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Simvastatin osmotic pump preparation and preparation method thereof

A technology for simvastatin and osmotic pump tablets, applied in the field of simvastatin sustained and controlled release preparations, can solve the problems of high preparation cost, poor bioavailability, and no improvement in overall mortality

Active Publication Date: 2012-06-27
HEFEI LIFEON PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The data of a systematic review in 2003 showed that 10mg simvastatin can reduce the risk of coronary heart disease in LDL-C (27%) and moderate risk groups, but pravastatin 40mg, atorvastatin 10mg, lovastatin 20-40 mg did not show an advantage in improving overall mortality in primary prevention studies
[0009] Chinese patent CN1951385A discloses a kind of simvastatin sustained-release pellets, but its sustained-release effect needs to be further improved
However, the drug release of the above preparations still has not reached the ideal zero-order drug release state, and the bioavailability has not reached a good state, and the preparation cost is correspondingly high

Method used

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  • Simvastatin osmotic pump preparation and preparation method thereof
  • Simvastatin osmotic pump preparation and preparation method thereof
  • Simvastatin osmotic pump preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051]

[0052] Controlled Release Film Coat Composition Dosage per tablet (mg) Proportion(%) Cellulose acetate 7.2 90 Polyethylene glycol-1500 0.4 5 triethyl citrate 0.4 5

[0053] Preparation Process:

[0054] Pass the simvastatin, polyoxyethylene (2 million), sucrose, lactose, dextrin, microcrystalline cellulose, povidone, sodium lauryl sulfate, and vitamin C to be prepared through an 80-mesh sieve and mix thoroughly. Add ethanol to make the soft material; the soft material is granulated with a 30-mesh sieve; after drying, the granules are sieved with a 20-mesh sieve, and then magnesium stearate is added and mixed well; the prepared granules are compressed with a tablet machine; the controlled-release film coating is formed The raw material is dissolved in acetone, and the tablet core is coated with a controlled-release film, and the weight of the coating is increased by 6% to 8%. A small hole of 0.4-0.8mm is punched on both side...

Embodiment 2

[0056]

[0057] Controlled Release Film Coat Composition Dosage per tablet (mg) Proportion(%) Cellulose acetate 6.4 80 Polyethylene glycol-1500 1.6 20

[0058] Preparation Process:

[0059]Pass the simvastatin, polyoxyethylene (2 million), sucrose, lactose, dextrin, microcrystalline cellulose, povidone, and vitamin C to be prepared through an 80-mesh sieve, mix them well, and set aside; polysorbate- 80 plus ethanol to dissolve and add the above dry powder to make soft material; the soft material is granulated with a 30-mesh sieve; after drying, 20-mesh sieve is granulated, and then magnesium stearate is added and mixed; the prepared granules are compressed with a tablet machine; Dissolve the raw materials of the controlled-release film coating in acetone, and coat the tablet core with a controlled-release film. The weight of the coating increases by 6% to 8%. A 0.4 A small hole of ~0.8mm.

Embodiment 3

[0061]

[0062] Controlled Release Film Coat Composition Dosage per tablet (mg) Proportion(%) Cellulose acetate 6.4 80 Polyethylene glycol-1500 1.6 20

[0063] Preparation Process:

[0064] Pass the simvastatin, polyoxyethylene (2 million), sucrose, lactose, dextrin, microcrystalline cellulose, povidone, sodium lauryl sulfate, and vitamin C to be prepared through an 80-mesh sieve and mix thoroughly. Add ethanol to make the soft material; the soft material is granulated with a 30-mesh sieve; after drying, the granules are sieved with a 20-mesh sieve, and then magnesium stearate is added and mixed well; the prepared granules are compressed with a tablet machine; the controlled-release film coating is formed The raw material is dissolved in acetone, and the tablet core is coated with a controlled-release film, and the weight of the coating is increased by 6% to 8%. A small hole of 0.4-0.8mm is punched on both sides of the controlled-release film...

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Abstract

The invention discloses simvastatin monolayer osmotic pump sustained release tablets. Each simvastatin monolayer osmotic pump sustained release tablet comprises a tablet core and a controlled-release film coated layer, wherein the tablet core contains the following components in percentage by weight: 1 to 20 percent of simvastatin serving as a main medicine, 1 to 25 percent of filling agent, 50 to 90 percent of penetrating agent, 1 to 15 percent of adhesive, 0.5 to 5 percent of release conditioning agent and 0.5 to 3 percent of lubricating agent; the controlled-release film coated layer comprises a controlled-release film-forming material, a plasticizer and / or a pore-forming agent; the filling agent comprises microcrystalline cellulose and dextrin; and the penetrating agent contains cane sugar and lactose.

Description

technical field [0001] The invention relates to a simvastatin sustained and controlled release preparation, in particular to a simvastatin oral osmotic pump preparation. Background technique [0002] Simvastatin (simvastatin) is a statin (statin) blood lipid-lowering drug. It is a methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitor that inhibits the synthesis of endogenous cholesterol and is used to control blood cholesterol. content and the prevention of cardiovascular disease. It is clinically used to treat hypercholesterolemia and coronary heart disease. [0003] Simvastatin is a best-selling cholesterol-lowering drug in the world. It is sold as a single-ingredient generic drug and brand-name drug Zocor (Merck, Merck), as well as a compound preparation Torin with ezetimibe and a compound preparation Simcor with niacin. In 2004, 10 mg simvastatin was available in pharmacies as an OTC drug in the UK. At present, simvastatin is the most widely used statin blood ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/36A61K9/44A61K31/366A61P3/06
Inventor 季俊虬高美华陈军何杰
Owner HEFEI LIFEON PHARMA
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