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Lornoxicam freeze-dried orally disintegrating tablet and preparation method thereof

A technology of lornoxicam and orally disintegrating tablets, which can be applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as gritty feeling and the like

Inactive Publication Date: 2020-01-07
HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

"Lornoxicam Orally Disintegrating Composition and Preparation Method thereof" CN200410053987.X, the specification discloses that the dissolution rate of the existing lornoxicam orally disintegrating tablets is >85% in 45 minutes; "a lornoxicam orally disintegrating tablet Tablet and its preparation method "CN20140240014.0, the specification discloses that the in vitro disintegration result of the existing lornoxicam orally disintegrating tablet is: the average oral disappearance time is 25s, and there is a gritty feeling

Method used

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  • Lornoxicam freeze-dried orally disintegrating tablet and preparation method thereof
  • Lornoxicam freeze-dried orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] ingredient Amount of each component (g) Lornoxicam0.8 gelatin0.8 Mannitol8.0 aspartame1.0 Strawberry flavor0.4

[0031] The preparation steps of freeze-dried orally disintegrating tablets are as follows:

[0032] Dissolve: add the adhesive to the water, mix and heat to 50℃, continue to mix until completely dissolved; add the evenly mixed matrix proppant and other excipients and the mixture of lornoxicam, stir until uniform, continue to add flavors and Essence, stir and mix evenly, dilute the mixture with water to 80ml;

[0033] Injection mould: absorb 0.8ml / piece of liquid medicine and inject the liquid medicine into the mould;

[0034] Quick freezing: make the liquid medicine quickly freeze into a solid at -70℃;

[0035] Freeze-drying: The temperature of the freeze-drying machine is reduced to -45°C, and the mold containing the liquid medicine is placed in the freeze-drying machine. After half an hour, vacuum is applied. When the vacuum degree reaches below 10 Pa, keep...

Embodiment 2

[0041] ingredient Amount of each component (g) Lornoxicam1.0 gelatin0.7 Mannitol7.0 sucrose1.0 Orange flavor0.4

[0042] The preparation steps of freeze-dried orally disintegrating tablets are as follows:

[0043] Dissolve: add the adhesive to the water, mix and heat to 50°C, continue to mix until completely dissolved; add the well-mixed matrix proppant and the mixture of other excipients and lornoxicam, stir until uniform, continue to add flavors and Essence, stir and mix well, dilute the mixture with water to 70ml;

[0044] Injection mould: absorb 0.7ml / piece of liquid medicine and inject liquid medicine into the mould;

[0045] Quick freezing: make the liquid medicine quickly freeze into a solid at -80℃;

[0046] Freeze-drying: The temperature of the freeze-drying machine is cooled to -45°C, the mold containing the liquid medicine is placed in the freeze-drying machine, and the vacuum is drawn after half an hour.

[0047] When the vacuum is below 30Pa, keep it warm for 2 hou...

Embodiment 3

[0053] ingredient Amount of each component (g) Lornoxicam0.4 gelatin1.0 Mannitol8.0 sucrose1.0 Orange flavor0.4

[0054] The preparation steps of freeze-dried orally disintegrating tablets are as follows:

[0055] Dissolve: add the adhesive to the water, mix and heat to 50°C, continue to mix until completely dissolved; add the well-mixed matrix proppant and the mixture of other excipients and lornoxicam, stir until uniform, continue to add flavors and Essence, stir and mix evenly, dilute the mixture with water to 100ml;

[0056] Injection mould: absorb 1ml / piece of liquid medicine and inject the liquid medicine into the mould;

[0057] Quick freezing: make the liquid medicine quickly freeze into a solid at -90℃;

[0058] Freeze-drying: The temperature of the freeze-drying machine is cooled to -45°C, the mold containing the liquid medicine is put into the freeze-drying machine, and the vacuum is drawn after half an hour

[0059] When the vacuum is below 15 Pa, keep it warm for 2...

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Abstract

The invention provides a lornoxicam freeze-dried orally disintegrating tablet and a preparation method thereof. The lornoxicam freeze-dried orally disintegrating tablet consists of lornoxicam and a matrix, wherein the single dosage effective component lornoxicam is 4-10mg; and the matrix comprises 0.8-10mg of an adhesive, 10-200mg of a framework support agent, 0-10mg of a flavoring agent and 0-10mg of an essence. The preparation method of the lornoxicam freeze-dried orally disintegrating tablet provided by the invention comprises steps of dissolution, mold injection, quick freezing, freeze-drying and product packaging. The lornoxicam freeze-dried orally disintegrating tablet provided by the invention is simple and convenient to take and rapid to disintegrate, can be dissolved immediately after being orally taken, can be directly taken without water and is rapid to absorb, and a first pass effect can be avoided.

Description

Technical field [0001] The invention relates to the field of oral preparations, in particular to a freeze-dried orally disintegrating tablet of lornoxicam and its preparation methods. Background technique [0002] Lornoxicam (Lornoxicam) is the chloride of tenoxicam. Its effect is similar to piroxicam, with analgesic, anti-inflammatory and antipyretic effects. It can selectively inhibit COX-2, and its strength is slightly weaker than piroxicam. Activate the opioid neuropeptide system to play a central analgesic effect. [0003] [0004] Lornoxicam was first developed and synthesized by Nycomed (now Takeda Pharmaceutical). Its dosage forms mainly include tablets and powder for injection. Lornoxicam tablets were approved for marketing in Denmark in 1997 and approved for marketing in Japan in 2001. Lornoxicam for injection was approved in Denmark in 1998 under the trade name XEFO. The antipyretic effect of this product is weak, and the required dose is 10 times the anti-inflamma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/42A61K47/26A61K31/542A61P29/00
CPCA61K9/0056A61K9/2018A61K9/2063A61K9/2095A61K31/542A61P29/00
Inventor 温跃兰闻杰蔡晨光子陈金晶张佳欢
Owner HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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