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Product introduction:

Posaconazole can be used in the treatment of aspergillosis, conjugated mycosis and Fusarium disease, and in the treatment of some fluconazole resistant Candida infections.

市场价:

  • Product information
  • 产品描述
  • 参数配置


1、 Product introduction

Chinese Name

English Name

Declaration Type

Department

Reportable Dosage Form

Declaration Progress 

Strength

CAS
泊沙康唑Posaconazole5+4GastroenterologyTablet, injection, suspension

Ready to declare

See details below171228-49-2

Indication】

        This product is suitable for the treatment of a variety of adult invasive fungal infections which are intolerant or refractory to amphotericin B.


Reportable Dosage Form &Strength

      100mg tablet and sustained-release tablet; 40mg / ml oral suspension; 300mg / 16.7ml injection (18mg / ml).


Usage and Dosage

Indication

Usage and Dosage

Prevention of invasive Aspergillus and Candida infection


Sustained release tablet


Initial dose: 300mg (3 tablets), twice in the first day

Maintenance dose: 300 mg (3 tablets) once a day from the next day. The duration of treatment depends on the recovery of neutrophils or immunosuppression.


Oral suspension


200 mg (5 ml) three times a day. The duration of treatment depends on the recovery of neutrophils or immunosuppression.

oropharyngeal candidiasis


Oral suspension


Initial dose: 100mg (2.5ml) every time, twice on the first day; maintenance dose: 100mg (2.5ml) every time, once on the first day, lasting for 13 days. 

Oral and pharyngeal candidiasis resistant to fluconazole and itraconazole


Oral suspension


400 mg (10 ml) twice a day. The duration of treatment depends on the recovery of neutrophils or immunosuppression.



Mechanism of Action

       The structure of this product is similar to itraconazole, and its mechanism is to inhibit sterol 14 α - demethylase, the key enzyme of ergosterol biosynthesis on fungal cell membrane, so as to destroy the integrity of membrane, affect the function of membrane linked protein, and finally inhibit the growth or kill fungi. The mutant of Candida albicans is resistant to itraconazole, fluconazole and voriconazole due to the mutation of 4 α - demethylase, but it is still sensitive to this product. This product is more effective than itraconazole and voriconazole in inhibiting sterol biosynthesis of Aspergillus fumigatus and Aspergillus flavus.


Development Progress】

       Our company is in the process of sorting out translation materials and is expected to apply for registration of imported raw materials in the third quarter of 2017.


Research and production at home and abroad】

        Posaconazole was initially developed by Schering plough, and then Schering plough was acquired by mosadon. Mosadon subsequently developed tablets and injections, which were first listed in Europe on October 25, 2005. The US FDA approved posaconazole oral suspension on September 15, 2009, and sustained-release tablets on November 25, 2013. Intravenous injections were approved in March 2014. Up to now, they have reached 70% in the world Many countries and regions have been approved and listed in more than 40 countries and regions such as the United States and the European Union. In China, the imported posaconazole oral suspension was approved on February 3, 2015 under the trade name of 'nocofil'.


2、 Product Character


1). The sales growth in foreign countries is fast, and the sales amount of sample hospitals just listed in 2014 reached 4890285 yuan;


2). Posaconazole is a broad-spectrum triazole antifungal drug, which is mainly used to prevent and treat invasive fungal infection caused by Aspergillus and Candida. It is the only antifungal drug approved to prevent invasive fungal infection caused by Aspergillus;


3). At present, only the original research and import are available in China, and there are few manufacturers to declare, so there is a large market prospect.


3、 Clinical Application

      

Various clinical studies (including preventive studies) have proved that posaconazole has a wide range of safety and good tolerance. The most common treatment-related serious adverse reactions were bilirubinemia, liver enzyme elevation, liver cell damage, nausea and vomiting. Posaconazole has broad-spectrum antifungal activity. It has a significant effect on the treatment of refractory infection and severe infection.


1).Candidiasis in the mouth and throat is the most common opportunistic fungal infection in AIDS patients. Posaconazole has a significant effect on different types of candidiasis.


2). Aspergillus infection a retrospective study found that in patients with hematological malignancies and pulmonary Aspergillus infection, the efficacy of posaconazole salvage treatment was comparable to that of amphotericin B liposome combined with itraconazole, which was superior to the former single drug treatment, and fewer patients needed mechanical ventilation treatment. Posaconazole has obvious advantages in the treatment of refractory Aspergillus infection of different species.


3). The infection of conjugated bacteria is of high mortality and rapid progress. Rhizopus, Mucor, erysipelas and Coleoptera are the main pathogens. The results showed that posaconazole was the only effective azole drug for the infection of Zygomycetes.


4). Fusarium infection is second only to Aspergillus in the patients with malignant hematological diseases, and its mortality rate is more than 70%. The results showed that posaconazole had strong tissue penetration and high concentration in vitreous.


5). Biphasic fungal infection of coccidiosis often results in pulmonary and disseminated infection due to the inhalation of joint spores. Traditional antifungal drugs have a high failure rate and are easy to recur. The results showed that the cure rate of posaconazole was high and the symptoms of the patients were significantly improved after 6 to 34 weeks of remedial treatment.


2、 Patent information

1). Compound patent

The compound patent of posaconazole is us94 / 14236, the Chinese patent number is zl94195025.5, the application date is December 20, 1994, and it expires in December 2014.


2). Crystal patent

Original research applied for crystal type patent zl98811886.6 in China on October 5, 1998, and disclosed crystal type I, II, III, of which crystal type II and III are unstable, so only crystal type I is protected. In the original research, crystal y was developed and applied for Chinese patent with the application number of 200980119683. X, which has been authorized and the application date is May 28, 2009. Crystal y has the same stability as crystal I, and crystal y has better water solubility.


3). Patent for pharmaceutical composition

The original research institute applied for the patent of oral suspension preparation on April 1, 2002, with the patent number of zl02807740.7. The patent application No. of tablet and capsule preparation originally applied for on April 15, 2009 is cn 20098012487, and the legal status is the effectiveness of quality examination, which has not been authorized yet. The original research institute applied for the patent of suspension preparation for injection on May 27, 2005, which was sterilized by final steam with the application No. of 200580024854.2. It has no right. If the legal status is announced, it will be deemed to be withdrawn. The original research institute applied for intravenous infusion preparation on June 24, 2011, application No. is cn 201180031488, and the legal status is the effectiveness of quality review.


5、Domestic Declaration


Declaration Type

Reportable Dosage Form

Number of Declared Preparations

Number of Existing Preparation Enterprises

5+4

Tablet, oral suspension, injection

7 imported and 15 domestic1 imported 




 Posaconazole 泊沙康唑 CAS号:171228-49-2

Guangzhou Tosun Pharmaceutical Ltd

FL 4-5,No.3, 2nd Kehui street, Science Park, Guangzhou High-tech Industrial Development Zone, Guangzhou, China. 510663

Tel: +86-20-66392521; Fax: +86-20-66392525

Posaconazole can be used in the treatment of aspergillosis, conjugated mycosis and Fusarium disease, and in the treatment of some fluconazole resistant Candida infections.

Antifungal agents for the prevention of infection caused by Aspergillus


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