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

Abstract

Spray-drying is an increasingly popular technology for the production of amorphous solid dispersions (ASDs) in the pharmaceutical industry that is used in the early evaluation and industrial production of formulations. Efficient screening of ASD in the earliest phase of drug development is therefore critical. A novel miniaturized atomization equipment for screening spray-dried solid dispersions (SDSDs) in early formulation and process development was developed. An in-depth comparison between the equipment/process parameters and performance of our novel screening device and a laboratory Büchi B290 mini spray-dryer was performed. Equipment qualification was conducted by comparing the particle/powder attributes, i.e., miscibility/solid state, residual solvent, and morphological properties of binary SDSDs of itraconazole prepared at both screening and laboratory scales. The operating mode of the miniaturized device was able to reproduce similar process conditions/parameters (e.g., outlet temperature (Tout)) and to provide particles with similar drug–polymer miscibility and morphology as laboratory-scale SDSDs. These findings confirm that the design and operation of this novel screening equipment mimic the microscale evaporation mechanism of a larger spray-dryer. The miniaturized spray-dryer was therefore able to provide a rational prediction of adequate polymer and drug loading (DL) for SDSD development while reducing active pharmaceutical ingredient (API) consumption by a factor of 120 and cycle time by a factor of 4.

Nano-Dry-Melting: A Novel Technology for Manufacturing of Pharmaceutical Amorphous Solid Dispersions

“…The investigated process characteristics are the product temperature as well as the heat exposure time. In general, the product residence time in a spray dryer can be estimated using an already established assumption that the time is as long as the residence time of the drying gas [ 24 ]. Equation (10)) was used for the calculation of the residence time , in which corresponds to the volume of the drying chamber and to the volumetric drying gas flow.…”

The influence of flavoring components on the physicochemical properties of spray-dried high oleic (HO) and tofu line (TL) soymilk powder

“…The shrinkage on the surface of the spherical particle might be due to the relatively low concentration of total solid in the feed solution. A slight increase in the concentration of feed solution improves the particle sphericity by forming a thicker shell on the surface of the particle (Lourenço et al, 2020) (Ousset et al, 2018). At 150,00x morphology of spray-dried soymilk powder particles appears primarily smooth with some coalescence.…”

“…(Figures 3 and 4 C, F). Scanning electron microscopic images of soymilk powder attribute the similar quality to spray-dried powder particles such as cheese powder (Koca et al, 2015), spray-dried solid dispersion (Ousset et al, 2018), soymilk powder (Osthoff et al, 2010).…”

“…Spray drying is a one-step drying process that is utilized extensively in the flavoring, cosmetic, pharmaceutical, and food sectors (Sosnik and Seremeta, 2015). The spray dryer is fitted with a spray nozzle with a specified size (0.15-2 mm) of the nozzle tip, which converts the feed solution into mist and transports it to the drying chamber (Ousset et al, 2018). Mini spray dryer is integrated with a two-fluid nozzle, in which compressed gas (air or N2) disperses the feed solution into the fine droplets inside the drying chamber (Spray Dryer Manual).…”

A Novel Protocol Using Small-Scale Spray-Drying for the Efficient Screening of Solid Dispersions in Early Drug Development and Formulation, as a Straight Pathway from Screening to Manufacturing Stages

“…However, the effect of the preparation method on the properties of screened ASDs and, more generally, on the outcome of the screening is often underestimated [ 14 ]. The fact that standard screening methodologies e.g., solvent casting and quench cooling are not representative of the operating mode and process conditions of regular spray-dryer, increases the risk to generate ‘false negative and positive’ results [ 15 , 16 ]. These samples are known to display different properties in terms of drug–polymer miscibility, glass transition temperature (T g ), physical stability, inter-components interactions and dissolution kinetics between screening and manufacturing scale [ 15 , 17 , 18 , 19 ].…”