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Levothyroxine sodium micro-tablet as well as preparation method and preparation thereof

A technology of levothyroxine sodium and microtablets, which is applied in the directions of pill delivery, pharmaceutical formulations, medical preparations with inactive ingredients, etc., can solve problems such as uneven content of levothyroxine sodium, improve bioavailability, solve Non-uniform, uniformity-friendly effect

Active Publication Date: 2022-03-08
BEIJING VAGARY PHARM TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, the invention not only solves the above problems, but also efficiently solves the problem of uneven content of levothyroxine sodium, and can significantly improve the stability of the preparation and the bioavailability

Method used

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  • Levothyroxine sodium micro-tablet as well as preparation method and preparation thereof
  • Levothyroxine sodium micro-tablet as well as preparation method and preparation thereof
  • Levothyroxine sodium micro-tablet as well as preparation method and preparation thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0060] A levothyroxine sodium microtablet, the components: 0.05 parts of levothyroxine sodium, 59.95 parts of microcrystalline cellulose, 30 parts of mannitol, 3.67 parts of croscarmellose sodium, 1.83 parts of low-substituted hydroxypropyl cellulose, 3 parts of hydroxypropyl cellulose, 1 part of magnesium stearate, 0.5 parts of silicon dioxide;

[0061] The preparation method of above-mentioned microchip:

[0062] (1) Get levothyroxine sodium and hydroxypropyl cellulose dissolved in water and disperse evenly;

[0063] (2) Spray (1) into the mixture of microcrystalline cellulose and mannitol, granulate, and dry;

[0064] (3) mix (2) with croscarmellose sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, and silicon dioxide;

[0065] (4) Made into microtablets with a diameter of 3 mm and a tablet weight of 25 mg, containing 12.5 μg of levothyroxine sodium per tablet.

Embodiment 2

[0067] A levothyroxine sodium microtablet, the components: 0.01 parts of levothyroxine sodium, 43.99 parts of microcrystalline cellulose, 45 parts of mannitol, 4.5 parts of croscarmellose sodium, 4 parts of hypromellose, stearin 0.5 parts of magnesium oxide, 2 parts of silicon dioxide;

[0068] The preparation method of above-mentioned microchip:

[0069] (1) get hydroxypropyl cellulose and make solution with water;

[0070] (2) Get levothyroxine sodium, carry out micronization with jet mill, control particle size result to be D 90 = 23.19 μm;

[0071] (3) Disperse (2) with water, mix with (1), and shear with a high-speed dispersing shear at a speed of 6000 rpm for 5 minutes;

[0072] (4) Get microcrystalline cellulose and mannitol, mix in wet mixing granulator, stirring speed 300rpm, shearing speed

[0073] 1000rpm, time 3min;

[0074] (5) Spray (3) into (4) with an atomization system, and the result of controlling the droplet size is D 90 =100μm, at the same time, stir...

Embodiment 3

[0080] A levothyroxine sodium microtablet, components: 0.0125 parts of levothyroxine sodium, 67.9875 parts of microcrystalline cellulose, 18 parts of mannitol, 6.5 parts of croscarmellose sodium, 5 parts of hypromellose, stearin Magnesium acid 2 parts, silicon dioxide 0.5 parts.

[0081] The preparation method of above-mentioned microchip:

[0082] (1) get hydroxypropyl cellulose and make solution with water;

[0083] (2) Get levothyroxine sodium, carry out micronization with jet mill, control particle size result to be D 90 = 42.56 μm;

[0084] (3) Disperse (2) with water, mix with (1), and shear with a high-speed dispersing shear at a speed of 8000 rpm for 2 minutes;

[0085] (4) Take microcrystalline cellulose and mannitol, mix them in a boiling granulator, control the material temperature not to exceed 35°C, and boil for 5 minutes;

[0086] (5) Spray (3) into (4) with an atomization system, and the result of controlling the droplet size is D 90 =190μm, at the same tim...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a levothyroxine sodium micro-tablet as well as a preparation method and a preparation thereof. The levothyroxine sodium micro-tablet comprises levothyroxine sodium and auxiliary materials, the diameter of the micro-tablet is 1-5 mm, the weight of the micro-tablet is 1-50 mg, and the content of levothyroxine sodium in each micro-tablet is 1-25 micrograms. The number of the micro-tablets in the preparation is one or more. The invention also provides a preparation method of the micro-tablet. According to the micro-tablet, small-dose direct administration can be realized, the dosage is accurate, the micro-tablet is convenient to use, the medication compliance is improved, the administration dosage can be more accurately controlled, the adverse reaction of the same variety sold in the existing market is reduced, and the medication safety is further improved; the problem that the content of levothyroxine sodium is not uniform is efficiently solved; meanwhile, the stability of the preparation can be remarkably improved, and the bioavailability is remarkably improved.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a levothyroxine sodium microtablet and a preparation method and preparation thereof. Background technique [0002] Levothyroxine sodium, English name Levothyroxine Sodium, its structural formula is: [0003] [0004] Levothyroxine sodium is off-white to light brown powder or crystalline powder. Slightly soluble in ethanol, almost insoluble in water; dissolved in hot 1mol / L sodium hydroxide solution. It is unstable to heat, and it is easy to deiodine under heating conditions, that is, it produces purple iodine vapor. [0005] The preparation process in the patent WO9959551 uses gelatin as a binder. Although the stability of the preparation is theoretically improved, the gelatin solution needs to be kept warm during the preparation process, and levothyroxine sodium is unstable to heat, so the preparation process does not Conducive to the stability of the prepara...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/198A61K47/38A61K47/36A61P5/14A61P35/00A61P43/00
CPCA61K31/198A61K9/2095A61K9/2054A61K9/2059A61P5/14A61P35/00A61P43/00
Inventor 张蓓
Owner BEIJING VAGARY PHARM TECH LTD
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