Nanodrugs: pharmacokinetics and safety

Onoue, Satomi; Yamada, Shizuo; Chan, Hak‐Kim

doi:10.2147/ijn.s38378

Cited by 291 publications

(159 citation statements)

References 90 publications

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“…The improved performance of the active molecules in nanostructured systems as vehicles can be related to the optimization of pharmacokinetic parameters, metabolic stability, the great membrane permeability, 54 various nanodrug systems have been developed for different routes of administration, which include dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles. Nanodrug systems have been employed to improve the efficacy, safety, physicochemical properties, and pharmacokinetic/pharmacodynamic profile of pharmaceutical substances.…”

Section: Figure 2 Pseudoternary Diagrams Indicating Microemulsion (1mentioning

confidence: 99%

Microemulsion of Brazil nut oil as a natural product to improve superoxide release in human phagocytes

et al. 2017

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The aim of this study was to develop and characterize a Brazil nut oil microemulsion system and determine the effect of this microemulsion on the superoxide release in human phagocytes. The microemulsion was formulated using distilled water, Brazil nut as the oily phase, Sorbitan monooleate, Polysorbate 80, and butan-1-ol. Hydrophile-lipophile balance of Brazil nut oil was determined, pseudoternary diagrams were prepared, and microemulsion diagram regions were preselected. Preliminary and accelerated stability tests, rheological characterization and dynamic light scattering were performed. The immunomodulatory effect of the microemulsion on the interactions with leukocytes was determined by superoxide release. The developed formulations were classified as oil-in-water, showed a Newtonian profile, with linear viscosity and droplet sizes of 46.9; 66.5 and 34.3 nm. When we assessed the interaction of the microemulsion of Brazil nut oil with phagocytes, we observed an increase in superoxide release. Our findings indicate that the developed formulation improved the immunomodulatory activity of the Brazil nut oil, proving to be a natural product option for future applications, in particular for infectious diseases.

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Section: Figure 2 Pseudoternary Diagrams Indicating Microemulsion (1mentioning

confidence: 99%

Microemulsion of Brazil nut oil as a natural product to improve superoxide release in human phagocytes

et al. 2017

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“…It should also be realized that the nanoformulation compared to the regular formulation may change the pharmacokinetic profile of the drug after administration, and therefore also the toxicokinetics. 7 Four of the five sets concerned liposomal formulations, and four of the five sets concerned an application in cancer treatment (chemotherapy) ( Table 3). While comparing nab-paclitaxel and conventional paclitaxel, nab-paclitaxel has more reported side effects than paclitaxel.…”

Section: Discussionmentioning

confidence: 99%

“…5,6 Differences in toxicokinetics of nanomedicines compared to conventional, non-nanoformulated medicines may result in marked differences in toxicity and side effects. 7 The aim of this study was to investigate whether specific toxicity could be related to NMPs, or certain structural types or groups of NMPs, by analyzing the publicly available preclinical toxicity data on approved NMPs. In addition, by comparing several sets of products with the same active pharmaceutical ingredient (API) in a conventional formulation versus a nanoformulation, we aimed to identify whether any side effects observed in humans are specifically associated with the nanoformulation compared to the conventional formulation.…”

Section: Introductionmentioning

confidence: 99%

Nanomedicinal products: a survey on specific toxicity and side effects

Brand¹,

Noorlander²,

Giannakou³

et al. 2017

IJN

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Due to their specific properties and pharmacokinetics, nanomedicinal products (NMPs) may present different toxicity and side effects compared to non-nanoformulated, conventional medicines. To facilitate the safety assessment of NMPs, we aimed to gain insight into toxic effects specific for NMPs by systematically analyzing the available toxicity data on approved NMPs in the European Union. In addition, by comparing five sets of products with the same active pharmaceutical ingredient (API) in a conventional formulation versus a nanoformulation, we aimed to identify any side effects specific for the nano aspect of NMPs. The objective was to investigate whether specific toxicity could be related to certain structural types of NMPs and whether a nanoformulation of an API altered the nature of side effects of the product in humans compared to a conventional formulation. The survey of toxicity data did not reveal nanospecific toxicity that could be related to certain types of structures of NMPs, other than those reported previously in relation to accumulation of iron nanoparticles (NPs). However, given the limited data for some of the product groups or toxicological end points in the analysis, conclusions with regard to (a lack of) potential nanomedicine-specific effects need to be considered carefully. Results from the comparison of side effects of five sets of drugs (mainly liposomes and/or cytostatics) confirmed the induction of pseudo-allergic responses associated with specific NMPs in the literature, in addition to the side effects common to both nanoformulations and regular formulations, eg, with liposomal doxorubicin, and possibly liposomal daunorubicin. Based on the available data, immunotoxicological effects of certain NMPs cannot be excluded, and we conclude that this end point requires further attention.

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“…Nesses dispositivos, em geral, as moléculas farmacêuticas, pró-drogas ou outro material de interesse são ligadas à superfície de nanomateriais biocompatíveis e liberadas de acordo com programas preestabelecidos. Esses nanomedicamentos são capazes de atravessar as membranas biológicas e liberar a substância medicamentosa nos tecidos ou células doentes 6 . Recentemente, uma nova categoria de substâncias também tem sido utilizada na medicina.…”

Section: ▄ Introduçãounclassified

Desafios ao controle da qualidade de medicamentos no Brasil

et al. 2017

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Resumo Introdução O desenvolvimento científico e tecnológico, assim como a adoção de políticas públicas voltadas à redução do custo dos medicamentos, tem ampliado o acesso da população a alternativas terapêuticas, as quais incluem medicamentos genéricos, biossimilares, nanomedicamentos e complexos não biológicos. As categorias já comercializadas exigem procedimentos próprios para a garantia de sua qualidade, eficácia terapêutica e segurança. Nesse contexto, o presente estudo procura realizar uma avaliação do cenário atual no Brasil sobre esse tema, apontando para situações que certamente terão de ser enfrentadas em um futuro próximo. Metodologia Foi realizado um levantamento de dados nas bases eletrônicas MEDLINE, PubMed e SCIELO, buscando artigos originais, tanto em português quanto em inglês, indexados retrospectivamente até 1999. Foram utilizados termos de busca relevantes em língua portuguesa e inglesa. Mais de 50 artigos científicos foram encontrados. Resultados e Discussão A maioria dos artigos avaliados aponta problemas tanto na fabricação quanto no controle de medicamentos genéricos e biossimilares, seja no mercado internacional, seja no nacional. No entanto, novas formas medicamentosas estão sendo criadas e necessitam do desenvolvimento de legislação e de metodologias específicas para a garantia da qualidade desses produtos. Uma avaliação do atual sistema brasileiro de registro e controle da qualidade aponta falhas e, especialmente, falta de uma farmacovigilância mais bem estruturada e ativa no país. Conclusão O atual cenário demonstra que os órgãos responsáveis no país necessitam rever a atual sistemática utilizada na fabricação e controle de medicamentos e aprimorá-la, bem como se preparar para o enfrentamento de outras demandas, algumas ainda mais complexas, que já se encontram em desenvolvimento.

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Nanodrugs: pharmacokinetics and safety

Cited by 291 publications

References 90 publications

Microemulsion of Brazil nut oil as a natural product to improve superoxide release in human phagocytes

Microemulsion of Brazil nut oil as a natural product to improve superoxide release in human phagocytes

Nanomedicinal products: a survey on specific toxicity and side effects

Desafios ao controle da qualidade de medicamentos no Brasil

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