Cipla Gets CDSCO Panel Nod To Study Inhaled Itraconazole Dry Powder for inhalation

Written by Dr. Divya Colin Published On 2022-07-16T18:00:38+05:30 | Updated On 16 July 2022 6:00 PM IST

Cipla Gets CDSCO Panel Nod To Study Inhaled Itraconazole Dry Powder for inhalation

New Delhi: Pharmaceutical major, Cipla has got the go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct Phase II clinical trial for the Inhaled Itraconazole Dry Powder for inhalation 10 mg Capsule.

This came after the firm presented the proposal to conduct Phase II clinical trial for Inhaled Itraconazole Dry Powder for inhalation 10 mg Capsule before the committee.

Itraconazole (ITZ) dry powders for inhalation (DPI) composed of nanoparticles (NP) embedded in carrier microparticles.

DPIs were initially produced by reducing the ITZ particle size to the nanometer range using high-pressure homogenization with tocopherol polyethylene 1000 succinate (TPGS, 10% w/w ITZ) as a stabilizer. The optimized nanosuspension and the initial microsuspension were then spray-dried with different proportions of or in the absence of mannitol and/or sodium taurocholate.

Itraconazole is an antifungal agent used for the treatment of various fungal infections in immunocompromised and non-immunocompromised patients, such as pulmonary and extrapulmonary blastomycosis, histoplasmosis, and onychomycosis.

Itraconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Itraconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.

At the recent SEC meeting for Pulmonary held on 07.07.2022,the expert panel reviewed the proposal proposed by drug-major Cipla to conduct Phase II clinical trial of Itraconazole Dry Powder for inhalation 10 mg Capsule.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase II clinical trial as per protocol presented.

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.