Deliquescence and hygroscopic growth measurements were performed for four internally mixed aerosol mixtures:  NaCl-glutaric acid, NaCl-pinonic acid, (NH4)2SO4-glutaric acid, and (NH4)2SO4-pinonic acid with varying organic mass fractions (0, 0.2, 0.5, 0.8, and 1.0). No effect on the deliquescence relative humidity of the salts was observed for any of the organic mixtures tested. The NaCl-organic mixed aerosols deliquesced at a relative humidity (DRH) 75 ± 1% and the (NH4)2SO4-organic aerosol at 79 ± 1% independent of organic mass fraction. The growth factors at RH = 85 ± 1%, G(85%), were also measured for the different aerosol mixtures. There was an observed decrease in G(85%) with increasing mass fraction of the organic. Measured G(85%) for the mixtures can be approximated as a first step with the assumption that the species absorb water independently. Overall, the organic portion was observed to enhance the water uptake of the (NH4)2SO4-organic aerosol systems by as much as a factor of 2−3 for particles consisting of 80% organic acids. The NaCl-organic mixtures presented evidence of positive and negative interaction depending on organic mass fraction, ranging from a 40% decrease to an 20% increase in water uptake as compared to that by the inorganic fraction alone.

The Food and Drug Administration (FDA) regulates pharmaceutical drug products to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has a great deal of potential to address issues of agility, flexibility, cost, and robustness in the development of pharmaceutical manufacturing processes. Over the past decade, there have been significant advancements in science and engineering to support the implementation of continuous pharmaceutical manufacturing. These investments along with the adoption of the quality-by-design (QbD) paradigm for pharmaceutical development and the advancement of process analytical technology (PAT) for designing, analyzing, and controlling manufacturing have progressed the scientific and regulatory readiness for continuous manufacturing. The FDA supports the implementation of continuous manufacturing using science-and risk-based approaches.

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The Center for Drug Evaluation and Research (CDER) within the US Food and Drug Administration (FDA) is tracking the use of nanotechnology in drug products by building and interrogating a technical profile of products containing nanomaterials submitted to CDER. In this Analysis, data from more than 350 products show an increase in the submissions of drug products containing nanomaterials over the last two decades. Of these, 65% are investigational new drugs, 17% are new drug applications and 18% are abbreviated new drug applications, with the largest class of products being liposomal formulations intended for cancer treatments. Approximately 80% of products have average particle sizes of 300 nm or lower. This analysis identifies several trends in the development of drug products containing nanomaterials, including the relative rate of approvals of these products, and provides a comprehensive overview on the landscape of nanotechnology application in medicine.

Abstract. Atmospheric aerosols have mixed chemical composition, with a variety of inorganic (e.g., sulfate, nitrate, ammonium, and sodium) and organic species often present in a single particle. In the present study, we investigate experimentally the cloud condensation nuclei (CCN) activation of submicron aerosol consisting of an inorganic core (e.g., ammonium sulfate) coated by an organic film, at typical atmospheric supersaturations. We use two types of organic coatings on the (NH4)2SO4 particles. The first is glutaric acid, a CCN active organic found in the atmosphere, and the second species is dioctylphthalate (DOP), a nonhygroscopic organic. The CCN activation of (NH4)2SO4-glutaric acid particles was measured at a supersaturation of 0.3%, for different inorganic core sizes and organic film thickness. We found that a coating of glutaric acid increases the CCN activation of an (NH4)2SO4 particle and that this behavior can be predicted by KiShler theory. The deviation from KiShler theory for the mixed aerosol was determined by comparing theoretical and experimental CCN activation diameters for the particles and was found to be within experimental error. A thick coating of DOP (at least 70% by mass) did not hinder the activation of (NH4)2SO4 particles at supersaturations of 0.5 and 1.0%. The values for the measured activation diameters for the DOP coated (NH4)2SO4 particles were within the experimental error determined by the pure inorganic experiments, indicating that DOP was most likely acting as inert mass during activation.