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Method for simply preparing high-drug-loading-capacity slow-release preparation for treating colitis and crohn disease

A technology for sustained-release tablets and tablets, which is applied in the fields of pharmaceutical formulation, drug delivery, drug combination, etc., and can solve the problems of high manufacturing cost and high rate of defective products

Active Publication Date: 2016-01-27
INNOVACO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0027] In summary, most of the existing mesalazine sustained-release methods are to prepare pellets first, and then wrap the pellets with a sustained-release coating layer to form sustained-release pellets and directly pack them into capsules or medicine bags, or add diluents and compress them into tablets ( Sustained-release pellets are embedded in the tablet), due to the existence of pellets and coating, this kind of manufacturing cost is extremely high, and the residual product rate is high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] Example 1: Preparation of mesalazine sustained-release tablets and sustained-release capsules

[0122] formula:

[0123] 100 parts by weight of mesalazine,

[0124] 3 parts by weight of povidone (PVPK15),

[0125] 4 parts by weight of glyceryl behenate.

[0126] Preparation method (wet granulation and tableting):

[0127] (1) Making soft materials: Mix mesalazine (actual feed 15kg) and glyceryl behenate to prepare 5% PVP aqueous solution as a binder to make soft materials;

[0128] (2) Wet granules: pass the soft material through a 16-mesh sieve to make wet granules;

[0129] (3) Drying granules: drying the obtained wet granules in circulating hot air at 45°C to remove moisture (until the moisture content in the granules is less than 2%);

[0130] (4) Final mixing: (In this example, there is no material added with particles, so this step is not performed);

[0131] (5) Tableting: Using 8 different size dies, the obtained dry particles are divided into 8 batches for tableting. The amou...

Embodiment 2

[0136] Example 2: Preparation of mesalazine sustained-release tablets and sustained-release capsules

[0137] formula:

[0138] 100 parts by weight of mesalazine,

[0139] 3 parts by weight of povidone (PVPK15),

[0140] 4 parts by weight of glyceryl behenate.

[0141] Preparation method (wet granulation and tableting):

[0142] (1) Making soft materials: Mix mesalazine (actual feed 15kg), PVP and glyceryl behenate, and prepare water as a wetting agent to make soft materials;

[0143] (2) Wet granules: pass the soft material through a 16-mesh sieve to make wet granules;

[0144] (3) Drying granules: drying the obtained wet granules in circulating hot air at 45°C to remove moisture (until the moisture content in the granules is less than 2%);

[0145] (4) Final mixing: (In this example, there is no material added with particles, so this step is not performed);

[0146] (5) Tableting: Using 8 different size dies, the obtained dry particles are divided into 8 batches for tableting. The amount o...

Embodiment 3

[0151] Example 3: Preparation of mesalazine sustained-release tablets and sustained-release capsules

[0152] formula:

[0153] 100 parts by weight of mesalazine,

[0154] 3 parts by weight of povidone (PVPK15),

[0155] 4 parts by weight of glyceryl behenate.

[0156] Preparation method (dry granulation and tableting):

[0157] (1) Granulation: Mix mesalazine (actual feed 15kg), PVP and glyceryl behenate, and use a dry granulator (LGJ type, Huaquan) to make granules at one time (passing 16 mesh sieve);

[0158] (2) Tableting: Using 8 different size dies, the obtained dry granules are divided into 8 batches for tableting. The amount of mesalazine in each tablet is 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 250mg, And 500mg.

[0159] (3) Put the obtained 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 250mg tablets in hollow capsules so that the content of mesalazine in each pill is 500mg (25mg, 50mg, 100mg, 250mg four tablets Filling), 450 mg (75 mg and 150 mg tablet filling), 400 mg (200 mg tablet f...

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PUM

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Abstract

The invention provides a method for simply preparing a high-drug-loading-capacity slow-release preparation for treating colitis and crohn diseases, particularly relates to a method for simply preparing the high-drug-loading-capacity slow-release preparation using mesalazine (5-aminosalicylic acid) as active ingredients for treating colitis and crohn diseases, and more particularly relates to a method for simply preparing a high-drug-loading-capacity tablet using the mesalazine as active ingredients for treating colitis and crohn diseases. The high-drug-loading-capacity tablet prepared by the method has the characteristics that the fractional dose adaptability is high; and the high-drug-loading-capacity tablet is suitable for patients in all ages. The high-drug-loading-capacity slow-release preparation can also be shown in a capsule form.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for simply preparing a high-drug-loading preparation for the treatment of colitis and Crohn's disease (usually called inflammatory bowel disease (IBD)), and in particular to a simple preparation method for the treatment of colitis And Crohn’s disease, the method of high drug loading preparations with mesalazine (ie 5-aminosalicylic acid, Mesalazine, Mesalamine, 5-ASA, also known as mesalamine) as the active ingredient, and more particularly relates to a A simple method for preparing high drug-loading tablets with mesalazine as the active ingredient for the treatment of colitis and Crohn's disease. The invention also relates to the prepared tablets with high drug loading capacity. In particular, the preparation of the present invention is suitable for patients of all ages, such as children, due to its strong adaptability in divided doses. Background technique [0002] Ulcerat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/32A61K31/606A61K9/48A61P1/04G01N21/33
CPCA61K9/48A61K31/606A61K47/32G01N21/33
Inventor 魏世峰汪鹤龄
Owner INNOVACO PHARMA