Isosorbide mononitrate orally disintegrating tablets

A technology of isosorbide dinitrate and orally disintegrating tablets, which can be used in pill delivery, cardiovascular system diseases, and devices for making drugs into special physical or ingestion forms, and can solve the problems of poor hardness and integrity of tablets, production conditions, etc. High, need special packaging and other problems, to achieve the effect of overcoming disintegration, high dissolution release, 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

[0015] The present invention disperses isosorbide mononitrate in a non-physiologically active water-soluble carrier to prepare a drug-carrier solid dispersion, and isosorbide mononitrate is dispersed in the carrier in an ultrafine crystal state to form a uniform deep eutectic physical The mixture microcrystalline dispersion system, and then mixed with disintegrants, fillers, glidants, lubricants, and flavoring agents, and then directly compressed into tablets. Solved th...

Method used

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  • Isosorbide mononitrate orally disintegrating tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 melting hot extrusion method

[0030] Prescription: Isosorbide Mononitrate 10g

[0031] Macrogol 6000 10g

[0032]Mannitol 55g

[0033] Microcrystalline Cellulose 25g

[0034] Low-substituted hydroxypropyl cellulose 5g

[0035] Croscarmellose Sodium 5g

[0036] Cross-linked polyvinylpyrrolidone 5g

[0037] Stevia 3g

[0038] Micronized silica gel 1g

[0039] Magnesium Stearate 1g

[0040] Makes 1000 pieces

[0041] Preparation method: Take the prescription amount of isosorbide mononitrate and add it to the prescription amount of polyethylene glycol 6000 heated at 90-100°C to melt, stir well and evenly to form a molten mixture, and use a melting heat extruder under negative pressure Take the molten mixture 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 granulator, cool and solidify rapidly at 0°C, and then freeze it at -10°C 2 hours, take it out, dry, ...

Embodiment 2

[0042] Embodiment 2 melt hot extrusion method

[0043] Prescription: Isosorbide Mononitrate 10g

[0044] Macrogol 6000 5g

[0045] Mannitol 50g

[0046] Microcrystalline Cellulose 30g

[0047] Low-substituted hydroxypropyl cellulose 10g

[0048] Croscarmellose Sodium 5g

[0049] Cross-linked polyvinylpyrrolidone 10g

[0050] Stevia 1g

[0051] Micronized silica gel 2g

[0052] Magnesium stearate 0.5g

[0053] Makes 1000 pieces

[0054] Preparation method: Take the prescription amount of isosorbide mononitrate and add it to the prescription amount of polyethylene glycol 6000 heated at 90-100°C to melt, stir well and evenly to form a molten mixture, and use a melting heat extruder under negative pressure Take the molten mixture material, cool it down to 35°C under gradient cooling, extrude it with compressed air, and granulate it through a sieve plate with a rotary swinging granulator. Freeze for 1 hour, take it out, dry, crush, pass through an 80 mesh sieve, and pass ...

Embodiment 3

[0055] Embodiment 3 melting hot extrusion method

[0056] Prescription: Isosorbide Mononitrate 10g

[0057] Macrogol 6000 15g

[0058] Mannitol 40g

[0059] Microcrystalline Cellulose 35g

[0060] Low-substituted hydroxypropyl cellulose 10g

[0061] Croscarmellose Sodium 10g

[0062] Cross-linked polyvinylpyrrolidone 10g

[0063] Stevia 1g

[0064] Micronized silica gel 1.5g

[0065] Magnesium Stearate 1g

[0066] Makes 1000 pieces

[0067] Preparation method: Take the prescription amount of isosorbide mononitrate and add it to the prescription amount of polyethylene glycol 6000 heated at 90-100°C to melt, stir well and evenly to form a molten mixture, and use a melting heat extruder under negative pressure Take the molten mixture material, cool it down to 30°C under gradient cooling, extrude it with compressed air, granulate it through a sieve plate with a rotary swinging granulator, cool and solidify rapidly at -3°C, and then cool it at -10°C Freeze for 3 hours, ta...

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PUM

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Abstract

The invention relates to isosorbide mononitrate 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 that suffering angina pectoris and coronary heart disease.

Description

technical field [0001] The invention relates to an orally disintegrating tablet of isosorbide mononitrate and a prescription and a process for preparing an orally disintegrating tablet of isosorbide mononitrate by adopting gradient cooling through molten hot extrusion and granulating and direct tableting by a rotary swinging granulator. Background technique [0002] Isosorbide mononitrate is the main biologically active metabolite of isosorbide dinitrate. Like other nitrate vasodilators, the main pharmacological effect is to relax vascular smooth muscle. Compared with isosorbide dinitrate, isosorbide mononitrate not only has the characteristics of rapid and complete absorption, no first-pass effect, high bioavailability, long duration of action, high clinical efficacy, etc., but also has outstanding advantages such as small individual differences and low toxicity , can prevent and reduce drug resistance in patients, is currently one of the best drugs for preventing and treat...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/34A61K47/38A61P9/10A61J3/10
Inventor 刘智钱进陶琳刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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