Stable pharmaceutical composition and preparation method thereof

A composition and drug technology, which is applied in the direction of drug combination, pharmaceutical formula, heterocyclic compound active ingredients, etc., can solve the problems of difficult control of results, cumbersome operation, and high difficulty, and achieve the reduction of related substances, ensure uniformity, and equipment requirements low effect

Active Publication Date: 2015-11-04
燃点(南京)生物医药科技有限公司
View PDF9 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[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 succ...

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Stable pharmaceutical composition and preparation method thereof
  • Stable pharmaceutical composition and preparation method thereof
  • Stable pharmaceutical composition and preparation method thereof

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...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
Viscosityaaaaaaaaaa
Viscosityaaaaaaaaaa
Viscosityaaaaaaaaaa
Login to view more

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap