Recent advances in the engineering of nanosized active pharmaceutical ingredients: Promises and challenges

• Nanoparticle engineering is a promising tool to resolve many current issues associated with poorly soluble APIs.
• Serious challenges are associated with the preparation of nanosized APIs.
• Main challenges include separating nanosized APIs from surfactants, low yield, contamination with microsized particles, and re-suspending of nanosized APIs after drying.
• The optimization of nanosizing processes might open new horizons in the development of pharmaceutical products.

The advances in the field of nanotechnology have revolutionized the field of delivery of poorly soluble active pharmaceutical ingredients (APIs). Nanosized formulations have been extensively investigated to achieve a rapid dissolution and therefore pharmacokinetic properties similar to those observed in solutions. The present review outlines the recent advances, promises and challenges of the engineering nanosized APIs. The principles, merits, demerits and applications of the current ‘bottom-up’ and ‘top-down’ technologies by which the state of the art nanosized APIs can be produced were described. Although the number of research reports on the nanoparticle engineering topic has been growing in the last decade, the challenge is to take numerous research outcomes and convert them into strategies for the development of marketable products.

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