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Fenofibrate osmotic pump controlled release preparation and preparation method thereof

A technology of fenofibrate and controlled-release preparations, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., to achieve the effect of reducing the number of medications, reducing side effects, and stabilizing and lasting blood drug concentration

Inactive Publication Date: 2009-05-06
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is very difficult to develop fenofibrate osmotic pump formulations for daily administration

Method used

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  • Fenofibrate osmotic pump controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Fenofibrate double-layer osmotic pump

[0033] Tablet core prescription (by weight)

[0034] Drug layer:

[0035] Fenofibrate 250mg

[0036] NaCl 65mg

[0037] Polyoxyethylene WSR205 200mg

[0038] Magnesium stearate amount

[0039] Booster layer:

[0040] Polyoxyethylene WSR303 145mg

[0041] Lactose 10mg

[0042] Iron oxide red 1mg

[0043] 95% ethanol appropriate amount

[0044] Semi-permeable membrane prescription (by weight)

[0045] Cellulose acetate 18g

[0046] Polyethylene glycol 2000 4g

[0047] Solvent formulation for dissolving coating material (volume calculation)

[0048] Acetone 500ml

[0049] water 50ml

[0050] Preparation Process:

[0051] Mix the prescribed amount of medicine with NaCl and WSR205 that have passed through an 80-mesh sieve, use 95% ethanol solution as a binder to make soft materials, granulate with a 20-mesh sieve, dry the wet granules, and use a 18-mesh sieve to granulate. After adding lubricant and mixing eve...

Embodiment 2

[0052] Example 2 Fenofibrate double-layer osmotic pump

[0053] Tablet core prescription (by weight)

[0054] Drug layer:

[0055] Fenofibrate 250mg

[0056] Polyoxyethylene PEO 1105 100mg

[0057] Polyoxyethylene PEO N80 100mg

[0058] Xylitol 100mg

[0059] Booster layer:

[0060] Sodium Alginate 140mg

[0061] Sodium Bicarbonate 30mg

[0062] Iron oxide red 1mg

[0063] Magnesium stearate amount

[0064] 10% PVP alcohol solution

[0065] Semi-permeable membrane prescription (by weight)

[0066] Cellulose acetate 15g

[0067] PEG4000 5g

[0068] Solvent ratio of coating film material (calculated by volume)

[0069] Acetone 500ml

[0070] water 30ml

[0071] Mix the prescribed amount of medicine with NaCl, PEO 1105 and PEO N80 that have passed through a 80-mesh sieve, and use 10% PVP alcohol solution as a binder to make a soft material, granulate with a 20-mesh sieve, and dry the wet granules with an 18-mesh sieve. The whole dry granules are mixed with lubricant...

Embodiment 3

[0072] Example 3 Fenofibrate double-layer osmotic pump

[0073] Tablet core prescription (by weight)

[0074] Drug-containing layer:

[0075] Fenofibrate 250mg

[0076] Polyoxyethylene PEO N12K 175mg

[0077] Glucose 125mg

[0078] Booster layer:

[0079] Polyoxyethylene WSR 303 145mg

[0080] NaCl 5mg

[0081] Iron oxide red amount

[0082] Magnesium stearate amount

[0083] 1% HPMC alcohol solution

[0084] Semi-permeable membrane prescription (by weight)

[0085] Cellulose acetate 25g

[0086] PEG1500 7g

[0087] Solvent ratio of coating film material (calculated by volume)

[0088] Acetone 1000ml

[0089] water 80ml

[0090] Mix the prescribed amount of medicine with glucose and PEO N12K that have passed through an 80-mesh sieve, use 10% PVP ethanol solution as a binder to make a soft material, granulate with a 20-mesh sieve, dry the wet granules, and use an 18-mesh sieve to granulate. After the dry granules are mixed with lubricant, the tablet core is obtai...

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Abstract

The invention belongs to the field of medicament preparation and discloses a fenofibrate osmotic pump type controlled release preparation and a preparation method thereof. The preparation is formed by an osmotic pump tablet core and a controlled release coat coated outside the tablet core. The weight of the osmotic pump controlled release tablet core is as follows: 250mg / tablet of fenofibrate, 25mg to 100mg / tablet of osmotic active matter, 200mg of 300mg / tablet of accessory which can lead the medicament in a medicine containing layer to be easily released, 75 to 150mg / tablet of accessory which leads the medicament to be easily released in a promoting layer and proper amount of other accessories. The weight of the osmotic pump coat is as follows: 15g to 30g / 100 tablets of semi-transparent membrane coat macromolecule material and 2 to 10g / 100 tablets of pore-foaming agent. The invention can effectively adjust the release speed of the medicament by adjusting the tablet core and the prescription of the coat and obtain more stable and durable effective blood medicine concentration, thereby reducing the side effect and the taking times of the medicament, ensuring that the suction of themedicament is not affected by whether the patient eats or not and the environment in a body, and improving the compliance of a sufferer. The invention can be broadly applied to curing hyperlipemia.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a fenofibrate osmotic pump type controlled-release preparation, specifically a fenofibrate double-layer osmotic pump type controlled-release preparation and a preparation method thereof. Background technique [0002] Fenofibrate Standardized Capsules was first researched and developed by the French Liboforni Pharmaceutical Company. It was approved as a Class A drug by the FDA in 1994. The sales volume of fibrates accounts for 13%-15% of the market share of blood lipid-lowering drugs, of which imported drugs account for about half. The commonly used phenoxyacetic acids in hospitals are fenofibrate, gemfibrozil, and bezafibrate, among which fenofibrate occupies the largest share in the purchase amount of blood lipid-regulating drugs. [0003] Fenofibrate controlled-release tablet is a phenoxy acid prodrug with hypolipidemic effect, which is rapidly absorbed orall...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/215A61P3/06
Inventor 潘卫三杨星钢孙光美聂淑芳唐歆关津
Owner SHENYANG PHARMA UNIVERSITY
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