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Solid preparation and preparation method thereof

A technology for solid preparations and adhesives, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations with non-active ingredients, etc., can solve problems such as the limitation of viscosity properties of active ingredients, shorten research and development time, improve quality, and improve industrialization. potential effect

Active Publication Date: 2019-01-04
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the application of this technology is limited by the viscosity properties of the active ingredient (i.e. the main drug) itself

Method used

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  • Solid preparation and preparation method thereof
  • Solid preparation and preparation method thereof
  • Solid preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0039] The present embodiment provides a solid preparation with high drug loading, and its prescription is as follows:

[0040]

[0041] Its preparation method is as follows:

[0042] (1) Pulverize the main ingredient so that 60% of the weight passes through a 200 mesh sieve, and the weight of more than 60 mesh sieve is less than 2%. Combine with the sieved filler and disintegrant, and pre-mix for 5 minutes in a high-shear granulator to obtain a pre-mixed material.

[0043] (2) The binder is formulated into an aqueous solution with a mass concentration of 25%, added to the premixed material, granulated by a high-shear granulator, dried at 50°C for 10 minutes, and granulated to obtain a dry intermediate, wetted The agent water is eventually removed.

[0044] (3) Add a lubricant to the dry intermediate and mix for 5 minutes to obtain granules.

[0045] (4) Compressing the prepared granules with a tablet machine to obtain the solid preparation with high drug loading.

[00...

Embodiment 2

[0049] The present embodiment provides a solid preparation with high drug loading, and its prescription is as follows:

[0050]

[0051]

[0052] Its preparation method is as follows:

[0053] (1) Pulverize the main ingredient so that 60% of the weight passes through a 200 mesh sieve, and the weight of more than 60 mesh sieve is less than 2%. Combine with the sieved filler and disintegrant, and pre-mix for 5 minutes in a high-shear granulator to obtain a pre-mixed material.

[0054] (2) The binder is formulated into an aqueous solution with a mass concentration of 20%, added to the premixed material, granulated by a high-shear granulator, dried at 50°C for 8min, and granulated to obtain a dry intermediate, wetted The agent water is eventually removed.

[0055] (3) Add a lubricant and a glidant to the dry intermediate and mix for 5 minutes to obtain granules.

[0056] (4) Compressing the prepared granules with a tablet machine to obtain the solid preparation with high ...

Embodiment 3

[0060] The present embodiment provides a solid preparation with high drug loading, and its prescription is as follows:

[0061]

[0062] Its preparation method is as follows:

[0063] (1) Pulverize the main ingredient so that 60% of the weight passes through a 200 mesh sieve, and the weight of more than 60 mesh sieve is less than 2%. Combine with the sieved filler and disintegrant, and pre-mix for 5 minutes in a high-shear granulator to obtain a pre-mixed material.

[0064] (2) The binder is formulated into an aqueous solution with a mass concentration of 20%, added to the premixed material, granulated by a high-shear granulator, dried at 55°C for 4min, and granulated to obtain a dry intermediate, wetted The agent water is eventually removed.

[0065] (3) Add a lubricant and a glidant to the dry intermediate and mix for 5 minutes to obtain granules.

[0066] (4) Compressing the prepared granules with a tablet machine to obtain the solid preparation with high drug loading...

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Abstract

The invention relates to a solid preparation high in drug loading capacity and a preparation method thereof. The solid preparation high in drug loading capacity is prepared from, by weight, 80% or above of main drugs and 20% or below of adjuvant material, wherein the adjuvant material comprises an adhesive which accounts for, by weight, 3.0-15.0% of the solid preparation, and the adhesive is ultra-low-viscosity hydroxypropyl methyl cellulose which refers to the hydroxypropyl methyl cellulose meeting the following condition that the viscosity of the water solution of the hydroxypropyl methyl cellulose with the mass concentration of 2% is 2-4 centipoises at the temperature of 20 DEG C. The drug loading capacity of the solid preparation is up to 80% or above, quick release still can be kept,and a good product compressibility still can be kept. The weight and the size of the drug are effectively reduced, and compared with other adhesives in use, the production time can be effectively shortened, and the production cost is reduced.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a solid preparation with high drug loading and a preparation method thereof. Background technique [0002] Immediate-release preparations refer to a type of preparation in which the drug is rapidly dissolved and released from the preparation, so that it can be absorbed quickly and the curative effect can be exerted rapidly. At the same time, the rapid and complete release of the drug from the preparation can usually effectively improve the bioavailability of the drug. For the convenience of patients to carry and take, immediate-release preparations are often prepared in the form of granules, tablets or capsules. [0003] Depending on symptoms, weight, disease progression, and other conditions, the dosage of the drug is different. For the convenience of medication, drugs with different specifications are usually developed. During the drug development process, the same ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K31/155A61K31/4015A61K31/43A61K31/5383A61K9/20A61K9/48
CPCA61K9/0002A61K9/1652A61K9/2054A61K31/155A61K31/4015A61K31/43A61K31/5383
Inventor 谭晓峰周伟杰梁文伟赖树挺刘锋
Owner AC PHARMA CO LTD
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