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Sofosbuvir film coating tablet preparation and preparation method thereof

A film coating, sofosbuvir technology, applied in the direction of antiviral agents, pharmaceutical formulations, medical preparations containing active ingredients, etc., to achieve the effect of stable blood drug concentration and improved convenience

Inactive Publication Date: 2015-04-29
ANHUI YELLEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, domestic research on sofosbuvir film-coated tablets is still blank

Method used

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  • Sofosbuvir film coating tablet preparation and preparation method thereof
  • Sofosbuvir film coating tablet preparation and preparation method thereof
  • Sofosbuvir film coating tablet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Prescription composition: Prescription amount (mg / tablet)

[0044] Sofosbuvir 400

[0045] Croscarmellose Sodium 96

[0046] Microcrystalline Cellulose 592

[0047] Magnesium Stearate 12

[0048] According to above-mentioned prescription quantity, preparation process is as follows:

[0049] (1) Material pretreatment: sieve sofosbuvir, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate for later use;

[0050] (2) Mixing: Weigh the active drug sofosbuvir, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate in the prescribed amount and mix evenly;

[0051] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0052] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of croscarmellose sodium and magnesium stearate;

[0053] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0054] (6) Film coating: film-coat the qua...

Embodiment 2

[0056] Prescription composition: Prescription amount (mg / tablet)

[0057] Sofosbuvir 400

[0058] Hypromellose 96

[0059] Microcrystalline Cellulose 592

[0060] Magnesium Stearate 12

[0061] According to above-mentioned prescription quantity, preparation process is as follows:

[0062] (1) Material pretreatment: sieve sofosbuvir, hypromellose, microcrystalline cellulose, and magnesium stearate for later use;

[0063] (2) Mixing: Weigh the prescription amount of active drug sofosbuvir, hypromellose, microcrystalline cellulose, and magnesium stearate and mix evenly;

[0064] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0065] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of hypromellose and magnesium stearate;

[0066] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0067] (6) Film coating: film-coat the qualified tablets prepared in (5).

Embodiment 3

[0069] Prescription composition: Prescription amount (mg / tablet)

[0070] Sofosbuvir 400

[0071] Croscarmellose Sodium 96

[0072] Mannitol 592

[0073] Magnesium Stearate 12

[0074] According to above-mentioned prescription quantity, preparation process is as follows:

[0075] (1) Material pretreatment: sieve sofosbuvir, croscarmellose sodium, mannitol, and magnesium stearate for later use;

[0076] (2) Mixing: Weigh the active drug sofosbuvir, croscarmellose sodium, mannitol, and magnesium stearate in the prescribed amount and mix evenly;

[0077] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0078] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of croscarmellose sodium and magnesium stearate;

[0079] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0080] (6) Film coating: film-coat the qualified tablets prepared in (5).

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Abstract

The invention discloses a sofosbuvir film coating tablet preparation. The preparation is prepared from the following active ingredients in percentage by mass: 25.0-40.0 percent of sofosbuvir, 2.0-8.0 percent of a disintegrating agent, 50.0-80.0 percent of a diluting agent and 0.5-1.5 percent of a lubricating agent, wherein the disintegrating agent is one or more of croscarmellose sodium, hydroxypropyl methylcellulose and sodium carboxymethyl starch, one or two of sodium carboxymethylcellulose and hydroxypropyl methylcellulose as first choice, and preferably sodium carboxymethylcellulose; the diluting agent is one or more of microcrystalline cellulose, mannitol, lactose and polyethylene glycol, one or two of microcrystalline cellulose and mannitol as first choice, and preferably microcrystalline cellulose; and the lubricating agent is one or more of magnesium stearate, talcum powder, aerosil and calcium stearate, one or two of magnesium stearate and aerosil, and preferably magnesium stearate. The preparation has the advantages of simple process, high yield, good stability and the like, and is easy for large-scale industrial production.

Description

technical field [0001] The invention discloses a sofosbuvir film-coated tablet preparation and a preparation method thereof, which are applied in the field of preparation of therapeutic preparations for hepatitis C virus. Background technique [0002] Hepatitis C virus, referred to as hepatitis C or hepatitis C for short, is a viral hepatitis caused by hepatitis C virus (Hepatitis C Virus, HCV) infection, which is mainly transmitted through blood transfusion or injection. [0003] According to the statistics of the World Health Organization, the global HCV infection is about 3.0%, about 180 million people are infected with HCV, and nearly 40 million people are infected with hepatitis C every year. Therefore, hepatitis C is called a "virus time bomb" by the World Health Organization, and the number of deaths due to hepatitis C reaches 350,000 people every year. Hepatitis C can lead to chronic inflammation, necrosis and fibrosis of the liver, and some patients can develop liv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/7072A61P1/16A61P31/14
Inventor 顾世海
Owner ANHUI YELLEN PHARMA
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