Exploring precipitation techniques as an alternative to batch micronization.
An abundance of academic and industrial research into alternative particle production techniques has taken place over the years, but as yet only one product (spray-dried insulin) has reached the market. Many product developers perceive this lack of progress as a failure of alternative techniques to deliver on the large scale, but progress has also suffered as the result of an ideological rejection of production techniques alternative to micronization. However, given recent advances in our ability to produce controlled crystal forms and homogeneous particle populations, crystallization of active pharmaceutical ingredient (API) while limiting crystal growth to the respirable size range seems like the natural next step.