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Ledipasvir and sofosbuvir compound coating tablet preparation and preparation method thereof

A technology of coated tablets and preparations, applied in the direction of sugar-coated pills, pill delivery, antiviral agents, etc., to achieve stable blood drug concentration and improve 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 the preparation of ledipasvir and sofosbuvir compound coated tablets is still blank. Facing the high price of new drugs that have just been launched, it is necessary to develop a safer, more effective and cheaper ledipasvir and sofosbuvir Compound-coated tablet preparations have become a top priority for my country's pharmaceutical industry

Method used

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  • Ledipasvir and sofosbuvir compound coating tablet preparation and preparation method thereof
  • Ledipasvir and sofosbuvir compound coating tablet preparation and preparation method thereof
  • Ledipasvir and sofosbuvir compound coating tablet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] prescription:

[0044] Composition Prescription amount (mg / tablet)

[0045] Reddy Pawee 90

[0046] Sofosbuvir 400

[0047] Croscarmellose Sodium 96

[0048] Microcrystalline Cellulose 502

[0049] Magnesium Stearate 12

[0050] According to above-mentioned prescription quantity, preparation process is as follows:

[0051] (1) Material pretreatment: sieve ledipasvir, sofosbuvir, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate, and set aside;

[0052] (2) Mixing: Weigh the prescription amount of the active drug ledipasvir, sofosbuvir, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate and mix evenly;

[0053] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0054] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of croscarmellose sodium and magnesium stearate;

[0055] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rot...

Embodiment 2

[0058] prescription:

[0059] Composition Prescription amount (mg / tablet)

[0060] Reddy Pawee 90

[0061] Sofosbuvir 400

[0062] Hypromellose 96

[0063] Microcrystalline Cellulose 502

[0064] Magnesium Stearate 12

[0065] According to above-mentioned prescription quantity, preparation process is as follows:

[0066] (1) Material pretreatment: sieve ledipasvir, sofosbuvir, hypromellose, microcrystalline cellulose, and magnesium stearate, and set aside;

[0067] (2) Mixing: Weigh the prescribed amount of active drug ledipasvir, sofosbuvir, hypromellose, microcrystalline cellulose, and magnesium stearate and mix evenly;

[0068] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0069] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of hypromellose and magnesium stearate;

[0070] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0071] (6) Film coati...

Embodiment 3

[0073] prescription:

[0074] Composition Prescription amount (mg / tablet)

[0075] Reddy Pawee 90

[0076] Sofosbuvir 400

[0077] Croscarmellose Sodium 96

[0078] Mannitol 502

[0079] Magnesium Stearate 12

[0080] According to above-mentioned prescription quantity, preparation process is as follows:

[0081] (1) Material pretreatment: sieve ledipasvir, sofosbuvir, croscarmellose sodium, mannitol, and magnesium stearate, and set aside;

[0082] (2) Mixing: Weigh the prescription amount of the active drug ledipasvir, sofosbuvir, croscarmellose sodium, mannitol, and magnesium stearate and mix evenly;

[0083] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0084] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of croscarmellose sodium and magnesium stearate;

[0085] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0086] (6) Film coating: film-coa...

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Abstract

The invention discloses a ledipasvir and sofosbuvir compound coating tablet preparation. The preparation is prepared from the following active ingredients in percentage by mass: 45.0-55.0 percent of ledipasvir and sofosbuvir, 2.0-8.0 percent of a disintegrating agent, 30-40 percent of a diluting agent and 0.5-1.5 percent of a lubricating agent, wherein the disintegrating agent is one or more of povidone, croscarmellose sodium, hydroxypropyl methylcellulose and sodium carboxymethyl starch; the diluting agent is one or more of microcrystalline cellulose, mannitol, lactose and polyethylene glycol; the lubricating agent is one or more of magnesium stearate, talcum powder, aerosil and calcium stearate. The ledipasvir and sofosbuvir compound coating tablet preparation is prepared by coating with a rhombic buccal tablet, and the tablet content has good uniformity. 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 compound coated tablet preparation of ledipasvir and sofosbuvir and a preparation method thereof, which are applied in the field of treatment of hepatitis C virus. Background technique [0002] Hepatitis C virus [0003] Chronic hepatitis, referred to as hepatitis C or hepatitis C, is a viral hepatitis caused by hepatitis C virus (Hepatitis C Virus, HCV) infection, mainly through blood transfusion or injection. [0004] 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. HCV infection mainly includes two kinds of immune-mediated and HCV direct damage. Liver inflammation leads to decreased liver function or even failure. The pathological manifestations are mainly liver cell necrosis and lymphocyte infiltration. Most hepatitis C patients do not find symptoms of ...

Claims

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Application Information

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IPC IPC(8): A61K31/7072A61K9/28A61P31/14A61P1/16A61K31/4184
Inventor 顾世海
Owner ANHUI YELLEN PHARMA
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