The design and scale-up of spray dried particle delivery systems

Abstract

The rising demand for pharmaceutical particles with tailored physicochemical properties has opened new markets for spray drying especially for solubility enhancement, improving inhalation medicines and stabilization of biopharmaceuticals. Despite this, the spray drying literature is scattered and often does not address the principles underpinning robust development of pharmaceuticals. It is therefore necessary to present clearer picture of the field and highlight the factors influencing particle design and scale-up. Areas covered: The review presents a systematic analysis of the trends in development of particle delivery systems using spray drying. This is followed by exploring the mechanisms governing particle formation in the process stages. Particle design factors including those of equipment configurations and feed/process attributes were highlighted. Finally, the review summarises the current industrial approaches for upscaling pharmaceutical spray drying. Expert opinion: Spray drying provides the ability to design particles of the desired functionality. This greatly benefits the pharmaceutical sector especially as product specifications are becoming more encompassing and exacting. One of the biggest barriers to product translation remains one of scale-up/scale-down. A shift from trial and error approaches to model-based particle design helps to enhance control over product properties. To this end, process innovations and advanced manufacturing technologies are particularly welcomed.

Challenges associated with spray drying of lactic acid bacteria: Understanding cell viability loss

“…The powder's sterility is maintained by filtering atmospheric air before it is injected into the drying chamber (GEA, 2020d). Use of this aseptic spray dryer process is a very recent development in pharmaceutical applications (Al‐Khattawi et al., 2018; Arpagaus, 2018; Fragale et al., 2014; C. Zhu et al., 2014). To ensure the microbial safety of the air and thus, the final product, some industrial milk drying plants install air filters at the entrance to the drying chamber to filter out unwanted microbial cells (Tamime, 2009).…”

Meeting the unmet: from traditional to cutting-edge techniques for poly lactide and poly lactide-co-glycolide microparticle manufacturing

“…at pilot and production scales the particle residence time is much higher than at lab scale and yield may vary due to a different adhesion extent to the equipment walls. Complete understanding of scale-dependent and scale-independent factors is therefore strategic along with the design and engineering of a pilot model accounting for critical geometrical and workout requirements (Al-Khattawi et al 2018). This is one of the reasons for the as yet limited spray-dried depot products on the market.…”

Comparison of a Novel Miniaturized Screening Device with Büchi B290 Mini Spray-Dryer for the Development of Spray-Dried Solid Dispersions (SDSDs)

“…T out is often considered as one of the most important CPPs of spray-drying, identified as a key process parameter to be evaluated during the scale-up procedure [28,33,34]. As T out represents the highest temperature encountered by the dried particles during droplet drying [19], a change in T out can affect the physical and structural properties of the particles.…”