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Irbesartan capsule and preparation method thereof

A technology of irbesartan and capsules is applied in the application field of the consistency evaluation field of generic drugs, and can solve the problems of no bioequivalence, large differences after meals, etc.

Active Publication Date: 2019-01-08
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the results of the study showed that although the same prescription and process were used to prepare irbesartan tablets (R) and irbesartan capsules (T), in a pH1.2 dissolution medium (paddle method, 50 rpm), 30 minutes Its dissolution rate in vitro all exceeds 80% (conforms to the relevant regulations of the Chinese Pharmacopoeia), but it does not have bioequivalence in vivo, especially after a meal.

Method used

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  • Irbesartan capsule and preparation method thereof
  • Irbesartan capsule and preparation method thereof
  • Irbesartan capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] The preparation of embodiment 1 irbesartan capsule (specification: 0.15g)

[0087] According to the prescriptions 1-4 listed in Table 8, get the materials and mark them well. The raw and auxiliary materials are passed through a 60-mesh sieve in a vibrating sieve. Weigh raw materials and excipients according to the prescription design. Receive the adhesive and prepare an adhesive solution with pure water. Put the weighed raw and auxiliary materials into the fluidized bed one-step granulator in turn, turn on the fan, and mix for 5 minutes. The prepared adhesive is top-sprayed, the air inlet temperature is controlled at 60-70°C, the material temperature is set at 50°C, dried until the water content is not higher than 2%, and the material is collected. The above-mentioned dried irbesartan granules were sized in a granulator with a sieve particle size of 2 mm. After the granulation is completed, first add the flow aid and mix in the three-dimensional mixer for 5 minutes....

Embodiment 2

[0091] Example 2 Accelerated Test Stability Research Comparison of Irbesartan Capsules (Prescription 1-2) Prepared by the Preparation Method of the Present Invention and the Original Research Product (R)

[0092] Take irbesartan capsules A and 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%. , 2 months, 3 months, and 6 months at the end of sampling once respectively, check its character, content, dissolution rate and related substances, and the results are as shown in Table 9.

[0093]

[0094] The results in Table 9 show that: the irbesartan capsules (T1, T2) prepared by the present invention are placed for 6 months in a constant temperature and humidity chamber with humidity RH75%±5% at a temperature of 40 ± 2°C. No significant changes were seen in the content and content, and the related substances were not higher than the original research product, which was basi...

Embodiment 3

[0095] Example 3 Postprandial bioequivalence study of irbesartan capsules (T1, T2) prepared by the preparation method of the present invention and the original research product (R) in human body

[0096] The purpose of this test is to evaluate the test preparation T1 of irbesartan capsules (specification: 0.15g, batch number: 20171201) and the test preparation T2 of irbesartan capsules (specification: 0.15g, batch number: 20171202, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.) and irbesartan tablet reference preparation (trade name: Amber, specification: 0.15g, batch number: 6A248, manufacturer: Sanofi, France) Kinetic characteristics and bioequivalence.

[0097] Check-in: The subjects will be admitted to the clinical trial ward before 18:30 on the day before the administration of the first cycle, unified life management, and any food and drink other than the unified diet is prohibited. Subjects were fasted from food and water after dinner on the day before each cycle ...

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Abstract

The invention discloses irbesartan capsules and a preparation method thereof, and application in consistence evaluation on generic drugs. The preparation method comprises the following steps: uniformly mixing irbesartan, a filler, a disintegrant, a hydrogel matrix material, an acidifier and a surfactant according to a certain ratio, dissolving an adhesive into purified water, spraying into a fluidized bed pelletizing coating machine, carrying out primary pelletizing, drying, uniformly mixing a flow aid and a lubricant, and filling common gelatin capsules with the mixture, thereby obtaining theirbesartan capsules. In the acceleration testing and long-term testing and stability investigation process, properties, dissolution rates, related substances and the like of the irbesartan capsules produced by using the preparation process disclosed by the invention are not remarkably changed, and the irbesartan capsules have effects equivalent to those of a conventional product (the product nameis irbesartan tablet, the trade name is irbesartan, the specification is 0.15g, the producer is Sanofi Winthrop Industrie) on in-vivo organisms.

Description

technical field [0001] The invention relates to an irbesartan capsule, a preparation method thereof, and an application in the field of consistency evaluation of generic drugs. Background technique [0002] With the development of society and economy and the change of people's lifestyle, the prevalence of hypertension in our country is increasing day by day. According to statistics, there were more than 300 million hypertensive patients in my country in 2014, and the prevalence rate of hypertension in adults aged 18 and over was 27.2%, which is consistent with the data from the 2010 Chinese Resident Nutrition and Chronic Disease Survey (the prevalence of hypertension among people aged ≧ 18 years old rate of 25.2%), the prevalence of hypertension was significantly increased. Therefore, the control and treatment of hypertension is a major project of public health in our country. [0003] Hypertension is a long-term chronic disease that in many cases requires life-long treatme...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/4184A61K47/32A61K47/36A61K47/38A61K47/12A61K47/04A61K47/20A61K47/26A61K47/18A61P9/12
CPCA61K9/485A61K9/4858A61K9/4866A61K31/4184A61P9/12
Inventor 谢斌张志刚谢岳庭孙学惠陈新民
Owner 珠海润都制药股份有限公司
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