Drug Delivery Report

By René Bommer
Director Business Development, Ing. Erich Pfeiffer  GmbH, Pharma Division,  Oeschlestr. 54-56,  D-78315
Radolfzell, Germany

Introduction

The positive market reception  for the Advanced Preservative Free system provided the Pfeiffer development team with a new, highly complex challenge. In the market there was a clear demand for extending  the benefits of the Advanced Preservative Free nasal pump
to other applications.  What would be the best response? In this article, René Bommer and Jochen Kern, from Ing. Erich Pfeiffer GmbH, trace the development from a mono- product  line to the new Cartridge  system, a modular product.

The Advanced Preservative Free Heritage

Launched in 2003,  the Pfeiffer Advanced Preservative Free system is a multidose system for the application of preservative-free  solutions via the nasal route.  Patented filter technology  prevents bacteriological contamination of the drug product  on its metal-free  path.  This mechanical device is 100% sealed and has interchangeable secondary packaging. Since its launch, the Advanced Preservative
Free system has offered producers  of unpreserved nasal medication  around  the world an effective solution and won a number  of prestigious design awards.

Finding a Solution for Non-nasal and Preserved Applications

The development of a new system, integrating all of
the benefits of its predecessor, had two specific goals. It needed to be suitable for applications other than  nasal,
and for solutions containing  preservatives. These objectives marked the start of an intensive two-year development phase at Ing. Erich Pfeiffer GmbH in Radolfzell,
Germany. The brief was to develop a modular system
to accommodate these  diverse application needs and, if possible, set new standards in flexibility and customisation. It was also necessary to maintain the established performance levels of the Advanced Preservative Free system including low actuation force, strong priming and re-priming action, plus the emission of a smooth  spray.

Cartridge Family Ready for Sampling

Now, in the third quarter  of 2006,  the new, modular Pfeiffer Cartridge  system is ready for sampling. This follows an extensive testing period, as well as independent verification of the system's microbiological properties  by the Qualis laboratory in Constance, Germany. Designed as an open platform, the family comprises
otic, topical/oral and nasal sprays, as well as a nasal drop dispenser.  Preserved and non-preserved solutions can be accommodated and dispensed  by this product  family. There are options of crimp, screw or snap-on  closures, plus a choice of colours, material and designs.
For all of the applications,  the pump functionality
is essentially the same, leading to a smooth  spray and high performance reliability. In the topical version, the tip-seal is smaller in size but the mechanical  properties remain constant. For nasal applications there is a choice of two devices with the spray and drop dispenser.  The
Cartridge  pump can be integrated into existing processes and products,  and the interchangeable design aims at giving customers  branding  opportunities to support  their product  differentiation. Standardised filling procedures and assistance with regulatory  affairs are key elements  of the accompanying  customer  support  package  that  has been created  parallel to the development, ready for the market introduction.
The measurable results of this development process can be summarised  in a verified two-digit list of unique benefits. Some are tip-seal driven, others related to microbiological integrity and several more are expressed in specific usage characteristics.

Propriety Tip-seal Technology

The propriety and patented Pfeiffer tip-seal, and the special micro filter with its textile membrane, equip the Cartridge system to prevent microbes entering  the system and to
stop the clogging of the tip of the pump.  This is key when dispensing crystalline solutions, such as throat  medication containing  sugar or steroidal medication.  The sealed mechanism  brings reliable protection against  evaporation and particles or dust. Eliminating the risk of evaporation
is crucial when dispensing a range of substances
- for example those containing  alcohol with its volatile behaviour.
The tip-seal is instrumental  to the system's proven priming and re-priming action, leading to a significant reduction  in drug wastage. This protection against  a loss of prime means for example that  even after a two-week period of inactivity in a bathroom cupboard, the Pfeiffer Cartridge  spray will dispense the correct dosage, in the appropriate concentration.

A Metal-free Route

The Pfeiffer Cartridge  system facilitates a fully metal-free path  for the pump's contents. This feature  is expected
to have a meaningful  impact in the rapidly growing field of homeopathic medicine for instance.  Being highly diluted, homeopathic medicines are extremely sensitive to contamination, even from the mild scent of everyday
substances  such as peppermint or coffee. Any contact  with metal during dispensing would be detrimental to medicines of this type and potentially render them completely ineffective. From a regulation  point of view, it is also a source of confidence  and efficiency for pharmaceutical manufacturers to be able to completely eliminate the
need for tests relating to metal content in dispensers, for example where active pharmaceutical ingredients  such as proteins and peptides  are concerned.

The Customisation Challenge

In developing the new Cartridge  system, Pfeiffer faced challenging demands for flexibility, without  compromising any aspects of performance, dependability  or user- friendliness. The resultant  modular product  family is geared to allow the relatively simple customisation of the dose volume. Regardless of changes  in the outer dimensions
of the package,  for example, to accommodate products specifically for adults or children, the overall spray package height  remains constant, regardless of the dosage. Filling flexibility is also facilitated by the ability to integrate the production of two dose-volumes  in the same line.
The concept  behind the secondary packaging  is two- fold. From a design and marketing  perspective  the aim is to offer clear product  differentiation without  complexity. From the development point of view, the constant design of the primary packaging  aims to fulfill regulatory  criteria at the start, independent of the parallel development
of the secondary packaging  (including inter-changeable finger flange). In other words, since the primary package is not adjusted,  its registration  remains valid, so there is absolutely no need for usability trials or other related, resource-consuming administrative  activity.

Conclusion

The Cartridge  family has the clear objective of ensuring that  scientifically proven characteristics  translate  directly into sales and marketing  advantages for pharmaceutical manufacturers.The resultant  modular system is unusual in its ability to provide the market with reliable performance excellence and a clear competitive business advantage, all under the umbrella of flexibility. Minimum investment  is thus required to bring maximum success on the market,  through using one dependable dispensing solution for many formulations  and applications.  In the Cartridge  family, marketing  and science meet in a win-win situation to satisfy the toughest efficiency, performance and design requirements of the increasingly competitive global pharmaceutical market.

Acknowledgements
Thanks go to Svenja Moll-Pichler, Marketing Manager  at Ing. Erich Pfeiffer GmbH, Pharma Division, for her support in supplying material for this article.