Smaller is Better - Pharmaceutical Executive


Smaller is Better

Pharmaceutical Executive

Nanobiotechnology Manufacturing Techniques

Elan Corporation is one of the most successful nanobiotechnology integrators, with four partnered drugs on the market. Elan's proprietary NanoCrystal technology utilizes a wet-milling technique to reduce the drug crystal size to 1,000 nanometers. At this small size, the greater surface area of the crystals increases the solubility of the drug. The latest company to adopt Elan's technology is Abbott Laboratories, which uses it for TriCor (fenofibrate), a cholesterol-lowering drug. Previously, TriCor had to be taken with food at a higher dose, but this third-generation TriCor allows the patient to take a lower dose at a convenient time. This strategy not only has the potential to improve patient compliance, it has fended off potential generic manufacturers. Generic drug makers can reproduce the active ingredient, but they are not allowed to copy the enhanced nanobiotechnology delivery system. Elan also helped transform Rapamune (sirolimus), a Wyeth drug used to counteract organ rejection, from an oral suspension to a simple pill.

SkyePharma's Insoluble Drug Delivery (IDD) platform is another promising advance in nanotechnology. The new, proprietary technology creates drug particles that range from 40 to 1,000 nanometers, dramatically increasing their solubility. One of its first products, TriGlide, contains fenofibrate, the active ingredient in TriCor, and boasts the same patient benefits. When comparing the two new delivery systems, the main competitive advantage is dosing control—in particular, lowering the total amount of the drug in the patient's system. For fenofibrates, the NanoCrystal Technology by Elan has succeeded in lowering the overall TriCor dose more than TriGlide by SkyePharma.

Complex Solutions Deliver Hope

Dendrimers are among the most widely studied molecules in all of chemistry and nanobiotechnology. These exciting molecules are extremely flexible and offer a variety of applications. Dendrimers consist of three basic parts: a core molecule, the branching molecules, and the surface molecules. These combine to form a spherical shape that creates a large surface area. Large dendrimers can form into spheres that encapsulate poorly soluble molecules. Scientists manipulate the branching molecules to form a dendrimer of a specific size, and attach surface molecules at the end of the branching molecule to give the whole structure the desired chemical properties—hydrophilic, hydrophobic, or electrophilic. Or the surface molecules can incorporate a cell receptor or antigen.

The Michigan Nanotechnology Institute for Medicine and Biological Sciences (M-NIMBS) is at the forefront of dendrimer-based research. The young company has created an extensive catalog of dendrimers with surface molecules useful in therapeutics or delivery.

M-NIMBS has created some of the first biological nanodevices for the treatment of cancer. The goal is to create a dendrimer that can recognize a certain cancer-specific receptor, deliver a therapeutic (lethal) drug, and contain an imaging agent to show the occurrence of cell death. Such a molecule could revolutionize treatment by providing patients with safe mechanisms to destroy their cancer with minimal side effects. While this technology is in very early stages of development and has not reached clinical trials in humans, M-NIMBS is actively pursuing a treatment for head and neck cancer as well as prostate cancer.

Utilizing the principles of dendrimers, StarPharma and Dendritic NanoTechnologies have developed a product that has the potential to drastically reduce the incidence of HIV and Herpes infections. Applied as a gel, their dendrimers bind to the GP120 protein on the surface of HIV, preventing it from binding to T-cells and infecting the individual. The product, VivaGel, has entered human clinical trials and has a potential market entry date of 2008.

Looking Ahead

These and other drug-delivery companies are developing novel ways to improve the delivery of medications. The hope is that they will not only be more patient-friendly, but also more effective. Most of these companies develop technology and then look for companies with existing drugs or drug-discovery capacity to create a partnership. These new-found partnerships are restoring lost revenue opportunities by helping more drugs overcome solubility issues and extending product lifecycles to other new delivery characteristics. Nanobiotechnology is a growing field. Newly approved products demonstrate its exciting potential every year. The future of drug delivery may not be the visible patch, pill, or injection, but rather, molecular characteristics measured in nanometers.

Jason McKinnie is an industry analyst at Frost & Sullivan. He can be reached at


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