Aptar Pharma says new eDevices will speed up regulatory approval
The firm gave in-PharmaTechnologist an exclusive first look at its newly expanded measured dosage tech at last week’s Pharmapack Europe 2012.
Joachim Koerner, VP of eDevice R&D, prescription division, said the platform – which consists of dose display e-Dose Counter, and dose restrictor e-Lockout – is the type of controlled self-administration measure regulators are leaning towards at the moment.
He said: “More and more regulators are asking for safety features added to products, for instance to prevent overdosing, like our e-Lockout system does.
“For example in the US the regulators ask for dose counters or indicators when you try to get new asthma COPD (chronic obstructive pulmonary disease) inhalers or other pressurized metered-dose inhalers (pDMI) into the market.
“We meet the regulator recommendations for nasal spray devices and pDMIs and also pain treatment.”
He added that the platform technology offering is highly customisable, and will therefore save clients the time and expense of trial do-overs.
“We have a close link to the primary package,” he said. “We know exactly what the performance of the primary package is and do not touch the spray performance characteristics of the primary package while adapting our eDevice.
“That means there is no need to re-do clinical studies and so they save a lot of time and money.”
