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Pharmaceutical formulation in the form of bilayered tablets comprising HMG-CoA reductase inhibitor and irbesartan

A technology for reductase inhibitors and pharmaceutical preparations, applied in the field of pharmaceutical preparations, can solve the problems of difficult to accurately predict delayed release time, difficult to constant delayed release rate products, etc., to improve bioavailability, improve stability, and improve dissolution rate. Effect

Active Publication Date: 2013-03-27
HANMI SCI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this delayed release formulation is only designed for in vitro testing (e.g., dissolution tester), and it is difficult to prepare a product with a constant delayed release rate by using the formulation
In addition, due to individual differences in gastrointestinal motility, it is also difficult to predict the delayed release time precisely

Method used

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  • Pharmaceutical formulation in the form of bilayered tablets comprising HMG-CoA reductase inhibitor and irbesartan
  • Pharmaceutical formulation in the form of bilayered tablets comprising HMG-CoA reductase inhibitor and irbesartan
  • Pharmaceutical formulation in the form of bilayered tablets comprising HMG-CoA reductase inhibitor and irbesartan

Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1-1

[0065] Preparation Example 1-1: Preparation of particles containing irbesartan

[0066] According to the composition described in Table 1, irbesartan (Hanmi Fine Chemical Co., Ltd., Korea), mannitol, pregelatinized starch and croscarmellose sodium (DMV international) were mixed, and then dissolved with A binding solution of povidone (BASF, Germany) in water knead the mixture, dry and pass through a 30-mesh sieve to obtain wet granules, then add magnesium stearate and mix to prepare Erbe Sartan granules.

preparation Embodiment 1-2

[0067] Preparation Example 1-2: Preparation of particles containing irbesartan

[0068] According to the composition described in Table 1, irbesartan (Hanmi Fine Chemical Co., Ltd., Korea), mannitol, pregelatinized starch and croscarmellose sodium (DMV international) were mixed, and then dissolved with A binding solution of povidone (BASF, Germany) and poloxamer 188 (BASF, Germany) in water knead the mixture, dry and pass through a 30-mesh sieve to obtain wet granules, and then add magnesium stearate And mixed to prepare irbesartan granules.

[0069]

[0070] Granules containing irbesartan (unit: mg)

[0071] ingredient Preparation Example 1-1 Preparation Example 1-2 Irbesartan 150 150 Mannitol 47 47 Pregelatinized starch 23 23 Croscarmellose Sodium 12 12 Povidone 8 8 Poloxamer 188 9

preparation Embodiment 2-1

[0072] Preparation Example 2-1: Preparation of particles containing atorvastatin

[0073] According to the composition described in Table 2, combine atorvastatin calcium (TEVA, India), mannitol, microcrystalline cellulose and crospovidone (BASF, Germany) with NaHCO 3 (Pendrice Soda, Australia), then knead the mixture with a binding solution of HPC (hydroxypropyl cellulose) and polysorbate 80 (Croda, USA) dissolved in water, dry and pass through a 30-mesh screen to Wet granules are obtained, and then magnesium stearate is added and mixed to prepare HMG-CoA reductase inhibitor granules.

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PUM

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Abstract

Provided is a pharmaceutical formulation in the form of bilayered tablets consisting of a first layer containing irbesartan or pharmaceutically acceptable salts thereof and a second layer containing an HMG-CoA reductase inhibitor and a basic additive, which can improve the dissolution rate and stability of irbesartan and an HMG-CoA reductase inhibitor to enhance the bioavailability of the drug compared to conventional complex formulations and to minimize the generation of the related compounds, thereby being effectively used as a stable and superior therapeutic agent for hypertension and hypercholesterolemia.

Description

Technical field [0001] The present invention relates to a pharmaceutical preparation in the form of a bilayer tablet containing an HMG-CoA reductase inhibitor and irbesartan as active ingredients, which has improved stability and dissolution rate. Background technique [0002] Hyperlipidemia is a condition in which the level of lipids (for example, cholesterol, triglycerides, etc.) in plasma is abnormally increased. Hyperlipidemia (especially hypercholesterolemia) induces arterial thrombosis, leading to arteriosclerosis, in which the arterial wall thickens due to lipid accumulation. Arteriosclerosis is clinically important because it can lead to cardiovascular diseases such as ischemic heart disease, angina pectoris, and myocardial infarction. Prevention of arteriosclerosis can be achieved by treating hypercholesterolemia, which is highly related to it. [0003] Hyperlipidemia or elevated plasma lipid levels are associated with increased frequency of cardiovascular disease and ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/20A61K31/415A61K31/40A61P3/06A61P3/00
CPCA61K9/2054A61K9/1652A61K9/1611A61K31/40A61K9/2009A61K9/209A61K45/06A61K31/415A61P3/00A61P3/06A61P43/00A61P9/12A61K2300/00A61K9/20A61K47/36A61K31/41
Inventor 金用镒罗荣俊金珉贞金永勋朴宰贤禹锺守
Owner HANMI SCI CO LTD
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