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Abstract
Preparation of drug nanoparticles via wet media milling (nanomilling) is a very versatile drug delivery platform and is suitable for oral, injectable, inhalable, and buccal applications. Wet media milling followed by various drying processes has become a well-established and proven formulation approach especially for bioavailability enhancement of poorly water-soluble drugs. It has several advantages such as organic solvent-free processing, tunable and relatively high drug loading, and applicability to a multitude of poorly water-soluble drugs. Although the physical stability of the wet-milled suspensions (nanosuspensions) has attracted a lot of attention, fundamental understanding of the process has been lacking until recently. The objective of this review paper is to present fundamental insights from available published literature while summarizing the recent advances and highlighting the gap areas that have not received adequate attention. First, stabilization by conventionally used polymers/surfactants and novel stabilizers is reviewed. Then, a fundamental understanding of the process parameters, with a focus on wet stirred media milling, is revealed based on microhydrodynamic models. This review is expected to bring a holistic formulation-process perspective to the nanomilling process and pave the way for robust process development scale-up. Finally, challenges are indicated with a view to shedding light on future opportunities.
Highlights
The number of poorly water-soluble drug candidates coming out of drug discovery has increased tremendously over the past few decades [1,2,3,4]
While F can successfully explain the impact of all process parameters [45], it may be inadequate to explain the impact of bead size, which is usually regarded as an equipment parameter in media milling
This study has provided a comprehensive review of the pharmaceutical wet media milling studies mainly in the last decade, while covering both the formulation/stabilization aspects as well as processing aspects/issues in view of some advanced microhydrodynamic models
Summary
The number of poorly water-soluble drug candidates coming out of drug discovery has increased tremendously over the past few decades [1,2,3,4]. There are several approaches to producing drug nanoparticles such as wet media milling (referred to as nanomilling in the context of this review paper with a focus on nanosuspension preparation), homogenization, liquid antisolvent precipitation, melt emulsification, precipitation using supercritical fluid, evaporative precipitation, and micro-emulsions, and these approaches have been covered in several review papers [11,12,13,14,15,16] Their advantages and disadvantages have been discussed and compared [17,18,19,20].
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