Tropisetron hydrochloride oral disintegration tablet preparation and its preparing method

A technology for tropisetron hydrochloride and oral disintegrating tablets, which is applied in the directions of pill delivery, digestive system, drug combination, etc., can solve the problems of complex process and high cost, and achieve the effects of simple process, low cost and good taste

Inactive Publication Date: 2005-10-19
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 problems of high cost, complex process and strict requirements on preparation conditions for the production of tropisetron hydrochloride orally disintegrating tablets, the present invention designs and develops tropisetron hydrochloride orally disintegrating tablet preparation and its preparation method ;Use tropisetron hydrochloride as medicine, with lactose, mannitol, crospovidone, magnesium stearate, microcrystalline cellulose, distilled water, stevioside as dressing, press 1: 0.2~2.5: 0.2~5.0: 0.2~1.0: 0.1~0.5: 0.1~1.0: 0.01~0.2: 0.1~1.0 Proportion ingredients, using wet granulation tableting method, using ordinary tablet press, by controlling process parameters, to make tropisetron hydrochloride oral cavity Disintegrating tablets, tropisetron hydrochloride orally disintegrating tablets have a good taste, and the disintegration time is between 15-60 seconds

Method used

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  • Tropisetron hydrochloride oral disintegration tablet preparation and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1: Preparation of Tropisetron Hydrochloride Orally Disintegrating Tablets (1000 tablets)

[0014] ① Pass 30g of tropisetron hydrochloride through a 100-mesh sieve, pass through a 100-mesh sieve for the auxiliary materials respectively, put the auxiliary materials in an oven at 50°C for 3 hours, and set aside.

[0015] ② Mix 20g of mannitol with tropisetron hydrochloride.

[0016] ③ Another 30g of lactose is mixed with the mixture in step ② according to the method of equal increment.

[0017] ④ Use distilled water to make soft material from the above mixture, use a 30-mesh sieve to make granules, and dry the wet granules at 40°C for 30 minutes. The obtained dry granules were sized through a 30-mesh sieve, and then 0.3 g of magnesium stearate, 1.5 g of microcrystalline cellulose, and 4 g of crospovidone were added and mixed uniformly.

[0018] ⑤ determination of intermediate content.

[0019] ⑥Adopt 6.0-8.5mm shallow arc punched tablets, control the tablet w...

Embodiment 2

[0022] Embodiment 2: Preparation of Tropisetron Hydrochloride Orally Disintegrating Tablets (1000 tablets)

[0023] ① Pass 30g of tropisetron hydrochloride through a 100-mesh sieve, pass through a 100-mesh sieve for the auxiliary materials respectively, put the auxiliary materials in an oven at 50°C for 3 hours, and set aside.

[0024] ② Mix 30g of mannitol with tropisetron hydrochloride.

[0025] ③ Another 20g of lactose is mixed with the mixture in step ② according to the method of equal increase.

[0026] ④ Use distilled water to make soft material from the above mixture, use a 30-mesh sieve to make granules, and dry the wet granules at 40°C for 30 minutes. The obtained dry granules were sized through a 30-mesh sieve, and then 0.15 g of magnesium stearate, 5.0 g of microcrystalline cellulose, and 8 g of crospovidone were added and mixed uniformly.

[0027] ⑤ determination of intermediate content.

[0028] ⑥Adopt 6.0-8.5mm shallow arc punched tablets, control the tablet w...

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Abstract

The present invention relates to medicine preparation, and a kind of orally disintegrated tropisetron hydrochloride tablet and its preparation process. The orally disintegrated tropisetron hydrochloride tablet is prepared with tropisetron hydrochloride as effective component, and lactose, mannitol, crosslinked polyvidon, magnesium stearate, microcrystalline cellulose, distilled water and steviosin as supplementary material, and through mixing in certain proportion and wet tabletting. It has hardness of 1.0-3.5 kg, and may be disintegrated in oral cavity within 1 min. It may be prepared in common tabletting machine.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations, belongs to an oral drug delivery system, and is a tropisetron hydrochloride orally disintegrating tablet preparation and a preparation method thereof. Background technique: [0002] Orally disintegrating tablets (also known as orally dissolving tablets) are a new type of dosage form that has rapidly emerged in the pharmaceutical field in recent years. It has the advantages of convenient administration, fast absorption, high bioavailability and little irritation to the mucous membrane of the digestive tract. It does not need water when taken, and disintegrates quickly in the oral cavity within 60 seconds. Although freeze-dried tablets are relatively mature in many preparation processes, the cost is too high, the process is complicated, and the requirements for preparation conditions are very strict, so it is difficult to adapt to the actual situation of domestic pharmaceuticals. At pre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/439A61P1/08
Inventor 王立强
Owner 王立强
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