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With detailed knowledge of the mechanical properties of excipients and formulated powders, we improved the lead formulation by overcoming manufacturability deficiencies using predictive and material sparing (<10 g) approaches.
During the course of formulation development, we could quickly identify manufacturability deficiencies in the lead formulation.
Two lead formulation candidates were selected based on their predicted stability profile.
The aerosol performance of the resulting dry powders as delivered from an Aerolizer® dry powder inhaler (DPI) exceeded the performance of commercially available DPIs; the emitted mass and the in vitro total lung mass of the lead formulation were 82.7% and 69.7% of filled capsule mass, respectively.
This article highlights the value of performing a second, more stressful digestion test to identify LBFs near a performance threshold and to facilitate lead formulation selection in instances where several LBF prototypes perform adequately under standard digestion conditions (but where further discrimination is necessary).
The lead formulation, DB4-PDB12, was optimally PEGylated not only to ensure colloidal stability (no change in size by DLS between 0 and 24 h) and neutral surface charge (0.139 mV) but also to maintain higher cell uptake (> 90% positive cells) than the most densely PEGylated particles.
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Lead formulations were significantly more effective in generating anti-ovalbumin IgG titers.
Lead formulations were tested in vivo for their ability to generate antibody titers against topically applied ovalbumin, a model antigen.
The stability of the lead formulations was also evaluated over 2 years to demonstrate a 2-year shelf life of this product.
The lead formulations dried off within a day after application with no noticeable residue at the treatment site, while others produced appreciable powdery residue or a large wet and oily spot.
In all other cases the bacterial coverage on lead formulations was compared with silver hydrogels.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com