Opportunities and obstacles to the development of nanopharmaceuticals for human use

Abstract

Pharmaceutical nanotechnology has generated breakthrough developments in improving health care and human life from its emergence. The biomaterials employed mainly aim at improving drug delivery systems, imaging and diagnostic technologies while the nanoscale materials are in widespread use in other industries such as electronics and optics. Such advancement may revolutionize the drug development and therapy with new and more efficient treatments. Although, nanotechnology assists humankind in improving its well being, it has certain limitations that entail thorough investigation by the regulatory and scientific authorities. To address concerns regarding the safety and toxicity profile of the nanopharmaceuticals, we have reviewed the challenges and solutions of nanopharmaceuticals use in human health and the related health risks. In this regard, regulatory and scientific bodies such as countries’ Food and Drug Administration (FDA), Organization for Economic Co-operation and Development (OECD), European Medicine Agency (EMA), Environmental Protection Agency (EPA), National Institute for Occupational Safety and Health (NIOSH), and World Health Organization (WHO) can participate in developing and reinforcing safety measures and regulatory frameworks to insure the public health. The regulatory authorities may enforce the nanopharmaceutical industries to conduct comprehensive toxicity tests and monitor the adverse drug reaction reports in close collaboration with the scientific community to act accordingly and inform the public as the implementation of the strategy.Graphical abstractNanopharmaceuticals have tremendous potential for human use as therapeutic or diagnostic agents. But their toxicity profile should be well addressed and the respective regulatory framework developed and reinforced by the authorities.

Dendrimers for ocular drug delivery

“…This has created a number of barriers to clinical approval that industry and the regulatory agencies have yet to work out. 75 First, the long-term safety of dendrimers is a primary concern. 76 Dendrimers are small enough (in most formulations) that they will ultimately end up entering systemic circulation regardless of their initial route of administration.…”

Advanced Delivery System of Polyphenols for Effective Cancer Prevention and Therapy

“…Although many results show dramatic anticancer effects of polyphenols through formulation, such as the studies described in Section 2, applying nanoformulation as a DDS is rare. One of the concerns is that the toxicity of the delivered drug does not translate to the nanoformulation, which means that sufficient toxicity studies are required [118]. In addition, the main limitation of nanoparticles is that they are rapidly eliminated due to their size, even though they have increased retention time and penetration in the blood compared to free drugs.…”

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

“…The scaling-up of a production process requires an absolute control or each and every technical parameter, in such a fashion that only slight differences can be found between different batches of the same nanoproduct. To assist on the development of clinically accepted nanopharmaceutical batches, the "guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials", of the Eudralex, Volume X, is of instrumental value as it displays specifications about the development of IMP (Investigational Medicinal Products) [75]. Examples of currently ongoing or upcoming clinical trials involving the use of nanopharmaceuticals are listed in Table 1.…”