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Oral complex composition comprising omega-3 fatty acid ester and HMG-CoA reductase inhibitor

A technology of fatty acid ester and composition, which is applied in the field of oral compound composition, and can solve problems such as non-existence

Inactive Publication Date: 2013-12-11
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, there is no compound composition drug containing omega-3 fatty acid ester and HMG-CoA reductase inhibitor with the same statin dissolution rate as the commercially available statin drug

Method used

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  • Oral complex composition comprising omega-3 fatty acid ester and HMG-CoA reductase inhibitor
  • Oral complex composition comprising omega-3 fatty acid ester and HMG-CoA reductase inhibitor
  • Oral complex composition comprising omega-3 fatty acid ester and HMG-CoA reductase inhibitor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0044] The following examples are provided to illustrate preferred embodiments of the invention and are not intended to limit the scope of the invention.

[0045] The preparation method of soft capsule core

Embodiment 1 to 7

[0054] Examples 1 to 7: Omega-3 Fatty Acid Ester Soft Capsules with Hydrophobic Barrier Coating

[0055] According to the ingredients described in Table 1, except that ethyl cellulose (Dow Chemical Company, US) was added as the hydrophobic coating, soft capsules with a hydrophobic barrier coating were prepared by repeating the procedure of Comparative Example 3.

[0056] The composition of the soft capsule and barrier coating is summarized in Table 1.

[0057] Table 1

[0058]

[0059]

[0060] Second coating

Embodiment 8 to 12

[0064] Examples 8 to 12: Omega-3 fatty acid ester soft capsules with rosuvastatin coating

[0065] Add rosuvastatin calcium, hydroxypropyl methylcellulose (HPMC2910, Shinetsu Co., Ltd., Japan), and polyethylene glycol (PEG6000, Sanyo Chemical Industries, Ltd., Japan) to a mixture of ethanol and water . PVA (Kurary Co., Ltd., Japan) or PVA-PEG graft copolymer (Kollicoat IR, BASF SE, Germany) was further added to the mixture, followed by mixing to obtain a coating solution.

[0066] The coating solution was coated on the surface of the omega-3 fatty acid ester soft capsules obtained in Example 5 by using a coater (SFC-3, SEJONG Co., Ltd.), wherein the supply air temperature was 45°C and the product temperature was adjusted to 30°C. The product was dried for 30 minutes to remove residual solvent, thereby obtaining a composite composition.

[0067] The composition of this second coating is summarized in Table 2.

[0068] Table 2

[0069]

[0070]

[0071] Evaluate

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PUM

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Abstract

An oral complex composition comprising omega-3 fatty acid esters and HMG-CoA reductase inhibitor, can effectively raise serum HDL level while reducing serum LDL and TG levels and can be used to treat hyperlipidemia owing to its good drug dissolution rate and storage stability with showing no delayed release behavior even after 6 months of accelerated storage.

Description

technical field [0001] The present invention relates to an oral composite composition containing omega-3 fatty acid ester and a HMG-CoA reductase inhibitor. Background technique [0002] Marine oil (also commonly known as fish oil) is a major source of omega-3 fatty acids, namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which regulate lipid metabolism. Omega-3 increases serum high-density lipoprotein (HDL) cholesterol and decreases serum triglycerides (TG), systolic and diastolic blood pressure, heart rate, and blood coagulation factor VII-phospholipid complex without harmful side effects activation. [0003] Currently available omega-3 fatty acid ester-containing drugs are omega-3 fatty acid ethyl esters (hereinafter referred to as "omega-3 fatty acid esters"), which are omega-3 fatty acids (that is, obtained from fish oils containing DHA and EPA). polyunsaturated fatty acids) ethyl esterified concentrates, and under the product name sell. Such omega...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/48A61K47/48A61K31/20
CPCA61K9/4808A61K31/202A61K31/505A61K9/4891A61P3/00A61P3/06A61P43/00A61P7/02A61P9/00A61P9/12A61P3/10A61K2300/00A61K47/50A61K9/28A61K9/48A61K31/20A61K31/23
Inventor 金用镒尹银镇林昊泽申伦燮朴宰贤禹锺守
Owner HANMI PHARMA