MERXIN MRX003 capsule dry powder inhaler is used for pulmonary delivery and in particular for the treatment of chronic, obstructive pulmonary diseas- es (COPD) and asthma. The API is aerosolized and distributed with the respiratory system to find its way deep into the lungs of the patient. The cor- rect interplay of inhaler and formulation plays a decisive role in the success of the treatment.The first product target for MRX003 was a generic version of an API. Because of the nature of the generic market, it was of essential to achieve the shortest possible time to launch. This was achieved through a close cooperation between the partners. Decades of expertise and know-how in inhaler design and production were combined between MERXIN and us. Jochen Wegerer (Program Manager,
Gerresheimer Regensburg GmbH, Wackersdorf) was impressed by the cooperation: “The good teamwork within the project is noteworthy. Chal- lenges were always discussed in a goal-oriented, creative, and open man- ner, so that approaches to solutions could be formulated and implemented within the shortest time possible.”
The design of the manufacturing process of MRX003, had to deliver high product quality with the most stable, fully automated processes possible and to enable affordable production for
the generic drugs market. “With the help of our DMF package, we were able to create, implement, and qualify
the molds to be very robust,” Richard Gradl (Mold Engineer, Gerresheimer Regensburg GmbH, Wackersdorf) ex- plains. “The stable component quality and high process capability of the molds ensure good conditions in the series production environment.” Our
risk management approach was based on procedures that were tailored to the special features of the project, from qualification and validation to long-term production security, as highlighted by Tobias Bernklau (Global Head of Quality Engineering, Gerresheimer Regensburg GmbH, Wackersdorf): “The focus is always on the user for all decisions. For critical areas and functions, we deliberately invest more effort than for less critical areas and functions.”
