Nanotechnology in Drug Discovery

Nanoscience and nanotechnology is the  application and development of incredibly tiny elements which can be used in all  fields of science, like chemistry, biology, physics, materials science, and engineering.

Use of nanotechnology in FDA-regulated products has been evolving from several years, including food, cosmetics, medical devices and medicine. Within the reach of the Center for Drug Evaluation and Research (CDER) of the FDA, the pharmaceutical products that contain nanomaterials have a great diversity.

The number of FDA approved pharmaceutical products containing nanomaterials has been increased, by covering  investigational new drugs, new medicine applications,  generics drug applications. Since the early 1970s more than 60 proposals have been approved and this interest is continuously  increasing.

Pharmaceutical products that contain nanomaterials are unique in several ways as they can undergo different chemical, physical, or biological properties compared to other drug types. In some cases, this may have an impact on the product's efficiency,  safety, or potency. Drug products containing nanomaterials can follow a different path in the body compared to a small molecule drug. After the entry of drugs developed by nanomaterials into the bloodstream, it gets interacted with specialized immune cells called macrophages that engulf and carry a drug to the region for which it was designed, like where bacteria, fungi or viruses live. For a small molecule, certain areas are often difficult to reach.

In addition, a pharmaceutical drug designed  by using  nanomaterial may have a unique "coating" that inhibits it from reacting with immune cells, enabling the drug to persist in the bloodstream for longer periods of time until it reaches cancer tissues. The ability to target body areas and avoid others will greatly lower the possibility of side effects, such as sensitivity to non-target tissues, and possibly improving treatment efficacy. For these benefits nanomaterials are most extensively used in cancer or infection care. Formulations like liposomes, nanocrystals and nano-emulsions are some of the most common types of pharmaceutical products that are approved with nanomaterials.

Research work to Address Challenges Related to Nanotechnology:

The Office of Testing and Analysis (OTR) at CDER's Office of Pharmaceutical Safety has been conducting a study for a century to better understand the manufacturing and quality problems associated with nanomaterial-containing pharmaceutical products with the purpose of providing organization guidance and legal review.

OTR outlines challenges involved with the development of new nanotechnology medicines and sets clear criteria to open the way for possible nanomaterial-containing generics to be authorized.

Recent research concentrate on recognizing the essential processes and material properties that can influence the quality, and understanding quality within the effectiveness and safety context. For example, if the manufacturing process is modified in some way, what will be the effect of this on product quality?

How stable is a nanomaterial like a liposome and how does the nature of it impact its stability? To what level can variations in manufacturing, such as changes in temperature or drying, affect particle size, body distribution and overall stability, be allowed? Producers must pick and execute the right quality control measures to monitor and account for any variability.