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Metformin hydrochloride controlled-release tablet

A technology of metformin hydrochloride controlled-release tablets and metformin hydrochloride, which is applied in the direction of medical preparations, coatings, and pill delivery of non-active ingredients, which can solve the problems of taking 2 or 3 times a day and short half-life, so as to increase compliance , Reduce production costs, reduce the effect of treatment costs

Inactive Publication Date: 2020-05-08
XINFA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the short half-life of metformin, common preparations need to be taken 2 or 3 times a day

Method used

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  • Metformin hydrochloride controlled-release tablet
  • Metformin hydrochloride controlled-release tablet
  • Metformin hydrochloride controlled-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033] (1) Take metformin hydrochloride and pass through an 80-mesh sieve, and add the sieved metformin hydrochloride into the wet granulator;

[0034] (2) Add the fillers and binders into the wet granulator, the speed of the wet granulator is 20rpm, and spray 20% of the solid feed into purified water to granulate for 15 minutes;

[0035] (3) Dry the prepared granules in an oven at 40°C for 20 minutes, and control the moisture content of the granules at 3%;

[0036] (4) Add the dried particles into the mixer, set the speed at 60rpm, and mix for 10min;

[0037] (5) Add the lubricant into the mixer, continue mixing for 2-5 minutes, and take out the mixed materials for later use;

[0038] (6) Prepare the blank core material and purified water into a suspension, and the blank core material accounts for 25%;

[0039] (7) Spray the prepared suspension into the centrifugal granulator, set the rotation speed to 200rpm, set the spray speed to 30g / min, and set the drying t...

Embodiment 2

[0046]

[0047] (1) Take metformin hydrochloride and pass through an 80-mesh sieve, and add the sieved metformin hydrochloride into the wet granulator;

[0048] (2) Add the fillers and binders into the wet granulator, the speed of the wet granulator is 20rpm, spray 20% of the solid feed into purified water and granulate for 15min;

[0049] (3) Dry the prepared granules in an oven at 40°C for 20 minutes, and control the moisture content of the granules at 2%;

[0050] (4) Add the dried particles into the mixer, set the speed at 60rpm, and mix for 10min;

[0051] (5) Add the lubricant into the mixer, continue mixing for 2-5 minutes, and take out the mixed materials for later use;

[0052] (6) Prepare the blank core material and purified water into a suspension, and the blank core material accounts for 35%;

[0053] (7) Spray the prepared suspension into the centrifugal granulator, set the rotation speed to 200rpm, set the spray speed to 30g / min, and set the drying temperatu...

Embodiment 3

[0060]

[0061] (1) Take metformin hydrochloride and pass through an 80-mesh sieve, and add the sieved metformin hydrochloride into the wet granulator;

[0062] (2) Add the fillers and binders into the wet granulator, the speed of the wet granulator is 40pm, and spray 20% solids into purified water for granulation for 15 minutes;

[0063] (3) Dry the prepared granules in an oven at 40°C for 20 minutes, and control the moisture content of the granules at 1%;

[0064] (4) Add the dried particles into the mixer, set the speed at 60rpm, and mix for 10min;

[0065] (5) Add the lubricant into the mixer, continue mixing for 2-5 minutes, and take out the mixed materials for later use;

[0066] (6) Prepare the blank core material and purified water into a suspension, and the blank core material accounts for 25-35%;

[0067] (7) Spray the prepared suspension into the centrifugal granulator, set the rotation speed to 200rpm, set the spray speed to 30g / min, and set the drying tempera...

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Abstract

The present invention discloses a metformin hydrochloride controlled-release tablet. The metformin hydrochloride controlled-release tablet comprises a blank pill core, a drug-loading layer and a controlled-release film layer. The metformin hydrochloride controlled-release tablet is characterized in that the blank pill core is composed of one or more of microcrystalline cellulose, lactose and a sucrose pill core, the drug-loading layer comprises metformin hydrochloride, a filler, a binder and a lubricant, and the controlled-release film layer comprises a controlled-release material and a pore-forming agent. Advantages are that the metformin hydrochloride controlled-release tablet reduces the number of daily medication by patients with type 2 diabetes by changing medication from 2 or 3 timesa day to once a day, can improve bioavailability, also increases patient compliance, also reduces production cost, reduces patient treatment cost, and reduces national medical insurance support and financial burden from 10 yuan per tablet to 0.3 yuan per tablet.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to metformin hydrochloride controlled-release tablets and a preparation method thereof. Background technique [0002] The chemical name of metformin (1,1-dimethylbiguanide) is commonly used as a drug and its hydrochloride is a white crystal or crystalline powder; it is odorless. Soluble in water, soluble in methanol, slightly soluble in ethanol, insoluble in chloroform, acetonitrile or ether. The brand name of the original metformin drug is "Gehuazhi", which is developed and produced by Bristol-Myers Squibb. Metformin hydrochloride is a biguanide hypoglycemic drug. It is used for type 2 diabetic patients who are not satisfied with simple diet control, especially obese and hyperinsulinemia patients. This drug not only has hypoglycemic effect, but also may reduce weight. and the effects of hyperinsulinemia. It can be effective for some patients with poor curat...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/22A61K47/38A61K31/155A61P3/10
CPCA61K9/2886A61K9/2866A61K31/155A61P3/10
Inventor 马俊王恒刘钊何江波
Owner XINFA PHARMA
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