Unlock instant, AI-driven research and patent intelligence for your innovation.

Telbivudine orally-disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and telbivudine, applied in the field of medicine

Inactive Publication Date: 2015-05-27
TIANJIN HANKANG PHARMA BIOTECH
View PDF4 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Telbivudine is highly specific to HBV DNA, but has no effect on human DNA and other viral DNA

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Telbivudine orally-disintegrating tablet and preparation method thereof
  • Telbivudine orally-disintegrating tablet and preparation method thereof
  • Telbivudine orally-disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The weight ratios of the raw materials are: Telbivudine 100, lactose 48, sorbitol 130, microcrystalline cellulose 110, low-substituted hydroxypropyl cellulose 26, saccharin sodium 1.0, and magnesium stearate 5.

[0030] Preparation:

[0031] (1) Telbivudine, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sorbitol, and magnesium stearate are dried at 110°C for 1 hour, crushed through a 100 mesh sieve, and lactose and saccharin sodium are crushed through a 100 mesh sieve spare;

[0032] (2) Weigh telbivudine, sorbitol, lactose, sodium saccharin, 1 / 4 amount of low-substituted hydroxypropyl cellulose, 1 / 4 amount of microcrystalline cellulose and mix in proportion to obtain a mixture;

[0033] (3) Add 50% ethanol solution to the mixture material obtained in step (2) to make suitable soft materials, granulate with a 32-mesh sieve, dry the wet granules at 40 ±5°C, and size them with a 32-mesh sieve;

[0034] (4) Mix the particles obtained in step (3) with the bala...

Embodiment 2

[0037] The weight ratios of the raw and auxiliary materials are: Telbivudine 100, lactose 60, sorbitol 150, microcrystalline cellulose 118, low-substituted hydroxypropyl cellulose 28, saccharin sodium 0.9, magnesium stearate 5.6.

[0038] Preparation:

[0039] (1) Telbivudine, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sorbitol, and magnesium stearate are dried at 110°C for 1 hour, crushed through a 100 mesh sieve, and lactose and saccharin sodium are crushed through a 100 mesh sieve spare;

[0040] (2) Weigh telbivudine, sorbitol, lactose, sodium saccharin, 1 / 4 amount of low-substituted hydroxypropyl cellulose, 1 / 4 amount of microcrystalline cellulose and mix in proportion to obtain a mixture;

[0041] (3) Add 50% ethanol solution to the mixture material obtained in step (2) to make suitable soft materials, granulate with a 32-mesh sieve, dry the wet granules at 40 ±5°C, and size them with a 32-mesh sieve;

[0042] (4) Mix the particles obtained in step (3) w...

Embodiment 3

[0045] The weight ratio of the raw and auxiliary materials is: Telbivudine 100, lactose 50, sorbitol 125, microcrystalline cellulose 109, low-substituted hydroxypropyl cellulose 25, saccharin sodium 1.4, magnesium stearate 4.8.

[0046] Preparation:

[0047] (1) Telbivudine, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sorbitol, and magnesium stearate are dried at 110°C for 1 hour, crushed through a 100 mesh sieve, and lactose and saccharin sodium are crushed through a 100 mesh sieve spare;

[0048] (2) Weigh telbivudine, sorbitol, lactose, sodium saccharin, 1 / 4 amount of low-substituted hydroxypropyl cellulose, 1 / 4 amount of microcrystalline cellulose and mix in proportion to obtain a mixture;

[0049] (3) Add 50% ethanol solution to the mixture material obtained in step (2) to make suitable soft materials, granulate with a 32-mesh sieve, dry the wet granules at 40 ±5°C, and size them with a 32-mesh sieve;

[0050] (4) Mix the particles obtained in step (3) wit...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention belongs to the technical field of medicine and relates to a telbivudine orally-disintegrating tablet and a preparation method thereof. The telbivudine orally-disintegrating tablet comprises telbivudine as a main component, and a disintegrating agent, a filler and a flavoring agent as auxiliary components. The telbivudine orally-disintegrating tablet can be disintegrated or dissolved in oral cavity without water, has the characteristics of taking convenience, fast absorption and high bioavailability, can improve drug compliance of patients and improves clinical drug selectivity aiming at different patients.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to telbivudine monohydrate and a preparation method thereof, and also relates to the application of the compound composition for treating chronic hepatitis B. Background technique [0002] Hepatitis B is a disease caused by infection with HBV. After a person is infected with HBV, the virus has not been cleared for 6 months, which is called chronic hepatitis B. The final destination of chronic hepatitis B is the gradual development of liver cirrhosis and liver cancer. [0003] Chronic hepatitis B is prevalent in the world. Among the 6 billion people in the world, about 2 billion people have been infected with HBV, of which 350-400 million people are chronic HBV infection, accounting for about 6% of the global population. According to the report of the World Health Organization, about 1 million people die from liver diseases related to HBV infection every year in the wor...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7072A61P1/16A61P31/20
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH