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Orally disintegrating tablet of levonogestrel and its preparing process

A technology of levonorgestrel and orally disintegrating tablets, which is applied in the field of levonorgestrel orally disintegrating tablet preparations and its preparation, can solve the problems of complicated process and high cost, and achieve simple process, low cost and good taste Effect

Inactive Publication Date: 2005-07-06
王立强
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In order to solve the current production of levonorgestrel orally disintegrating tablets, the cost is too high, the process is complicated, and the requirements for the preparation conditions are very strict. The present invention designs and develops a levonorgestrel orally disintegrating tablet preparation and its preparation method

Method used

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  • Orally disintegrating tablet of levonogestrel and its preparing process

Examples

Experimental program
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Effect test

Embodiment 1

[0015] Embodiment 1: Preparation of levonorgestrel orally disintegrating tablets (1000 tablets)

[0016] ①Take 0.75 g of the raw drug levonorgestrel and pass through a 600-mesh sieve, pass the excipients through a 100-mesh sieve respectively, put them in an oven at 50°C for 3 hours, and set aside;

[0017] ②Take 40g of mannitol and mix it with levonorgestrel according to the method of equal increase;

[0018] ③Another 54g of lactose is mixed with the mixture of step ② in the same way by the method of equal increase.

[0019] ④ Dissolve 0.3g of menthol in 3mL of 95% ethanol to make a menthol ethanol solution;

[0020] ⑤ Evenly add the menthol ethanol solution to the mixture obtained in step 3, and dry in an oven at 40°C to evaporate the ethanol, which takes 5 minutes;

[0021] ⑥Use 95% ethanol to make the above mixture into soft materials, use a 30-mesh sieve to make granules, dry the wet granules at 50°C for 2-3 hours, and sieve the 30-mesh sieve for granulation, then add 0....

Embodiment 2

[0026] Embodiment 2: Preparation of levonorgestrel orally disintegrating tablets (1000 tablets)

[0027] ① Pass 0.75 g of the raw material levonorgestrel through a 600-mesh sieve, pass through a 100-mesh sieve for the excipients, and bake in an oven at 50°C for 3 hours, and set aside;

[0028] ②Take 22g of mannitol and mix it with levonorgestrel according to the method of equal increase;

[0029] ③In addition, 72g of lactose is mixed with the mixture of step ② in the same way according to the method of equal increase;

[0030] ④ Dissolve 0.15g of menthol in 2mL of 95% ethanol to make a menthol ethanol solution;

[0031] ⑤ Evenly add the menthol ethanol solution to the mixture obtained in step 3, and dry in an oven at 40°C to evaporate the ethanol, which takes 5 minutes;

[0032] ⑥Use 95% ethanol to make the above mixture into soft material, use a 30-mesh sieve to make granules, dry the wet granules at 50°C for 2-3 hours, granulate with a 30-mesh sieve, then add 0.5g magnesiu...

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Abstract

The invention provides an orally disintegrating tablet of levonogestrel and its preparing process, wherein the preparation is prepared by using Levonorgestrel as the medicament, using lactose, mannitol, low substituted methylcellulose propylene glycol ether, magnesium stearate, 95% ethanol, menthol as raw material by a finite proportion, wherein wet method granulation and pelleting are carried out, the prepared orally disintegrating tablet has a hardness of 1.0-3.5 kg, it can be disintegrated within 1 minute, the disintegrated powder can pass through 24 mesh Levonorgestrel disintegrating tablet.

Description

Technical areas: [0001] The invention relates to the field of pharmaceutical preparations, belongs to an oral drug delivery system, and is a levonorgestrel orally disintegrating tablet preparation and a preparation method thereof. Background technique: [0002] Orally disintegrating tablets (also called orally dissolving tablets) are a new type of dosage form that has emerged rapidly in the field of pharmaceuticals in recent years. It has the advantages of convenient taking, fast absorption, high bioavailability and little irritation to the gastrointestinal mucosa. No water is needed when taking it, and it quickly disintegrates in the mouth within 60 seconds. Although freeze-dried tablets are relatively mature among many preparation processes, the cost is too high, the process is complex, and the requirements for preparation conditions are very strict, making it difficult to adapt to the actual situation of domestic pharmaceuticals. At present, the preparation of orally di...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/565A61P15/00
Inventor 王立强贾福存
Owner 王立强
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