Toxicity and Regulatory Concerns for Nanoformulations in Medicine

Gaur, Nimisha; Sharma, Navneet; Dahiya, Aditya; Yadav, Pooja; Ojha, Himanshu; Goyal, Ramesh K.; Sharma, Rakesh

doi:10.1002/9781119592990.ch13

Cited by 7 publications

(4 citation statements)

References 141 publications

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“…• Lack of a unified definition or classification of nanomedicines/nanomaterials [17][18][19] • Lack of agreed regulations [17][18][19] • Analytical methods differ for each nanomaterial [13,20,21] • PK profiles diverge from standardized constituent materials [22,23] • Stability issues after scale-up for manufacturing [13,21,24,25] • Current in vitro and pre-clinical toxicological studies fail to mimic in vivo complexity [26][27][28][29][30][31] • Systemic biodistribution and fate [3,[31][32][33][34] • Possible environmental impact [17,19,30] The European Union and the United Kingdom…”

Section: Challenges Hampering Nanomedicine Regulationmentioning

confidence: 99%

Current hurdles to the translation of nanomedicines from bench to the clinic

Đorđević

Medel

Conejos‐Sánchez

et al. 2021

Drug Deliv. and Transl. Res.

167

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The field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract

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Section: Challenges Hampering Nanomedicine Regulationmentioning

confidence: 99%

Current hurdles to the translation of nanomedicines from bench to the clinic

Đorđević

Medel

Conejos‐Sánchez

et al. 2021

Drug Deliv. and Transl. Res.

167

View full text Add to dashboard Cite

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“…Nanomedicine and nanotoxicology are strictly linked, since both can explore the same mechanisms and affect identical metabolic pathways [61]. Bearing in mind that newly NMs can exhibit specific toxicity, it is necessary to summarize and reassess the data accumulated from time to time, thereby ensuring safety [62]. The development of current nanotoxicology studies is surprising, mainly in the biological area [41,47,63].…”

Section: Nanotoxicology: From Past Lights and Shadows To Current Concmentioning

confidence: 99%

Nanotoxicology and Nanosafety: Safety-by-Design and Testing at a Glance

Zielińska

Costa

Ferreira

et al. 2020

IJERPH

150

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This review offers a systematic discussion about nanotoxicology and nanosafety associated with nanomaterials during manufacture and further biomedical applications. A detailed introduction on nanomaterials and their most frequently uses, followed by the critical risk aspects related to regulatory uses and commercialization, is provided. Moreover, the impact of nanotoxicology in research over the last decades is discussed, together with the currently available toxicological methods in cell cultures (in vitro) and in living organisms (in vivo). A special focus is given to inorganic nanoparticles such as titanium dioxide nanoparticles (TiO2NPs) and silver nanoparticles (AgNPs). In vitro and in vivo case studies for the selected nanoparticles are discussed. The final part of this work describes the significance of nano-security for both risk assessment and environmental nanosafety. “Safety-by-Design” is defined as a starting point consisting on the implementation of the principles of drug discovery and development. The concept “Safety-by-Design” appears to be a way to “ensure safety”, but the superficiality and the lack of articulation with which it is treated still raises many doubts. Although the approach of “Safety-by-Design” to the principles of drug development has helped in the assessment of the toxicity of nanomaterials, a combination of scientific efforts is constantly urgent to ensure the consistency of methods and processes. This will ensure that the quality of nanomaterials is controlled and their safe development is promoted. Safety issues are considered strategies for discovering novel toxicological-related mechanisms still needed to be promoted.

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“…In the absence of explicit guidelines, certain assessments related to the safety, toxicity, and compatibility of nanoformulations are conducted following strategies akin to those employed for conventional therapies [298,299].…”

Section: Regulatory Aspects/challenges Of Intranasal Nanocarrier Drug...mentioning

confidence: 99%

“…This regulatory gap has constrained the full clinical potential of nanomedicines, underscoring the urgency of collaborative initiatives among global regulatory bodies to establish a robust framework for nanocarrier development. In the absence of explicit guidelines, certain assessments related to the safety, toxicity, and compatibility of nanoformulations are conducted following strategies akin to those employed for conventional therapies [ 298 , 299 ].…”

Section: Regulatory Aspects/challenges Of Intranasal Nanocarrier Drug...mentioning

confidence: 99%

Intranasal Drug Delivery by Nanotechnology: Advances in and Challenges for Alzheimer’s Disease Management

Dighe,

Jog,

Momin

et al. 2023

Pharmaceutics

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Alzheimer’s disease, a progressive neurodegenerative condition, is characterized by a gradual decline in cognitive functions. Current treatment approaches primarily involve the administration of medications through oral, parenteral, and transdermal routes, aiming to improve cognitive function and alleviate symptoms. However, these treatments face limitations, such as low bioavailability and inadequate permeation. Alternative invasive methods, while explored, often entail discomfort and require specialized assistance. Therefore, the development of a non-invasive and efficient delivery system is crucial. Intranasal delivery has emerged as a potential solution, although it is constrained by the unique conditions of the nasal cavity. An innovative approach involves the use of nano-carriers based on nanotechnology for intranasal delivery. This strategy has the potential to overcome current limitations by providing enhanced bioavailability, improved permeation, effective traversal of the blood–brain barrier, extended retention within the body, and precise targeting of the brain. The comprehensive review focuses on the advancements in designing various types of nano-carriers, including polymeric nanoparticles, metal nanoparticles, lipid nanoparticles, liposomes, nanoemulsions, Quantum dots, and dendrimers. These nano-carriers are specifically tailored for the intranasal delivery of therapeutic agents aimed at combatting Alzheimer’s disease. In summary, the development and utilization of intranasal delivery systems based on nanotechnology show significant potential in surmounting the constraints of current Alzheimer’s disease treatment strategies. Nevertheless, it is essential to acknowledge regulatory as well as toxicity concerns associated with this route; meticulous consideration is required when engineering a carrier. This comprehensive review underscores the potential to revolutionize Alzheimer’s disease management and highlights the importance of addressing regulatory considerations for safe and effective implementations. Embracing this strategy could lead to substantial advancements in the field of Alzheimer’s disease treatment.

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Toxicity and Regulatory Concerns for Nanoformulations in Medicine

Cited by 7 publications

References 141 publications

Current hurdles to the translation of nanomedicines from bench to the clinic

Current hurdles to the translation of nanomedicines from bench to the clinic

Nanotoxicology and Nanosafety: Safety-by-Design and Testing at a Glance

Intranasal Drug Delivery by Nanotechnology: Advances in and Challenges for Alzheimer’s Disease Management

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