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Oral disintegrating acotiamide hydrochloride tablet and preparation method thereof

A technology of acotiamide hydrochloride and orally disintegrating tablets, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of poor taste, poor taste masking effect, and dissolution rate. Slow and other problems, to achieve the effect of easy storage and transportation, reduce friability, and improve dissolution rate

Active Publication Date: 2019-07-12
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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  • Oral disintegrating acotiamide hydrochloride tablet and preparation method thereof
  • Oral disintegrating acotiamide hydrochloride tablet and preparation method thereof
  • Oral disintegrating acotiamide hydrochloride tablet and preparation method thereof

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preparation example Construction

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

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

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

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

[0058] 4) Take the unmasked acotiamide hydrochloride pellets in step 2) and coat them with the taste-masking coating solution to obtain the acotiamide hydrochloride taste-masked pellets,

[0059] 5) Mix an...

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 pellets is:

[0069] 1) Acotiamide hydrochloride is carried out jet milling, and the particle size is controlled to be D 90 not more than 10 μm,

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

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

[0072] 4) Coating the untaste-masked acotiamide hydrochloride pellets with a taste-masking coating solution to prepare the taste-masked acotiamide hydrochloride pellets.

Embodiment 2

[0074] Table 2 shows the orally 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: first mix and sieve acotiamide hydrochloride taste-masked pellets with sucralose, essence, and silicon dioxide, then mix with crospovidone and mannitol, and press into tablets.

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

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Abstract

The invention discloses an oral disintegrating acotiamide hydrochloride tablet and a preparation method thereof. The oral disintegrating acotiamide hydrochloride tablet comprises, by weight, the following components: 40-90% of acotiamide hydrochloride bitter taste masking pellets, 4.5-49.9% of a filler, 4-10% of a disintegrating agent, 0.5-1.0% of a lubricant, 0-2.0% of a corrigent and 0-0.2% of essence, wherein the acotiamide hydrochloride bitter taste masking pellets are prepared from, by weight, 55-65% of acotiamide hydrochloride, 20-35% of blank pellet cores, 1-5% of a binder, 6-12% of bitter taste masking coating material and 0.7-1.2% of a pore-forming agent. The oral disintegrating acotiamide hydrochloride tablet can be rapidly disintegrated into fine particles in the oral cavity, does not need to be taken by water, is comfortable and cool in taste after being put into the mouth, does not have obvious gritty feeling, is pleasant in taste, is convenient for patients to swallow, isparticularly suitable for old people, children and people with dysphagia and can improve the medication compliance of patients and increase the populations using the tablet.

Description

technical field [0001] The invention relates to the technical field of acotiamide hydrochloride preparations, in particular to an orally disintegrating acotiamide hydrochloride tablet. In addition, the present invention also relates to a preparation method of the acotiamide hydrochloride orally disintegrating tablet. Background technique [0002] Acotiamide Hydrochloride Hydrate, the chemical name is N-{2-[bis(1-methylethyl)amino]ethyl}-2-[(2-hydroxy-4,5-di Methoxybenzoyl)amino]thiazole-4-carboxamide hydrochloride trihydrate. It is a new M1, M2 receptor antagonist developed by Japan Zeria Shinyaku Kogyo Co., Ltd. On June 6, 2013, it was jointly launched by Astellas Pharmaceuticals and Zeria Pharmaceuticals in Japan, and was the first to be approved for marketing, becoming the world's first functional dyspepsia (FD) treatment drug. Postprandial fullness, upper abdominal distension, early satiety. Its chemical structural formula is as follows: [0003] [0004] Orally ...

Claims

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Application Information

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Patent Type & Authority Applications(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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