Luke Schenck
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View article: A Precipitation-Based Process to Generate a Solid Formulation of a Therapeutic Monoclonal Antibody: An Alternative to Lyophilization
A Precipitation-Based Process to Generate a Solid Formulation of a Therapeutic Monoclonal Antibody: An Alternative to Lyophilization Open
Lyophilization, or freeze-drying, is the default technique for the manufacture of solid-state formulations of therapeutic proteins. This established method offers several advantages, including improved product stability by minimizing chemi…
View article: Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib
Process-Induced Crystal Surface Anisotropy and the Impact on the Powder Properties of Odanacatib Open
Crystalline active pharmaceutical ingredients with comparable size and surface area can demonstrate surface anisotropy induced during crystallization or downstream unit operations such as milling. To the extent that varying surface propert…
View article: Evaluating Spray Drying and Co-Precipitation as Manufacturing Processes for Amorphous Solid Dispersions of a Low Tg API
Evaluating Spray Drying and Co-Precipitation as Manufacturing Processes for Amorphous Solid Dispersions of a Low Tg API Open
Amorphous solid dispersions feature prominently in the approach to mitigate low bioavailability of poorly water-soluble small molecules, particularly in the early development space focusing on toxicity evaluations and clinical studies in n…
View article: Varied Bulk Powder Properties of Micro-Sized API within Size Specifications as a Result of Particle Engineering Methods
Varied Bulk Powder Properties of Micro-Sized API within Size Specifications as a Result of Particle Engineering Methods Open
Micronized particles are commonly used to improve the content uniformity (CU), dissolution performance, and bioavailability of active pharmaceutical ingredients (API). Different particle engineering routes have been developed to prepare mi…
View article: A Combined Isolation and Formulation Approach to Convert Nanomilled Suspensions into High Drug-Loaded Composite Particles That Readily Reconstitute
A Combined Isolation and Formulation Approach to Convert Nanomilled Suspensions into High Drug-Loaded Composite Particles That Readily Reconstitute Open
The advantage of nanoparticles to improve bioavailability of poorly soluble drugs is well known. However, the higher-energy state of nanoparticles beneficial for bioavailability presents challenges for both the stability of nanosuspensions…
View article: Optimizing Solvent Selection and Processing Conditions to Generate High Bulk-Density, Co-Precipitated Amorphous Dispersions of Posaconazole
Optimizing Solvent Selection and Processing Conditions to Generate High Bulk-Density, Co-Precipitated Amorphous Dispersions of Posaconazole Open
Co-precipitation is an emerging method to generate amorphous solid dispersions (ASDs), notable for its ability to enable the production of ASDs containing pharmaceuticals with thermal instability and limited solubility. As is true for spra…
View article: Hierarchical Particle Approach for Co-Precipitated Amorphous Solid Dispersions for Use in Preclinical In Vivo Studies
Hierarchical Particle Approach for Co-Precipitated Amorphous Solid Dispersions for Use in Preclinical In Vivo Studies Open
Amorphous solid dispersions (ASD) have become a well-established strategy to improve exposure for compounds with insufficient aqueous solubility. Of methods to generate ASDs, spray drying is a leading route due to its relative simplicity, …