Regulatory Perspectives and Concerns Related to Nanoparticle-Based Lung Delivery

Authored by: Johirul Islam , Hemanga Hazarika , Prabin Kr Roy , Pompy Patowary , Pronobesh Chattopadhyay , Yashwant V Pathak , Kamaruz Zaman

Handbook of Lung Targeted Drug Delivery Systems

Print publication date:  October  2021
Online publication date:  October  2021

Print ISBN: 9780367490676
eBook ISBN: 9781003046547
Adobe ISBN:


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Recently, an unprecedented exploration in nanoparticle (NP)-based drug delivery has been witnessed in diseases like lung cancer, cystic fibrosis, asthma, tuberculosis, and chronic obstructive pulmonary disease due to their unique properties including their large surface to mass ratio and their ability to carry and absorb active compounds. Although NPs were developed to deliver the chemical entity to the target site or uptake by target cells or to reduce the toxicity or side effects of the free drugs on the non-target cells or organs, the carrier system itself may possess hazards for the patients. The types of hazards produced by the NPs for drug delivery are far more intense than the conventional hazards by the classical compound and may exert adverse effects on pulmonary structure and function. Despite this fact, assessment of risk associated with the use of NPs and respective regulations have been introduced only recently. Efforts have been made in the past to form “nano-regulations,” however, unfortunately, this has not beeen possible so far due to disagreement on the existing regulations among “nanonations” on the information relating to the environment and safety concerns of nanomaterials. In this purview, this chapter aims to introduce the effects of NPs on the lungs and associated diseases and their mechanisms, existing guidelines and regulation for NPs, and preclinical and clinical elaborations of NPs. This chapter is expected to strengthen the scientific knowledge relating to the regulatory, safety, and toxicological concerns related to NP-based lung delivery.

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