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Granisetron hydrochloride orally disintegrating tablets

A technology of granisetron hydrochloride and orally disintegrating tablets, which is applied in the direction of pill delivery, digestive system, drug combination, etc., can solve the problems of incomplete dispersion, disintegration of orally disintegrating tablets, poor tablet hardness and integrity, and achieve High dissolution rate, overcoming disintegration, fast disintegration and dispersion

Inactive Publication Date: 2008-01-02
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0038] In the present invention, granisetron hydrochloride is dispersed in a physiologically inactive water-soluble carrier to prepare a drug-carrier solid dispersion, and granisetron hydrochloride is dispersed in the carrier in an ultrafine crystal state to form a uniform eutectic physical mixture. crystal dispersion system, and then mixed with disintegrants, fillers, glidants, lubricants, and flavoring agents, and then directly compressed into tablets. Freeze-drying, vacuum-drying, and spray-drying make orally disintegrating tablets with complex production processes and equipment, high production conditions, poor tablet hardness and integrity, special packaging, inconvenient storage, transportation, and taking, and overcome the problems of conventional melting. Problems of disintegration and incomplete dispersion of orally disintegrating tablets prepared by direct compression method after preparing solid dispersion

Method used

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  • Granisetron hydrochloride orally disintegrating tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1 Melting hot extrusion method

[0053] Prescription: Granisetron Hydrochloride 1g

[0054] Macrogol 6000 5g

[0055] Mannitol 40g

[0056] Microcrystalline Cellulose 25g

[0057] Low-substituted hydroxypropyl cellulose 5g

[0058] Croscarmellose Sodium 5g

[0059] Cross-linked polyvinylpyrrolidone 5g

[0060] Citrate 0.5g

[0061] Stevia 1g

[0062] Flavor 1g

[0063] Micronized silica gel 0.5g

[0064] Magnesium stearate 0.5g

[0065]

[0066] Makes 1000 pieces

[0067] Preparation method: Take the prescribed amount of granisetron hydrochloride and add it to the prescribed amount of polyethylene glycol 6000 heated at 90-100°C to melt, stir well and evenly to form a molten mixture, and take it out under negative pressure with a melting heat extruder. Melt the mixed material, cool it down to 40°C under gradient cooling, extrude it with compressed air, granulate it through a sieve plate with a rotary swinging...

Embodiment 2

[0068] Embodiment 2 melt hot extrusion method

[0069] Prescription: Granisetron Hydrochloride 1g

[0070] Macrogol 6000 10g

[0071] Mannitol 20g

[0072] Microcrystalline Cellulose 20g

[0073] Low-substituted hydroxypropyl cellulose 10g

[0074] Croscarmellose Sodium 10g

[0075] Cross-linked polyvinylpyrrolidone 10g

[0076] Citrate 0.5g

[0077] Stevia 1g

[0078] Flavor 1g

[0079] Micronized silica gel 1g

[0080] Magnesium stearate 0.5g

[0081]

[0082] Makes 1000 pieces

[0083] Preparation method: Take the prescribed amount of granisetron hydrochloride and add it to the prescribed amount of polyethylene glycol 6000 heated at 90-100°C to melt, stir well and evenly to form a molten mixture, and take it out under negative pressure with a melting heat extruder. Melt the mixed material, cool it down to 45°C under gradient cooling, extrude it with compressed air, granulate it through a sieve plate with a rotary swinging...

Embodiment 3

[0084] Embodiment 3 melting hot extrusion method

[0085] Prescription: Granisetron Hydrochloride 1g

[0086] Macrogol 6000 10g

[0087] Mannitol 30g

[0088] Microcrystalline Cellulose 40g

[0089] Low-substituted hydroxypropyl cellulose 5g

[0090] Croscarmellose Sodium 10g

[0091] Cross-linked polyvinylpyrrolidone 5g

[0092] Citrate 2g

[0093] Stevia 1g

[0094] Flavor 1g

[0095] Micronized silica gel 2g

[0096] Magnesium stearate 0.5g

[0097]

[0098] Makes 1000 pieces

[0099] Preparation method: Take the prescribed amount of granisetron hydrochloride and add it to the prescribed amount of polyethylene glycol 6000 heated at 90-100°C to melt, stir well and evenly to form a molten mixture, and take it out under negative pressure with a melting heat extruder. Melt the mixed material, cool it down to 50°C under gradient cooling, extrude it with compressed air, granulate it through a sieve plate with a rotary swinging ...

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PUM

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Abstract

The invention relates to granisetron hydrochloride mouth slaking tablet and the formula and preparing process. The process employs rotary oscillating granulator to produce said slaking agent through direct sheeting method after heat extrusion by melting and gradient cooling. When compared with mouth slaking agent produced with normal melting method, the mouth slaking agent in this invention is characterized by faster slaking speed, higher dissolution rate, intact tablet outlook, stronger rigidity and good taste. If compared with current freeze drying, vacuum drying, spray drying technique, the invention is characterized in that it needs no special production device and condition, no special package, the production process is simple, quality is stable and suitable for industrial production. It provides new products for patients that is dysphagia and bedridden, for old people and children, especially for patients suffering tumor chemotherapy and radiotheraphy.

Description

technical field [0001] The invention relates to a granisetron hydrochloride orally disintegrating tablet and a prescription and a process for preparing the granisetron hydrochloride orally disintegrating tablet through a rotary swinging granulator granulation direct tableting method after gradient cooling by melting and hot extrusion. Background technique [0002] Tumor has become the first enemy that threatens human life and health. According to a research report released by the International Cancer Research Center of the World Health Organization in May 2003, according to the current trend of cancer incidence, the incidence of cancer in the world in 2002 increased by 50% compared with the past, and the number of new cancer patients in the world will reach 1500 every year. million people. According to the research report of the center, the cancer with the highest incidence rate in the world is lung cancer, with 1.2 million new patients every year; breast cancer, with about...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/439A61K9/20A61K47/34A61K47/38A61P1/08A61K47/10
Inventor 刘智钱进陶琳刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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