Simeprevir tablet composition

A technology of simeprevir and a composition, which is applied in the field of pharmaceutical preparations, can solve the problems that affect the expansion of the applicable population, the dissolution rate of smelprevir tablets is not easy to meet the standard regulations, etc., and achieves the effects of being convenient to take and increasing the dissolution rate

Inactive Publication Date: 2018-01-09
WEIHAI GUANBIAO INFORMATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Semeprevir is a white to off-white powder, almost insoluble in water and various pH ranges, almost insoluble in propylene glycol, and very slightly soluble in ethanol. Because some people have a feeling of being stuck after taking the capsule, it affects their health. Applicable crowd expansion
In the work of making tablets, it was found that the dissolution rate of semeprevir tablets is not easy to meet the standard requirements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0018] Example 2, D90 150g of simeprevir at 46 microns, 8g of lecithin, 56g of lactose, 1.0g of sodium lauryl sulfate, 3g of polyvinylpyrrolidone, 8g of polyethylene glycol 4000, 1.2g of fumed silica, Magnesium stearate 1.5g. Prepare 1000 tablets according to the preparation method described in the technical scheme.

Embodiment 3

[0019] Example 3, 150g of simeprevir at 38 microns for D90, 5.5g of lecithin, 40g of lactose, 0.8g of sodium lauryl sulfate, 6g of polyvinylpyrrolidone, 5g of polyethylene glycol 4000, and 0.9g of fumed silica , magnesium stearate 0.9g. Prepare 1000 tablets according to the preparation method described in the technical scheme.

Embodiment 4

[0020] Example 4, D90 150g of simeprevir at 42 microns, 6g of lecithin, 46g of lactose, 1.0g of sodium lauryl sulfate, 5g of polyvinylpyrrolidone, 6g of polyethylene glycol 4000, 1.0g of fumed silica, Magnesium stearate 1.0g. Prepare 1000 tablets according to the preparation method described in the technical scheme.

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PUM

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Abstract

The invention relates to a simeprevir tablet composition, which belongs to the technical field of pharmaceutical preparations. The technical scheme of the present invention is: a kind of simeprevir tablet composition, in the composition of unit dose, contain the simeprevir 150mg of D90 in 30-46 micron, lecithin 4-8mg, lactose 30-56mg, Sodium lauryl sulfate 0.7-1.0mg, polyvinylpyrrolidone 3-6mg, polyethylene glycol 4000 4-8mg, fumed silicon dioxide 0.8-1.2mg, magnesium stearate 0.8-1.5mg. The invention provides qualified tablet composition for hepatitis C patients, which is convenient for patients to take.

Description

technical field [0001] The invention relates to a simeprevir tablet composition, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Hepatitis C (HCV) is a blood-borne infectious liver disease that can cause significant damage to the liver if left untreated. In the United States, about 3.2 million people live with hepatitis C and about 15,000 people die from the disease each year, mostly from hepatitis C-related diseases such as cirrhosis and liver cancer. [0003] Simeprevir, alias: simeprevir, English name: simeprevir. In November 2013, it was approved for marketing by the FDA, and the commercially available specification is: 150mg capsules. Semeprevir is a new generation of NS3 / 4A protease inhibitors, a once-daily oral drug, jointly developed by Medivir and Johnson & Johnson (Janssen), for the treatment of compensated liver disease in adult patients with chronic hepatitis C, including various stage of liver fibrosis, its w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/24A61K47/20A61K31/4709A61P1/16A61P31/14
Inventor 孙爱梅
Owner WEIHAI GUANBIAO INFORMATION TECH
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