Method of producing double-layer core permeation pump patch of medicament

A technology of osmotic pump tablets and drug layers, which is applied in the direction of medical formula, medical preparations of non-active ingredients, pill delivery, etc., can solve the problems that the punching speed needs to be improved, maintain blood drug concentration, simplify the process, overcome The effect of taking more

Inactive Publication Date: 2008-04-02
ZHEJIANG UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, the performance of domestic punching equipment ne

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  • Method of producing double-layer core permeation pump patch of medicament
  • Method of producing double-layer core permeation pump patch of medicament

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preparation example Construction

[0025] A preparation method of a double-layer core osmotic pump tablet comprises the following steps:

[0026] 1) Mix 1-100 parts by weight of drug or drug solid dispersion with 1-150 parts by weight of penetrant, 1-150 parts by weight of thickener and 0.1-200 parts by weight of filler passed through a 100-mesh sieve, and add 0.1- 50 parts by weight of binder are wet granulated, dried in an oven at 55-65 degrees, granulated, and 0.1-30 parts by weight of lubricant is added to obtain the core material of the drug layer. The weight percentage of the drug in the drug solid dispersion is 10-70%;

[0027] 2) Mix 1-150 parts by weight of penetrating agent, 1-150 parts by weight of expansion agent, and 0.1-200 parts by weight of filler that have passed through a 100-mesh sieve, and add 0.1-50 parts by weight of binder to wet granulate. Dry at 55-65 degrees, granulate, add 0.1-30 parts by weight of lubricant to obtain the core material of the push layer, and use water or alcohol as t...

Embodiment 1

[0041] Mix insoluble drug nifedipine 30g with sodium chloride 60g passing through a 100-mesh sieve, polyvinylpyrrolidone 80g, and starch 8g, and then make a soft material with an aqueous solution of 10% by weight of polyvinylpyrrolidone and pass through a 16-mesh sieve. The granules are put into an oven and dried for 24 hours at 60 degrees, then granulated through a 14-mesh sieve, and 1% by weight of magnesium stearate is added to obtain the drug layer tablet core material. Mix 50 g of carboxymethylcellulose sodium salt, 50 g of sodium chloride, and 6 g of starch that have passed through a 100-mesh sieve, and then use an aqueous solution of 10% by weight polyvinylpyrrolidone to make a soft material, pass through a 16-mesh sieve for granulation, and put into an oven Dried at 60°C for 24 hours, granulated through a 14-mesh sieve, and added with 1% by weight magnesium stearate to obtain the core material for the push layer. Use a tablet press with a steel needle on the upper punc...

Embodiment 2

[0044] The nifedipine-poloxamer 188 solid dispersion (nifedipine weight [0] percentage is 50%) 60g that contains insoluble drug nifedipine and the sodium chloride 40g that crosses 100 mesh sieves, polyoxyethylene pyrrolidone After mixing 50g and 10g of microcrystalline cellulose evenly, make a soft material with an aqueous solution of 10% by weight of polyvinylpyrrolidone, pass through a 16-mesh sieve to granulate, put it into an oven at 60 degrees and dry it for 24 hours, and then pass through a 14-mesh sieve The granules are granulated, and 1% by weight of magnesium stearate is added to obtain the drug layer tablet core material. After the carboxymethylcellulose sodium salt 50g that crossed 100 mesh sieves, sodium chloride 50g, and microcrystalline cellulose 40g were mixed evenly, soft materials were made with an aqueous solution of 10% by weight polyvinylpyrrolidone, and granulated through 16 mesh sieves. Put it into an oven and dry it for 24 hours at 60 degrees, then pass ...

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Abstract

The invention discloses a drug double layer core osmotic pump tablet and the preparation method. The drug or the solid dispersion of the drug is mixed uniformly with penetrating agent, thickener and filler, added with adhesive to produce soft material and granulation, baked, and added with lubricant, and then drug layer core tablet material is produced. The penetrating agent, expansive agent and the filler are mixed uniformly, are added with adhesive to produce soft material and particles, are baked and are added with lubricant, and then promoting layer core tablet material is produced. The drug layer core tablet material and the promoting layer core tablet material are punched by a preforming machine with a needle punch to produce double layer core tablet of drug layer with concave holes. Coating liquid containing semi-permeable polymer changes the double layer core tablet of drug layer with concave holes into coated tablet in the coating pot, which is baked to produce double layer core osmotic pump tablet. The double layer core osmotic pump tablet prepared by the invention is similar to zero level release drugs. The invention disuses the slotting process after coating in preparing double layer core osmotic pump tablets without resorting to expensive laser drilling machine, simplifies the preparation process, reduces the cost and fits for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine manufacturing, in particular to a method for preparing a drug double-layer core osmotic pump tablet. Background technique [0002] Rajan K Verma, Divi Murali Krishna and Sanjay Garg (Journal of Controlled Release, 2002, 79:7-27), and Giancarlo Santus and Richard W Baker (Journal of Controlled Release, 1995, 35:1-21) on the principles of osmotic pump tablets and the development process are reviewed in detail. Zhuang Yue et al. (Practical Pharmaceutical Preparation Technology, Beijing: People's Health Publishing House, 1999) introduced the tablet press. [0003] Osmotic pump tablets directly use the osmotic pressure difference as the driving force to control the uniform release of drugs. It is the most ideal oral controlled-release preparation so far. Side effects; (2) Long action time, realize once-a-day administration, reduce the inconvenience of frequent administration; (3) The drug release re...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K47/32A61K47/34A61K47/38A61K47/10A61K47/26
Inventor 刘龙孝陈靖
Owner ZHEJIANG UNIV
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