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Oseltamivir lyophilized orally-disintegrating tablets and preparation method thereof

A technology for oseltamivir phosphate and orally disintegrating tablets, which is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of not being easy to take and the like

Inactive Publication Date: 2015-02-25
BEIJING SUNHO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Still need right amount of water when it takes medicine, it is not easy enough to take

Method used

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  • Oseltamivir lyophilized orally-disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Element Content (g) Mannitol 15.000 hydrolyzed gelatin 12.500 Oseltamivir Phosphate 6.569 (equivalent to oseltamivir 5g) Dextran 1.500 aspartame 0.900 milk flavor 0.600

[0040] The preparation steps of freeze-dried orally disintegrating tablet are as follows:

[0041] Dissolution: Add hydrolyzed gelatin (adhesive) to 60ml of water, mix and heat, continue to mix until completely dissolved; add the mixture of mannitol (skeleton agent) and oseltamivir phosphate, stir until uniform, continue to add dextran (lyoprotectant) and aspartame and milk-flavored essence (flavoring agent), stir evenly, dilute the mixture to 100ml with water, stir and mix evenly;

[0042] Injection molding: absorb the liquid medicine and inject the liquid medicine into the mold at 0.2ml / tablet;

[0043] Quick-freezing: The medicine liquid is quickly frozen into a solid under the environment of -60°C;

[0044] Freeze-drying: Cool...

Embodiment 2

[0052] Element Content (g) Mannitol 30.000 Purulan 0.500 Oseltamivir Phosphate 6.569 (equivalent to oseltamivir 5g) Sucralose 1.000

[0053] The preparation steps of freeze-dried orally disintegrating tablet are as follows:

[0054] Dissolution: Add pullulan (adhesive) to 60ml of water, mix and heat to 40°C, continue to mix until completely dissolved; add the well-mixed mixture of mannitol (skeleton agent) and oseltamivir phosphate, and stir until uniform , continue to add triclosan (flavoring agent), stir evenly, dilute the mixed solution to 100ml with water, stir and mix evenly;

[0055] Injection molding: absorb the liquid medicine and inject the liquid medicine into the mold at 0.2ml / tablet;

[0056] Quick-freezing: -120 ℃ environment makes the liquid medicine be frozen into a solid rapidly;

[0057] Freeze-drying: Cool down the freeze-dryer to -20°C, put the mold containing the liquid medicine into the freeze-dryer, v...

Embodiment 3

[0065] Element Content (g) Mannitol 10.000 gelatin 10.000 Oseltamivir Phosphate 6.569 (equivalent to oseltamivir 5g) Dextran 1.200 Sucralose 0.400 sodium bicarbonate 4.600 strawberry flavor 0.200

[0066] The preparation steps of freeze-dried orally disintegrating tablet are as follows:

[0067] Dissolution: Add gelatin to 50ml of water, mix and heat to 40°C, continue to mix until the gelatin is completely dissolved; add a mixture of well-mixed mannitol and sodium bicarbonate and 6.569g of oseltamivir phosphate (equivalent to oseltamivir 5g) , stir until uniform, continue to add dextran, sucralose and strawberry flavor, stir evenly, dilute the mixture to 80ml with water, stir and mix evenly;

[0068] Injection molding: absorb the liquid medicine and inject the liquid medicine into the mold at a rate of 0.4ml / tablet;

[0069] Quick-freezing: the medicine liquid is quickly frozen into a solid under ...

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Abstract

The present invention provides oseltamivir lyophilized orally-disintegrating tablets and a preparation method thereof, and belongs to the field of pharmaceutical preparations. The oseltamivir lyophilized orally-disintegrating tablets comprise oseltamivir phosphate or oseltamivir and a matrix, wherein the oseltamivir lyophilized orally-disintegrating tablets contain (calculated as the oseltamivir) 10-75 parts by weight of the effective component, and the matrix contains 1-60 parts by weight of a framework support agent, 1-50 parts by weight of a binder, 0-10 parts by weight of a lyoprotectant, and 0-10 parts by weight of a flavoring agent, and can further contains 0-10 parts by weight of a flavoring agent and 0-69 parts by weight of an inorganic alkali. The oseltamivir lyophilized orally-disintegrating tablet preparation method comprises dissolving, mold injection, rapid freezing, freeze-drying and product packaging. The oseltamivir lyophilized orally-disintegrating tablets of the present invention have characteristics of convenient taking, taking without water, rapid absorption, and first pass effect avoiding.

Description

technical field [0001] The invention relates to the field of oral preparations, in particular to an oseltamivir freeze-dried orally disintegrating tablet and a preparation method thereof. Background technique [0002] Influenza virus is an RNA virus that causes influenza in humans, dogs, horses, pigs and poultry. Influenza virus can cause more serious symptoms such as pneumonia or heart and lung failure in the elderly or children with weakened immunity and some patients with immune disorders. [0003] [0004] Oseltamivir is a specific inhibitor of neuraminidase, which inhibits the action of neuraminidase and can inhibit the mature influenza virus from leaving the host cell, thereby inhibiting the spread of influenza virus in the human body To play a role in the treatment of influenza. Oseltamivir is a neuraminidase inhibitor with high efficiency, low toxicity and strong specificity, which was successfully developed based on the three-dimensional structure of the target...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/215A61K47/42A61K47/36A61P31/16
Inventor 张寒颜克序修勇
Owner BEIJING SUNHO PHARMA
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