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

ABSTRACT

Introduction: 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.

KEYWORDS:

• Spray drying
• particle design
• drug delivery
• scale-up
• solubility
• pulmonary
• biopharmaceuticals
• controlled-release

Article highlights

• Spray drying technology will continue to strengthen its position in the pharmaceutical industry in the coming years.

• The last few years have seen new adopters of the technology especially in the UK pharmaceutical CDMO industry.

• Systematic analysis showed that solubility enhancement and optimising aerosolization properties are the main drug delivery applications of spray drying.

• According to current regulatory trends, it is quite probable that API physical specifications will become more encompassing and exacting in the future.

• The spray drying process provides unique particle design capabilities useful to accelerate the development of high quality APIs and precision pharmaceutical products.

• Scale-up of spray drying remains one of the biggest challenges, though, advanced characterization and modelling approaches currently facilitate the process.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

No funding was received.