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A levothyroxine sodium freeze-dried orally disintegrating tablet

A technology of levothyroxine sodium and orally disintegrating tablets, which is applied in the directions of pill delivery, endocrine system diseases, organic active ingredients, etc.

Inactive Publication Date: 2018-12-18
BEIJING DO-PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Since the therapeutic dose of levothyroxine sodium is very small and the preparation specifications are very small, it is well known that the conventional wet or dry oral solid preparation process is difficult to ensure the uniformity of small-scale products
The very narrow therapeutic index of levothyroxine sodium indicates that the current oral tablets often need to be manually broken and taken to adjust the dosage of the patient, which has a higher risk of use than other drugs

Method used

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  • A levothyroxine sodium freeze-dried orally disintegrating tablet
  • A levothyroxine sodium freeze-dried orally disintegrating tablet
  • A levothyroxine sodium freeze-dried orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033]

[0034] Add the prescribed amount of gelatin to 300ml of water, heat to 80°C, and stir to dissolve completely. Add the prescribed amount of mannitol and stir to dissolve completely. Cool the solution down to about 25°C, add levothyroxine sodium, and stir to dissolve completely. Dispense the solution into aluminum-plastic blisters, 300μl / tablet. Rapid freezing, so that the levothyroxine sodium solution is rapidly lowered to -50°C~-80°C, and completely frozen. Ensure that the temperature of the frozen product is within the original range, and transfer the pre-frozen slices to the freeze dryer. Vacuumize and start freeze-drying, the vacuum requirement is <1bar. Continue freeze-drying for 6 hours, when the time is up, stop freeze-drying and refrigeration, maintain vacuum, wait for the sample to naturally heat up to 25°C for 20 minutes, and then come out of the cabinet. If it cannot reach 25°C, start the heating function of the freeze-drying mechanism, heat to the sa...

Embodiment 2

[0038]

Embodiment 3

[0040]

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Abstract

A method for preparing a levothyroxine sodium orally disintegrating tablet is provided. A freeze-drying process is adopted by the tablet to ensure stability of levothyroxine sodium, thus overcoming medicine taking inconvenience of patients.

Description

technical field [0001] The invention relates to a preparation method of levothyroxine sodium orally disintegrating tablets. The orally disintegrating tablet adopts a freeze-drying process, and the stability of levothyroxine sodium is fully guaranteed, which greatly improves the medication compliance of patients with thyroxine deficiency who have undergone throat and neck surgery, are unconscious, unable to take care of themselves or resist taking medicine. It belongs to the field of medicine. Background technique [0002] Thyroxine is an endogenous hormone produced by the body itself and is critical to the health and functions of the body. Levothyroxine sodium, also known as tetraiodothyronine sodium (L-T4), is the monosodium salt of the L-isomer of human endogenous thyroxine. Hyperthyroidism, reduction or removal will directly lead to high, low or lack of thyroxine levels in the human body. Hyperthyroidism causes hypermetabolism and sympathetic nerve excitement, causing ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/42A61K31/198A61P5/16A61P5/14
CPCA61K9/0056A61K9/2063A61K31/198A61P5/14A61P5/16
Inventor 张严源吴龙昊李鹏飞
Owner BEIJING DO-PHARMA TECH CO LTD