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Bazedoxifene acetate capsule and preparation method thereof

A technology of bazedoxifene acetate, capsules, applied in the field of medicine

Inactive Publication Date: 2015-04-29
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no marketed preparation of bazedoxifene acetate in China, and there are four in the re-examination stage, and the dosage forms of their applications are all tablets

Method used

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  • Bazedoxifene acetate capsule and preparation method thereof
  • Bazedoxifene acetate capsule and preparation method thereof
  • Bazedoxifene acetate capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Preparation of Bazedoxifene Acetate Capsules (20mg)

[0031]

[0032] Preparation Process:

[0033] (1) co-micronizing bazedoxifene acetate and silicon dioxide;

[0034] (2) Add and mix the raw materials of co-micronized powder with the prescribed amount of lactose, microcrystalline cellulose, pregelatinized starch, and ascorbic acid;

[0035] (3) Perform dry granulation of the above mixture to control the particle size so that the particles between 30-80 mesh account for 70-80%;

[0036] (4) Prepare a coating liquid, and use a fluidized bed to coat the granules;

[0037] (5) After the coating is completed, fill No. 1 capsules, with a loading range of 370-430 mg.

Embodiment 2

[0038] Preparation of Example 2 Bazedoxifene Acetate Capsules (20mg)

[0039]

[0040] Preparation Process:

[0041] (1) co-micronizing bazedoxifene acetate and silicon dioxide;

[0042] (2) Add and mix the raw materials of co-micronized powder with the prescribed amount of lactose, microcrystalline cellulose, pregelatinized starch, and ascorbic acid;

[0043] (3) Perform dry granulation of the above mixture to control the particle size so that the particles between 30-80 mesh account for 70-80%;

[0044] (4) Prepare a coating liquid, and use a fluidized bed to coat the granules;

[0045] (5) After the coating is completed, fill No. 1 capsules, with a loading range of 370-430 mg.

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PUM

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Abstract

The invention discloses a bazedoxifene acetate capsule which is used for preventing the osteoporosis of postmenopausal women. The capsule is convenient to carry and take, and compared with a tablet and a pill, the bazedoxifene acetate capsule is dispersed in stomachs and dissolved out more quickly, and takes the effect more quickly. Meanwhile, the invention further discloses a preparation method of the bazedoxifene acetate capsule. Compared with a common capsule granulating method, capsule grains prepared by the preparation method can improve the stability of drugs and preparations of the drugs effectively.

Description

technical field [0001] The present invention relates to selective estrogen receptor modulators 1-[4-(2-azepan-1-yl-ethoxy)-benzyl]-2-(4-hydroxy-phenyl)-3 -Methyl-1 H - Indole-5-phenol acetic acid (bazedoxifene acetate) capsules and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Postmenopausal osteoporosis (postmenopausal osteoporosis, POP) is a common disease related to aging, which mainly occurs in postmenopausal women. Due to estrogen deficiency, bone mass decreases and changes in bone tissue structure lead to increased bone fragility and easy fracture. As well as the pain, bone deformation, complications and even death caused by fractures, it seriously affects the health and quality of life of the elderly, and even shortens life expectancy, increasing the financial and human burden of the country and families. [0003] Bazedoxifene acetate (1-[4-(2-azepan-1-yl-ethoxy)-benzyl]-2-(4-hydroxy-phenyl)-3-methyl-1 H -...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/55A61K47/34A61K47/04A61P15/12A61P19/10
Inventor 许尤新刁媛媛马苏峰
Owner AVENTIS PHARMA HAINAN
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