Voriconazole composition and preparation method thereof

A technology of voriconazole and voriconazole tablets, which is applied in the direction of pill delivery, antifungal agents, etc., and can solve the problems of shortening the time to maintain the drug effect, problems with the speed or degree of drug absorption, and small safety index

Inactive Publication Date: 2012-10-31
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The absorption rate of drugs in the body is often determined by the speed of dissolution. Before being absorbed, the drugs in oral solid preparations must go through the process of disintegration and/or dissolution and then turn into a solution. If the drug is not easily released from the preparation or the drug If the dissolution rate is extremely slow, there may be problems with t

Method used

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  • Voriconazole composition and preparation method thereof
  • Voriconazole composition and preparation method thereof
  • Voriconazole composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0044] Example 1

[0045]

[0046] Preparation Process:

[0047] (i) Weigh the internal phase materials into the high-speed mixing granulator, turn on the mixer and stir to make the mixing uniform;

[0048] (ii) Prepare PVP-K90 into a 5g / 100g aqueous solution, add it to the internal phase material, and prepare the soft material with a high-speed stirring granulator;

[0049] (iii) Swing granulator to prepare 24 mesh granules;

[0050] (iv) Dry the obtained particles using a fluidized bed, and the drying temperature is controlled at 30-40°C;

[0051] (v) The dried granules are sized through a 20-mesh sieve;

[0052] (vi) The particles and the external phase materials are evenly mixed;

[0053] (vii) Compression into tablets.

[0054] (viii) High-efficiency coating machine coating, coating weight gain 3.5%.

Example Embodiment

[0055] Example 2

[0056]

[0057]

[0058] Preparation Process:

[0059] (i) Weigh the internal phase materials into the high-speed mixing granulator, turn on the mixer and stir to make the mixing uniform;

[0060] (ii) Prepare PVP-K90 into a 5g / 100g aqueous solution, add it to the internal phase material, and prepare the soft material with a high-speed stirring granulator;

[0061] (iii) Swing granulator to prepare 24 mesh granules;

[0062] (iv) Dry the obtained particles using a fluidized bed, and the drying temperature is controlled at 30-40°C;

[0063] (v) The dried granules are sized through a 20-mesh sieve;

[0064] (vi) The particles and the external phase materials are evenly mixed;

[0065] (vii) Compression into tablets.

[0066] (viii) Efficient coating machine coating, coating weight gain 5.0%.

Example Embodiment

[0067] Example 3

[0068]

[0069] Preparation Process:

[0070] (i) Weigh the internal phase materials into the high-speed mixing granulator, turn on the mixer and stir to make the mixing uniform;

[0071] (ii) Prepare PVP-K90 into a 5g / 100g aqueous solution, add it to the internal phase material, and prepare the soft material with a high-speed stirring granulator;

[0072] (iii) Swing granulator to prepare 24 mesh granules;

[0073] (iv) Dry the obtained particles using a fluidized bed, and the drying temperature is controlled at 30-40°C;

[0074] (v) The dried granules are sized through a 20-mesh sieve;

[0075] (vi) The particles and the external phase materials are evenly mixed;

[0076] (vii) Compression into tablets.

[0077] (viii) High-efficiency coating machine coating, coating weight gain 3.5%.

[0078] The following comparative examples are voriconazole tablets prepared with several concentrations of PVP-K30 and several concentrations of PVP-K90. The prescription is as follows:

...

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Abstract

The invention relates to a voriconazole tablet, wherein the tablet core of the tablet comprises lactose hydrous, pregelatinized starch, croscarmellose sodium, povidone K90 and magnesium stearate. The prepared tablet core can reach higher hardness, is low in friability, facilitates coating, and can maintain the physical form during packaging and transport process; and although the hardness of the tablet core is higher, the dissolution rate of the tablet is not influenced, and the tablet can be disintegrated within about 20 minutes or a shorter time.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition of voriconazole and a preparation method thereof. Background technique [0002] Voriconazole, the English name is voriconazole, the chemical name is (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidine)-1-(1H-1,2, 4-triazol-1-yl)-2-butanol. [0003] Voriconazole belongs to triazole antifungal drugs, mainly used for invasive aspergillin, candida infection resistant to fluconazole, severe infection caused by fungi of the genus Fusarium and Scedospora, and also commonly used for neuter Empiric treatment of febrile neutropenic patients. [0004] At present, the imported product of voriconazole oral preparations in my country is a tablet named VFEND, produced by the original manufacturer Pfizer, with a specification of 50mg or 200mg, and the excipients are lactose monohydrate, pregelatinized starch, and croscarmellose sodium (cross-linked CMC-Na), povidone...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/506A61K47/38A61P31/10
Inventor 辛伟张志宏张素娟杨丽霞梁敏王世霞
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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