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Venlafaxine hydrochloride controlled release tablets and preparation method thereof

A technology of venlafaxine hydrochloride and controlled-release tablets, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as low drug load and avoid difficulty in swallowing , The effect of reducing production cost and reliable quality control

Active Publication Date: 2011-01-26
HEFEI LIFEON PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, as mentioned earlier, the problem of low drug loading in existing technologies must be solved

Method used

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  • Venlafaxine hydrochloride controlled release tablets and preparation method thereof
  • Venlafaxine hydrochloride controlled release tablets and preparation method thereof
  • Venlafaxine hydrochloride controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] (1) Tablet core prescription

[0055] Composition g / 1000 tablets

[0056] Venlafaxine Hydrochloride 85

[0057] Polyethylene oxide (molecular weight 5 million) 5

[0058] Microcrystalline Cellulose 40

[0059] Sodium chloride 10

[0060] Dextrin 20

[0061] Povidone 5

[0062] Magnesium stearate 0.5

[0063] Theoretical weight per tablet: 165.5mg

[0064] (2) Preparation method

[0065] Mix the proportioned venlafaxine hydrochloride, polyoxyethylene, microcrystalline cellulose, sodium chloride, dextrin, and povidone evenly, add an appropriate amount of ethanol to make a soft material, granulate with a 30-mesh sieve, and dry at 40°C. 20 mesh whole grains. Add the proportioned amount of magnesium stearate, mix well, and press into tablets with a shallow concave die to obtain the product.

[0066] The composition ratio of the controlled-release film coat is as follows:

[0067] Cellulose acetate 100g

[0068] Dimethyl phthalate 1g

[0069] Macrogol 1500 20g

...

Embodiment 2

[0075] (1) Tablet core prescription

[0076] Composition g / 1000 tablets

[0077] Venlafaxine Hydrochloride 85

[0078] Polyethylene oxide (molecular weight 5 million) 10

[0079] Microcrystalline Cellulose 10

[0080] Sodium chloride 20

[0081] Dextrin 25

[0082] povidone 5

[0083] Magnesium stearate 0.5

[0084] Theoretical weight per tablet: 155.5mg

[0085] (2) The preparation method is the same as in Example 1.

[0086] Embodiment 2 selects the diameter as The weight gain of the controlled-release film coating is controlled in the range of about 5%; double-sided laser drilling is adopted, and the pore size is controlled in the range of about 0.3 mm to 0.4 mm.

Embodiment 3

[0088] (1) Tablet core prescription

[0089] Composition g / 1000 tablets

[0090] Venlafaxine Hydrochloride 85

[0091] Polyethylene oxide (molecular weight 5 million) 5

[0092] Microcrystalline Cellulose 35

[0093] Sodium chloride 15

[0094] Dextrin 54

[0095] Povidone 10

[0096] Magnesium Stearate 1

[0097] Theoretical weight per tablet: 205mg

[0098] (2) preparation method is the same as embodiment 1

[0099] Embodiment 3 selects diameter as The weight gain of the controlled-release film coating is controlled in the range of about 4%; the single-sided laser drilling is adopted, and the pore size is controlled at about 0.5mm.

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Abstract

The invention discloses venlafaxine hydrochloride controlled release tablets and a preparation method thereof. The venlafaxine hydrochloride controlled release tablets are elementary osmotic pump (EOP) controlled release tablets which comprise single-layer tablet cores, insoluble semi-permeable membranes and medicament release holes. In the invention, the high-molecular-weight ethylene oxide, microcrystalline cellulose and sodium chloride three auxiliary materials mixed in a proper ratio form a balance system for medicament dissolution and osmotic pressure generation in a pump chamber, and tablet weight is adjusted by using detrix as a filler, so that a high-medicament-capacity osmotic pump preparation can be obtained and the stable and lasting release can be kept. The preparation effectively overcome the shortcomings that the conventional sustained-release preparation is limited in the stability and controllability of the medicament release and can generate stable and constant-speed release, and the medicament release is protected from the influences of stomach and intestine environments, so that individual difference is reduced and the medicament controlled release design aim of giving play to curing effects and reducing side effects is further fulfilled.

Description

technical field [0001] The invention relates to a venlafaxine hydrochloride controlled-release preparation, in particular to an oral venlafaxine hydrochloride osmotic pump controlled-release tablet and a preparation method thereof. Background technique [0002] Venlafaxine is a 5-hydroxytryptamine (5-HT) and norepinephrine (NE) dual recovery blocker developed by Wyeth Corporation of the United States, which is clinically used for the treatment of depression and generalized anxiety disorder. Depression, as a "by-product" of the rapid development of modern economy, has affected people's lives more and more widely. Statistics show that 70% of people in our country are in a sub-health state, and patients with mental-related diseases account for about 5% to 10% of the population. Mental disorders and psychological disorders have become frequently-occurring and common diseases. The "World Health Report" issued by the World Health Organization (WHO) shows that depression has becom...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/22A61K9/30A61K9/36A61K9/44A61K47/32A61K47/38A61P25/22A61P25/24
Inventor 季俊虬高美华陈军夏军
Owner HEFEI LIFEON PHARMA
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