Pharmaceutical composition containing voriconazole

A technology of voriconazole and its composition, which is applied in the field of preparation of pharmaceutical composition and its tablet, can solve problems such as side effects, difference in dissolution rate, low bioavailability, etc., achieve good stability, complete dissolution, and simple production and operation Effect

Active Publication Date: 2015-06-10
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This can lead to differences in the dissolution rate of the tablet in different media, resulting in a tablet with high bioavailability in some populations and low bioavailability in others (e.g., acid-deprived populations) , which will hinder the treatment of patients, so it is necessary to develop a tablet with little difference in dissolution in different media
[0005] In addition, voriconazole will decompose during production and storage, which will affect the curative effect and may cause side effects, so its related substances should be strictly controlled

Method used

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  • Pharmaceutical composition containing voriconazole
  • Pharmaceutical composition containing voriconazole
  • Pharmaceutical composition containing voriconazole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] prescription

[0074] Voriconazole 10g

[0075] dry starch 4g

[0076] Micronized silica gel 1.8g

[0077] Mannitol 50g

[0078] Propylparaben 2g

[0079] Povidone 6g

[0080] Preparation

[0081] (1) After mixing 10g of voriconazole, 2g of propyl p-hydroxybenzoate, and 10g of mannitol, carry out microwave vacuum drying;

[0082] (2) The mixture obtained in step (1) is crushed, passed through an 80-mesh sieve, and set aside;

[0083] (3) Pass the remaining 40g of mannitol, 4g of dry starch, and 1.8g of micropowdered silica gel through an 80-mesh sieve, and set aside;

[0084] (4) Pour the mannitol, dry starch, and micropowdered silica gel sieved in step (3), and the mixture obtained in step (2) into a mixer for mixing;

[0085] (5) The mixture in step (4) is crushed at a low temperature and at a slow speed, and passed through a 80-mesh sieve;

[0086] (6) Add 6 g of povidone to the granules obtained in step (5) as a binder, mix, and press into tablets.

Embodiment 2

[0088] prescription

[0089] Voriconazole 15g

[0090] Sodium carboxymethyl starch 8g

[0091] Talc powder 2.8g

[0092] Anhydrous Lactose 45g

[0093] Propylparaben 4.7g

[0094] Povidone 9.3g

[0095] Preparation

[0096] (1) After mixing 15g of voriconazole, 4.7g of propyl p-hydroxybenzoate, and 15g of anhydrous lactose, carry out microwave vacuum drying;

[0097] (2) The mixture obtained in step (1) is crushed, passed through an 80-mesh sieve, and set aside;

[0098] (3) Pass 30g of anhydrous lactose, 8g of sodium carboxymethyl starch, and 2.8g of talcum powder through an 80-mesh sieve respectively, and set aside;

[0099] (4) Pour the anhydrous lactose, sodium carboxymethyl starch, and talcum powder sieved in step (3), and the mixture obtained in step (2) into a mixer for mixing;

[0100] (5) The mixture in step (4) is crushed at a low temperature and at a slow speed, and passed through a 80-mesh sieve;

[0101] (6) Add 9.3 g of povidone to the granules obtained ...

Embodiment 3

[0103] prescription

[0104] Voriconazole 20g

[0105] Low-substituted hydroxypropyl cellulose 12g

[0106] Micronized silica gel 2.5g

[0107] Anhydrous Lactose 40g

[0108] Propylparaben 3.7g

[0109] Povidone 12g

[0110] Preparation

[0111] (1) After mixing 20g of voriconazole, 3.7g of propyl p-hydroxybenzoate and 10g of anhydrous lactose, carry out microwave vacuum drying;

[0112] (2) The mixture obtained in step (1) is crushed, passed through a 100-mesh sieve, and set aside;

[0113] (3) Pass 30g of anhydrous lactose, 12g of low-substituted hydroxypropyl cellulose, and 2.5g of micropowder silica gel through a 100-mesh sieve, and set aside;

[0114] (4) Pour the remaining amount of anhydrous lactose, low-substituted hydroxypropyl cellulose, micronized silica after sieving, and the mixture obtained in step (2) into a mixer for mixing;

[0115] (5) The mixture in step (4) is pulverized at a low temperature and slowly, and passed through a 100-mesh sieve;

[0116]...

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PUM

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Abstract

The invention specifically relates to a pharmaceutical composition containing voriconazole, belonging to the field of medicine. The pharmaceutical composition contains voriconazole, polyvinylpyrrolidone, a filler, a disintegrating agent, a lubricant and propyl p-hydroxybenzoate. The pharmaceutical composition has the advantages of good stability, complete dissolution and ,pre excellent quality; and a production method for the pharmaceutical composition is easy and practical to operate and applicable to industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition containing voriconazole and a preparation method of tablets thereof. Background technique [0002] Voriconazole is a second-generation synthetic triazole antifungal drug. Manufactured by Pfizer, USA, for the treatment of invasive aspergillosis; severe invasive infections caused by fluconazole-resistant Candida species (including Candida krusei); Infect. It is mainly used to treat progressive, potentially life-threatening infections in immunocompromised patients. [0003] CN101390861 discloses a voriconazole solid composition, which adopts the solid dispersion technology with poloxamer as the carrier in the preparation process, and the existing form can be dispersible tablet, orally disintegrating tablet, chewable tablet, but its preparation process is relatively complicated , the increase in process steps will cause the active ingredi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/506A61K47/14A61P31/10
Inventor 张春苗徐璐王小雪
Owner 长春海悦药业股份有限公司
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