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Oral complex formulation comprising omega-3 fatty acid and HMG-CoA reductase inhibitor with improved stability

A technology of reductase inhibitor and compound preparation, which is applied in the directions of organic active ingredients, anhydride/acid/halide active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as the inability to guarantee drug stability.

Inactive Publication Date: 2014-07-30
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is a disadvantage in that drug stability between two different drugs cannot be guaranteed when directly mixed

Method used

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  • Oral complex formulation comprising omega-3 fatty acid and HMG-CoA reductase inhibitor with improved stability
  • Oral complex formulation comprising omega-3 fatty acid and HMG-CoA reductase inhibitor with improved stability
  • Oral complex formulation comprising omega-3 fatty acid and HMG-CoA reductase inhibitor with improved stability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-1 to 1-3 and comparative Embodiment 1

[0082] Examples 1-1 to 1-3 and Comparative Example 1: Preparation of Capsules and Effects Dependent on Capsule Components

[0083] Due to restrictions on the amount of material allowed for soft capsules (which will be used to encapsulate omega-3 fatty acid ester oil), soft capsules with different compositions were prepared and stability tests were carried out to determine Proper mixing ratio between glycan solutions.

[0084] 1) Preparation of capsules

[0085] By following the ingredients described in Table 2, and using conventional methods, soft or hard gelatin capsules were prepared, followed by filling the gelatin thus obtained with 1,000 mg of omega-3 fatty acid ester oil (KD pharma, Germany, EP grade) capsules to obtain capsules of Examples 1-1 to 1-3 and Comparative Example 1. Sorbitol sorbitan solutions were used as plasticizers for the capsules of Examples 1-1 to 1-3, and glycerin was used for the capsules of Comparative Example 1. In addition, a small amount of ...

Embodiment 2

[0094] Embodiment 2: Preparation of oral compound preparation comprising rosuvastatin

[0095] The first and second coatings were applied according to the ingredients described in Table 3, using the capsules of Example 1-1 as the core. For the first coat, hydroxypropylmethylcellulose (HPMC), polyethylene glycol (PEG), polyvinylpyrrolidone (PVP) and ethylcellulose (Aqualon N7 grade, ASHLAND) were dissolved in a weight ratio of 3 : 7 mixed solvent of ethanol and water, and then by means of the mixture thus obtained and using a coating device (Sejong, SFC-30) for water-resistant coating. Subsequently, for the second coat, rosuvastatin calcium, alkaline stabilizer (MgCO 3 ), polyvinylpyrrolidone and polyvinyl alcohol-polyethylene glycol graft copolymer (Kollicoat IR, BASF) were dissolved in a mixed solvent of ethanol and water at a weight ratio of 3:7, and then by means of the mixture thus obtained and using A coating device (Sejong, SFC-30) was used for the second coating follo...

Embodiment 3 and 4

[0106] Examples 3 and 4: Preparation of Oral Compound Preparations Containing Atorvastatin

[0107] The first and second coatings were applied according to the ingredients described in Table 4 and using the capsules of Example 1-1 as the core. For the first coating, hydroxypropylmethylcellulose (HPMC), polyethylene glycol, polyvinylpyrrolidone, and ethylcellulose were dissolved in a mixed solvent of ethanol and water at a weight ratio of 3:7, and then A water-resistant coating was performed on the mixture thus obtained using a coating device (Sejong, SFC-30). Subsequently, for the second coat, atorvastatin calcium, alkaline stabilizer, polyvinylpyrrolidone and polyvinyl alcohol-polyethylene glycol graft copolymer were dissolved in a mixture of ethanol and water in a weight ratio of 3:7 solvent, and then a second coating was performed by means of the mixture thus obtained using a coating device (Sejong, SFC-30), followed by drying to obtain the oral compound preparations of Ex...

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Abstract

The present invention relates to an oral complex formulation comprising omega-3 fatty acid or its derivatives encapsulated in a hard or soft capsule containing sorbitol and sorbitan, as well as an HMG-CoA reductase inhibitor. The formulation of the present invention comprising omega-3 fatty acid encapsulated with sorbitol and sorbitan provides better prevention related materials from being formed, leading to improved long-term storage stability. The oral complex formulation of the present invention also can raise the serum HDL-cholesterol level, while reducing both LDL-cholesterol and TG levels. The oral complex formulation of the present invention is useful for treatment of hyperlipidemia.

Description

technical field [0001] The present invention relates to an oral compound preparation, which comprises omega-3 fatty acid loaded in a hard or soft capsule, and an HMG-CoA reductase inhibitor. Background technique [0002] Marine oil, also commonly referred to as fish oil, is a major source of omega-3 fatty acids, which regulate lipid metabolism, eg, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omega-3 fatty acids lower serum triglyceride (TG) and serum low-density lipoprotein (LDL) cholesterol levels, lower systolic and diastolic blood pressure, and heart rate, and inhibit phospholipid complexes (a blood clotting factor) without adverse side effects activation. [0003] Those omega-3 fatty acids currently available as prescription drugs are omega-3 fatty acid ethyl esters (hereinafter, referred to as "omega-3 fatty acid esters"). In other words, they are ethyl esters of omega-3 fatty acids, which are polyunsaturated fatty acids obtained from fish oil (compris...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/54A61K31/20A61K9/20
CPCA61K9/4808A61K9/4816A61K9/4891A61K31/232A61K31/505A61K45/06A61P3/06A61P43/00A61K2300/00A61K9/48A61K31/20A61K31/40
Inventor 金辰哲金载镐尹银镇金用镒朴宰贤禹锺守
Owner HANMI PHARMA