The slight changes in dissolution may suggests that exposure to moisture contributed to conformational transition in SF spray-dried powder. SF:NS (2:1) spray dried powder exposed to 76% relative humidity provides similar release during stage 1 and 2 dissolution testing, but showed slightly lower NS release during stage 3 testing. These data could support the hypothesis that the conformational transition rate depended on the rearrangement

of hydrogen bonds between SF chains; however additional studies are needed for confirm this assumption. Previous work has shown Inhibitors,research,lifescience,medical that the conformation transition of SF from random coil to β-sheet is due to the rearrangement of the hydrogen bonds between the polypeptide chains and the transition may be a nucleation-dependent aggregation [21]. The modest effect on dissolution

Alpelisib chemical structure performance observed (Figure 5) was due to the Inhibitors,research,lifescience,medical fact that when both the SF microparticles that were initially exposed to water and those not exposed to water are subjected to the dissolution media, they can further rearrange their chains making the initial humidity effect negligible. Figure 5 Comparison of naproxen release from SF:NS (2:1) spray-dry powder; non-exposed (■) to 76% Inhibitors,research,lifescience,medical relative humidity (Control), exposed (◊) to 76% relative humidity and accelerated stability (▲) at 60°C. … Additional accelerated stability studies on naproxen-containing SF microparticles were performed. The data presented in Figure 5 demonstrated that the release profile of naproxen from SF microparticles exposed to either high humidity (76%) or 60°C for 1 week is comparable to naproxen release from control Inhibitors,research,lifescience,medical samples. SEM images of SF microparticles obtained by spray drying are illustrated in Figure 6. SEM Images 6(a), 6(b), 6(c), and 6(d) show the microparticles formed from each spray-dried powder blend. The images provide evidence that microparticles were formed during the spray drying process. As seen in the images the SF microparticles collapsed, leaving behind imploded micro-particulates. The addition of 5% ethanol

to microparticles loaded with naproxen Inhibitors,research,lifescience,medical and control blends (refered to as (c) and (d) in Figure 6) was shown to produce microparticles that are less aggregated and more smooth, on average, which is possibly attributed to an accelerated evaporation process in the presence of alcohol. Further studies of spray-drying conditions are required to address the observation Bay 11-7085 of collapsed SF microparticles. The volume, intensity, and number weighted analysis with the DLS instrument showed that the mean particle size for the SF:NS (2:1) microparticles was 26.05 ± 1.92μm. This is in close agreement with the particle size established by the SEM images. Figure 6 SEM images of spray-dried microparticles. SF solution with spray-dried microparticles (a), SF:NS (2:1) blend spray-dried microparticles (b), SF solution with additional 5% ethanol spray dried microparticles (c), and …