Earlier work provided direction for development of responsive drug delivery systems based on modulation of the structure, amphiphilicity, and surface density of bioactive peptides entrapped within pendant polyethylene oxide (PEO) brush layers. In this work, we describe the sequential and competitive adsorption behavior of such peptides at pendant PEO layers. Three cationic peptides were used for this purpose: the arginine-rich, amphiphilic peptide WLBU2, a peptide chemically identical to WLBU2 but of scrambled sequence (S-WLBU2), and the non-amphiphilic peptide poly-L-arginine (PLR). Optical waveguide lightmode spectroscopy (OWLS) was used to quantify the rate and extent of peptide adsorption and elution at surfaces coated with PEO. UV spectroscopy and time-of-flight secondary ion mass spectrometry (TOF-SIMS) were used to quantify the extent of peptide exchange during the course of sequential and competitive adsorption. Circular dichroism (CD) was used to evaluate conformational changes after adsorption of peptide mixtures at PEO-coated silica nanoparticles. Results indicated that amphiphilic peptides are able to displace adsorbed, non-amphiphilic peptides in PEO layers, while non-amphiphilic peptides were not able to displace more amphiphilic peptides. In addition, peptides of greater amphiphilicity dominated the adsorption at the PEO layer from mixtures with less amphiphilic or non-amphiphilic peptides.

Drug Development & Delivery

Formulation of poorly soluble drugs: a modern simulation-based approach

Author: McVey, Alexander ; Konagurthu, Sanjay

A review.Leading companies in other industries have shown that designing for quality and manufacturability from the earliest stages can pos. impact the outcomes for a product.In addition, predictive modeling and directed product analyses can significantly reduce time-to-market and overall product costs.To enable such approaches in pharmaceutical formulation development, there is a strong need for deeper mechanistic understanding to support efficient and robust formulation activities for poorly soluble mols.To meet this need and the demands of clients seeking solubilization solutions, Agere is taking a modern approach to solubilization formulation development that incorporates Quality-by-Design (QbD) principles at the preclin. stages of the drug development process.We have developed a platform, Quadrant 2, that is based on a comprehensive understanding of multiple proven solubilization technologies coupled with materials science and a targeted application of mol. modeling.The primary advantage of this approach is that it enables a faster, more informed formulation development process that promises to minimize costly iterations and reformulations as drug products proceed into the clinic.This following presents a case study in which a model BCS Class II compound, dipyridamole, was evaluated as an amorphous dispersion using mol. modeling combined with exptl. data.All work described was conducted using Agere's Quadrant 2 platform.

Application of scalable amorphous drug delivery systems in discovery and clinical development

Author: Smithey, Dan

Up to 70% of compounds in modern Discovery portfolios are insoluble in water.More than ever before, many of these compounds are being advanced into the clinic.As such, the pharmaceutical industry is increasingly embracing new technologies that can enable high absorption of these compoundsAmorphous solid dispersions are being utilized extensively and have demonstrated recent com. success.Preferred processes are spray drying and twin-screw melt extrusion, which are well established.However, the need for rigorous science-based methods for rapid and early selection of amorphous solid dispersion formulations remains, especially for application in Discovery.Such methods would ideally address 1) selection of excipient and API loading, 2) assessment of in vivo relevant performance, 3) solid-state characterization, and 4) solid dosage form considerations.This presentation will provide an overview of these critical scientific issues that must be addressed in order to develop com. viable, robust, and stable formulations.

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