Cancer therapy using nanoformulated substances: scientific, regulatory and financial aspects

Alphandéry, Edouard; Grand-Dewyse, Pierre; Lefèvre, R; Mandawala, Chalani; Durand-Dubief, Mickaël

doi:10.1586/14737140.2015.1086647

Cited by 92 publications

(43 citation statements)

References 102 publications

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“…Mepact ® designated as an ‘orphan’ drug by the European Medicines Agency (EMA) in 2004 and it was the first drug approved for the management of high-grade, resectable, non-metastatic bone tumours combined with postoperative combination chemotherapy in children, adolescents and young adults who have gone through full macroscopic surgical resection. Mepact ® contains <100 nm multilamellar vesicles of liposome encapsulated muramyl tripeptide phosphatidylethanolamine (L-MTP-PE) [34]. MTP-PE is a fabricated lipophilic derivative of muramyl dipeptide (MDP) (a naturally occurring constituent of bacterial cell walls) and it is a conjugate of MTP and dipalmitoylphosphatidylethanolamine (DPPE).…”

Section: Clinically Available Liposome-based Productsmentioning

confidence: 99%

Liposomal Formulations in Clinical Use: An Updated Review

et al. 2017

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Liposomes are the first nano drug delivery systems that have been successfully translated into real-time clinical applications. These closed bilayer phospholipid vesicles have witnessed many technical advances in recent years since their first development in 1965. Delivery of therapeutics by liposomes alters their biodistribution profile, which further enhances the therapeutic index of various drugs. Extensive research is being carried out using these nano drug delivery systems in diverse areas including the delivery of anti-cancer, anti-fungal, anti-inflammatory drugs and therapeutic genes. The significant contribution of liposomes as drug delivery systems in the healthcare sector is known by many clinical products, e.g., Doxil®, Ambisome®, DepoDur™, etc. This review provides a detailed update on liposomal technologies e.g., DepoFoam™ Technology, Stealth technology, etc., the formulation aspects of clinically used products and ongoing clinical trials on liposomes.

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Section: Clinically Available Liposome-based Productsmentioning

confidence: 99%

Liposomal Formulations in Clinical Use: An Updated Review

et al. 2017

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“…These examples of a shift in toxicological profile due to changes in the pharmacokinetics of drugs could still reduce the overall toxicity of a drug, the severity of the side effects, or better suit specific patients. 12 A liposomal formulation of cytarabine (DepoCyt ® ) has been reported to cause the same efficacy but less toxicity in the treatment of specific cancers compared to unbound cytarabine, 13,14 and a liposomal formulation of daunorubicin citrate (DaunoXome ® ) is associated with reduced cardiotoxicity compared to conventional daunorubicin. 15 In addition to the six liposomal encapsulations, other structures of nanocarriers are applied, such as docetaxel solubilized by micelle formation with polysorbate 80 (Taxotere ® ), proteinbound pemetrexed (Alimta ® ), or albumin-bound paclitaxel (Abraxane ® ).…”

Section: Cytostaticsmentioning

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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“…This evolution is abetted by the unprecedented expansion of clinically-promising nanoscale systems for drug delivery (18), including polymeric particles, inorganic particles (i.e., silica (19)), metallic particles (i.e., gold (20)), iron oxide (20) and solid lipid-based materials, to address unmet clinical needs. Their tunable size, surface chemistry, and architecture confer distinct biological properties and enable transport of diverse payloads with high efficiency (21).…”

Section: Overcoming Hurdles To Translating Anti-cancer Nanoparticlesmentioning

confidence: 99%

Advances in the clinical translation of nanotechnology

Scheinberg

Grimm

Heller

et al. 2017

Current Opinion in Biotechnology

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The use of novel materials in the nano-scale size range for applications in devices, drugs and diagnostic agents comes with a number of new opportunities, and also serious challenges to human applications. The larger size of particulate-based agents, as compared to traditional drugs, allows for the significant advantages of multivalency and multi-functionality. However, the human use of nanomaterials requires a thorough understanding of the biocompatibility of the synthetic molecules and their complex pharmacology. Possible toxicities created by the unusual properties of the nanoparticles are neither well-understood, nor predictable yet. A key to the successful use of the burgeoning field of nanomaterials as diagnostic and therapeutic agents will be to appropriately match the biophysical features of the particle to the disease system to be evaluated or treated.

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Cancer therapy using nanoformulated substances: scientific, regulatory and financial aspects

Cited by 92 publications

References 102 publications

Liposomal Formulations in Clinical Use: An Updated Review

Liposomal Formulations in Clinical Use: An Updated Review

Nanomedicinal products: a survey on specific toxicity and side effects

Advances in the clinical translation of nanotechnology

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