International Research Journal of Engineering and Technology (IRJET)
e-ISSN: 2395-0056
Volume: 10 Issue: 06 | Jun 2023
p-ISSN: 2395-0072
www.irjet.net
FORMULATION AND EVALUATION OF ITRACONAZOLE AEROSOL FOR ANTIFUNGAL ACTIVITY: A REVIEW Manisha Dubey1, Shourya Pratap2, Murlye Dhar Singh3, Chandan Yadav4 1Master of Pharmacy, Pharmaceutics, IPSR Sohramau, Unnao
2 Assistant professor, Pharmaceutical Chemistry, IPSR Sohramau, Unnao 3 Assistant professor, Pharmacology, Sherwood College of pharmacy 4 Assistant professor, Pharmaceutics Sherwood College of pharmacy
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Abstract - Itraconazole is an antifungal medication that
higher concentrations of the drug at the site of infection while minimizing systemic side effects. Various studies and clinical trials were conducted to evaluate the safety and efficacy of itraconazole aerosol [4].
One study published in the journal Mycoses in 2016 found that itraconazole aerosol was effective in treating pulmonary aspergillosis in mice. The study found that the aerosol delivery of itraconazole directly to the lungs resulted in higher concentrations of the drug in lung tissue, which improved the drug's effectiveness against the fungal infection.
One significant milestone in the development of itraconazole aerosol was the initiation of a Phase II clinical trial called the "Study of Itraconazole in Stable Non-Cystic Fibrosis Bronchiectasis" (the ITRA study) in 2013 [4]. This trial evaluated the use of itraconazole inhalation solution in patients with non-cystic fibrosis bronchiectasis, a condition characterized by permanent dilation of the bronchi, often associated with recurrent respiratory infections [5-6].
belongs to the azole class of drugs. While it is primarily available in oral form, there is some research on the use of itraconazole aerosol for antifungal activity.
Another study published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery in 2018 investigated the use of itraconazole dry powder aerosol for the treatment of invasive pulmonary aspergillosis in rats. The study found that the dry powder aerosol formulation of itraconazole was well-tolerated and showed promising antifungal activity.
Based on the positive results from the ITRA study and subsequent studies, in February 2018, the U.S [7]. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the itraconazole inhalation solution for the treatment of Aspergillus infections in patients with cystic fibrosis [8-9].
Overall, these studies suggest that aerosol delivery of itraconazole may have potential for the treatment of fungal infections of the respiratory tract. However, more research is needed to determine the safety and efficacy of this approach in humans. It is important to note that the use of itraconazole aerosol for antifungal activity is not yet approved by regulatory agencies and should only be used under the guidance of a healthcare professional.
In July 2020, the FDA approved the use of itraconazole inhalation solution under the brand name Tolsura for the treatment of fungal infections caused by Aspergillus in patients with cystic fibrosis [10-11]. It is important to note that the approval specifically relates to patients with cystic fibrosis, and the use of itraconazole aerosol in other populations may vary depending on specific indications and regulatory approvals in different countries [12].
Key Words: antifungal medication, itraconazole, azole class, aerosol delivery, pulmonary aspergillosis, antifungal activity, respiratory tract, safety, efficacy, healthcare professional.
The development of itraconazole aerosol represents a significant advancement in the treatment of fungal lung infections, offering a targeted approach to deliver antifungal medication directly to the site of infection [13]. However, it is always important to consult a healthcare professional for specific information about the availability, indications, and appropriate use of medications [14].
1. INTRODUCTION The history of itraconazole aerosol begins with the recognition of the need for an effective treatment for fungal infections in the lungs, especially in patients with conditions such as cystic fibrosis or compromised immune systems [1]. Systemic antifungal medications, such as oral itraconazole, had limitations in their ability to effectively reach the lungs at therapeutic concentrations [2].
Itraconazole aerosol is a potential method for delivering the antifungal medication itraconazole directly to the respiratory tract for the treatment of fungal infections such as pulmonary aspergillosis [15]. Studies have shown that aerosol delivery of itraconazole can result in higher concentrations of the drug in lung tissue, improving its effectiveness against the fungal infection [16-17]. However,
In the early 2000s, researchers began investigating the possibility of delivering itraconazole directly to the lungs using an aerosol formulation [3]. The aim was to achieve
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