Antilipidemic pharmaceutical compositions and process for preparation thereof

A technology of blood lipid-lowering drugs and compositions, applied in the field of oral pharmaceutical compositions, capable of solving problems such as reduced compliance

Inactive Publication Date: 2009-12-02
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] Moreover, the study found that as the number of prescribed medications increased, patient compliance with those medications decreased

Method used

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  • Antilipidemic pharmaceutical compositions and process for preparation thereof
  • Antilipidemic pharmaceutical compositions and process for preparation thereof
  • Antilipidemic pharmaceutical compositions and process for preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0105] Particle I:

[0106] Preparation of Fenofibrate Granules I

[0107] composition

[0108]

[0109] step:

[0110] 1. Dissolve fenofibrate, polyvinylpyrrolidone and sodium lauryl sulfate in water and stir to form a clear solution.

[0111] 2. A mixture of acetone:dichloromethane (70:30 ratio) was added to the solution from step 1 while stirring and stirring was continued for 45 minutes.

[0112] 3. Spray the solution from step 2 onto the mixture of pregelatinized starch and lactose to form fenofibrate granules.

[0113] 4. The dried granules of step 3 were sieved and mixed with cross-linked polyvinylpyrrolidone, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate to form a fenofibrate granule mixture.

Embodiment 2

[0115] Particle II:

[0116] Preparation of Fenofibrate Granules II

[0117] composition

[0118]

[0119] step:

[0120] 1. Dissolve fenofibrate, polyvinylpyrrolidone, and docusate sodium in isopropanol and stir to form a clear solution.

[0121] 2. Spray the solution from step 1 onto the mixture of microcrystalline cellulose, sodium lauryl sulfate and red iron oxide to form fenofibrate granules.

[0122] 3. The dried granules from step 2 were sieved and blended with cross-linked polyvinylpyrrolidone, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate to form a fenofibrate granule mixture.

[0123] Particle III:

[0124] Preparation of Ezetimibe Granules

[0125] composition

[0126]

[0127]

[0128] step:

[0129] 1. Mix ezetimibe, croscarmellose sodium and lactose together to form a homogeneous mixture.

[0130] 2. Sodium lauryl sulfate and polyvinylpyrrolidone were dissolved in water and mixed with the mixture of step 1 to form e...

Embodiment 3

[0162] The fenofibrate granules of Example 1 were compressed with a special tool to form a monolithic tablet. The tablets were coated with the coating composition described above.

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PUM

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Abstract

The present invention relates to a new process for preparing an oral pharmaceutical composition comprising fenofibrate alone or in combination with at least one other antilipidemic agent in a single dosage form that can be conveniently administered once or twice in a day.

Description

field of invention [0001] The present invention relates to a new process for the preparation of oral pharmaceutical compositions comprising fenofibrate alone or in combination with at least one hypolipidemic drug in a single dosage form, which can be conveniently administered once a day or Two doses. Background of the invention [0002] In the human body, cholesterol and triglyceride (TG) are components of lipoprotein complexes in the blood stream, which can be separated by ultracentrifugation to form high-density lipoprotein (HDL), intermediate-density lipoprotein (IDL), and low-density lipoprotein ( LDL) and very low-density lipoprotein (VLDL) fractions. Cholesterol and triglycerides are synthesized in the liver, incorporated into VLDL and released into the blood. High levels of total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apo-B, the membrane complex of LDL-C) induce human atherosclerosis, and HDL- Decreased levels of C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/50A61K31/216
Inventor S·马丹R·辛格P·太吉V·K·阿罗拉
Owner RANBAXY LAB LTD
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