The news report cited increasing costs of steel and other building materials as a major reason for the cutback and the delay
in the construction start. Industry analysts linked the decision to erosion in Lilly's insulin market share and declining
sales of one of the company's insulin products, "Humulin."
Compounding Pharmacies' Lawsuit Against FDA Will Continue
The US District Court for the Western District of Texas (Midland, TX) has ruled that a lawsuit against the US Food and Drug
Administration (Rockville, MD,
http://www.fda.gov/) will proceed, despite a request from FDA to drop the case.
A coalition of 10 compounding pharmacies sued FDA for engaging in "unlawful" inspections of state-regulated pharmacies. At
the center of the lawsuit is a 2003 FDA compliance policy guideline (CPG 7125.40), which prohibits the compounding of drugs
from bulk ingredients. The agency has since inspected several compounding pharmacies to enforce the guidelines.
The pharmacies petitioned the court to allow them to continue using compounding methods without FDA considering them manufacturers
or requiring them to meet the agency's manufacturing guidelines. The coalition alleges that federal law prohibits FDA from
inspecting state- regulated pharmacies and that the agency is exercising jurisdiction without the authority to do so.
Self-Assembly Nanotechnology Improves Microencapsulation
A group of chemical engineers from Rice University (Houston, TX,
http://www.rice.edu/) has developed an environmentally friendly microencapsulation technique that enables researchers to produce microcapsules
quickly and easily.
Though microencapsulation is a promising technique for drug delivery, traditional production methods require multiple steps
that could affect the drug molecule. With sacrificial core templating, for example, microcapsules are made by layering a coating
onto a template or a core. The core must be dissolved or burned out to form a hollow center, which could damage the drug or
its carrier. In addition, techniques using flow methods only produce large capsules and have limited applications.
The Rice technique involves self-assembly, which means that hollow spheres form spontaneously when certain polymer and salt
components are combined. "If you know how to mix things, you can make microcapsules," says Michael S. Wong, assistant professor
of Chemical Engineering at Rice. "That's the novelty of what we've been able to do. It's easy and has a lot of potential applications."
Researchers mix together three common off-the-shelf ingredients: a water-soluble, cationic polymer such as polylisine or polyallylamine,
citric acid, and silica nanoparticles. The mixing process occurs in water at room temperature, under normal pressure, and
at mild, near-neutral pHs. Upon mixing, 1-4-μm particles form in less than a minute. According to Wong, the structures hold
up under their own weight and will not puncture or collapse like deflated balloons. In addition, the research team believes
the technique will be suitable for large-scale production.
Because the process occurs in water, any chemical or drug that's suspended in the water gets trapped inside the hollow sphere
when it forms. To encapsulate a drug particle, for example, the team adds the "cargo" to the solution and then mixes in the
other components. A hollow sphere naturally forms around the droplet of water that contains one drug molecule. Says Wong,
"It's green chemistry. You don't have to waste solvents, and it happens very easily, quickly, and nondestructively."1
One application of interest could be timed and controlled drug release in the body. The research team is currently exploring
how to use factors such as pH level or temperature to prompt the microcapsules to open and release drug. The team has already
experimented with magnetic microcapsules (using iron oxide nanoparticles rather than silica) that enable physicians to control
exactly where the drug will be released using magnets.