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Orally disintegrating tablets of adefovir dipivoxil and method for preparing the same

A technology of adefovir dipivoxil and orally disintegrating tablets, which is applied in the fields of pill delivery, digestive system, antiviral agents, etc., and can solve problems such as insufficient safety verification, unfavorable taking, and low sweetness of sucrose

Inactive Publication Date: 2010-06-23
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The sweetness of sucrose is low, and it is not conducive to diabetics and other patients with poor glucose metabolism
The sweetness of stevioside is 200 times that of sucrose, and the use of stevioside has been controversial in countries all over the world. The US FDA has refused to approve the application of stevioside as a food additive three times, believing that its safety has not been fully confirmed.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Adefovir dipivoxil 10%

[0025] Mannitol 45%

[0026] Lactose 34%

[0027] Low Substituted Hypromellose 8%

[0028] Lemon essence 0.7%

[0029] Menthol 1.2%

[0030] Sucralose 0.1%

[0031] Magnesium Stearate 1%

[0032] 100%

[0033] Preparation:

[0034] Mix adefovir dipivoxil and sucralose with mannitol, lactose, low-substituted hydroxypropyl cellulose, and lemon flavor evenly. After granulating through a dry granulator, add menthol and magnesium stearate, mix evenly, and use a 6mm punch Molded sheet form. The weight of the tablet is 100mg, and the disintegration time is 20-30 seconds.

Embodiment 2

[0036] Adefovir dipivoxil 10%

[0037] Mannitol 89.9%

[0038] Sucralose 0.1%

[0039] 100%

[0040] Preparation:

[0041] Dilute adefovir dipivoxil, mannitol and sucralose with an appropriate amount of water, mix evenly, place in an 8mm sheet mold, freeze-dry in a freeze dryer until the material is completely dry and then formed. The weight of the tablet is 100mg, and the disintegration time is 3-5 seconds.

Embodiment 3

[0043] Adefovir dipivoxil 10%

[0044] Mannitol 49%

[0045] Microcrystalline Cellulose 30%

[0046] Low Substituted Hypromellose 8%

[0047] Menthol 1.85%

[0048] Sucralose 0.15%

[0049] Magnesium Stearate 1%

[0050] 100%

[0051] Preparation:

[0052] Mix adefovir dipivoxil and sucralose with mannitol, lactose, low-substituted hydroxypropyl cellulose, and lemon flavor evenly, and granulate through a wet granulator. After drying and sizing, add microcrystalline cellulose, menthol and After the magnesium stearate is evenly mixed, it is formed into tablets with a 6mm die. The weight of the tablet is 100mg, and the disintegration time is 30-35 seconds.

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PUM

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Abstract

The invention discloses an adefovir dipivoxil orally disintegrating tablet and the preparation method. The orally disintegrating tablet contains active component adefovir dipivoxil, sweetenersucralose and other pharmaceutically acceptable excipients, and is prepared in freeze-drying method, powder pressing method, granulating and tabletting method. The orally disintegrating tablet has the advantages of good taste, easy administration and is used to treat chronic hepatitis B.

Description

technical field [0001] The invention relates to an improved prescription of adefovir dipivoxil orally disintegrating tablets for treating chronic hepatitis B and a preparation method thereof. Background technique [0002] At present, there are 370 million hepatitis B patients in the world, and almost 1 million patients die from the disease-related diseases every year. Among the Chinese population, there are 120 million chronic hepatitis B virus carriers, 34 million chronic hepatitis patients, and 270,000 patients who die from the disease-related diseases every year. [0003] Adefovir dipivoxil is the prodrug of the adenine phosphate compound adefovir. After oral administration, it is converted into adefovir in the body to exert antiviral effect. According to the current basic and clinical research data on adefovir, adefovir can effectively inhibit HBV DNA, and it also has obvious inhibitory effect on lamivudine-resistant mutant strains, and adefovir-resistant related viruse...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/675A61K9/20A61K47/38A61P1/16A61P31/20
Inventor 李铮
Owner BEIJING D VENTUREPHARM TECH DEV