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Desmethylvenlafaxine controlled release tablet and preparation method thereof

A technology for desvenlafaxine and controlled-release tablets, which is used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of restricting the promotion of osmotic pump products, difficult production, and long production cycle. , to improve reliability and stability, reduce labor intensity, and reduce equipment costs

Active Publication Date: 2012-02-15
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the above-mentioned preparations can realize the sustained release of drugs, the industrial production of the above-mentioned osmotic pump preparations has too many processes, the control indicators of each process are very strict, the production is difficult, the production cycle is long, the cost is high, and the waste rate is high. Promotion of pump products

Method used

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  • Desmethylvenlafaxine controlled release tablet and preparation method thereof
  • Desmethylvenlafaxine controlled release tablet and preparation method thereof
  • Desmethylvenlafaxine controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Chip composition:

[0036]

[0037] Coating film composition:

[0038] Cellulose acetate 21g

[0039] Hydroxypropyl Cellulose (Klucel LF) 9g

[0040] Dibutyl sebacate 2g

[0041] Make 1000 tablets by the following preparation method:

[0042] (1) Tablet core preparation Take sodium chloride and pulverize, pass through a 100-mesh sieve, mix evenly with medicine and microcrystalline cellulose, use ethanol as a wetting agent, make a soft material, pass through a 30-mesh sieve to granulate, and dry at 50°C for 2 hour, granulate, add magnesium stearate, mix, tabletting, adopt conventional tabletting technology to compress 1000 tablets.

[0043] (2) Tablet core coating: take cellulose acetate, add acetone 600ml, stir to dissolve; take another hydroxypropyl cellulose (Klucel LF) and put it in a 50ml measuring bottle, add water to dissolve it, and add it to the above 1500ml acetic acid In the cellulose acetone solution, stir while adding to dissolve all the hydroxypropyl ...

Embodiment 2

[0046] Chip composition:

[0047] Chip composition:

[0048]

[0049] Coating film composition:

[0050] Ethylcellulose 12g

[0051] Poloxamer 237 6g

[0052] Triethyl citrate 2g

[0053] Make 1000 tablets by the following preparation method:

[0054] (1) Tablet core preparation Take mannitol and crush it, pass through a 100-mesh sieve, mix evenly with desvenlafaxine succinate, HPMC-K4M, HPMC-K100LV, use ethanol as a wetting agent, make a soft material, pass through a 30-mesh Sieve and granulate, dry at 45°C for 2 hours, granulate, add magnesium stearate, mix well, compress into tablets, and compress 1000 tablets by conventional tablet technology.

[0055] (2) Tablet core coating: Take poloxamer 237, ethyl cellulose and hydroxypropyl cellulose, add 1500 ml of ethanol, stir to dissolve. Add triethyl citrate and shake well to obtain a coating solution. Put the tablet cores prepared above in a coating machine, pass hot air, keep the temperature between 30-40°C, and spra...

Embodiment 3

[0058] Chip composition:

[0059]

[0060]

[0061] Coating film composition:

[0062] Cellulose diacetate 26.5g

[0063] Hydroxypropyl Cellulose Klucel GF 1.5g

[0064] Dibutyl sebacate 2g

[0065] The composition of the film coating layer containing the main drug:

[0066] Desvenlafaxine Succinate 15g

[0067] Hypromellose 20g

[0068] Polyethylene glycol (1000) 2g

[0069] Make 1000 tablets by the following preparation method:

[0070] (1) Tablet core preparation: crush sodium chloride, add the main ingredient and 1 / 2 microcrystalline cellulose, pass through a 60-mesh sieve, and mix well. Add appropriate amount of 10% polyvinylpyrrolidone k-30 ethanol solution to make a soft material, pass through a 30-mesh sieve to granulate, and place in an oven to heat and dry at 50°C. The prepared granules are mixed with the remaining microcrystalline cellulose and magnesium stearate, and then added into a tablet machine for tablet compression.

[0071] (2) Tablet core co...

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Abstract

The invention relates to a desmethylvenlafaxine controlled release tablet and a preparation method thereof. In the controlled release tablet, a certain amount of and even a small amount of macromolecular hydrophilic or water-soluble polymer as a pore-foaming agent is added to form continuous micropores to provide channels for drug release, and mechanical drilling is not needed, thereby simplifying the preparation process, greatly reducing the production cost and labor intensity and improving the stability and safety of the preparation.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a desvenlafaxine controlled-release tablet and a preparation method thereof. Background technique [0002] In 1955, two Australian scholars, Rose and Nelson, invented a simple osmotic pump for animal drug delivery. Since Alza Company simplified and improved the osmotic pump in the 1970s, osmotic pump preparations have successively experienced single-chamber osmotic pumps, Single-chamber double-layer osmotic pumps, double-chamber osmotic pumps, and other forms of time-release osmotic pumps have been developed in order to adapt to the circadian rhythm of the human body. However, the above-mentioned osmotic pump preparations require mechanical drilling to achieve drug release. Although the above-mentioned preparations can realize the sustained release of drugs, the industrial production of the above-mentioned osmotic pump preparations has too many processes, th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/32A61K9/36A61K31/137A61P25/24A61P25/22
Inventor 蒋海松王锦刚
Owner COSCI MED TECH CO LTD