Lorcaserin hydrochloride osmotic pump controlled release preparation and preparation method thereof

A lorcaserin hydrochloride and osmotic pump controlled release technology, which is applied in the field of medicine, can solve problems such as body dependence, damage to the release mechanism of sustained-release tablets, and sudden drug release.

Active Publication Date: 2021-04-27
ANHUI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The study found that lorcaserin hydrochloride matrix sustained-release preparations are bioequivalent to lorcaserin hydrochloride tablets, but the dose of lorcaserin hydrochloride should not exceed 10 mg twice a day (b.i.d), which may cause body It is dependent on laziness, and there is also the risk of drug burst release after the combined administration of lorcaserin hydrochloride matrix sustained-release preparations and food, which may be due to the changes in the environment of the gastrointestinal tract after food administration that causes lorcaserin hydrochloride The release mechanism of sustained-release tablets is disrupted, resulting in potential safety risks for patients taking lorcaserin matrix sustained-release tablets

Method used

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  • Lorcaserin hydrochloride osmotic pump controlled release preparation and preparation method thereof
  • Lorcaserin hydrochloride osmotic pump controlled release preparation and preparation method thereof
  • Lorcaserin hydrochloride osmotic pump controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] A 250 mg dose of lorcaserin hydrochloride osmotic pump tablets was prepared.

[0074] Tablet core: pass 20mg of lorcaserin hydrochloride, 100mg of mannitol, 7.5mg of polyvinylpyrrolidone, and 117.5mg of microcrystalline cellulose through an 80-mesh sieve, weigh them and mix them in equal amounts, add 250mg of 70% ethanol solution to make a soft material , granulated with a 20-mesh sieve, dried at 40°C for 6 hours, added with 5g of magnesium stearate and mixed evenly.

[0075] Preparation of coating solution: Weigh 10g of cellulose acetate and dissolve it in 500ml of acetone to prepare a solution of cellulose acetate in acetone, continue to add 0.75g of dibutyl phthalate DBP and 1g of PEG400, and place it on a magnetic stirrer without heating Stir under conditions until the solution is completely dissolved.

[0076] Tablet compression and coating: install the upper and lower punches, adjust the punching pressure to 60N, fill in 250 mg of tablet core granules and press i...

Embodiment 2

[0078] Pass 18mg of lorcaserin hydrochloride, 90mg of mannitol, 7mg of polyvinylpyrrolidone, and 110mg of microcrystalline cellulose through an 80-mesh sieve, weigh them according to the prescription amount, mix them by equal addition method, add 200mg of 70% ethanol solution to make a soft material, and use Granulate with a 20-mesh sieve, dry at 40°C for 6 hours, add 4g of magnesium stearate and mix well.

[0079] Preparation of coating solution: Dissolve 8g of cellulose acetate in 500ml of acetone to prepare a cellulose acetate acetone solution, add 0.7g of dibutyl phthalate DBP and 0.8g of PEG400, and place it on a magnetic stirrer without heating Stir under conditions until the solution is completely dissolved.

[0080] Tablet compression and coating: Install the upper and lower punches, adjust the tablet weight, and adjust the punching pressure to 75N, fill in 250mg of tablet core granules and press into tablets. Put the tablet cores in the coating pan, coat with the pre...

Embodiment 3

[0082] Pass 25mg of lorcaserin hydrochloride, 110mg of mannitol, 8mg of polyvinylpyrrolidone, and 120mg of microcrystalline cellulose through an 80-mesh sieve, weigh them according to the prescription amount, mix them by equal addition method, add 300mg of 75% ethanol solution to make a soft material, and use Granulate with a 20-mesh sieve, dry at 45°C for 6 hours, add 6g of magnesium stearate and mix well.

[0083] Preparation of coating solution: Dissolve 15g of cellulose acetate in 500ml of acetone to prepare a 3% cellulose acetate acetone solution, continue to add 5g of dibutyl phthalate DBP and 1.2g of PEG400, place on a magnetic stirrer Stir without heating until the solution is completely dissolved.

[0084] Tablet compression and coating: install the upper and lower punches, adjust the tablet weight, and adjust the punching pressure to 80N, fill in 250mg of tablet core granules and press into tablets. Put the tablet cores in the coating pan, coat with the prepared coa...

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Abstract

The invention relates to a lorcaserin hydrochloride osmotic pump controlled release preparation and a preparation method thereof. The lorcaserin hydrochloride osmotic pump controlled release preparation is a lorcaserin hydrochloride osmotic pump controlled release tablet, which comprises a tablet core and a controlled release semipermeable coating film wrapping the periphery of the tablet core. The lorcaserin hydrochloride osmotic pump controlled release preparation can be slowly and stably released in the gastrointestinal tract environment, and is simple to take and obvious in medicine effect.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a lorcaserin hydrochloride osmotic pump controlled-release preparation and a preparation method thereof. Background technique [0002] According to the study of the Obesity Research Collaborative Group of "Global Burden of Disease 2015", in 2015, there were approximately 107.7 million obese children and 603.7 million obese adults worldwide. Obesity rates in children and adults are 5% and 12%, respectively. According to statistics from the National Health and Family Planning Commission, the overweight rate of adults aged 18 and over in the country is 30.1%, and the obesity rate is 11.9%. The overweight rate of children and adolescents aged 6-17 is 9.6%, and the obesity rate is 6.4%. Obesity, as a health hazard that cannot be ignored in the modern population, will greatly increase the incidence of cardiovascular and cerebrovascular diseases and tumors. Therefore, weight loss drugs have rec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/32A61K9/22A61K9/28A61K31/55A61K47/38A61K47/36A61K47/26A61K47/02A61P3/04
CPCA61K9/2059A61K9/2054A61K9/2018A61K9/2009A61K9/2866A61K9/2846A61K9/284A61K9/2853A61K31/55A61P3/04
Inventor 汪电雷黄鹏蒋成君王重阳周丽
Owner ANHUI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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