Background Papers - On nano-pharmaceuticals

Background Papers - On nano-pharmaceuticals

A nanometer (nm) is one billionth of a meter. That is about 1/80,000 of the width of human hair. Nanotechnology deals with nanometer-scale materials and structures. Nanotechnology applications can be seen in electronics, medicine, energy, materials, and environmental science. Nanoscale materials are being developed to improve drug delivery, diagnostics, imaging, and regenerative medicine.

Nanotechnology in healthcare

Now nanoparticles can be engineered to carry drugs to specific cells or tissues. It enhances drug stability, improves solubility, and controls drug release. These will make therapy more effective and targeted. Bypassing biological barriers and delivering drugs to previously inaccessible areas will become possible.

Nanofibers, nano-gels, and nano-scaffolds can promote the repair and regeneration of damaged tissues and organs. Nano-particle-based therapies are promising in cancer treatment, antimicrobial therapies, and targeted therapy delivery. Targeted drug delivery helps increase drug concentration at the target and, at the same time reducing side effects of healthy tissues. Nanoparticles will now be combined with antibodies or peptides to selectively bind to markers on diseased cells making drug delivery precise.

There are excellent examples of using nanoparticles as contrast agents in MRI (magnetic resonance imaging). These are helping improve tumor detection and targeting of anti-cancer medication to specific tumors.

There are many other use cases of nanoparticles in gene therapy, immunotherapy enhancements, and combined therapeutic and diagnostic treatments called theranostics. Innovations include the development of nanosuspensions, nano-emulsions, and nanosponges. Nanoparticles based techniques are a hot area of innovation and research. New and newer use cases and solutions are being developed.

Combination drug therapies

Combining multiple drug molecules into a single nanoparticle will be possible, making combination therapy more effective.

Examples of nano-particles-based medicine:

  1. Doxil is liposomal doxorubicin that is used to treat various cancers. This medication contains liposomes and doxorubicin. Liposomes protect the drug from degradation prolonging its circulation time. It helps the medication accumulate in tumor tissues making it more effective. The medicine treats ovarian cancer, multiple myeloma, and AIDs-related Kaposi’s sarcoma.
  2. Abraxane is albumin-bound paclitaxel. The medication allows for improved solubility, controlled drug release, and enhanced tumor targeting. Abraxanne is approved for treating breast cancer, non-small cell lung cancer, and pancreatic cancer.
  3. Onivyde is a liposomal formulation of the chemotherapy drug irinotecan. It is indicated for the treatment of metastatic pancreatic cancer. Ipsen manufactures the medication.
  4. Feraheme is an iron oxide nanoparticle-based formulation used as an intravenous iron replacement therapy for treating iron deficiency anemia in adult patients. AMAG Pharmaceuticals manufacture the formulation.

Some other major companies engaged in nanoparticle-based medication manufacture include Merck & Co and Novartis.

Challenges and failure

As is most emerging technologies, nanomedicine-based formulations are seeing clinical failures. Some of the documented causes for failure are:

  1. Toxicity in Phase 1 clinical trials (Fogel, 2018)
  2. The drug carrier of nanomedicine affects its physicochemical properties leading to failure. ( Patra et al., 2018)
  3. Wrong selection of patients for clinical trials (Sacristan et al., 2016)
  4. Production processes and reproducibility quality is another critical cause that leads to the failure of nanomedicines. (Soares et al., 2018)

Some of the reported failures of nanotechnology-based formulations are:

Caldolor was a nanomedicine developed as an intravenous formulation of ibuprofen. It was produced to provide pain relief and reduce fever. Safety profile issues led to the failure of the medicine to gain FDA approval in 2006.

BIND-14 was a nanoparticle-based drug delivery system developed to target and deliver chemotherapy drugs directly to cancer cells. The drug was designed to treat solid tumors, including prostate, lung, and pancreatic cancers. The Phase II clinical trials were unsuccessful and further development was discontinued in 2016.

BrachySil was another nanomedicine developed to deliver radioactive particles directly to pancreatic cancer tumors. The medicine, if successful, would have provided localized radiation therapy while minimizing damage to healthy tissues. The medication failed in Phase III clinical trials leading to the termination of the trial in 2014.

Alnisleukin is a recombinant interleukin-2 (IL-2) therapy used in kidney cancers. It is a biologic drug with nanoscale components. Even though the drug has received FDA approval, its usage has declined due to limited response rates, significant toxicity, and the availability of more effective treatments.

Failures are not restricted to nanomedicines. These are common features of drug development. Failures provide opportunities for learning and improvement.

Global nanomedicine market size


Grand View Research valued the global nanomedicine market, in 2020, at USD 215 billion. They estimate that this could grow at a compound annual growth rate (CAGR) of 8.7 percent and is expected to reach USD 405.9 billion by 2028. The growth of this market is attributed to the following factors:

The incidence of chronic diseases like cancer, cardiovascular disorders, neurological conditions, and infectious diseases is driving demand for innovative and targeted therapies. Nanomedicine offers effective treatments with reduced side effects. The market adoption of these drugs is also high.

Continuous advancements in nanotechnology include developing improved materials, fabrication techniques, and methods. These are resulting in the development of new nanomedicine products and therapies.

Governments worldwide are investing in nanomedicine research and development. Funding programs, grants, and collaborations are on offer. These are accelerating nanomedicine innovations in clinical applications.

Regulatory agencies like US FDA and European Medicines Agency (EMA) have recognized the potential of nanomedicine. They are actively engaged in developing guidelines for evaluating and approving nanomedicine products. A supporting regulatory environment facilitates the commercialization of nanomedicine drugs, promoting market growth.

Collaborations between academic institutions, pharmaceutical companies, and nanotechnology firms foster innovation and support nanomedicine formulation development efforts. Nanomedicine enables personalized medicine approaches by delivering therapies with high specificity to target cells or tissues. The growing focus on precision medicine and targeted therapies further fuels the demand for nanomedicine drugs.

Emerging nanomedicines under trial

Several trials and developments are reported in a scenario where demand for nanomedicines is quite high.

NanoVelcro CTC Assay uses nanoscale wires coated with antibodies to capture and analyze circulating tumor cells  (CTCs). It can improve cancer diagnosis, monitor treatment response, and facilitate personalized medicine.

Nanoscale particles called nanoFlares are designed to detect and monitor specific genetic targets within cells. The technique can help measure gene expression levels and provide insights into disease progression and therapy response.

Cancer-targeting nano vaccines can potentially trigger a robust immune response against cancer cells. That can lead to tumor regression and long-term immune memory. Such vaccines are under development.

Nanoparticles can be delivery vehicles for gene therapies transporting therapeutic genes into target cells. The particles protect the genes from degradation and enhance their uptake by cells. The treatments can treat genetic disorders, cancer, and other diseases.

RNA-based therapies, such as RNA interference and messenger RNA therapies, are under development to treat various diseases. Nanoparticles can encapsulate and protect RNA molecules. It will facilitate their delivery to target cells and tissues.

Some other nanoparticle-based innovations with potential for deployment in the future include nanoscale drug delivery systems, nanobots for targeted therapy, and nanosensors for disease monitoring.

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