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Orally disintegrating tablet containing levothyroxine sodium

A technology of levothyroxine sodium and orally disintegrating tablets, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and pill delivery, etc., can solve the problem of low dissolution efficiency of levothyroxine sodium and drug exposure time. growth, increased risk of levothyroxine sodium being broken down, degraded, or contaminated

Pending Publication Date: 2019-11-08
BEIJING DO-PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The preparation technology of levothyroxine sodium orally disintegrating tablets disclosed in patent CN109010295A, in practice, levothyroxine sodium needs to be stirred for a long time in water before it can be dissolved smoothly, which leads to a decrease in the production efficiency of the product, and the drug exposure time is too long Long, increase the risk of levothyroxine sodium decomposition, degradation or contamination
[0009] Therefore, in obtaining highly effective orally disintegrating tablets of levothyroxine sodium, it is still necessary to solve the inefficiency of dissolving levothyroxine sodium in water, how to shorten the preparation time, and further ensure the stability of levothyroxine sodium in the product preparation process

Method used

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  • Orally disintegrating tablet containing levothyroxine sodium
  • Orally disintegrating tablet containing levothyroxine sodium
  • Orally disintegrating tablet containing levothyroxine sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] components Dosage g / 1000 tablets Levothyroxine Sodium 0.05 gelatin 2 Polyoxyethylene 40 stearate 1.6 Povidone K30 0.6 Mannitol 40 water (sublimation) Add to 400g

[0054] 1. Weigh the prescribed amount of gelatin and add it to 300g of water, heat to 80°C, stir for about 10 minutes to dissolve.

[0055] 2. Add the prescribed amount of polyoxyethylene stearate 40, povidone K30, and mannitol, and stir for about 10 minutes to dissolve.

[0056] 3. Add the prescribed amount of levothyroxine sodium and stir for about 5 minutes to dissolve.

[0057] 4. Add water to the above solution to make up to 400g.

[0058] 5. Divide the sample into aluminum-plastic blisters at a volume of 0.4ml per piece, place the sample in a freeze dryer, set the freeze-drying parameters, and start freeze-drying.

[0059] Freeze-drying parameters

[0060] Set temperature °C set time min Duration min The first stage -50 1 90...

Embodiment 2

[0095] Investigate the dissolution curve of freeze-dried tablets to simulate the absorption rate in vivo.

[0096] Self-made sheet: the finished product of Example 1

[0097] Commercially available tablets: Euthyroxine Sodium Levothyroxine Tablets 50μg

[0098] Dissolution method:

[0099] Basis: USP Act 1

[0100] Paddle

[0101] Dissolution medium: 500ml of 0.01mol / L hydrochloric acid solution containing 0.2% sodium lauryl sulfate

[0102] Speed: 50rpm

[0103] Sampling point: 5, 15, 30, 45min

[0104] Temperature: 37°C

[0105] Test results: dissolution content data

[0106] 5min 15min 30min 45min Example 1 93.31 99.66 98.23 102.71 Example 1-2 92.66 96.84 98.21 102.85 Example 1-3 94.58 96.69 97.66 102.34 average 93.52 97.73 98.03 102.63 commercial film 1 25.45 44.65 69.82 98.63 commercial film 2 24.25 45.58 69.56 97.22 commercial film 3 24.87 44.23 68.62 97.65 average 24.86 44.82 ...

Embodiment 3

[0110] Simulated mouth melting experiment

[0111] According to the USP standard, its release in the oral cavity was simulated through the dissolution test of self-made and commercially available tablets.

[0112] Self-made sheet: the finished product of Example 1

[0113] Commercially available tablets: Euthyroxine Sodium Levothyroxine Tablets 50μg

[0114] Solubility experiment: put the sample in 37°C water and observe the phenomenon statically

[0115] Way Example 1 commercial film Static observation in 2ml water 9 seconds to completely melt Unable to disintegrate completely, a large amount of sediment Static observation in 200ml water 7 seconds to completely melt 20 minutes and 10 seconds completely disintegrated, a large amount of sediment

[0116] Experiments show that the self-made tablet can be quickly dispersed and dissolved in a small amount of water, which is more beneficial to patients with thyroxine deficiency who have throat ...

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PUM

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Abstract

The invention provides an orally disintegrating tablet containing levothyroxine sodium and a preparation method of the orally disintegrating tablet. The orally disintegrating tablet is prepared from the levothyroxine sodium and polyoxyethylene stearate as active components. The orally disintegrating tablet is prepared through a freeze drying mode.

Description

technical field [0001] The invention relates to a levothyroxine sodium orally disintegrating tablet, a preparation method thereof, and a carrier system for the levothyroxine sodium orally disintegrating tablet. The orally disintegrating tablet contains levothyroxine sodium and polyoxyethylene stearate as active ingredients. The disintegrating tablet of the present invention is prepared by freeze-drying. Further, the levothyroxine sodium orally disintegrating tablet of the present invention has greatly improved the compliance of patients with traditional levothyroxine sodium, and the carrier system of the present invention has improved the production efficiency of the levothyroxine sodium orally disintegrating tablet, avoiding the The risk of easy decomposition or degradation during the production of levothyroxine sodium preparations. Background technique [0002] Thyroid hormone is an essential component for normal growth and development of the human body, and insufficient...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/14A61K47/42A61K31/198A61P5/14
CPCA61K9/0056A61K9/2031A61K9/2063A61K31/198A61P5/14
Inventor 李鹏飞张严源吴龙昊
Owner BEIJING DO-PHARMA TECH CO LTD