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Stable pharmaceutical composition and its preparation method

A technology for compositions and medicines, applied in the directions of medicine combinations, medicine formulations, active ingredients of heterocyclic compounds, etc., can solve the problems of difficult control of results, great difficulty, complicated operation, etc., and achieves reduction of related substances, low equipment requirements, and stability. good effect

Active Publication Date: 2020-07-21
燃点(南京)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Patent Document 3 also discloses that when solifenacin succinate is developed as an excellent therapeutic agent for urinary frequency and urinary incontinence, polyvinylpyrrolidone, a binder commonly used by those skilled in the art, is used by fluidized bed granulation, etc. Or hypromellose is carried out drug coating and obtains the pharmaceutical preparation, under the accelerated test of stability test, the result shows that the residual rate of solifenacin succinate is reduced, it is difficult to obtain pharmaceutical Very stable solifenacin preparation (instructions page 2 [0019])
[0010] It can be seen that, according to the inspiration of the prior art, in the process of preparing solifenacin succinate into a stable pharmaceutical composition, it is obvious that hypromellose is not suitable for use as a binder, because hypromellose Solifenacin succinate in non-crystalline form has a great relationship with the formation of solifenacin succinate amorphous, and the non-crystalline form of solifenacin succinate is the main reason for the decomposition of the active ingredient of the drug over time. The results of the stability test also showed that the use of In the composition prepared from hypromellose, the residual rate of solifenacin succinate is reduced, the stability of the preparation is insufficient, and it is difficult to obtain a pharmaceutically very stable solifenacin succinate preparation
Moreover, the prior art also shows that solifenacin or its salt has a strong focus, so it is difficult to ensure the uniformity of content in direct compression, and the mixture will adhere to the punch during the compression process, so now The existing technology prefers wet granulation, and wet granulation requires adjusting the moisture content of the drug product during the manufacturing process or suppressing the amorphous content of the drug product by heating and / or humidifying the composition obtained after wet granulation
This preparation method needs to control the moisture content in the preparation process, which is not only cumbersome and difficult to operate, but also difficult to control the result, the effect is not good, and it is not conducive to large-scale industrial production

Method used

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  • Stable pharmaceutical composition and its preparation method
  • Stable pharmaceutical composition and its preparation method
  • Stable pharmaceutical composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Tablet core prescription (calculated per 100,000 tablets):

[0035]

[0036] Tablet core: pass solifenacin succinate through a 100-mesh sieve, and other excipients through a 50-mesh sieve; weigh the raw and auxiliary materials of the prescribed amount; put the raw and auxiliary materials except magnesium stearate in a SYH-50 three-dimensional mixer , close the feed port of the mixer, and the pre-mixing time is 30 minutes; open the feed port of the three-dimensional mixer, add the weighed magnesium stearate into the SYH-50 three-dimensional mixer, and close the feed port of the mixer , the mixing time is 2 minutes; tablet compression is carried out after the total mixing is completed. During the production process, samples should be taken to check the tablet appearance, hardness, friability and average tablet weight and record them.

[0037] Coating: Weigh the prescribed amount of Opadry, dissolve it in purified water at a ratio of 12% (w / w), and stir for 30 minutes t...

Embodiment 2

[0040] Tablet core prescription (calculated per 100,000 tablets):

[0041]

[0042] Tablet core: pass solifenacin succinate through a 100-mesh sieve, and other excipients through a 50-mesh sieve; weigh the raw and auxiliary materials of the prescribed amount; put the raw and auxiliary materials except magnesium stearate in a SYH-50 three-dimensional mixer , close the feed port of the mixer, and the pre-mixing time is 30 minutes; open the feed port of the three-dimensional mixer, add the weighed magnesium stearate into the SYH-50 three-dimensional mixer, and close the feed port of the mixer , the total mixing time is 2 minutes; after the mixing is completed, tablet compression should be carried out. During the production process, samples should be taken to check the tablet appearance, hardness, friability and average tablet weight, and record them.

[0043] Coating: Weigh the prescribed amount of Opadry, dissolve it in purified water at a ratio of 12% (w / w), and stir for 30 ...

Embodiment 3

[0046] Tablet core prescription (calculated per 100,000 tablets):

[0047]

[0048]

[0049] Tablet core: pass solifenacin succinate through a 100-mesh sieve, and other auxiliary materials through a 50-mesh sieve; weigh the raw and auxiliary materials of the prescribed amount; put the raw and auxiliary materials except silicon dioxide in a SYH-50 three-dimensional mixer, Close the feed port of the mixer, and the pre-mixing time is 30 minutes; open the feed port of the three-dimensional mixer, add the weighed silicon dioxide in the SYH-50 type three-dimensional mixer, close the feed port of the mixer, the total The mixing time is 5 minutes; tablet compression is carried out after the total mixing is completed. During the production process, samples should be taken to check the tablet appearance, hardness, friability and average tablet weight and record them.

[0050] Coating: Weigh the prescribed amount of Opadry, dissolve it in purified water at a ratio of 12% (w / w), and...

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Abstract

The invention provides a stable pharmaceutical composition and its preparation method. The pharmaceutical composition contains solifenacin succinate and hydroxypropyl methylcellulose, wherein viscosity of hydroxypropyl methylcellulose is 1-4mPa.s.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable pharmaceutical composition and a preparation method thereof. Background technique [0002] Overactive Bladder (OAB), referred to as overactive bladder, is a syndrome characterized by urinary urgency symptoms, often accompanied by urinary symptoms, with or without urge urinary incontinence, urodynamically May show detrusor overactivity, but also other forms of urethro-bladder dysfunction. OAB has no clear etiology and does not include symptoms caused by acute urinary tract infection or other forms of localized vesicourethral lesions. Overactive bladder brings a lot of inconvenience to the life of patients, which will greatly affect the quality of life of patients, and even affect their daily life and work. [0003] Solifenacin Succinate was developed by Astellas, and its structural formula is as follows: [0004] [0005] Prior Art Patent Document 1 disclo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K9/20A61K31/49A61P13/10
Inventor 秦勇朱亚芳金春徐成王琦
Owner 燃点(南京)生物医药科技有限公司
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