Nanotechnology within medicine, or namely, nanomedicine, has become an exciting avenue for the field of pharmaceuticals.
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This area of research has gained traction since its introduction in 1959 by the American physicist and Nobel Prize laureate, Richard Feynman. The versatility of this field can be almost said to be limitless, with continual discoveries for innovative applications by researchers, which has also included drug discovery.
Drug discovery refers to the process of designing novel drugs. This can be a relatively long process that can take approximately 12 years or more to complete, from the stage of identifying a target, such as a receptor, gene, or protein, to the stage where the drug is approved and is ready for marketing.
While this field has made significant contributions to society within medicine and human health, it is also faced with many obstacles.
Developing a drug is considered a complex process, with the early stages consisting of screening for active compounds, which are also required to have a therapeutic impact on the target chosen.
The Food and Drug Administration (FDA) has reported five stages of the drug development process, comprising: (i) discovery and development, (ii) pre-clinical research, (iii) clinical research, (iv) FDA drug review, and (v) FDA post-market drug safety monitoring.
The discovery of new drugs depends on novel insight or information about a disease process. These can include numerous amounts of tests on molecular compounds to find a beneficial effect on diseases, improvements on existing treatments that have adverse effects, as well as new technology that may provide novel and innovative methods of targeting specific areas of concern within the body.
What may start off as a large volume of drug candidates in the early stages slowly dwindles into a small number of compounds that have true potential to reach FDA approval for the disease, for which it is intended.
Another challenge in this area also consists of cost, with the development of a ‘new molecular entity’, such as a small compound, or a ‘new biological entity’, which refers to biological medicines including antibodies or gene therapies, having high expenditure. The development of these types of drugs has been predicted to cost approximately $2.6 billion.
As expected, this can be a large obstacle for many drug companies, and even more so for new drug companies that may have underestimated the large volume of molecules (and the associated price) required to produce a novel drug treatment during each stage of development.
Increasing the optimization of drug formulation with high load capacity is also a challenge for researchers to ensure a significant volume of the drug will be available and well-distributed with each dosage; this is also related to the obstacle of optimizing the most appropriate drug delivery system for each formulation.
These challenges can be burdensome for researchers, but with the advancement of nanotechnology, a promising solution for the pharmaceutical industry may be developed.
Boosting Drug Discovery with Nanotechnology
Nanotechnology, which utilizes particles and materials within the nanoscale of 1 and 100 nm, can hold a significant role in pharmaceuticals, as these particles are smaller than conventional drug molecules, enabling entry through biological barriers that would otherwise be an obstacle.
Such size is significant as the passing of biological barriers such as the blood-brain barrier, which prevents many drugs from crossing into the brain, can enable the treatment of an array of brain-related diseases and disorders. An example of this includes brain cancer, such as glioblastoma multiforme, a common brain tumor that is associated with poor prognosis. This brain cancer can be described as being incurable and has an average survival rate of 15 months, with only 5.5% surviving five years after receiving a diagnosis.
Increasing the ability to target brain-related diseases such as glioblastomas through the inclusion of nanotechnology into drug formulation, or nanoformulation, can enhance the number of approved drugs to treat incurable diseases.
Drug discovery through this innovative approach can be boosted as this may enable precise targeting of receptors, proteins, and other biological molecules, enhancing the efficacy of drug development and delivery. This can also be furthered due to nanoparticles having higher solubility and surface functionalization, allowing ligands to be placed on their surfaces to enable higher levels of targeting.
Since the 1970s, there have been approximately more than 60 drug applications that have been approved comprising nanomaterials, which have continued to gain traction over the years.
Nanomaterial-based drug formulations may include different biological pathways than a conventional small molecule drug and subsequently, this may influence the safety and quality and even efficacy of the drug. This challenge would require further investigations on the complexities of nanoformulations and how this may affect a patient in vivo.
These challenges led to the Nanotechnology Risk Assessment Working Group being used to assess the potential effect of nanotechnology on drugs in 2014, with the expertise of the FDA’s Center for Drug Evaluation and Research (CDER).
Such a development has enabled drug standards to be developed, with the CDER introducing a guide in 2017 for drug and biological products that include nanomaterials. Guidance for this innovative category can allow for a larger volume of drugs to be developed for diseases and disorders that have previously been challenging to treat, such as brain cancer.
References and Further Reading
Bayda, S., Adeel, M., Tuccinardi, T., Cordani, M. and Rizzolio, F., 2019. The History of Nanoscience and Nanotechnology: From Chemical–Physical Applications to Nanomedicine. Molecules, 25(1), p.112. Available at: 10.3390/molecules25010112
Kanderi T, Gupta V. Glioblastoma Multiforme. [Updated 2021 Nov 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK558954/
Kumar Dash, D., Kant Panik, R., Kumar Sahu, A. and Tripathi, V., 2020. Role of Nanobiotechnology in Drug Discovery, Development and Molecular Diagnostic. Applications of Nanobiotechnology,. Available at: https://www.intechopen.com/chapters/72461
Mohs, R. and Greig, N., 2017. Drug discovery and development: Role of basic biological research. Alzheimer's & Dementia: Translational Research & Clinical Interventions, 3(4), pp.651-657. Available at: 10.1016/j.trci.2017.10.005
Shi, J., Votruba, A., Farokhzad, O. and Langer, R., 2010. Nanotechnology in Drug Delivery and Tissue Engineering: From Discovery to Applications. Nano Letters, 10(9), pp.3223-3230. Available at: 10.1021/nl102184c
U.S. Food and Drug Administration. 2022. Step 1: Discovery and Development. [online] Available at: https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-development
U.S. Food and Drug Administration. 2022. Advancing the Science of Nanotechnology in Drug Development. [online] Available at: https://www.fda.gov/drugs/news-events-human-drugs/advancing-science-nanotechnology-drug-development