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Itopride hydrochloride tablet and preparation method of tablet

A technology of itopride hydrochloride tablets and itopride hydrochloride, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of water becoming sticky and easy to absorb moisture , material stickiness and other problems

Pending Publication Date: 2020-07-07
珠海润都制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Since itopride hydrochloride raw material has the characteristics of easy moisture absorption, stickiness when exposed to water, and easy crystallization, resulting in sticky materials and poor granulation, in order to reduce the difficulty of granulating itopride hydrochloride and materials, and To reduce the production cost of Itopride Hydrochloride Tablets without reducing the quality of the product, to ensure that the product is bioequivalent to the original research product, we have invented a preparation method for Itopride Hydrochloride Tablets, which uses the powder directly The production technique of pressing, the inventor finds in research, also there is no itopride hydrochloride tablet that bibliographical information powder direct-compression process prepares at present

Method used

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  • Itopride hydrochloride tablet and preparation method of tablet
  • Itopride hydrochloride tablet and preparation method of tablet
  • Itopride hydrochloride tablet and preparation method of tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 Preparation of Itopride Hydrochloride Tablets (Specification: 0.05g)

[0032]As shown in Table 1, according to the type of material designed by the prescription, the bulk drug and auxiliary materials are vibrated through a 60-mesh sieve. The excipients include fillers (lactose, corn starch), disintegrants (carboxymethylcellulose), glidants (silicon dioxide), lubricants (magnesium stearate). Weigh the crude drug, filler, disintegrant, glidant and lubricant according to the prescription design, place in a three-dimensional mixer, mix for 15 minutes, and detect the actual content of itopride hydrochloride. Put it in the feeding hopper of a Bosch tablet press, the design tablet weight is 130mg, the tablet hardness is about 50-80N, and the tablet is pressed. The particle size distribution of the raw material is D10<10μm, D50<20μm, D90<50μm, the tableting speed is 300,000 tablets / hour, and the HPMC coating material of Colorcon is used for coating, and the weight ga...

Embodiment 2

[0038] Example 2 Comparison of Accelerated Test Stability Study of Prescription 2 Itopride Hydrochloride Tablets and Original Research Product (R)

[0039] Take itopride hydrochloride tablets and the original research product R, pack them in aluminum-plastic blisters, and place them in a constant temperature and humidity box with a temperature of 40±2°C and a humidity of RH75%±5%. Sampling once at the end of 1 month and 6 months respectively to check its properties, content, dissolution rate and related substances, the results are shown in Table 6.

[0040]

[0041] The results in Table 6 show that the itopride hydrochloride tablets prepared by prescription 2 of the present invention are placed at 40 ± 2°C for 3 months and 6 months respectively in a constant temperature and humidity chamber with humidity RH75% ± 5%. , dissolution rate and content have no significant change, showing that the itopride hydrochloride tablet prepared by the present invention has good stability a...

Embodiment 3

[0042] Example 3 Comparison of Pharmacokinetic Study of Prescription 2 Itopride Hydrochloride Tablets and Original Research Product (R) in Human Body

[0043] The purpose of this test is to evaluate the oral administration of itopride hydrochloride tablets (specification: 0.05g, prescription 2, test preparation) and the original research product of itopride hydrochloride tablets (trade name: Weilisu; specification : 0.05g; Licensee: ABBOTT LABORATORIES (M) SDN.BHD) after the pharmacokinetic characteristics and bioequivalence. Once the subjects were selected, 12 subjects were randomly divided into 3 groups of 4 persons.

[0044] At about 8:00 on the first day of the study, the subjects ate a high-fat meal (providing about 50% of the calories in the food), a high-calorie meal (about 800-1000 kcal, of which protein provided about 150 kcal and carbohydrates about Provide 250 kcal of heat, fat provides about 500-600 kcal of heat), eat within 30 minutes. 30 minutes after the subje...

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Abstract

The invention discloses an itopride hydrochloride tablet, a preparation method of the tablet, and application in consistency evaluation of generic drugs. The raw material medicine of itopride hydrochloride has the characteristics of easily absorbing moisture, becoming sticky in water and crystallization, so that the materials become sticky and has poor granulation. Therefore, wet granulation is not suitable for preparing itopride hydrochloride tablets. In the present invention, itopride hydrochloride and various auxiliary materials are mixed uniformly, and then tablets with a diameter of about7 mm, a thickness of about 3 mm and a weight of about 130 mg, are obtained by directly pressing the above mixture. According to the itopride tablets produced by directly pressing powder, not only thedifficulty of granulation can be solved, but also the production process is simple, and the manufacturing cost is low. The multiple dissolution curves of the tablets in vitro are consistent with thedissolution curves of the original research product, related substances have no obvious change in the process of an accelerated test and long-term test stability investigation, and the tablets are bioequivalent with the original research product after meal.

Description

technical field [0001] The invention relates to an itopride hydrochloride tablet, a preparation method thereof, and an application in the field of consistency evaluation of generic drugs. Background technique [0002] Itopride Hydrochloride (Itopride Hydrochloride) is a new type of digestive tract prokinetic drug, which was first successfully researched by Japan Hokuriku Pharmaceutical Company (in August 2002, Japan Hokuriku Pharmaceutical Company was acquired by Abbott), and was launched in 1995 Approved for listing in Japan, the product names are Ganaton and Elthon (the Chinese name of the domestic imported tablet is "Weilisu"). Itopride hydrochloride is a dopamine D2 receptor antagonist and acetylcholinesterase inhibitor, used for various symptoms caused by functional dyspepsia, such as: epigastric discomfort, postprandial fullness, early satiety, loss of appetite, nausea, vomiting etc. The drug is absorbed completely and rapidly after oral administration, with a relati...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/166A61K47/38A61P1/14
CPCA61K9/2095A61K9/2054A61K9/2866A61K31/166A61P1/14
Inventor 谢斌杨冬冯伟霞黄俊鹏关东祁红林黄肖艳罗伟苑刘杰陈新民
Owner 珠海润都制药股份有限公司
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