Metformin hydrochloride osmotic pump controlled release tablet and preparation method thereof

A technology of metformin hydrochloride and controlled-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc. It can solve the problems of decreased hardness, damage to the functionality of excipients, and unsuitable purified water. , to achieve the effects of drug release maintenance, improved release uniformity, and good release regulation

Active Publication Date: 2016-08-24
HEFEI LIFEON PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 2. After adding polyoxyethylene, it is inappropriate to use purified water, because polyoxyethylene will become sticky when it meets water, and as a result, serious spherical objects will be produced, which will be spherical and hard after drying. Due to the high toughness of polyoxyethylene, The hard group is not easy to break, and the tablet will have obvious spots;
[0013] 3. Polyoxyethylene is sensitive to temperature, and its denaturation point is 61°C to 63°C. Water is used as a wetting agent, and it takes a long time to dry at low temperature (40°C) to dry the water to the required limit. The relatively high temperature and high humidity baking time directly aggravates the instability of raw materials and destroys the functionality of excipients;
[0014] 4. After the water system is used, the hardness is greatly reduced, because the raw materials are easily soluble in water. After the water granulation is used, some raw materials are distributed in a dissolved state and wrapped on the surface of other raw and auxiliary materials. During tableting, only the raw materials are in contact with each other. Because metformin The reason of poor compressibility leads to the decrease of hardness, which cannot easily meet the requirements of the coating on the hardness and friability of the tablet core.

Method used

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  • Metformin hydrochloride osmotic pump controlled release tablet and preparation method thereof
  • Metformin hydrochloride osmotic pump controlled release tablet and preparation method thereof
  • Metformin hydrochloride osmotic pump controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] 1. Tablet core composition (mg / P)

[0063]

[0064] Granulation: powder metformin hydrochloride through a 100-mesh sieve, mix with other excipients except magnesium stearate evenly, use 95% ethanol to make soft material, wet granulate, dry below 40°C, control moisture at 2.0%

[0065] Below, 20 mesh sieve granules, add lubricant magnesium stearate and mix;

[0066] Tablet compression: use a shallow concave die to compress the tablets, set the rotary tablet press to compress the tablets, and control the hardness to 10-20kg / m2.

[0067] 2. Composition of the controlled-release coating layer

[0068]

[0069] 3. Composition of film coating

[0070]

[0071] Semi-permeable film coating: Take a certain amount of acetone, add cellulose acetate and PEG1500 to the acetone solution, stir to dissolve until a clear solution is obtained, and then use a high-efficiency coating pan to continuously coat the tablet core; the coating flow rate is about 100-150g / min, the tem...

Embodiment 2

[0076] Tablet core composition (mg / P)

[0077]

[0078] 1, semi-permeable membrane layer and film coating composition are the same as embodiment 1;

[0079] 2, production process is the same as embodiment 1;

[0080] 3. The weight gain of the coating is 4-6%.

Embodiment 3

[0082] Tablet core composition (mg / P)

[0083]

[0084] 1, semi-permeable membrane layer and film coating composition are the same as embodiment 1;

[0085] 2, production process is the same as embodiment 1;

[0086] 3. The weight gain of the coating is 4-6%.

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Abstract

The invention relates to the field of pharmaceutical preparations and particularly provides a controlled release tablet of metformin hydrochloride and a preparation method of the controlled release tablet. The controlled release tablet provided by the invention contains a tablet core, an insoluble semi-permeable membrane and a drug release micro-pore, wherein the tablet core contains metformin hydrochloride, an adhesive, a release regulator, an absorption accelerant and a lubricating agent. The metformin hydrochloride in the controlled release tablet provided by the invention can be stably released at a constant speed, so that absorption of drugs is more facilitated, and a better in vivo pharmacokinetic curve is realized. Moreover, the preparation method of the controlled release tablet is simple and easy in process, and the technical defect of poor compressibility of the tablet is solved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a metformin hydrochloride osmotic pump controlled-release tablet and a preparation method thereof. Background technique [0002] Metformin hydrochloride is an anti-diabetic drug, which can improve the blood sugar tolerance of patients with type II diabetes and lower the basal and postprandial blood sugar. The mechanism of action of metformin hydrochloride is to reduce the production of glycogen, reduce intestinal absorption of sugar, and improve insulin sensitivity by increasing the uptake and utilization of peripheral sugar. The above-mentioned therapeutic properties of metformin hydrochloride have received a large number of clinical research and application support, making it the first-line drug for patients with type II diabetes. [0003] There have been many developments and researches on metformin hydrochloride sustained-release and controlled-release preparations...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K31/155A61K47/32A61P3/10
Inventor 季俊虬高美华陈军何杰
Owner HEFEI LIFEON PHARMA
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