Development of A Closed, Ampoule-based Electronic Nebulizer System

Thomas Gallem

PARI Pharma GmbH
Steinerstrasse 15 A, DE-81369 München, Germany
Tel: +49 89 74 28 46 11         Fax: +49 89 74 28 46 50
Email: t.gallem@pari.de

Biography

Thomas Gallem is director of eFlow Product Design at PARI Pharma GmbH and intimately involved in the development of a novel electronic nebulizer product platform. He has an engineering degree in Micro- and Precision Engineering from the Munich Polytechnical Institute in Germany and a MBA degree from the Steinbeis University in Berlin. As one of the first members of the PARI Pharma team, he was instrumental in leading the design, prototyping and tooling processes. He holds a number of patents on novel devices for pulmonary drug delivery such as MDIs, holding chambers and electronic nebulizers.

Company Profile

PARI Pharma develops aerosol delivery devices and inhaled therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma specializes in treatments for pulmonary and nasal administration optimized to advanced delivery platforms, such as eFlow.

Focusing on comprehensive inhalation therapy development, including optimized nebulizer formulations, analytics, and aerosol characteri-zation, PARI Pharma has several clinical development programs ongoing, either partnered or proprietary. PARI Pharma, a PARI Medical Holding company, is located in Munich, Germany, with a major presence in the United States.

Abstract

The novel eFlow Closed System, a forward-looking device concept, has been developed to address an unmet need in the field of liquid inhalation therapy. The inhalation system features an integrated, single dose blow-fill-seal ampoule combined with a unique opening mechanism. Since a customized ampoule is required to operate the device, potential misuse, particularly with respect of choosing the wrong medication or filling the wrong dose, is minimized. Transferring the opening of the ampoule into the device and avoiding a separate nebulizer reservoir will announce several advantages such as to simplify filling procedures, to improve dose uniformity and hygiene requirements.

In the initial concept phase, the characteristics of the new device platform have been defined. Then a real material prototype has been built from pre-production moulds and tested In Vitro to identify if modifications will be needed to prepare for larger scale pre-series production. A critical milestone in the process from the initial idea to a successful product will be the acceptance and robustness of the device for delivery of liquid medications in clinical studies planned to start in 2009. The outcome of these studies will show, if inhalation products can be aerosolized and delivered by the eFlow Closed System device in a reproducible, therapeutically effective and safe way meeting with patients, caregivers and socioeconomic expectations.