July 2005 - Pharmaceutical Technology

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July 2005

Pharmaceutical Technology


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."

Laura Bush

REGULATORY

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.

—Kaylynn Chiarello

DRUG DELIVERY

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.


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