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Acotiamide hydrochloride sustained release tablet and preparation method thereof

A technology of acotiamide hydrochloride and acotiamide hydrochloride trihydrate, applied in the field of acotiamide hydrochloride sustained-release tablet and its preparation, can solve the problem of poor compliance, large difference in release degree, waste of manpower and material resources, etc. question

Inactive Publication Date: 2014-03-12
ANHUI PIOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pharmacokinetic study of this product shows that the half-life (t1 / 2) of oral acotiamide hydrochloride tablets in the human body is 2 hours, which requires administration three times a day to maintain effective blood drug concentration, poor compliance, and slow Release tablets can solve this problem
[0020] The process stability of sustained-release tablets has always been a difficult point in the development process of sustained-release tablets, which is mainly reflected in the process from laboratory preparation to mass production. The same prescription and process have large differences in release, and the prepared samples have undergone In the stability test, the change of the release rate is also relatively large. This difficulty has set up obstacles for the development of sustained-release preparations, and also increased a lot of repetitive research work from laboratory scale-up to production, wasting a lot of manpower and material resources

Method used

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  • Acotiamide hydrochloride sustained release tablet and preparation method thereof
  • Acotiamide hydrochloride sustained release tablet and preparation method thereof
  • Acotiamide hydrochloride sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] 1. Prescription

[0032] plain tablet prescription

[0033] After various prescription process research, according to the common ratio of various excipients, the prescription of plain tablets is determined as

[0034] Acotiamide Hydrochloride Sustained Release Tablets Prescription

[0035]

[0036] Coating prescription

[0037] Acotiamide Hydrochloride Sustained Release Tablets Coated Prescription 1000 Tablets

[0038]

[0039]

[0040] 2. Preparation process

[0041] Take acotiamide hydrochloride trihydrate, pulverize it and pass through an 80-mesh sieve, stir it with lactose in a high-speed mixer for 10 minutes, moisten it with 80% ethanol and granulate it, dry it at 50-55°C, and control the moisture content of the granules after drying When it is less than 0.5%, the granules pass through a 40-mesh sieve for granulation, add HPMC K4M, HPMC K15M, magnesium stearate and mix evenly, and then press into tablets. Controlled at 7-8kg, the prepared plain tablet...

Embodiment 2

[0053] 1. Prescription

[0054] plain tablet prescription

[0055] After various prescription process research, according to the common ratio of various excipients, the prescription of plain tablets is determined as

[0056] Acotiamide Hydrochloride Sustained Release Tablets Prescription

[0057]

[0058] Coating prescription

[0059] Acotiamide Hydrochloride Sustained Release Tablets Coated Prescription 1000 Tablets

[0060]

[0061] 2. Preparation process

[0062] Take acotiamide hydrochloride trihydrate, pulverize it and pass through an 80-mesh sieve, stir it with lactose in a high-speed mixer for 10 minutes, moisten it with 80% ethanol and granulate it, dry it at 50-55°C, and control the moisture content of the granules after drying When it is less than 0.5%, the granules pass through a 40-mesh sieve for granulation, add HPMC K4M, HPMC K15M, magnesium stearate and mix evenly, and then press into tablets. Controlled at 7-8kg, the prepared plain tablets were coated ...

Embodiment 3

[0073] Embodiment 3 stability study result

[0074] high temperature test

[0075] Take this product (Example 1 (100,000 pieces of pilot test product), batch number: 20130709), put it in a constant temperature drying oven at 60°C for 10 days, and take samples on the 5th and 10th days respectively. , Dissolution, related substances and labeling quantities and other inspection items were measured, and the results are shown in the table below:

[0076]

[0077] High Humidity Test

[0078] Take this product (Example 1 (100,000 pieces of pilot test product), batch number: 20130709), place it in a constant humidity airtight desiccator, and place it at 25°C and a relative humidity of 92.5% for 10 days. Samples were taken on the first 10 days, and the inspection items such as properties, moisture, dissolution rate, polymers, related substances and labeled quantities were measured. The results are shown in Table 14-2:

[0079]

[0080] Strong light exposure test

[0081] Take...

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Abstract

The invention discloses an acotiamide hydrochloride sustained release tablet and a preparation method thereof. The sustained release tablet, in unit dose package, comprises 150mg of acotiamide hydrochloride trihydrate, 200 to 300mg of sustained-release material, 300 to 400mg of stabilizer, adhesive, lubricant and coating material. The sustained release tablet has 12-hour sustained release effect and good chemical stability. The releasing rate of the sustained release tablet is good in repeatability from laboratory to mass production stages, and is basically unchanged through 6 month stability inspection.

Description

1. Technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an acotiamide hydrochloride sustained-release tablet and a preparation method thereof. 2. Background technology [0002] On June 5, 2013 local time, Japan's Angstless Pharmaceutical Co., Ltd. announced that Acofide, a functional dyspepsia (FD) treatment drug jointly developed by the company and Zeria Pharmaceuticals Co., Ltd. (Common name Acotiamide Hydrochloride Tablets) was first launched in Japan on June 6, 2013. The listed dosage form is ordinary tablet, and the listed specification is 100mg / tablet. The approved indications are: postprandial fullness, functional dyspepsia, epigastric fullness, and early satiety. [0003] The basic information of acotiamide hydrochloride tablets is as follows: [0004] Chinese name: Acotiamide Hydrochloride Tablets [0005] English or Latin name: Acotiamide hydrochloride hydrate Tablets [0006] Pinyin: Yansuan Akaot...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/426A61K47/34A61K47/26A61P1/14
Inventor 徐奎陈正晧魏伟
Owner ANHUI PIOM PHARMA
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