Formulation Development

FORMULATION DEVELOPMENT – Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form

John Baumann, Dan Dobry, and Rod Ray, PhD, review the development and use of amorphous SDDs and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms.

GENOMIC BIOMARKERS – EGFR Mutations, Apoptosis & Gefitinib Response: A Model for Integrating Genomic Biomarkers Into Successful Precision Medicine

Sirosh Bokhari, PhD, says by not recognizing the importance of integrating biomarkers early in drug development and not considering companion diagnostics as an ultimate goal, companies would not be ready to select a companion diagnostic partner and negotiate agreements with long-term implications.

ORALLY DISINTEGRATING TABLETS – Novel Controlled Release Formulation for Orally Disintegrating Tablets Using Ion Exchange Resins

Abhijit Gokhale, PhD, and Praba Sundararajan indicate that drugs not typically amenable to ODT formulations include those that present taste-masking difficulties or require controlled or sustained release. However, as the demand for ODTs continues to grow, formulation scientists are exploring ways to adapt ODT formulations for drugs that require controlled or sustained release for optimal therapeutic benefits.



HIGH PURITY EXCIPIENTS – A Simple Solution to a Complex Problem

William Small, PhD, and Arsalan Khan say drug degradation can have toxicological effects in many instances, and it is imperative that this mechanism be minimized as much as possible. The best solution to this is to ensure that appropriate ingredients, both high in quality and purity, are chosen and used throughout the entire drug product lifecycle.