Solifenacin succinate tablet and preparation method thereof

A solifenacin succinate tablet technology, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problem of ensuring the content and uniformity of active ingredients in solifenacin succinate tablets, amber Solifenacin acid has poor fluidity and compressibility, which affects drug efficacy and drug safety, so as to improve drug safety, ensure drug safety, and increase disintegration speed

Active Publication Date: 2022-03-01
YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Solifenacin succinate tablet is a prescription drug for treating symptoms such as overactive bladder, urgency, urinary incontinence, frequent urination, etc. The active ingredient is solifenacin succinate, and the clinical dosage of solifenacin succinate is Smaller, and solifenacin succinate has poor fluidity and compressibility, and has strong aggregation. It is difficult to ensure the uniformity of content by direct compression method, and the mixture will adhere to the On the punch, it is difficult to ensure the active ingredient content and uniformity of the prepared solifenacin succinate tablets; in addition, solifenacin succinate is extremely sensitive to water. Nasin crystals will be transformed into amorphous state in large quantities, and solifenacin succinate in amorphous state is easily degraded to generate impurities with no therapeutic effect, which seriously affects the efficacy and safety of medication

Method used

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  • Solifenacin succinate tablet and preparation method thereof
  • Solifenacin succinate tablet and preparation method thereof
  • Solifenacin succinate tablet and preparation method thereof

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preparation example Construction

[0056] The present application also provides a preparation method of solifenacin succinate tablet, which is used to prepare the solifenacin succinate tablet of any one of the above embodiments. The preparation method of solifenacin succinate tablet comprises part or all of the following steps: carrying out mixing and granulation operation of solifenacin succinate, hydrophobic binder and trehalose to obtain granules; Mixing and tableting operation, solifenacin succinate tablets are obtained.

[0057] The preparation method of the above-mentioned solifenacin succinate tablet, after making solifenacin succinate, hydrophobic binder and trehalose carry out mixed granulation operation to form granules, then make granules and disintegrating agent carry out mixed tabletting operation , effectively avoiding the addition of the disintegrating agent, the disintegrating agent dilutes the trehalose, thereby weakening the hygroscopic effect of the trehalose on solifenacin succinate and redu...

Embodiment 1

[0083] Weighing: Solifenacin succinate 1.5kg, trehalose 55kg, maltose 5kg, dry starch 20kg, hydroxypropyl cellulose 1kg and magnesium stearate 1kg;

[0084] Granulation: Mix 1.5 kg of solifenacin succinate and 45 kg of trehalose, then mix with 4 kg of maltose, and granulate to form solifenacin succinate granules;

[0085] Tablet compression: mix solifenacin succinate granules, trehalose 10kg, dry starch 20kg, hydroxypropyl cellulose 1kg, maltose 1kg and magnesium stearate 1kg, and compress into tablets to form solifenacin succinate tablets.

Embodiment 2

[0087] Weighing: Solifenacin succinate 2.5kg, trehalose 60kg, maltose 6kg, carboxymethyl starch sodium 25kg, poloxamer 1kg and calcium stearate 1kg;

[0088] Granulation: Mix 2.5kg of solifenacin succinate and 50kg of trehalose, then mix with 5kg of maltose, and granulate to form solifenacin succinate granules;

[0089] Tablet compression: mix solifenacin succinate granules, sodium carboxymethyl starch 25kg, poloxamer 2kg, trehalose 10kg, maltose 1kg and calcium stearate 1kg, and compress into tablets to form solifenacin succinate tablets ;

[0090] Coating: sucrose syrup and solifenacin succinate tablets are placed in a coating machine for coating to obtain solifenacin succinate coated tablets.

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Abstract

The invention provides a solifenacin succinate tablet and a preparation method thereof. The solifenacin succinate tablet comprises the following components: solifenacin succinate, trehalose, a disintegrating agent and a hydrophobic adhesive. The solifenacin succinate tablet disclosed by the invention is relatively good in uniformity and relatively high in medication safety.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a solifenacin succinate tablet and a preparation method thereof. Background technique [0002] Solifenacin succinate tablet is a prescription drug for treating symptoms such as overactive bladder, urgency, urinary incontinence, frequent urination, etc. The active ingredient is solifenacin succinate, and the clinical dosage of solifenacin succinate is Smaller, and solifenacin succinate has poor fluidity and compressibility, and has strong aggregation. It is difficult to ensure the uniformity of content by direct compression method, and the mixture will adhere to the On the punch, it is difficult to ensure the active ingredient content and uniformity of the prepared solifenacin succinate tablets; in addition, solifenacin succinate is extremely sensitive to water. Nasin crystals will be transformed into an amorphous state in large quantities, and solifenacin suc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26A61K31/49A61K47/26A61P13/00A61P13/10
CPCA61K31/49A61K9/2018A61P13/10A61P13/00A61K9/2081Y02A50/30
Inventor 汪刘恒任亚东夏春森刘志强袁海成
Owner YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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