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Simple method for preparation of high drug-loaded sustained-release preparations for colitis and Crohn's disease

A technology for sustained-release tablets and tablets, which can be used in pharmaceutical formulations, drug combinations, drug delivery, etc., and can solve the problems of high manufacturing costs and high residual product rates.

Active Publication Date: 2018-11-09
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

[0118] Embodiment 1: preparation mesalamine sustained-release tablet and sustained-release capsule

[0119] formula:

[0120] Mesalazine 100 parts by weight,

[0121] Povidone (PVP K15) 3 parts by weight,

[0122] 4 parts by weight of glyceryl behenate.

[0123] Preparation method (wet granulation tablet):

[0124] (1) soft material: mix mesalazine (actual feeding 15kg) and glyceryl behenate, prepare 5% PVP aqueous solution as adhesive, and make soft material;

[0125] (2) wet granules: pass the soft material through a 16-mesh sieve to make wet granules;

[0126] (3) dry granules: make the gained wet granules dry in 45 ℃ circulating hot air, remove moisture (to the moisture content in the granules is lower than 2%);

[0127] (4) final mixing: (in this example, there is no material added to the particles, so this step is not carried out);

[0128] (5) Tablet compression: With 8 dies of different sizes, the obtained dry granules are divided into 8 batches for compression, ...

Embodiment 2

[0133] Embodiment 2: Preparation of mesalamine sustained-release tablets and sustained-release capsules

[0134] formula:

[0135] Mesalazine 100 parts by weight,

[0136] Povidone (PVP K15) 3 parts by weight,

[0137] 4 parts by weight of glyceryl behenate.

[0138] Preparation method (wet granulation tablet):

[0139] (1) Making soft materials: mix mesalazine (actual feeding 15kg), PVP and glyceryl behenate, prepare water as a wetting agent, and make soft materials;

[0140] (2) wet granules: pass the soft material through a 16-mesh sieve to make wet granules;

[0141] (3) dry granules: make the gained wet granules dry in 45 ℃ circulating hot air, remove moisture (to the moisture content in the granules is lower than 2%);

[0142] (4) final mixing: (in this example, there is no material added to the particles, so this step is not carried out);

[0143] (5) Tablet compression: With 8 dies of different sizes, the obtained dry granules are divided into 8 batches for compr...

Embodiment 3

[0148] Embodiment 3: preparation mesalamine sustained-release tablet and sustained-release capsule

[0149] formula:

[0150] Mesalazine 100 parts by weight,

[0151] Povidone (PVP K15) 3 parts by weight,

[0152] 4 parts by weight of glyceryl behenate.

[0153] Preparation method (dry granulation and tablet compression):

[0154] (1) Granulation: Mix mesalazine (actual feeding 15kg), PVP and glyceryl behenate, and use a dry granulator (LGJ type, Huaquan) to make granules at one time (through a 16-mesh sieve);

[0155] (2) Tablet compression: With 8 dies of different sizes, the obtained dry granules are divided into 8 batches for compression, and the amount of mesalazine in each tablet is 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 250mg, and 500mg.

[0156] (3) The obtained 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 250mg tablets are placed in hollow capsules, so that the content of mesalazine in each grain is 500mg (25mg, 50mg, 100mg, 250mg four kinds of tablets Filling), 450mg...

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PUM

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Abstract

A high drug-loading capacity mesalazine (namely, 5-ASA) sustained release preparation for treating colitis and Crohn's disease, a preparation method therefor, and especially, a method for preparing tablets. The preparation can also be capsules.

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 treating colitis and Crohn's disease (usually called inflammatory bowel disease (IBD)), in particular to a method for simply preparing and treating colitis and Crohn's disease with mesalazine (i.e. 5-aminosalicylic acid, Mesalazine, Mesalamine, 5-ASA, also known as mesalamine) as the method of high drug-loading preparations of active ingredients, more particularly involving a A simple method for preparing high-loaded tablets with mesalazine as an active ingredient for the treatment of colitis and Crohn's disease. The present invention also relates to such high drug-loading tablets prepared. In particular, the preparation of the present invention is suitable for patients of all ages, for example suitable for children, due to its strong adaptability in divided doses. Background technique [0002] Ulcerative colitis ...

Claims

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Application Information

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Patent Type & Authority Patents(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