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Novel solifenacin succinate preparation suitable for oral administration

A solifenacin succinate and preparation technology, which is applied in the direction of non-active ingredient medical preparations, drug combinations, pill delivery, etc., can solve the problems of insufficient bioavailability, high requirements for production equipment, and increased impurity content in finished products, etc. problems, to achieve the effect of improving bioavailability, good pharmacological effects, and reducing adverse reactions

Inactive Publication Date: 2015-08-05
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it requires wet preparation of microparticles and then film coating to make orally disintegrating tablets. The preparation process is complex and requires high production equipment.
[0004] CN201310463801.7 discloses an orally disintegrating tablet of solifenacin succinate, which adopts wet granulation, often needs to introduce a liquid solvent in the granulation process, and the granulation process is complicated, and, in the granulation process, it , the active ingredients of the drug are prone to degradation reactions, resulting in an increase in the content of impurities in the finished product
[0005] Common tablet of solifenacin succinate is disclosed in CN201410812530.6, which adopts dry granulation, and the preparation method is simple, but its bioavailability cannot reach the standard of the original research

Method used

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  • Novel solifenacin succinate preparation suitable for oral administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018]

[0019] Solifenacin succinate was passed through a 100-mesh sieve, and calcium hydrogen phosphate, lactose, and polyoxyethylene-polyoxypropylene were passed through an 80-mesh sieve for subsequent use. Weigh the prescribed amount of solifenacin succinate, mix it with calcium hydrogen phosphate and lactose, and then add polyoxyethylene-polyoxypropylene, mix evenly, and finally take the prescribed amount of magnesium stearate and add the above powder, and mix well. Use φ8mm shallow concave punch, adjust tablet weight and pressure, and press tablet.

Embodiment 2

[0021]

[0022] Preparation method is the same as embodiment 1

Embodiment 3

[0024]

[0025] Preparation method is the same as embodiment 1

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Abstract

The invention relates to a novel oral administration preparation, and particularly relates to a preparation containing solifenacin or a salt of the solifenacin and specific pharmaceutic adjuvants. The preparation is high in stability and high in bioavailability and has small toxic or side effect of the medicine, and can effectively guarantee the purity of the solifenacin succinate preparation.

Description

technical field [0001] The invention relates to a pharmaceutical preparation for oral administration, in particular to an oral solid preparation of solifenacin succinate. Background technique [0002] Solifenacin succinate (solifenacin succinate) was developed by Japan Astellas Pharmaceutical Co., Ltd., is a competitive muscarine M 3 Receptor antagonists can be used as preventive or therapeutic agents for urinary diseases (such as neurogenic urinary frequency, neurogenic bladder, nocturia, unstable bladder, bladder contracture and chronic cystitis), and are mainly used clinically for overactive bladder ( Treatment of urinary incontinence and / or urinary frequency and urgency in patients with overactive bladder (OAB). [0003] According to the relevant research records on preparations in the WO2006070735 patent applied by Astellas, solifenacin is prone to degradation reactions in the finished preparations, resulting in a decrease in the effectiveness of the product, so it i...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/49A61K47/04A61P13/00A61P7/12
Inventor 谢媛张晓旭张榜玲
Owner CHINA PHARM UNIV