Sustained or controlled release solid composition comprising bupropion hydrochloride

A technology of bupropion hydrochloride and solid composition, which is applied in the field of sustained and controlled release solid composition, can solve the problems affecting the drug safety of patients, cumbersome preparation process, and long use time, and achieve controllable drug quality and safety, and simple preparation method , the effect of reducing the incidence

Inactive Publication Date: 2014-05-07
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this preparation method requires two stages of coating to control the release rate of the active ingredient from the tablet core, and the preparation process is cumbersome and takes a long time.
The release rate of bupropion is determined by the proportion of the two-layer coating ingredients to the dry weight of the tablet. This drug delivery system has high requirements for the integrity and uniformity of the coating. The breakage of the coating layer is very likely to cause the burst release of the drug in the body (see comparative patent example 2, in the case of only wrapping the moisture barrier layer, more than 40% of the active ingredients are released from the tablet core in 1 hour in the acidic medium. Released), affecting the patient's drug safety

Method used

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  • Sustained or controlled release solid composition comprising bupropion hydrochloride
  • Sustained or controlled release solid composition comprising bupropion hydrochloride
  • Sustained or controlled release solid composition comprising bupropion hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0034] Drug-containing matrix sustained-release tablet core prescription (based on 1000 tablets)

[0035]

[0036]

[0037] Preparation Process:

[0038] Mix bupropion hydrochloride and hydroxypropyl methylcellulose K100M evenly, add PVPK30 aqueous solution as a binder to make a soft material, granulate with 18 mesh, control the drying temperature at 50°C, and keep the moisture content of the granules within 3.0%. 24-mesh granules, mixed with magnesium stearate, and compressed into tablets.

[0039] Add acrylic resin L100-55, polyethylene glycol 6000, triethyl citrate, and talcum powder to 95% ethanol in sequence, and after stirring evenly, use a coating pan for coating, and the weight gain of the coating is 6%-7% .

[0040] The present invention measures the release rate of the above-mentioned bupropion hydrochloride sustained-release tablet.

[0041] Release measurement conditions:...

Embodiment 2

[0062] Example 2 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0063] Drug-containing matrix sustained-release tablet core prescription (based on 1000 tablets)

[0064]

[0065] Preparation Process:

[0066] Mix bupropion hydrochloride and ethyl cellulose evenly, add 60% ethanol to make soft material, granulate with 18 mesh, control the drying temperature at 50°C, keep the water content of the granules within 3.0%, granulate with 24 mesh, add hard Magnesium fatty acid is mixed evenly and pressed into tablets.

[0067] Add acrylic resin L100-55, polyethylene glycol 6000, triethyl citrate, and talcum powder to 95% ethanol in sequence, and after stirring evenly, use a coating pan for coating, and the weight gain of the coating is 5.5%-6.5% .

[0068] The present invention measures the release rate of the above-mentioned bupropion hydrochloride sustained-release tablet.

[0069] Release measurement conditions:

[0070] Instrument: ZRS-8G, Tianjin Tian...

Embodiment 3

[0077] Example 3 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0078] Drug-containing matrix sustained-release tablet core prescription (based on 1000 tablets)

[0079]

[0080]

[0081] Preparation Process:

[0082] Mix bupropion hydrochloride and acrylic resin L100-55 evenly, add soft materials made of 80% ethanol, granulate with 18 mesh, control the drying temperature at 50°C, keep the water content of the granules within 3.0%, granulate with 24 mesh, add Magnesium stearate is mixed evenly and compressed into tablets.

[0083] Add ethyl cellulose, hypromellose, diethyl phthalate, and talcum powder to 90% ethanol in sequence, and after stirring evenly, use a coating pan to coat, and the weight gain of the coating is 4%-5 %.

[0084] The present invention measures the release rate of the above-mentioned bupropion hydrochloride sustained-release tablet.

[0085] Release measurement conditions:

[0086] Instrument: ZRS-8G, Tianjin Tianda Tianfa ...

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Abstract

The invention belongs to the technical field of pharmacy, and particularly provides a sustained or controlled release solid composition comprising a bupropion hydrochloride framework and a retarding layer. The sustained or controlled release solid composition is characterized in that the solid composition is composed of a table core comprising effective dose of bupropion hydrochloride and a framework sustained release material for controlling drug release, and a water-insoluble retarding layer coating the tablet core. The sustained or controlled release solid composition comprising bupropion hydrochloride, provided by the invention is safe and effective clinically, and is convenient for administration. The preparation method of the sustained or controlled release solid composition is simple, and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a tablet core containing bupropion hydrochloride and a sustained-release framework material, and a slow-controlled release solid composition in which the tablet core is surrounded by a retardation layer. Background technique [0002] Depression is a common mental illness, mainly manifested as low mood, loss of interest, pessimism, slow thinking, lack of initiative, self-blame, poor diet and sleep, worry that you have various diseases, and feeling that you are suffering from various diseases in your body. Discomfort, and in severe cases, suicidal thoughts and behaviors may appear. Bupropion hydrochloride is a norepinephrine, serotonin, and dopamine reuptake inhibitor that can be used to treat depression. In addition, bupropion hydrochloride can also be used as an auxiliary drug for smoking cessation. [0003] At present, the medicines containing bupropion on the mar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K31/137A61K47/38A61K47/34A61K47/32A61P25/24A61P25/34
Inventor 马莉郭夏宋雪梅
Owner BEIJING VENTUREPHARM BIOTECH
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