Micronized deflazacort oral preparation and preparation method thereof

A technology for oral preparations of deflazacort, applied in the field of micronized oral preparations of deflazacort and its preparation, capable of solving problems such as low bioavailability and slow dissolution rate of common oral preparations

Inactive Publication Date: 2011-10-19
SHANGHAI ANHANTE BIOPHARM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Deflazacort is a poorly soluble drug, the dissolution rate of c

Method used

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  • Micronized deflazacort oral preparation and preparation method thereof
  • Micronized deflazacort oral preparation and preparation method thereof
  • Micronized deflazacort oral preparation and preparation method thereof

Examples

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Embodiment 1

[0056] Embodiment 1: micronized deflazacort tablet

[0057]

[0058] Preparation process: Add micronized Difucort powder in equal amounts and mix with lactose evenly, then mix evenly with sodium carboxymethyl starch, add 20ml of ethanol solution containing 10% PVP K30 to make granules, blow air at 70°C Dry, granulate, add magnesium stearate, mix evenly, and compress into tablets; each tablet contains 6mg of deflazacort.

Embodiment 2

[0059] Embodiment 2: micronized deflazacort tablet

[0060]

[0061] Preparation process: add micronized deflazacort powder in equal amounts and mix with lactose evenly, then mix evenly with microcrystalline fiber, add 25ml of ethanol solution containing 10% PVP K30 to make granules, and dry at 70°C with air blast. Whole grains, add magnesium stearate, mix well, and fill capsules; each capsule contains 6mg of deflazacort.

Embodiment 3

[0062] Embodiment 3: deflazacort tablet

[0063] Deflazacort 9mg, lactose monohydrate, microcrystalline cellulose, polyvinylpyrrolidone, magnesium stearate, hypromellose, titanium dioxide

[0064] Raw materials are micro-powdered, 800-1000 mesh; other auxiliary materials are crushed to 80 mesh; firstly, deflazacort and lactose are mixed in equal increments, and then mixed with other auxiliary materials evenly; the binder is added to the above-mentioned mixed materials, using Wet granulation, drying, sizing, adding lubricant, mixing; tabletting, coating, packaging, to obtain tablets;

[0065] The daily dosage of deflazacort tablets is 6-90 mg.

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Abstract

The invention discloses a deflazacort oral preparation and a preparation method thereof. The deflazacort oral preparation comprises micronized deflazacort, wherein 50 to 100% of deflazacort particles have particle sizes less than or equal to 50 micrometers. The micronized deflazacort oral preparation is prepared from 2 to 40% of micronized deflazacort, 50 to 95% of one or more fillers, 1 to 10% of one or more disintegrants, 1 to 10% of one or more binders and 0.3 to 1% of a lubricant. The micronized deflazacort oral preparation is characterized in that through a process of mixing raw materials and lactose in an equal amount increasing way, a uniformity degree and a dissolution rate of raw materials can be improved; micronized deflazacort can improve a dissolution degree in vitro; and selected and combined raw materials are suitable for drug molding and have a high stability and good drug effects.

Description

technical field [0001] The invention relates to an oral preparation and its preparation method and application, in particular to a micronized deflazacort oral preparation and its preparation method and application. Background technique [0002] Deflazacort, the English name is Deflazacort. It is a white crystalline powder. Belongs to adrenal corticosteroids and adrenocorticotropic hormone drugs. This product has anti-inflammatory and anti-allergic effects, and its effect is equivalent to 10^-20 times of prednisolone. It is suitable for adrenal hypofunction, autoimmune diseases, allergic diseases and blood system diseases, etc. [0003] Deflazacort is often administered as an oral preparation. For oral administration, the crystal form and particle size of the drug in the preparation are important factors affecting the bioavailability of the drug and directly affect the efficacy of the drug. Deflazacort is a poorly soluble drug, and the dissolution rate of common oral prep...

Claims

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Application Information

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IPC IPC(8): A61K31/58A61P29/00A61P37/08
Inventor 应述欢
Owner SHANGHAI ANHANTE BIOPHARM TECH
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