Beyond Micronization - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Beyond Micronization
Emerging methods could provide alternative ways of producing inhalable drug particles.


Pharmaceutical Technology
Volume 35, Issue 5, pp. 52-54


IMAGE: INFLUX PRODUCTIONS, PHOTODISK, GETTY IMAGES
Ask any manufacturer what process it uses to make inhalable drug particles, and the answer is likely to be micronization. This process has been the industry standard for decades, but it is not necessarily ideal. For starters, micronization is not well understood. In addition, a certain amount of material is lost during the process, so its final yield may not be optimal. Given these conditions, manufacturers have good reason to look for alternative processes for making inhalable medicines. Fortunately, several emerging methods show promise.

Particle replication in nonwetting templates

In 2005, researchers at the University of North Carolina (UNC) at Chapel Hill developed a technology called Particle Replication in Nonwetting Templates (PRINT). The method is based on the computer industry's procedure for making transistors, says Joseph DeSimone, professor of chemistry at UNC and leader of the research team. Using established technology, the researchers made etched silicon wafers to serve as templates for drug particles with previously determined characteristics. Using a template enables manufacturers to design the size and shape of their drug particles precisely, to target the upper airway or the alveolar sacs effectively, for example.

To scale up production, the team made a drum to pattern a print mold made of film that can be from 6 to 24 in. wide. The drum can make thousands of linear feet of molds, depending on the number of particles required.

After the molds are complete, their cavities are filled with the inhalable formulation, which can include the active ingredient alone or with excipients. Particles are harvested by adhesive films.

The PRINT technique, which complies with cGMP, can create traditional and large-molecule drugs for various diseases, including respiratory ailments such as cystic fibrosis and chronic obstructive pulmonary disease. The method also could be used to manufacture particles to fight bacterial infections or deliver chemotherapeutic agents to the lung. The researchers are interested in targeting the central nervous system through inhaled particles made using the PRINT process, says DeSimone.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here