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, i

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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PUM

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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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