Spray dried dispersions assessment

In-process controls such as stratined sampling, process analytical technology (PAT) application, and blend homogeneity. Assess modincation of dissolution through optimization of API characteristics and then perform assessment of specialized technologies [hot-melt extrusion (HME), spray-dried dispersion, solid dispersion, etc.] for long-term resolution... 

Amorphous solid dispersions are leveraged at varying stages in development for a number of reasons. For extruded dispersions, a limited number of polymer systems summarized in Table 6.3 form the backbone of the compositional definition. In early development, they are most commonly used to support elevated exposures necessary for preclinical assessment and/or assure phase stability when a crystalline form is not readily isolated. At this stage of development, the amount of material available for development will be restricted. As discussed previously, this constraint can challenge the utility of extruded systems where minimum batch sizes are significantly larger than for development of spray-dried dispersions or coprecipitated material. 

The flowability of SD and SFD powders containing nanoparticles was assessed by measuring the bulk and tap density of the powder. Dissolving the powder in deionized water to form a colloidal dispersion and comparing the nanoparticle size before and after SFD and SD processing measured the reconstitution-rate of spray-dried and spray-freeze-dried nanoparticle formulations as described in Ali and Lamprecht [16]. The nanoparticle size was determined by photon correlation spectroscopy (Brookhaven Instruments Corporation, Holtsville, NY, USA) [16]. 

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