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Pitavastatin calcium double-layer osmotic pump controlled-release tablet and preparation method thereof

A controlled-release technology of pitavastatin calcium and osmotic pumps, which is applied in pharmaceutical formulations, drug delivery, pill delivery, etc., can solve the problem of drug release stability, poor drug safety, reduced drug release speed, and drug inability to release To avoid large fluctuations in blood drug concentration, reduce individual differences, and reduce the number of medications

Inactive Publication Date: 2015-02-18
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

With the release of the drug and the dissolution of the excipients used as osmotic agents, the drug release rate will decrease with the decrease of the osmotic pressure difference between the inside and outside of the coating film. Always keep constant, so the drug usually cannot be released completely, the stability of the drug release and the safety of the drug are not very ideal

Method used

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  • Pitavastatin calcium double-layer osmotic pump controlled-release tablet and preparation method thereof
  • Pitavastatin calcium double-layer osmotic pump controlled-release tablet and preparation method thereof
  • Pitavastatin calcium double-layer osmotic pump controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] prescription:

[0048] (1) Drug-containing layer

[0049] Pitavastatin Calcium 0.5%

[0050] Dicalcium Phosphate 40%

[0051] Sodium bicarbonate 2%

[0052] Sodium Chloride 1.5%

[0053] Polyoxyethylene 19%

[0054] Magnesium Stearate 0.5%

[0055] Appropriate amount of water

[0056] (2) Push layer

[0057] Polyoxyethylene 25%

[0058] Sodium Chloride 11%

[0059] Magnesium Stearate 0.5%

[0060] Proper amount of ethanol

[0061] (3) Coating layer

[0062] Cellulose Acetate 95%

[0063] Macrogol 4000 5%

[0064] Proper amount of ethanol

[0065] Preparation:

[0066] (1) According to the above prescription, pitavastatin calcium is mixed with basic auxiliary materials, osmotic pressure active substances, penetration enhancers and other auxiliary materials and then granulated to obtain drug-containing layer granules; the penetration enhancer, osmotic pressure active substances and other auxiliary materials are mixed After granulation, the push layer granu...

Embodiment 2

[0071] prescription:

[0072] (1) Drug-containing layer

[0073] Pitavastatin Calcium 1%

[0074] Calcium Carbonate 15%

[0075] Magnesium Oxide 5%

[0076] Carbopol 35%

[0077] Lactose 6.5%

[0078] Magnesium Stearate 0.5%

[0079] Povidone K30 3%

[0080] Proper amount of ethanol

[0081] (2) Push layer

[0082] Polyoxyethylene 19%

[0083] Sodium Chloride 12%

[0084] Hypromellose 2.5%

[0085] Magnesium Stearate 0.5%

[0086] Proper amount of ethanol

[0087] (3) Coating layer

[0088] Cellulose acetate 91.3%

[0089] Triethyl Citrate 6.3%

[0090] Macrogol 400 2.4%

[0091] Proper amount of ethanol

[0092] Preparation:

[0093] (1) According to the above prescription, pitavastatin calcium is mixed with basic auxiliary materials, osmotic pressure active substances, penetration enhancers and other auxiliary materials and then granulated to obtain drug-containing layer granules; the penetration enhancer, osmotic pressure active substances and other auxili...

Embodiment 3

[0098] prescription:

[0099] (1) Drug-containing layer

[0100] Pitavastatin Calcium 0.8%

[0101] Sodium bicarbonate 10%

[0102] Sodium Chloride 12%

[0103] Polyoxyethylene 36%

[0104] Magnesium Stearate 0.6%

[0105] Proper amount of ethanol

[0106] (2) Push layer

[0107] Sodium Starch Carboxymethyl 30.5%

[0108] Sodium Chloride 9.5%

[0109] Magnesium Stearate 0.6%

[0110] Proper amount of ethanol

[0111] (3) Coating layer

[0112] Cellulose Acetate 95%

[0113] Macrogol 1500 5%

[0114] Proper amount of acetone

[0115] Preparation:

[0116] (1) According to the above prescription, pitavastatin calcium is mixed with basic auxiliary materials, osmotic pressure active substances, penetration enhancers and other auxiliary materials and then granulated to obtain drug-containing layer granules; the penetration enhancer, osmotic pressure active substances and other auxiliary materials are mixed After granulation, the push layer granules are obtained; the ...

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Abstract

The invention discloses a pitavastatin calcium double-layer osmotic pump controlled-release tablet and a preparation method thereof. The controlled-release tablet comprises a double-layer slab core consisting of a medicament-containing layer and a driving layer, and a layer of coating film which is wrapped on the outer surface of the double-layer slab core, belongs to semi-transparent films, and is provided with a medicament-releasing pore on the surface of the medicament-containing layer, wherein the medicament-containing layer in the slab core contains pitavastatin calcium which accounts for 0.1 to 1.0 percent of the weight of the double-layer slab core, and also contains a basic auxiliary material, an osmotic active substance, a penetration enhancer, a bonding agent and a lubricating agent; the driving layer contains a penetration enhancer, an osmotic active substance, a bonding agent and a lubricating agent; and the coating film comprises one or more of a film forming material or a pore-forming agent, a plasticizing agent and the like. The pitavastatin calcium double-layer osmotic pump controlled-release tablet has the characteristics of stable medicament releasing rate after being taken and easily controlled accumulative release rates in a specific time, can effectively reduce the medicament taking times of patients so as to improve adaptability of the patients, and has high safety and effectiveness.

Description

technical field [0001] The invention relates to a controlled-release pharmaceutical preparation, in particular to a double-layer osmotic pump controlled-release tablet of pitavastatin calcium for treating hypercholesterolemia and a preparation method thereof. Background technique [0002] The chemical name of Pitavastatin Calcium is (+)-bis{(3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl] -3,5-dihydroxy-6-heptanoic acid} monocalcium salt is a new type of statin hypolipidemic drug jointly developed by Nissan Chemical Industry Co., Ltd. and Kowa Co., Ltd., which was approved for marketing in Japan for the first time in July 2003. The marketed dosage form is tablet, and the indications are hypercholesterolemia and familial hypercholesterolemia. Pitavastatin Calcium is a third-generation statin drug. Compared with other statin drugs, it can effectively reduce LDL-C and TG levels, with "excellent" pharmacokinetic indicators, long half-life, low drug interaction poten...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/24A61K9/36A61K9/44A61K31/47A61P3/06
Inventor 胡淑娟张志芳
Owner 北京华禧联合科技发展有限公司
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