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Pharmaceutical composition containing solifenacin or salt thereof

A technology of solifenacin and solifenacin succinate, which is applied in the field of pharmaceutical compositions containing solifenacin or a salt thereof, can solve the problems of inconvenient mass production, high requirements for testing equipment, etc., and achieves improved production efficiency, Simple operation process and improved stability effect

Active Publication Date: 2015-07-01
ZHEJIANG JINGXIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This detection method has high requirements for detection equipment, which brings inconvenience to mass production.

Method used

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  • Pharmaceutical composition containing solifenacin or salt thereof
  • Pharmaceutical composition containing solifenacin or salt thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1: a kind of pharmaceutical composition containing solifenacin or its salt, it comprises following composition by weight ratio:

[0020] Element

weight%

Features

Solifenacin Succinate

3.33

active ingredient

lactose

78.77

filler

corn starch

13.90

filler

hypromellose

3.00

Adhesive

Magnesium stearate

1.00

lubricant

[0021] The percentages in the above formulations are calculated for tablets containing 5 mg of solifenacin succinate.

[0022] Weigh hypromellose according to the prescription amount, add water to prepare a solution with a concentration of 15% (w / v), and use it as binder solution A.

[0023] Weigh solifenacin succinate, lactose and cornstarch according to the prescription amount, mix them uniformly according to the method of equal volume addition, granulate with the above solution A, ventilate and dry at 55±5°C, and add stearic acid after the dry ...

Embodiment 2

[0024] Embodiment 2: a kind of pharmaceutical composition containing solifenacin or its salt, it comprises following composition by weight ratio:

[0025] Element

weight%

Features

Solifenacin Succinate

3.33

active ingredient

Butylated hydroxyanisole

0.10

antioxidant

lactose

78.67

filler

corn starch

13.90

filler

hypromellose

3.00

Adhesive

Magnesium stearate

1.00

lubricant

[0026] The percentages in the above formulations are calculated for tablets containing 5 mg of solifenacin succinate.

[0027] Weigh hypromellose according to the prescription amount, add water to prepare a solution with a concentration of 15% (w / v), and use it as binder solution A.

[0028] Weigh solifenacin succinate, lactose, butylated hydroxyanisole and cornstarch according to the prescription amount, mix them uniformly according to the method of equal volume addition, granulate with the...

Embodiment 3

[0029] Embodiment 3: a kind of pharmaceutical composition containing solifenacin or its salt, it comprises following composition by weight ratio:

[0030] Element

weight%

Features

Solifenacin Succinate

3.33

active ingredient

2,6 di-tert-butyl-p-cresol

0.10

antioxidant

lactose

78.67

filler

corn starch

13.90

filler

hypromellose

3.00

Adhesive

[0031] Magnesium stearate

1.00

lubricant

[0032] The percentages in the above formulations are calculated for tablets containing 5 mg of solifenacin succinate.

[0033] Weigh hypromellose according to the prescription amount, add water to prepare a solution with a concentration of 15% (w / v), and use it as binder solution A.

[0034] Weigh solifenacin succinate, lactose, 2,6-di-tert-butyl-p-cresol and cornstarch according to the prescription amount, mix them uniformly according to the method of equal volume addit...

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Abstract

The invention discloses a pharmaceutical composition containing solifenacin or salt thereof. The pharmaceutical composition mainly contains solifenacin or salt thereof and an antioxidant, and the weight ratio of the antioxidant to the solifenacin or salt thereof is at (1:70)-(1:20). According to the invention, the stability of the pharmaceutical composition containing the solifenacin or salt thereof is effectively improved, and the pharmaceutical composition is prepared by a conventional and simple preparation process; and the pharmaceutical composition has the advantages of simple process, convenience in operation and low cost.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing solifenacin or a salt thereof, belonging to the technical field of pharmacy. Background technique [0002] Solifenacin or its salts against muscarine M 3 Receptor has excellent selective antagonism, can be used as a urinary disease (such as neurogenic urinary frequency, neurogenic bladder, nocturia, unstable bladder, bladder contracture and chronic cystitis) and respiratory diseases (such as chronic obstructive pulmonary disease, prophylactic or therapeutic agent for chronic bronchitis, asthma and rhinitis). [0003] Solifenacin preparations currently on the market are 2.5mg, 5mg and 10mg tablets. In the non-patent literature published by the Ministry of Health, Labor and Welfare of Japan, it is described that compositions of solifenacin and its salts tend to produce degradation products in stability tests. According to the drug safety and quality requirements, the threshold of degrada...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/49A61K47/22A61K47/14A61K47/10A61K47/20A61P13/10A61P13/00A61P11/00
Inventor 欧阳梅洪赟飞朱云姣
Owner ZHEJIANG JINGXIN PHARMA
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