Serán to Present at AAPS PharmSci 360 in Orlando

Be sure not to miss our Rapid Fire Talks at AAPS!

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High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

Cindy Chung, Ph.D.

Monday, October 23, 2023 3:45 PM – 4:00 PM ET Location: 208 AB West

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Abstract:

With a growing interest across the industry for subcutaneous delivery of high concentration protein therapeutics, suspension formulations comprised of solid-state protein particles suspended in non-aqueous vehicles offer a platform approach. This approach overcomes the limitation of high protein solution viscosities that require larger needles for delivery and can improve product shelf life. In this talk, we will discuss the impact of vehicle selection on syringe dispense force and product stability. We will present a case study where spray dried protein particles are suspended in three neat vehicles at varying concentrations and discuss the impacts of solids loading on viscosity and glide force. We will also discuss how vehicle impacts particle and protein stability when stored at accelerated storage conditions as a suspension.

Learning Objectives:

- Discuss important considerations of vehicle selection for the development of an injectable protein suspension drug product for subcutaneous delivery

- Understand the relationship between viscosity and glide force for high concentration protein suspensions

- Understand the impacts of vehicle selection on protein suspension drug product stability

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Amorphous Dispersion Speciation: Impact of Polymer Chemistry and Molecular Weight

Wesley Tatum, Ph.D.

Tuesday, October 24, 2023 3:45 PM – 4:00 PM ET Location: 208 AB West

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Abstract:

Spray-dried dispersions (SDDs) are a key technology for enhancing bioavailability of poorly water-soluble compounds. SDD formulations enable increased intestinal absorption through two primary mechanisms: (1) increasing concentration of solvated drug leading to a higher driving force for passive diffusion through the intestinal epithelium, and (2) formation of colloidal species leading to increased rates of diffusion through the unstirred water layer and a rapid resupply of solvated drug at the surface of epithelial cells. While the former is achieved through the amorphous form, the latter is dependent on the formation and nature of colloidal species that are characteristic of SDD formulations.

Our previous work has shown distinct differences in polymer speciation in a given biorelevant media as a result of concentration and polymer chemistry. The goal of the current study is to evaluate how molecular properties, such as molecular weight and LogP influences the partitioning of drug molecules into the polymer colloids.

Learning Objectives:

- Understand the concept of speciation in amorphous solid dispersions

- Understand difference between polymer colloids formed from different polymers used in amorphous dispersions

- Understand how molecular properties influence the partitioning of drug molecules into colloids

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