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

A significant advantage of the PRINT method is that it consistently yields uniform populations of particles. "There's essentially no dispersion in size and shape. That's not been available before," says DeSimone.

The technology also lets formulators create particle sizes and shapes that traditional methods have not generated successfully in the past. For example, DeSimone's team has made cylindrical particles that are 80 nm in diameter, and they can achieve particle sizes as large as 5 µm. The team is also using PRINT to develop particles that can rotate automatically in a low-velocity airstream, much like a maple seed does when it falls from a tree. "We're getting into characteristics that have never been designed into a respiratory drug therapy," says DeSimone.

It's hard to achieve this kind of mixture through traditional particle approaches, such as spray drying from a solution, because ingredients in various phases tend to separate, and the processes give operators little latitude for controlling the ratio of matrix to drug. "With PRINT, we can precisely tailor the ratio of those two components because we're simply filling a cup," says DeSimone. The high level of control that PRINT offers could help manufacturers create multicomponent particles for targeted delivery.


Respirable drug particles processed through supercritical antisolvent precipitation.
On the other hand, risk-averse drug manufacturers could consider the PRINT technique's novelty a liability. Companies might be inclined to use micronization because they are familiar with that process. Also, the throughput of the PRINT technique, which has a two-dimensional format, is lower than that of volumetric processes such as spray drying.

Nevertheless, the PRINT technique shows great promise for manufacturing inhalable drug particles, according to DeSimone. The method can enable continuous manufacturing; provide control of size, shape, and chemical composition; enhance drug stability; and enable particles to be made from otherwise challenging formulations.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
What is the single greatest threat to maintaining manufacturing processes at your facility?
Quality issues
Facility/environment problems
Process development problems
Production equipment downtime
Raw material supply problems
Regulatory restrictions
Business decisions to limit production
Quality issues
67%
Facility/environment problems
0%
Process development problems
0%
Production equipment downtime
0%
Raw material supply problems
33%
Regulatory restrictions
0%
Business decisions to limit production
0%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Praise and Perils for Biotechnology Patent Policy
Risk-Mitigation Strategies in Drug Manufacturing for Emerging Markets
Quality Focus: Ensuring Raw Material Transparency
Advertising of Prescription Drugs  Keeping it Honest and Balanced
Key Ways for Ensuring Global Regulatory Compliance
Source: Pharmaceutical Technology,
Click here