Case Study
As appeared in May 2010 Tablets & Capsules Copyright CSC Publishing www.tabletscapsules.com
ANDA opportunities.
A West Coast manufacturer of generic pharmaceuticals focuses on commercializing extended-release and niche products. The company has an aggressive R&D approach and strives for creativity and speed in filing Abbreviated New Drug Applications (ANDAs).
It was in that vein that the company last year sought a pilot-scale system for laser-drilling tablets: to prepare itself for opportunities in the area of osmotic-release tablets. Typically, those tablets, either in single- or bi-layer form, include one or more holes through the tablet’s film coating, allowing gastric juices to infiltrate the core. Once ingested, the tablet creates a pumping effect that releases one or more actives over an extended period.
With the installation of a laser drill, the company would be poised to file its ANDA quickly, said the company’s vice president of R&D, who led the search. “We are a generic company and the minimum number of units we have to submit [with an ANDA] is 100,000, net yield. So how can you drill 100,000 tablets manually? I mean you could, but it would take forever.” Besides, he noted, as a generic manufacturer, “You need a variety of equipment, just in case.”
He soon learned, however, that there were few pilot-scale laser drills on the market. And only one vendor, Ackley Machine, Moorestown, NJ, could supply a completely automatic pilot-scale system. “I was surprised,” he said. “We checked around, and some other companies had a pilot-size system, but they were talking about $300,000 and that was for a system that operated semi-manually.”
The better price and performance, plus the company’s experience with Ackley’s tablet printing equipment, steered the search team to buy and install a VIP Series laser drill in June 2009. “The price is right compared with the other companies. Plus, we were confident that it was going to work for us since it uses the same system as the VIP printer,” he said. Like the laser drill, the single-lane printer uses precise gearing and a steel timing belt with carrier links to hold and convey the tablets. The company has used the printer to manufacture 150,000-tablet exhibition batches over the last 6 years.
Originally, the laser drill was designed to drill one hole but, at the company’s request, Ackley adapted it to drill two holes in bi-layer tablets, as long as the layers are different colors. Hole diameter and depth are adjustable and the machine is easy to operate. “Everything is automatic. It even rejects,” the vice president of R&D said. “If you set it to drill just the yellow side [of a bi-layer], it will, and it will reject the tablet if the side is another color.” The non-drilled tablets are then cycled through the machine again until the batch is complete.
The laser drill’s size (about 63 inches high, 40 inches wide, and 45 inches deep) and its mobile mounting are also beneficial. “You don’t need a big space, and everything is on the machine, and it’s moveable. You just plug it in. It’s a nice unit.”
Ackley Machine Corporation
Moorestown, NJ
856 234 3626
www.ackleymachine.com
