Metformin hydrochloride dual sustained and controlled release composition as well as preparation method and application thereof

A technology of metformin hydrochloride and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems of high production cost, reduced stability, and serious slow-release tablets, and achieve the effects of low production cost, improved compliance, and easy swallowing

Active Publication Date: 2021-06-22
CHONGQING CONQUER PHARML
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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
Sustained-release tablets with a matrix sustained-release mechanism are bulky, and the patient’s compliance with taking them is poor
[0006] The coating material of patent No. CN107049980A is that the coating film formed by ethyl cellulose, polyethylene glycol 6000 and cetyl alcohol has poor toughness; the coating film will gradually produce small cracks, which reduces its stability, and its tablet core The slow-release agent sodium carboxymethyl cellulose has poor slow-release effect, and the release degree of the long-term 30-month sample is close to the standard limit, and there is a quality risk
[0007] WO 1999 / 47128 discloses a biphasic controlled-release formulation technology with prolonged gastric retention using ionic polymers and non-ionic polymers requires a large amount of sustained-release agents, the size of the formulation is larger, and the convenience of administration deteriorates The problem
[0008] There are the following problems in the preparation of sustained release through the matrix: 1. uneven drug release, sudden release or no release phenomenon;
Therefore, the existing metformin hydrochloride controlled-release preparations still have high production costs, unsatisfactory release stability and patient oral compliance problems

Method used

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  • Metformin hydrochloride dual sustained and controlled release composition as well as preparation method and application thereof
  • Metformin hydrochloride dual sustained and controlled release composition as well as preparation method and application thereof
  • Metformin hydrochloride dual sustained and controlled release composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Embodiment 1. A kind of preparation method of film-controlled metformin double controlled-release tablet

[0076] 1. Weigh the components according to the formula of the tablet core and the formula of the coating solution

[0077] Table 1 The weight ratio table of the components of the film-controlled metformin dual controlled-release tablet

[0078]

[0079] 2. Preparation steps

[0080] 1. Preparation of sustained-release metformin hydrochloride tablet cores

[0081] (1) Metformin hydrochloride raw material and lactose, stearyl alcohol, polyethylene oxide are pulverized through a 100 mesh sieve;

[0082] (2) Put the powder sieve obtained in (1) into a wet granulator, stir evenly at a low speed, add 5% povidone K30 aqueous solution to make a soft material, and make it in a 12-mesh oscillating granulator with a frequency of 40-50Hz. grain;

[0083] (3) Dry the wet granules at 60°C, control the water content to 2.5% to 3.5%, take out, and granulate in a swinging g...

Embodiment 2

[0087] Embodiment 2. A kind of preparation method of film-controlled metformin double controlled-release tablet

[0088] 1. Weigh the components according to the formula of the tablet core and the formula of the coating solution

[0089] Table 2 The weight ratio of the components of the film-controlled metformin dual controlled-release tablet

[0090]

[0091] 2. Preparation steps

[0092] 1. Preparation of sustained-release metformin hydrochloride tablet cores

[0093] (1) Metformin hydrochloride raw material and lactose, stearyl alcohol, polyethylene oxide are pulverized through 80 mesh sieves;

[0094] (2) Put the powder sieve obtained in (1) into a wet granulator, stir evenly at a low speed, add 3% hypromellose aqueous solution to make a soft material, and use a 12-mesh oscillating granulator with a frequency of 40-50Hz Granulation;

[0095](3) Dry the wet granules at 60°C, control the water content to 2.5% to 3.5%, take out, and granulate in a swinging granulator w...

Embodiment 3

[0099] Embodiment 3 A kind of preparation method of film-controlled metformin double controlled-release tablet

[0100] 1. Weigh the components according to the formula of the tablet core and the formula of the coating solution

[0101] Table 3 The weight ratio table of the components of the film-controlled metformin dual controlled-release tablet

[0102]

[0103] 2. Preparation steps

[0104] 1. Preparation of sustained-release metformin hydrochloride tablet cores

[0105] (1) Metformin hydrochloride raw material and lactose, stearyl alcohol, polyethylene oxide are pulverized through a 120 mesh sieve;

[0106] (2) Add the powder sieve obtained in (1) into a wet granulator, stir evenly at a low speed, add 3% hydroxypropyl methylcellulose aqueous solution, mix the powder sieve and add a binder to make a soft material, Granulate in a 12-mesh oscillating granulator with a frequency of 40-50Hz;

[0107] (3) Dry the wet granules at 60°C, control the water content to 1.5% to...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and discloses a metformin hydrochloride dual controlled release composition, which is prepared from a controlled release coating film coated outside a tablet core of metformin hydrochloride containing a controlled release material, the metformin hydrochloride tablet core containing the sustained-release material is composed of metformin hydrochloride, the sustained-release material, a filling agent and an adhesive, the coating layer is composed of a coating sustained-release material, a plasticizer and a pore-foaming agent, the coating sustained-release material is cellulose acetate, the tablet core sustained-release material is a mixture of octadecanol and polyoxyethylene, and the coating sustained-release material is cellulose acetate. According to the technical scheme, compared with a traditional film-coated controlled release tablet, the film-controlled metformin hydrochloride dual controlled release composition has the advantages that the time for keeping the stable release degree is longer, the storage stability is better, the process is simple, expensive production equipment is not needed, the cost is low, and industrialization is easy.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to controlled-release preparations, more specifically to metformin hydrochloride controlled-release tablets and a preparation method thereof. Background technique [0002] Diabetes, as a serious non-communicable chronic disease, has become the "No. 3 killer" that threatens mankind after tumors and cardiovascular and cerebrovascular diseases. Metformin is a therapeutic agent for non-insulin-dependent diabetes mellitus, and chemically has a biguanide structure. Metformin controls glucose production in the gastrointestinal tract and increases glucose utilization in muscles, and thus has been used in the prevention and treatment of diabetes. In addition, metformin has the advantage of improving lipid metabolism to prevent weight gain, and can be used to prevent and treat the occurrence and exacerbation of diabetic complications (such as cardiovascular diseases, etc.). Metfor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/38A61K47/10A61K31/155A61P3/10
CPCA61K9/2866A61K9/2013A61K9/2031A61K31/155A61P3/10
Inventor 陈用芳吴奇财胡延贵杨绪凤何伟冉诗念朱元波刘双
Owner CHONGQING CONQUER PHARML
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