Method for preparing sustained-release tablets through granulating by adopting bonding agents in atomizing states

A technology of adhesives and sustained-release tablets, which is applied in the field of preparation of pharmaceutical preparations, can solve problems such as low yield of finished products, fluctuations in the release rate of finished sustained-release tablet preparations, unfavorable drug safety for patients taking drugs, etc., to reduce release rate fluctuations, The effect of reducing drug safety hazards

Active Publication Date: 2012-06-20
HARBIN PHARM GROUP SANJING PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This will cause the sustained-release matrix excipients to produce a large number of agglomerates that cannot be completely dispersed and cannot pass through the granulator during the production and preparation of the sustained-release tablet formulation, when the rest of the excipients are not wetted
In the end, these agglomerates are often treated as tailings in the formulation process, resulting in a low yield of finished products
In addition, due to the loss of a large amount of sustained-release matrix excipients in the preparation process, the release rate of the finished sustained-release tablet formulations will fluctuate greatly between batches, which is not conducive to the medication safety of patients taking medicine.

Method used

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  • Method for preparing sustained-release tablets through granulating by adopting bonding agents in atomizing states
  • Method for preparing sustained-release tablets through granulating by adopting bonding agents in atomizing states
  • Method for preparing sustained-release tablets through granulating by adopting bonding agents in atomizing states

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A method for preparing sustained-release tablets granulated in an atomized state of an adhesive, comprising the following steps:

[0019] (1) Weigh 20% of gliclazide, 35% of hypromellose, 34% of microcrystalline cellulose, and 10% of lactose by weight percentage and mix to obtain mixture 1;

[0020] (2) Spray water that accounts for 7% of the weight of the mixture 1 into the mixture 1 in a 120-degree solid conical atomization state, wet granulate, pass 16 mesh granulation, and dry the granules to a water content of 1%-7%. 16-mesh granules; mixed with magnesium stearate accounting for 1.0% of the weight of the whole granules, compressed into sustained-release tablets, and then film-coated to obtain the finished product of sustained-release tablets.

[0021] In this example, the average finished product yield of the prepared sustained-release tablets is 99.35%, while the finished product yield prepared by the traditional sustained-release tablet preparation method is only...

Embodiment 2

[0027] A method for preparing sustained-release tablets granulated in an atomized state of an adhesive, comprising the following steps:

[0028] (1) Weigh 10% nifedipine, 35% hypromellose, and 54% lactose by weight percentage and mix to obtain mixture 1;

[0029] (2) Water 5% by weight of the mixture 1 is sprayed into the mixture 1 in a 65-degree hollow square atomized state for wet granulation, passed through 16 mesh granulation, dried to a water content of 1%-7%, passed through 16 Then mix with magnesium stearate accounting for 1.0% of the weight of the whole granules, compress into sustained-release tablets, and then film-coat to obtain the finished product of sustained-release tablets.

[0030] In this example, the average finished product yield of the prepared sustained-release tablets was 98.72%, while the finished product yield of the traditional sustained-release tablet preparation method was only 87.21%. The finished nifedipine sustained-release tablets prepared by t...

Embodiment 3

[0036] A method for preparing sustained-release tablets granulated in an atomized state of an adhesive, comprising the following steps:

[0037] (1) Weigh 20% ibuprofen, 20% hypromellose, 34% precrossified starch, and 25% lactose by weight percentage and mix to obtain mixture 1;

[0038] (2) Spray water accounting for 10% of the weight of mixture 1 into mixture 1 in a 90-degree fan-shaped atomization state, wet granulate, pass through 16 mesh for granulation, dry the granules to a water content of 1%-7%, pass through 16 mesh Whole granules; mixed with micropowder silica gel accounting for 1.0% of the weight of the whole granules, compressed into sustained-release tablets, and then film-coated to obtain finished sustained-release tablets.

[0039] In this example, the average finished product yield of the prepared sustained-release tablets is 98.95%, while the finished product yield of the traditional sustained-release tablet preparation method is only 88.75%. The ibuprofen su...

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Abstract

The invention discloses a method for preparing sustained-release tablets through granulating by adopting bonding agents in atomizing states. The method comprises the following steps of: (1) weighing the following materials in percentage by weight: 5%-80% of medicines, 20%-60% of sustained-release skeleton auxiliary materials, 20%-60% of filler thinning agents and 0%-20% of disintegrating agents, and mixing to obtain a mixture A; (2) spraying the bonding agents accounting for 1%-30% of the weight of the mixture A into the mixture A for wet granulation and sieving integral granules of with a sieve of 16 meshes in the atomizing states and specific shapes, drying granules until the moisture contents of the granules are 1%-7%, and sieving the integral granules with the sieve of 16 meshes; thenmixing with lubricating agents accounting for 0.5%-10% of the weight of the integral granules, extruding into sustained-release tablets, and then carrying out film coating to obtain finished productsof sustained-release tablets. The sustained-release tablet preparation process has high finished product yield and extensive medicine carrying system and can effectively ensure the stable release andthe medication safety of the finished products because the release rate of prepared medicines among different batches has very little difference.

Description

technical field [0001] The invention relates to a method for preparing a pharmaceutical preparation, in particular to a method for preparing sustained-release tablets granulated in an atomized state of an adhesive. Background technique [0002] Any raw material drug used for clinical treatment must be made into different dosage forms of pharmaceutical preparations, and in the production process of pharmaceutical preparations, the process of pharmaceutical preparations will have a great impact on the finished preparations. With the development of society and the demand for new pharmaceutical preparations, the development of sustained-release tablet preparation technology has attracted extensive attention. [0003] In the current preparation technology of sustained-release tablet preparations, the sustained-release matrix excipients used are mostly povidone, methyl cellulose, ethyl cellulose, hypromellose, hypromellose, sodium carboxymethyl cellulose Wait. When the above-men...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61J3/00
Inventor 范宁曹林刘建军
Owner HARBIN PHARM GROUP SANJING PHARMACEUTICAL CO LTD
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