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Tablet composition with solifenacin and preparation method of tablet composition

A technology of solifenacin and composition, applied in the field of formulation and preparation of solifenacin solid tablets, capable of solving the problems of poor clinical promotion and application, slow effect, cumbersome treatment methods, etc.

Inactive Publication Date: 2016-03-02
SHANDONG ZHONGTAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are various disadvantages in the existing treatment methods: slow effect; low recovery rate of patients; cumbersome treatment methods; poor degree of clinical promotion and application, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment example 1

[0018] Solifenacin Succinate 5g

[0019] Lactose 74.3g

[0020] 20g pregelatinized starch

[0021] Silica 0.7g

[0022] Sieve solifenacin succinate powder, lactose, pregelatinized starch, and silicon dioxide powder, mix, compress into tablets, and coat to obtain solid tablet 1 of solifenacin.

Embodiment example 2

[0024] Solifenacin Succinate 5g

[0025] Lactose 47.25g

[0026] Microcrystalline cellulose 37.25g

[0027] 10g pregelatinized starch

[0028] Silica 0.5g

[0029] Sieve solifenacin succinate powder, lactose, microcrystalline cellulose, pregelatinized starch, and silicon dioxide powder, mix, compress into tablets, and coat to obtain solid tablet 2 of solifenacin.

Embodiment example 3

[0031] Solifenacin Succinate 5g

[0032] Microcrystalline cellulose 84g

[0033] Pregelatinized starch 10.5g

[0034] Silica 0.5g

[0035] Solifenacin succinate powder, microcrystalline cellulose, pregelatinized starch, and silicon dioxide powder were sieved, mixed, tabletted, and coated to obtain solid tablet 3 of solifenacin.

[0036] Solifenaxin Tablets Solid Tablet Index Test Scheme

[0037] 1. Drying (burning) weight loss = (W1-W2) / W1*100%

[0038] W1: Sample weight before drying (burning)

[0039] W2: Sample weight after drying (burning)

[0040] W1-W2: Sample weight lost during drying (burning)

[0041] 2. Disintegration time limit test: number the solid tablets in the above implementation cases as 1, 2, and 3, and after the water temperature of the disintegration time limit instrument is controlled to be constant at 37±1°C, take samples 1, 2, and 3 respectively Put 6 tablets in the screen of the disintegration time limit tester, start the disintegration instrume...

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PUM

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Abstract

The invention discloses a formula of a medicine composition with solifenacin and a preparation method of the tablet composition. The active component of the medicine composition is (1S)-(3R)-1-azabicyalo[2.2.2]oct-3-yl3,4-dihydro-l-phenyl-2-(1H)-isoquinoline carboxylic acid succinate (solifenacin). The preparation method includes the steps of smashing the active component and corresponding auxiliaries respectively, conducting physical mixing, conducting direct tabletting on dry powder, wrapping film coatings on tablets, and obtaining the medicine composition. The tablets can be used for treating or improving symptoms of overactive bladder including frequent micturition, urgent urination, acute urinary incontinence and other urinary tract symptoms.

Description

technical field [0001] The invention relates to a formula of solifenacin solid tablet and a preparation method thereof, belonging to the field of chemical medicine and pharmacy. Background technique [0002] Overactive bladder is a syndrome consisting of symptoms such as urgency, frequency, and urge incontinence. According to statistics, the incidence rate of females is significantly higher than that of males. According to relevant studies, there are currently known M1-55 subtypes of the M receptors of the detrusor muscle of the bladder. The two subtypes M2 and M3 play a major role, and the M3 receptor plays a major role in mediating the contraction of detrusor muscle. It can be seen that the main cause of overactive bladder is due to the excessive activity of the M receptor of the detrusor muscle of the bladder. According to reports, a series of quinucidine derivatives including solifenacin succinate or its salts have excellent selective antagonism on the M3 receptors of ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/49A61K47/38A61K47/26A61K47/36A61K47/02
Inventor 何小波李向阳李华利
Owner SHANDONG ZHONGTAI PHARMA
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