Nanopharmaceutics: Part II—Production Scales and Clinically Compliant Production Methods

Abstract

Due the implementation of nanotechnologies in the pharmaceutical industry over the last few decades, new type of cutting-edge formulations-nanopharmaceutics-have been proposed. These comprise pharmaceutical products at the nanoscale, developed from different types of materials with the purpose to, e.g., overcome solubility problems of poorly water-soluble drugs, the pharmacokinetic and pharmacodynamic profiles of known drugs but also of new biomolecules, to modify the release profile of loaded compounds, or to decrease the risk of toxicity by providing site-specific delivery reducing the systemic distribution and thus adverse side effects. To succeed with the development of a nanopharmaceutical formulation, it is first necessary to analyze the type of drug which is to be encapsulated, select the type matrix to load it (e.g., polymers, lipids, polysaccharides, proteins, metals), followed by the production procedure. Together these elements have to be compatible with the administration route. To be launched onto the market, the selected production method has to be scaled-up, and quality assurance implemented for the product to reach clinical trials, during which in vivo performance is evaluated. Regulatory issues concerning nanopharmaceutics still require expertise for harmonizing legislation and a clear understanding of clinically compliant production methods. The first part of this study addressing "Nanopharmaceutics: Part I-Clinical trials legislation and Good Manufacturing Practices (GMP) of nanotherapeutics in the EU" has been published in Pharmaceutics. This second part complements the study with the discussion about the production scales and clinically compliant production methods of nanopharmaceutics.Nanomaterials 2020, 10, 455 2 of 16 funding opportunities within Member States, Associated Countries and Third Countries. The strategic plan for the next Horizon Europe framework programme has clearly set nanomedicines and advanced therapies as priorities. To succeed, the nanoproduct needs to be manufacturable at large scale and its quality assured in order to reach clinical trials. The topic is indeed of high scientific interest considering the number of scientific papers dealing with clinical trials and nanoparticles over the last twenty years (Figure 1). Nanomaterials 2020, 10, x FOR PEER REVIEW 2 of 17European Commission aims to lead innovation towards the development of these nanopharmaceutics by launching several funding opportunities within Member States, Associated Countries and Third Countries. The strategic plan for the next Horizon Europe framework programme has clearly set nanomedicines and advanced therapies as priorities. To succeed, the nanoproduct needs to be manufacturable at large scale and its quality assured in order to reach clinical trials. The topic is indeed of high scientific interest considering the number of scientific papers dealing with clinical trials and nanoparticles over the last twenty years (Figure 1).

Factors Affecting the Retention Efficiency and Physicochemical Properties of Spray Dried Lipid Nanoparticles Loaded with Lippia sidoides Essential Oil

“…Encapsulation into lipid nanoparticles is receiving significant attention in the pharmaceutical and food sectors, as they offer several advantages, namely their biocompatibility, biodegradability and low toxicity, the possibility to encapsulate hydrophilic and lipophilic compounds, low production costs and easy scale-up [19][20][21][22][23]. Lipid nanoparticles are classified into different types produced by very different lipids and by different methods [24,25]. Among them, nanostructured lipid carriers (NLCs) receive special attention as, due to their solid matrix, they exhibit modified release profile and site-specific targeted delivery [26,27].…”

“…Besides, the presence of liquid lipid (oil) in their composition gives the additional advantage of enhanced drug-loading capacity [23]. As NLCs also have the capacity to load a range of nutraceuticals for oral administration [28], these particles hold a remarkable potential as a delivery system to build up the emerging area of the nanonutraceuticals with improved safety and efficacy [24,29,30].…”

In Vitro Characterization, Modelling, and Antioxidant Properties of Polyphenon-60 from Green Tea in Eudragit S100-2 Chitosan Microspheres

“…It is expected that S100Ch-PP60 microspheres can be further processed in foodstuff and in beverages to provide an alternative approach for the administration and delivery of phytochemicals with nutraceutical value. Indeed, micro/nano-nutraceuticals represent a useful tool in managing health conditions, particularly in patients not eligible for conventional therapy [45,46]. Follow up studies, use, and compliance [47][48][49][50], as well as communication strategies and assessment [51], should be applied also to nutraceuticals.…”

Nanomedicines for the Delivery of Antimicrobial Peptides (AMPs)

“…Besides, nanomaterials promote intracellular drug delivery, mitigating the development of drug-resistant bacteria and also allowing targeted organ accumulation by functionalized surface modifications, thus limiting systemic side effects and immunosuppression [2]. Despite these promising outcomes, the main challenge of establishing clinical use is related to the evaluation of interactions of nano-antibiotics with cells, tissues and organs achieving information about their possible toxic effects, together with the production on a large scale [1,14,15].…”