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Preparation method of irbesartan capsule

A technology for irbesartan and capsules, applied in the field of preparation of irbesartan capsules, can solve problems such as difficulty in development, and achieve the effects of shortening preparation time, improving dissolution and stability, and solving inconsistent dissolution curves

Active Publication Date: 2017-08-11
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

Due to the different in vitro dissolution profiles of capsules and tablets, it is very difficult to develop a capsule that matches the in vitro dissolution profile of a tablet

Method used

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  • Preparation method of irbesartan capsule
  • Preparation method of irbesartan capsule
  • Preparation method of irbesartan capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] The preparation of embodiment 1 irbesartan capsule (specification: 0.15g)

[0080] According to the type of material designed according to the prescription, the vibrating screen passes through a 60-mesh sieve. Weigh the raw material drug and various excipients according to the prescription design, put them in the wet granulator equipment, and mix for 5 minutes. Weigh the adhesive, and prepare an adhesive solution with 75% ethanol. Put the adhesive into the pulping device, turn on the manual pulping, and make soft materials, so that the wet granules can reach the state of being agglomerated and falling apart when touched. The soft material prepared above is placed in a rotary extrusion granulator with a screen diameter of 10 meshes, and is rotated and extruded to granulate. Set the material temperature to 50°C, and dry the irbesartan granules obtained by the above-mentioned extrusion granulation in a boiling dryer until the water content is not higher than 2%, and coll...

Embodiment 2

[0081] Example 2 Comparison of the in vitro dissolution curves of irbesartan capsules prepared by the present invention (prescription 1, prescription 2, prescription 3, prescription 4) and the original research product (R)

[0082] Get each 12 capsules of irbesartan capsules (prescription 1, prescription 2, prescription 3, prescription 4) prepared in Example 1 and the original research product (R), detect its hydrochloric acid solution at pH1.0, pH4.0 according to the following method The in vitro dissolution profiles of acetate buffered saline, pH 6.8 phosphate buffer and water. See Table 4 for prescriptions.

[0083] The method of table 5 irbesartan capsules in 4 different dissolution media

[0084] Dissolution medium method Rotating speed Surfactant Hydrochloric acid solution at pH 1.0 basket 75 rpm none Acetate buffer pH 4.0 basket 100 rpm 0.2% SDS Phosphate buffer at pH 6.8 basket 75 rpm none water basket 75 rpm ...

Embodiment 3

[0098] Example 3 The accelerated test stability research comparison of the irbesartan capsules (prescription 3) prepared by the preparation method of the present invention and the original research product (R)

[0099] 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 each sampling once, check its character, content, dissolution rate and related substances, the results are shown in Table 10.

[0100] The results in Table 10 show that: Rabeprazole enteric-coated capsules (A) 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, and the related substances, dissolution rate No significant changes were seen in the content and content, and the related substances were lower than the original rese...

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Abstract

The invention discloses a preparation method of an irbesartan capsule and application in the evaluation of generic drug consistency. After Irbesartan is mixed with various auxiliary materials to prepare a soft material, granulation is performed through an extruding granulation method, granules are evenly mixed with a lubricant after drying, and the capsule is filled. The irbesartan capsule produced by adopting the preparation process is consistent to an original research product (product name: irbesartan tablets; trade name: Avapro; specification: 0.15 g; production manufacturer: Sanofi Winthrop Industrie) on the aspect of multiple in-vitro dissolution curves, related substances have no obvious change in the test acceleration and long-term test stability investigation process and are biologically equivalent to the original research product.

Description

technical field [0001] The invention relates to a preparation method of irbesartan capsules 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 treatment. Howe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4184A61K47/38A61K47/36A61P9/12
CPCA61K9/1652A61K9/1682A61K31/4184
Inventor 谢斌陈新民莫泽艺刘杰关东李必禄谢岳庭冼伟宝周佳
Owner 珠海润都制药股份有限公司
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