The development of any metered dose inhaler (MDI) presents a considerable technical challenge. However, when producing a generic item, wherein the emphasis of the project is on matching an existing innovator product, these issues are greatly magnified. In particular, the actuator component of an MDI presents an opportunity to optimise the performance match of a generic formulation to meet current regulatory requirements.
This paper discusses various methods, such as computed tomography and scanning electron microscopy, which can be used to assess innovator actuators and enable a matched generic actuator to be produced. In addition, the paper considers the key factors involved in matching pharmaceutical performance, such as spray orifice diameter and the ability of a clear component strategy — as well as an excellent working relationship with development partners — to reduce product development timelines.
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