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Succinic acid solifenacin tablet capable of achieving direct powder compression and preparation method of succinic acid solifenacin tablet

Solifenacin succinate, a direct technology, is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pill delivery, which can solve problems such as poor fluidity and compressibility, and small doses

Active Publication Date: 2015-04-22
LEPU PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the poor fluidity and compressibility of solifenacin succinate, and the clinical dosage of solifenacin succinate is relatively small, each tablet of marketed products contains 2.5mg, 5mg, 10mg, which poses a higher technical challenge to quality standards such as full powder direct compression to ensure product content uniformity
There is no report on the preparation of solifenacin succinate tablets by direct compression of all powders

Method used

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  • Succinic acid solifenacin tablet capable of achieving direct powder compression and preparation method of succinic acid solifenacin tablet
  • Succinic acid solifenacin tablet capable of achieving direct powder compression and preparation method of succinic acid solifenacin tablet
  • Succinic acid solifenacin tablet capable of achieving direct powder compression and preparation method of succinic acid solifenacin tablet

Examples

Experimental program
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Effect test

Embodiment 1-5

[0022] The prescription quantity of raw and auxiliary materials of solifenacin succinate tablet in embodiment 1-5: (unit: g)

[0023]

[0024] The preparation of the above examples includes the following steps: 1) Take each raw material in proportion, mix the auxiliary materials evenly and pass through an 80-mesh sieve; 2) Mix the main ingredients and auxiliary materials evenly according to the "equal volume increasing method": take all the main ingredients and an equal amount of For excipients, place them in a mixing machine and mix evenly, then add the same amount of excipients as the mixture and mix evenly, so that the amount is increased until the excipients are added, and the mixing time is 10 minutes each time; Direct compression in a high-speed rotary tablet press.

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PUM

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Abstract

The invention belongs to the technical field of medicine preparations, and particularly relates to a succinic acid solifenacin tablet capable of achieving direct powder compression and a preparation method of the succinic acid solifenacin tablet. The tablet comprises the following components in percentage by mass: 1%-10% of succinic acid solifenacin, 10%-90% of a filler, 3%-20% of a disintegrating agent, 0.5%-5% of a lubricant and 0-5% of a flow aid. According to the succinic acid solifenacin tablet, the defect that direct dry compression cannot be carried out in the prior art is solved; and the prescription and the process for direct powder compression of the succinic acid solifenacin tablet are achieved, so that the preparation process is relatively simple and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solifenacin succinate tablet capable of powder direct compression and a preparation method thereof. Background technique [0002] Solifenacin Succinate, developed by Japan Astellas Pharmaceutical Co., Ltd., is a competitive muscarinic receptor antagonist with a higher selectivity for bladder than salivary gland. Muscarinic M3 receptors play an important role in several primarily cholinergic-mediated functions, including contraction of bladder smooth muscle and stimulation of salivation. Solifenacin succinate inhibits the overactivity of the detrusor muscle by blocking the muscarinic M3 receptors of bladder smooth muscle, thereby alleviating the symptoms of urge incontinence, urgency and frequency associated with overactive bladder. Treatment of urinary incontinence and / or frequency and urgency in patients with overactive bladder (OAB...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K47/38A61K47/32A61K31/4725A61P13/10
Inventor 王庆鹏孙冬梅魏巧熊长红
Owner LEPU PHARMACEUTICAL CO LTD
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