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Bazedoxifene acetate composition and bazedoxifene acetate film-coated tablet preparation method

A technology of bazedoxifene acetate and its composition, which is applied in the field of drug preparation, can solve problems such as cumbersome process, and achieve the effects of simple process, good stability, and easy industrial production

Pending Publication Date: 2021-05-07
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The antioxidants in the two patent documents all select vitamin E, but vitamin E (Vitamin E) is a kind of fat-soluble vitamin. In the embodiment of the existing patent that can be made into tablets, vitamin E TPGS needs to be heated and melted, Add bazedoxifene acetate and mix well, then add PEG 6000 and mix well to form a suspension eutectic solution, cool the above eutectic solution to room temperature and pulverize to complete the mixing and granulation of vitamin E and bazedoxifene acetate, The process is more cumbersome

Method used

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  • Bazedoxifene acetate composition and bazedoxifene acetate film-coated tablet preparation method
  • Bazedoxifene acetate composition and bazedoxifene acetate film-coated tablet preparation method
  • Bazedoxifene acetate composition and bazedoxifene acetate film-coated tablet preparation method

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Experimental program
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Effect test

Embodiment 1

[0024] Embodiment 1: A kind of prescription composition of bazedoxifene acetate tablet

[0025]

[0026]

Embodiment 2

[0027] Embodiment 2: A kind of prescription composition of bazedoxifene acetate tablet

[0028] components g / 1000 tablets Proportion% Function bazedoxifene acetate 22.6 7.53 active ingredient lactose 105 35 filler microcrystalline cellulose 105 35 filler pregelatinized starch 44.63 14.87 Adhesive Sodium carboxymethyl starch 12 4 disintegrant Vitamin C 4.5 1.5 antioxidant Sodium dodecyl sulfate 4.5 1.5 D silica 0.3 0.1 Glidant Magnesium stearate 1.5 0.5 lubricant

Embodiment 3

[0029] Embodiment 3: A kind of prescription composition of bazedoxifene acetate tablet

[0030]

[0031]

[0032] The preparation process description of bazedoxifene acetate tablet:

[0033] Sodium lauryl sulfate and purified water are prepared into a solution with a concentration of about 10% for later use.

[0034] The bazedoxifene acetate, filler, binder, disintegrant, and antioxidant are weighed and mixed together, and after mixing, a wetting agent solution is added to carry out wet granulation or fluidized bed granulation process. After granulation, dry at 50-60°C to control the water content to 1-4%, pass through a 40-mesh sieve for granulation. Add the rest of the materials, mix them, compress into tablets and coat them. Comparative example: in vitro release test of prepared samples

[0035] Control sample: bazedoxifene acetate tablets (specification 20 mg) with the trade name Viviant, manufactured by PfizerJapan Inc. / ファイザー Co., Ltd., batch number CJ6968, packa...

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Abstract

The invention discloses a bazedoxifene (Viviant) acetate composition and a bazedoxifene acetate film-coated tablet preparation method, and relates to the technical field of medicines. The bazedoxifene acetate composition comprises the following components by weight of 20-26 parts of bazedoxifene acetate, 250-350 parts of a filling agent, 30-50 parts of an adhesive, 8-15 parts of a disintegrating agent, 3-6 parts of an antioxidant, 2-6 parts of a flow aid, 0.1-0.5 part of a lubricant, 1-3 parts of a wetting agent, and a proper amount of a purified water solvent, wherein bazedoxifene acetate is a BCS II type medicine, and the particle size D90 is 30 microns; the antioxidant is vitamin C; and the filling agent is composed of lactose and microcrystalline cellulose, and the ratio of the lactose to the microcrystalline cellulose is 1: 2-2: 1 according to the weight fraction. The fluidized bed granulation technology adopting the process for preparation is simple in process, lower in cost and easy for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a bazedoxifene acetate composition and a method for preparing bazedoxifene acetate film-coated tablets. Background technique [0002] The chemical name of bazedoxifene acetate is (1-[4-(2-azepan-1-yl-ethoxy)-benzyl]-2-(4-hydroxy-phenyl)-3-methyl base-1H-indole-5-ol acetic acid), has the chemical structure shown below: [0003] [0004] It is a new type of third-generation selective estrogen receptor modulators (selective estro-genreceptor modulators, SERMs), which can competitively inhibit the binding of 17β-estradiol to estrogen receptors ERα and ERβ, thereby Activates estrogen receptors in skeletal tissue, thereby increasing bone density in the spine and hip. The drug is mainly used for the prevention and treatment of osteoporosis in postmenopausal women. It has almost no stimulation to the breast and uterus, and will not cause hyperplasia of the breast and en...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/55A61K47/36A61K47/38A61K47/26A61K47/22A61P15/12A61P19/10
CPCA61K31/55A61K9/2018A61K9/2054A61K9/2013A61K9/2059A61K9/2806A61P15/12A61P19/10
Inventor 沙薇柴萌萌王国景张亚萍吴金平
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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