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Beta-potastine besilate orally disintegrating tablet and preparation method thereof

A technology for oral disintegrating tablets and benzene sulfonate, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as insufficient bitterness masking effect and residual aftertaste. , to achieve the effect of good disintegration time limit, improved reproducibility, good taste and flavor

Active Publication Date: 2022-06-28
HANGZHOU HEZE PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to solve the above problems, the purpose of the scheme designed by the present invention is: the surface of the orally disintegrating tablet is smooth and beautiful, the hardness is suitable, it can disintegrate rapidly in the oral cavity, and the absorption is fast; The tablet has excellent friability, rapid disintegration, and excellent taste, especially solving the problems of insufficient bitterness masking effect and residual aftertaste in the direct compression method

Method used

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  • Beta-potastine besilate orally disintegrating tablet and preparation method thereof
  • Beta-potastine besilate orally disintegrating tablet and preparation method thereof
  • Beta-potastine besilate orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] prescription

[0079]

[0080] Pass the raw and auxiliary materials through a 40-mesh sieve respectively to remove the agglomerates, add the raw and auxiliary materials into the three-dimensional hopper mixer in sequence, set the mixing speed to 20 rpm, and mix for 10 min.

[0081] According to the particle content, the tablet weight should be converted into tablets, and 10.0mm circular shallow arc punching nails were used for tablet compression.

[0082] Experimental results:

[0083]

Embodiment 2

[0085] prescription

[0086]

[0087] Pass the raw and auxiliary materials through a 40-mesh sieve respectively to remove the agglomerates, add the raw and auxiliary materials into the three-dimensional hopper mixer in sequence, set the mixing speed to 20 rpm, and mix for 10 min.

[0088] According to the particle content, the tablet weight should be converted into tablets, and 10.0mm circular shallow arc punching nails were used for tablet compression.

[0089] Experimental results:

[0090]

Embodiment 3

[0092] prescription

[0093]

[0094] Pass the raw and auxiliary materials through a 40-mesh sieve respectively to remove the agglomerates, add the raw and auxiliary materials into the three-dimensional hopper mixer in sequence, set the mixing speed to 20 rpm, and mix for 10 min.

[0095] According to the particle content, the tablet weight should be converted into tablets, and 10.0mm circular shallow arc punching nails were used for tablet compression.

[0096] Experimental results:

[0097]

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Abstract

The invention discloses a bepotastine besilate orally disintegrating tablet and a preparation method thereof, the orally disintegrating tablet comprises the following components by mass: 2%-20% of bepotastine besilate, 35%-80% of a filler, 2%-35% of a disintegrating agent, 1%-10% of a lubricant, and 1-6% of a flavoring agent, the orally disintegrating tablet has a smooth and beautiful surface and appropriate hardness, can be rapidly disintegrated in the oral cavity, and can be rapidly absorbed; the orally disintegrating tablet has the advantages of fast effect taking, simple process, excellent friability, fast disintegration and excellent taste, and solves the problem of residual aftertaste and the problem of insufficient bitter taste covering effect.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a bepotastine besylate orally disintegrating tablet, and also to a preparation method of the orally disintegrating tablet. Background technique [0002] Orally disintegrating tablet is a new type of tablet that can be quickly disintegrated or dissolved without water in the oral cavity. It is especially suitable for the elderly, children, patients with dysphagia, drinking water inconvenience or coma. [0003] Bepotastine besylate is known to be used as a selective histamine 1 receptor antagonist used in allergic rhinitis, urticaria, etc., but has problems such as strong bitter taste. Therefore, for oral administration, it is necessary to mask the bitter taste. Regarding masking of the bitter taste of drugs, for example, as reported in Patent 201280020882.7, bepotastine or a pharmacologically acceptable salt thereof, a water-insoluble polymer, and optional excipients are mixed and ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K47/22A61K47/38A61K31/4545A61P37/08A61P11/02A61P17/00
CPCA61K9/2018A61K9/2013A61K9/2054A61K9/2095A61K9/0056A61K31/4545A61P37/08A61P11/02A61P17/00
Inventor 倪晟张庆周亮晓晨曦夏金强
Owner HANGZHOU HEZE PHARMA TECH
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