The development of any Metered Dose Inhaler (MDI) presents considerable technical challenges. However, in the development of a generic product, where the emphasis of the project is on matching an existing innovator product, these issues are greatly magnified. An expert knowledge of the influence of each of the many MDI components is critical to achieving a successful project outcome while compressing timelines to be first to reach the market.
This paper discusses the various methods that can be used to assess Innovator actuators such as Computed Tomography and Scanning electron microscopy to enable a matched generic actuator to be produced.
In addition the paper considers key factors for 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 reducing product development timelines.
The paper concludes that the development of actuators for generic MDIs is a technically challenging process that requires significant expertise. The growing market trend towards lower cost generic products means that companies need experienced partners to develop robust generic products that meet the requirements of the current regulatory landscape. The most qualified partners will be able to demonstrate significant experience of formulating, developing and gaining successful registration of multiple MDI products.