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Novel metformin hydrochloride sustained release pellets and preparation method thereof

A technology for metformin hydrochloride and sustained-release pellets, which is applied in the field of pharmaceutical preparations, can solve the problem that there is no metformin hydrochloride sustained-release pellets, etc., and achieves the effects of masking bad odor, enhancing drug stability, and improving bioavailability

Active Publication Date: 2013-04-17
GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The metformin hydrochloride sustained-release pellets reported in this paper are prepared by applying hot-melt coating technology. At present, there is no related report on the preparation of metformin hydrochloride sustained-release pellets by using hot-melt coating technology

Method used

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  • Novel metformin hydrochloride sustained release pellets and preparation method thereof
  • Novel metformin hydrochloride sustained release pellets and preparation method thereof
  • Novel metformin hydrochloride sustained release pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The percentage in the prescription is the percentage by weight of the component in the entire prescription, and the percentage of lipid material is calculated by the weight of the pill core, which is the same in the following examples.

[0039] (1) Components containing pill core:

[0040]

[0041] (2) Components of the sustained-release coating layer:

[0042] Glyceryl monostearate 10% to 50%, preferably 15% to 40%

[0043] To prepare metformin hydrochloride extended-release pellets:

[0044] Step 1: Mix metformin hydrochloride and lactose evenly, add a solution of hypromellose and water, and make the powder into a wet and uniform soft material with certain plasticity;

[0045] Step 2: Put the soft material in an extruder to extrude, put the extruded product in a spheronizer and spheronize, add an appropriate amount of talc powder during the spheronization process, spheronize to form a pellet core, and dry to obtain a pill core;

[0046] Step 3: Place the pill core...

Embodiment 2

[0054] (1) Components containing pill core:

[0055]

[0056] (2) Components of the sustained-release coating layer:

[0057] Glyceryl tristearate 10% to 50%, preferably 15% to 40%

[0058] To prepare metformin hydrochloride extended-release pellets:

[0059] Step 1: Mix metformin hydrochloride and microcrystalline cellulose evenly, add a uniformly mixed solution of starch and water, and make the powder into a moist and uniform soft material with certain plasticity;

[0060] Step 2: Put the soft material in an extruder to extrude, put the extruded product in a spheronizer and spheronize, add an appropriate amount of talc powder during the spheronization process, spheronize to form a pellet core, and dry to obtain a pill core;

[0061] Step 3: Place the pill core in a fluidized bed coating machine, heat to melt tristearin, coat it, and dry it to obtain metformin hydrochloride sustained-release pellets.

[0062] Atomization pressure: 0.254mpa

[0063] Wind speed: 6~7m / s ...

Embodiment 3

[0069] (1) Components containing pill core:

[0070]

[0071] (2) Components of the sustained-release coating layer:

[0072] Glyceryl behenate 10% to 50%, preferably 15% to 40%

[0073] To prepare metformin hydrochloride extended-release pellets:

[0074] Step 1: Mix metformin hydrochloride and lactose evenly, add a solution of polyvinylpyrrolidone and water, and make the powder into a moist and uniform soft material with certain plasticity;

[0075] Step 2: Put the soft material in an extruder to extrude, put the extruded product in a spheronizer and spheronize, add an appropriate amount of magnesium stearate during the spheronization process, spheronize to form a pellet core, and dry to obtain a pill core;

[0076] Step 3: Put the pill core containing the drug in a fluidized bed coating machine, heat to melt the glyceryl behenate, coat it, and dry it to obtain metformin hydrochloride sustained-release pellets.

[0077] Atomization pressure: 0.254mpa

[0078] Wind spe...

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Abstract

The invention discloses novel metformin hydrochloride sustained release pellets and a preparation method thereof. The metformin hydrochloride is formed by coating a sustained release coating layer outside a medicament-containing pellet core, and the medicament-containing pellet core is prepared from the following components by weight percent: 5-50% of metformin hydrochloride, 50-95% of excipient, filler, adhesive, wetting agent and antisticking agent, wherein the filler, the adhesive, the wetting agent and the antisticking agent account for 20-80%, 2-20%, 10-60% and 1-20% of the total weight of the metformin hydrochloride and the excipient respectively; and the sustained release coating layer is prepared from the following component according to weight percentage: grease material which accounts for 10-50% of the total weight of the metformin hydrochloride and the excipient. The metformin hydrochloride sustained release pellets prepared by the method not only can effectively reduce the accumulation of medicaments and the toxic and side effects of the metformin hydrochloride, but also can reduce the release of the medicaments and improve the bioavailability.

Description

technical field [0001] The invention provides a novel metformin hydrochloride sustained-release pellet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] [0003] Metformin hydrochloride (Metformin hydrochloride), chemical name 1,1-dimethylbiguanide hydrochloride, molecular formula C 4 h 11 N 5 ·HCl, molecular weight 165.63; white crystal or crystalline powder, odorless; easily soluble in water, soluble in methanol, slightly soluble in ethanol, insoluble in ether or chloroform; M.P.220~225℃; UV233nm. Metformin hydrochloride is a biguanide hypoglycemic drug, which is widely used in the treatment of type 2 diabetes due to its small adverse drug reactions. Metformin hydrochloride reduces glycogen output by inhibiting hepatic gluconeogenesis, and its main effect is to reduce fasting blood glucose concentration. It is a mixed therapy with biguanide as the main component. In clinical practice, repeated medi...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/155A61P3/10
Inventor 梁超峰应军陈桐楷孙湘陈玲黄良军黄春晖
Owner GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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