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Oral solid preparation of dutasteride and preparation method thereof

A solid preparation, dutasteride technology, applied in the field of pharmaceutical preparations, can solve the problems of diluents that are difficult to obtain prescription stability and safety, and achieve the effects of improving bioavailability, reducing local irritation, and solving availability

Inactive Publication Date: 2015-01-07
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In order to overcome the difficulties in obtaining diluents in the prior art, as well as the problems of prescription stability and safety, the present invention provides an oral solid preparation of dutasteride with a simple preparation process

Method used

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  • Oral solid preparation of dutasteride and preparation method thereof
  • Oral solid preparation of dutasteride and preparation method thereof
  • Oral solid preparation of dutasteride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] prescription:

[0036]

[0037]

[0038] Preparation method: weigh 2.5g of Eudragit and add it to a certain amount of ethanol, stir to dissolve; then weigh 0.05g of dutasteride, add it to a certain amount of ethanol, stir to dissolve, add 1.25g of talcum powder; The above two solutions are mixed evenly to obtain the coating solution.

[0039] Turn on the preheating of the fluidized bed, put the prescribed amount of microcrystalline cellulose pellets into the fluidized bed, and set the air inlet volume at 1500m 3 / h~2500m 3 / h to keep the pellets in a good fluidized state. When the temperature of the material reaches 20°C-50°C, turn on the liquid inlet pump, set the flow rate of the feed liquid at 50g / min-150g / min, and keep the coating liquid continuous during the coating process. Stir. After the coating solution is sprayed, keep the air volume and material temperature constant to dry the material. At the end of the drying, the moisture content is qualified as t...

Embodiment 2

[0041] prescription:

[0042]

[0043] Preparation method is the same as embodiment 1

Embodiment 3

[0045] prescription:

[0046]

[0047] Preparation method is the same as embodiment 1

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PUM

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Abstract

The invention relates to a pelleted oral solid preparation of dutasteride. A drug-containing pellet of the solid preparation is composed of the following components in percentage by weight: 0.25-2.50% of dutasteride, 12.50-20.50% of solubilizer, 6.00-12.50% of an antisticking agent, and 50.00-80.00% of a pellet core. The oral solid preparation disclosed by the invention has the characteristics of being wide in raw material source, high in stability, good in safety, high in dissolution rate and good in bioavailability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral solid preparation of dutasteride and a preparation method thereof. Background technique [0002] Dutasteride (Dutasteride, (5α,17β)-(2,5-bis(trifluoromethyl)phenyl)-3-oxo-4-aza-androst-1-ene-17-carboxamide) It is a new dual inhibitor of 5α-reductase, mainly used in the treatment of male benign prostatic hyperplasia. Its chemical structure is as follows: [0003] [0004] Dutasteride was first launched in the United States by GlaxoSmithKline in January 2003 under the trade name Avodart. On April 11, 2011, China Food and Drug Administration approved dutasteride soft capsules for sale in China , the trade name is Anfuda. [0005] Dutasteride is a white or off-white crystalline powder. Because it is almost insoluble in water, its dissolution and bioavailability in the body are limited. In order to ensure that dutasteride has good dissolution and bioavailability...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K47/32
CPCA61K31/58A61K9/0053A61K9/284A61K9/48
Inventor 房金波郭璇章晓骅徐丹杨治旻田舟山
Owner NANJING CHIA TAI TIANQING PHARMA