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Acotiamide hydrochloride orally disintegrating tablet and preparation method thereof

A technology of acotiamide hydrochloride and orally disintegrating tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of poor taste, slow dissolution rate, and taste masking effect To achieve the effects of easy storage and transportation, reduced friability, and pleasant taste

Active Publication Date: 2022-03-25
HUNAN WARRANT PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a cotiamide hydrochloride orally disintegrating tablet and a preparation method thereof to solve the technical problems of the existing acotiamide hydrochloride orally disintegrating tablet having poor taste-masking effect, bad taste and slow dissolution rate in the gastrointestinal tract

Method used

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  • Acotiamide hydrochloride orally disintegrating tablet and preparation method thereof
  • Acotiamide hydrochloride orally disintegrating tablet and preparation method thereof
  • Acotiamide hydrochloride orally disintegrating tablet and preparation method thereof

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preparation example Construction

[0054] According to another aspect of the present invention, there is provided a preparation method of the above-mentioned acotiamide hydrochloride orally disintegrating tablet, comprising the following steps:

[0055] 1) acotiamide hydrochloride is carried out jet pulverization to obtain micronized acotiamide hydrochloride, and the control particle size is D 90 not more than 10μm,

[0056] 2) suspending the micronized acotiamide hydrochloride in the binder solution, then spray-coating the suspension solution on the blank pellet core to obtain unmasked acotiamide hydrochloride micropellets,

[0057] 3) stirring and mixing the taste-masking coating material, the porogen and the ethanol solution to make a suspension dispersion to obtain a taste-masking coating liquid,

[0058] 4) in step 2), the taste-masked acotiamide hydrochloride micropills are coated with a taste-masking coating solution to obtain acotiamide hydrochloride taste-masked micropills,

[0059] 5) The acotiamide...

Embodiment 1

[0064] Table 1 is the composition of acotiamide hydrochloride pellets

[0065] Table 1

[0066]

[0067]

[0068] The preparation method of above-mentioned acotiamide hydrochloride pellet is:

[0069] 1) Acotiamide hydrochloride is carried out jet pulverization, and the control particle size is D 90 not more than 10μm,

[0070] 2) Suspend the micronized acotiamide hydrochloride in the binder hydroxypropyl methylcellulose solution, and spray-coat the hydroxypropyl methylcellulose solution suspended with the acotiamide hydrochloride micropowder to a On the blank pellet core, unmasked acotiamide hydrochloride pellets were prepared,

[0071] 3) stirring and mixing the taste-masking coating material, the porogen and the ethanol solution to make a suspension dispersion to obtain a taste-masking coating liquid,

[0072] 4) Take unmasked acotiamide hydrochloride pellets and coat with a taste-masking coating solution to obtain taste-masked acotiamide hydrochloride pellets.

Embodiment 2

[0074] Table 2 is the oral disintegrating tablet compression of the acotiamide hydrochloride taste-masked pellets prepared in the above-mentioned Example 1 in different proportions.

[0075] Table 2

[0076]

[0077] Preparation method: firstly, acotiamide hydrochloride taste-masked pellets are mixed with sucralose, essence and silicon dioxide and sieved, and then mixed with crospovidone and mannitol for tableting.

[0078] Results: The theoretical tablet weight of acotiamide hydrochloride orally disintegrating tablets prepared according to the above pellet ratio was not more than 500 mg, the tablet weight was suitable, and it was easy to take. The tablet weight of the orally disintegrating tablet 2 to the orally disintegrating tablet 6 is between 150 and 400 mg, and the tablet weight is very suitable.

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Abstract

The invention discloses an acotiamide hydrochloride orally disintegrating tablet and a preparation method thereof. The acotiamide hydrochloride orally disintegrating tablet comprises the following components in weight percent: acotiamide hydrochloride taste-masking pellets 40-90% , 4.5-49.9% filler, 4-10% disintegrant, 0.5-1.0% lubricant, 0-2.0% flavoring agent, 0-0.2% essence, wherein the acotiamide hydrochloride taste-masked pellets It consists of the following components: 55-65% of acotiamide hydrochloride, 20-35% of blank ball core, 1-5% of binder, 6-12% of taste-masking coating material, 0.7-1.2% of porogen, The above components are all in weight percentage. The acotiamide hydrochloride orally disintegrating tablet of the present invention can be rapidly disintegrated into fine particles in the oral cavity, and does not need to be taken with water. For the elderly, children and those with dysphagia, it can improve patients' medication compliance and expand the population of drug users.

Description

technical field [0001] The present invention relates to the technical field of acotiamide hydrochloride preparations, in particular to an orally disintegrating tablet of acotiamide hydrochloride. In addition, the present invention also relates to a preparation method of the above-mentioned acotiamide hydrochloride orally disintegrating tablet. Background technique [0002] Acotiamide Hydrochloride Hydrate, chemical name N-{2-[bis(1-methylethyl)amino]ethyl}-2-[(2-hydroxy-4,5-di Methoxybenzoyl)amino]thiazole-4-carboxamide hydrochloride trihydrate. It is a new type of M1, M2 receptor antagonist developed by Zeria New Pharmaceutical Industry Co., Ltd. of Japan. On June 6, 2013, it was jointly launched by Astellas Pharmaceuticals and Zeria Pharmaceuticals in Japan, and it was the first to be approved for marketing, becoming the world's first functional dyspepsia (FD) treatment drug. This product was approved for the treatment of FD caused by Postprandial fullness, epigastric d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/32A61K47/02A61K31/426A61P1/14
CPCA61K9/2081A61K9/2054A61K9/2027A61K9/2009A61K9/0056A61K31/426A61P1/14
Inventor 黄本东徐燕周志刚罗丽娜刘海艳
Owner HUNAN WARRANT PHARMA
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