Packaging
Reducing time to market in the face of increasingly stringent regulations
Thursday 14. May 2009 - New research and independent laboratory testing documents and assesses the results of a highly pro-active approach to the development of dispensing systems
Research published today by Pfeiffer Pharma reveals new insights into the value of integrating regulatory requirements into the development process of dispensing devices. In a sector where regulatory challenges are exerting increasing pressure on pharmaceutical manufacturers, efficient and focused development processes are key. The new insights demonstrate how the directives issued by agencies responsible for drug approvals must flow into the development briefings, in order to reduce the time to market and ensure performance safety and quality.
EU and FDA guidelines incorporated into development briefing
The new research analyses the development of the Pfeiffer Cartridge Pump System (CPS) in order to measure the precise benefits of the pro-active approach for customers and patients. The CPS is a newly developed multi-dose pharmaceutical pump system with a container closure system (CCS), characterised by a metal-free formulation flow path and a consistent spray pattern. It is suitable for preserved and unpreserved solutions. Currently, systems for intranasal and dermal administration are commercially available. Adaptors for other application routes, such as the ear or throat, are under development. Since with a spray system, the dispensing unit is an integral part of the drug product, compatibility is vital. With the CPS, Pfeiffer therefore decided to incorporate the EU and FDA guidelines** requiring information on the characteristics of each of the critical components of the CCS into its own development process to eliminate the need for additional post-development testing. A unique property of the CPS is that there are no metal parts in the fluid path. All other components of the pump are made solely of medical or pharmaceutical grade polyolefines.
Microbial integrity and other patient benefits
An independent laboratory* conducted stringent microbial integrity tests, which the CPS passed without exception. These tests analysed both the microbial integrity of the venting system and of the pumps tip seal mechanism. For these two test series, glass bottles were filled with sterile bacterial culture medium and the CPS nasal device was mounted under sterile conditions. In addition, Pfeiffer has also carefully monitored the pumps spray performance, comparing it with conventional systems. These tests demonstrated a consistent spray force and droplet distribution bringing clear patient benefits in terms of optimal application of the prescribed dosage.