Nanomedicines are perhaps at the heart of next-gen medicine. But what is it? Nanomedicines consist of active pharmaceutical ingredients or APIs such as small molecules packaged into nano-sized carriers made of excipients (basically vehicles for substances) like lipids and polymers. Nanoparticles tend to be smaller than cells but larger than most biomolecules, so the nanomedicine can interact with the body differently than the API alone. The properties of nanomedicines can be designed to control when and where in the body the API is available.
Nanomedicine uses the properties developed by a material at its nanometric scale which often differ in terms of physics, chemistry or biology from the same material at a bigger scale.
The nanometric size is also the scale of many biological mechanisms in the human body allowing nanoparticles and nanomaterials to potentially cross natural barriers to access new sites of delivery and to interact with DNA or small proteins at different levels, in blood or within organs, tissues or cells.
Nanomedicine has the potential to enable early detection and prevention and to drastically improve diagnosis, treatment and follow-up of many diseases including cancer but not only. Overall, Nanomedicine has nowadays hundreds of products under clinical trials, covering all major diseases including cardiovascular, neurodegenerative, musculoskeletal and inflammatory. Enabling technologies in all healthcare areas, nanomedicine is already accounting for approximatively 80 marketed products, ranging from nano-delivery and pharmaceutical to medical imaging, diagnostics and biomaterials.
How It Works (Emphasis on Cancer Treatment)
Nanoparticle drug-delivery systems can work in different ways. Along with carrying the drug for delivery, nanoparticles can be engineered to carry specific compounds that will let them bind, or attach to molecules on tumor cells. Once attached, they can safety deliver the drug to the specific tumor site.
Nanoparticles can also help with drug solubility. For a drug to work, it must be able to enter the bloodstream, which means it needs to be soluble. For example, the cancer drug paclitaxel (Taxol) is insoluble, so it has to be dissolved in a delivery agent to get into the blood. However, this agent can cause allergic reactions in patients.
To overcome these issues, chemists have developed a nanoparticle out of the naturally occurring protein called albumin. It carries the paclitaxel drug and makes it soluble but without the allergic reactions.
Tumors commonly have disordered and leaky blood vessels sprouting through and away from them. These vessels allow chemotherapy drugs to readily enter the tumor, but because chemotherapy molecules are so small, they also diffuse through the vessels and out of the tumor, attacking surrounding tissues. Nanoparticles are larger molecules that get trapped inside the tumor, where they do all the damage while limiting the damage on healthy cells.
Once they have delivered their drug cargo to cells, nanoparticles can be designed to break down into harmless byproducts.
Challenges in the Industry
The clinical translation of nanomedicines is an expensive and time-consuming process. Nanomedicine technology is usually far more complex in comparison to conventional formulation technology containing a free drug dispersed in a base (e.g., tablets, capsules and injections). Key issues include biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of nanomedicines on the market, irrelevant of whether they are therapeutically effective or not.
Traditionally, nanomedicine development has been based on a formulation-driven approach, whereby novel delivery systems are firstly engineered and characterized from a different perspective. It is only when attempting to align the nanomedicine with a pathological application that limitations in the clinical translation of the system have been identified. Understanding the relationship between biology and technology, including understanding the influence of disease pathophysiology on nanomedicine accumulation, distribution, retention and success, as well as the biopharmaceutical correlation between delivery system properties and behavior in animals versus humans are important determinants for the successful translation of nanomedicines. Therefore, applying a disease-driven approach by designing and developing nanomedicines that are able to exploit pathophysiological changes in disease biology has been suggested to improve clinical translation.
One of the important factors contributing to the slow pace in the clinical translation of nanomedicines is the structural and chemical complexity of the formulation itself. Platforms that require complex and/or laborious synthesis procedures generally have limited clinical translation potential, as they can be quite problematic to pharmaceutically manufacture on a large-scale. Pharmaceutical manufacturing development is centered on quality and cost. Quality includes the manufacturing process and stability of the formulation, with nanomedicine manufacturing being challenged by potential issues related to: poor quality control, incomplete purification from contaminants (e.g., by-products and starting materials), high material and/or manufacturing costs, low production yield, and scarcity of venture funds and pharmaceutical industry investment.
Detailed toxicology is essential for the clinical translation nanomedicines to determine the overall safety for human use. Pharmaceutical regulatory authorities generally recommend that the sponsor carefully assess for any changes in the drug substance and drug product manufacturing process or drug product formulation at any phase of clinical development, in order to determine if the changes can directly or indirectly affect the safety of the product. If any changes are identified, strict procedures are in place to ensure appropriate comparison testing of the drug substance and/or drug product produced from the previous manufacturing process with the changed manufacturing process to evaluate product equivalency, quality, and safety. When analytical data demonstrate that the materials manufactured before and after are not comparable, sponsors should perform additional qualification and/or bridging studies to support the safety and bioavailability of the material to be used in the proposed trials.
Intellectual Property (IP)
Given the complexities of incorporating nanotechnology into biomedical and clinical applications, there needs to be more precise definitions on what constitutes novel IP of a nanomedicine. Nanomedicines are complex as they have a number of variable components, and bridge between the field of medicine and medical device. Generally, the control of a nanomedicine product requires an IP position on: the encapsulated cargo, the carrier technology, and the characteristics of the drug and carrier together. Although this definition is straightforward, it does open up a number of problems with the issuing of patents to date.
For example, nanomedicines that incorporate existing drugs with novel carrier technology, or those that incorporate existing drugs with existing carrier technology for a new biomedical or disease application. The IP situation becomes even more confusing with more complex drug delivery systems, such as those which incorporate commercially available targeting dligands (e.g., antibodies) or coatings that are owned by other companies. IP strategies may likely involve multiple patents associated with any given technology and the need for cross-licensing arrangements. Therefore, new IP practices and protocols are required to simplify the pathway from invention into commercialization to reduce the time and expense required for negotiating collaboration and licensing agreements.
In this article, I talked about what nanomedicines are and what their various implications can be. In short, they can be used to enhance the effectiveness of medicine, especially when it comes to cancer treatments. However, there are also various challenges in this industry, ranging from cost to biocompatibility. All in all, nanomedicine has a bright future ahead of itself, and through further research and development, more and more breakthroughs will be sourced thus leading to the eventual common use of nanomedicines in everyday life. I hope this article gave you a better insight on the future of nanomedicines and how it can change the world.