Packaging

Milestone in Pharmaceutical Production Technology

Tuesday 06. May 2008 - AccuSpray from OYSTAR Manesty significantly reduces magnesium stearate concentrations

A completely new technology for the surface treatment of tablets reduces by several orders of magnitude, the quantity of the excipient magne-sium stearate added during the pharmaceutical manufacturing process. The British company OYSTAR Manesty has developed
a process for applying a lubricant film that is designed to radically cut magnesium stearate concentrations. The result: pharmaceuti-cal products of even greater purity with unaltered processing characteristics. Significantly the marked reduction in the force
required to eject tablets from the die will result in a longer tool service life. This together with the saving in magnesium stearate consumption will provide considerable cost savings as well pro-ducing very high quality tablets.
OYSTAR Manesty, located near Liverpool in the U.K., is a member of the German-based international OYSTAR. The Process & Packag-ing Group, headquartered in Stutensee near Karlsruhe. OYSTAR Manesty showcases its innovative technology under the name of AccuSpray at the interpack event in Dusseldorf, Germany.
Magnesium stearate is one of the most commonly used excipients in pharmaceutical manufacturing. It is added to granules to act as a lubricant and prevent the material sticking to the tools. OYSTAR Manesty technology can reduce magnesium stearate consumption from an average of 100 gram per production hour to as little as 4 gram.
The process involves spraying the excipient in a 10 percent magne-sium stearate/ ethanol solution into the compression die. A patented high-speed piezoelectric pump ensures exact metering of the sub-stance and keeps production rates constant. Analytical measure-ments show that the magnesium film completely encloses the tab-lets, even at the die walls. This film comprises only around 0.03 per-cent of the tablet weight.
The patented AccuSpray spray-gun module can be set up quickly.
A user-friendly operating console supports process control and pa-rameter configuration. The fact that the lubricant is concentrated only on the surface of the tablets means that the dies and punches are subjected to less force, reducing wear and tear. The AccuSpray module is initially available for tablet presses of the OYSTAR Manesty Xpress series.
AccuSpray from OYSTAR Manesty has the potential to increase pharmaceutical manufacturing efficiency and improve product qual-ity. The British mechanical engineering company has a long history of innovation: Its achievements include the first press in the world for the production of multi-layer tablets and the first automated sys-tem for monitoring tablet weight.
“AccuSpray is a technological milestone,” says OYSTAR Manesty Managing Director Matthias Meyer. “The ability to apply magnesium externally in such minute concentrations means that addition of the lubricant to the blend can be reduced to an absolute minimum. In some cases it can even be omitted altogether.” The new technology is particularly promising for effervescent and orally disintegrating dosage forms, which are supposed to dissolve rapidly in water with-out forming any residue.