearate

3.6

[0040] Preparation:

[0041] (1) Preparation of Venlafaxine Hydrochloride Sustained-release Granules: Weigh the prescription amount of Venlafaxine Hydrochloride, Glyceryl Behenate, Hypromellose and Anhydrous Dibasic Calcium Phosphate and mix them evenly, then place in a high-shear mixing system In the granulator, turn on the stirring paddle and the shearing paddle, the rotating speeds are 600r / min and 1000r / min respectively, heat to 90°C to melt the glyceryl behenate, continue stirring for 5min, adjust the rotating speed of the stirring paddle and the shearing paddle to 1000r / min respectively / min and 2000r...

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PUM

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Abstract

The invention belongs to the field of a pharmaceutical composition for treating depression, more exactly relates to a new pharmaceutical composition of a venlafaxine hydrochloride sustained release tablet as well as a preparation method thereof. The pharmaceutical composition of the sustained release tablet consists of the following components according to weight proportion: each tablet contains 75 mg of venlafaxine hydrochloride, 25 to 250 mg of glyceryl behenate, 15 to 200 mg of hydroxypropyl methylcellulose, 20 to 200 mg of anhydrous calcium hydrogen phosphate, 1.8 to 7.2 mg of silicon dioxide and 1.8 to 7.2 mg of magnesium stearate; and the venlafaxine hydrochloride sustained release tablet is prepared by a melting granulation method, the sustained release tablet prepared by the methodcan continuously and stably release the medicine within 24 hours, stable blood concentration is maintained, the medicine use times of patients are reduced, and the medicine use safety and the compliance of the patients are improved. Compared with other granulation methods, the preparation method is time-saving and energy-saving, so the preparation process is simple, rapid and economic, solvent residues are avoided and the preparation method is suitable for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical compositions for treating depression, and in particular relates to a novel pharmaceutical composition of venlafaxine hydrochloride sustained-release tablets and a preparation method thereof. Background technique [0002] Venlafaxine is a phenylethylamine derivative and a reuptake inhibitor of 5-HT, norepinephrine and dopamine, among which the reuptake inhibitory effect on 5-hydroxytryptamine is the strongest, and the reuptake inhibitory effect on norepinephrine is also strong. Stronger, weaker inhibitory effect on dopamine reuptake. [0003] The antidepressant effect appears faster than other antidepressants, the side effects are smaller than imipramine, and the effect is better than imipramine, and its curative effect is equivalent to that of trazodone. Higher doses of venlafaxine (greater than 150 mg per day) are more effective than low doses. It is clinically used to treat depression, anxiety, o...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/38A61K47/14A61K31/137A61P25/24
CPCA61K9/2013A61K9/2054A61K9/2095A61K31/137
Inventor 孙慧娟王明森李大伟张菊红王丽丽刘正平祝美华张建强
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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