Formulation and Delivery – Chemical
Patrick Doyle, PhD
Professor
MIT
Jaymin Shah, PhD
Research Fellow and Head of Topical and Advanced Drug Delivery
Pfizer Worldwide Research and Development
Groton, Connecticut
Bottom-up approaches to particle engineering allow for design of new processes which enable synthesis of API and co-processed API particles with optimized physical properties. Here I will review a suite of technologies which leverage microfluidic processes and soft matter principles for API particle engineering. The schemes can be classified as (i) ‘co-precipitation’ from microfluidic droplets containing API and excipient(s) via evaporative and solvent exchange methods, (ii) ‘staged precipitation’ which first involves the creation of hydrogel-based microcarriers followed by evaporative or solvent exchange-based crystallization within the microcarrier matrices, and (iii) ‘embedded nanoemulsions’ which involve the polymerization of a API-loaded nanoemulsions within polymer microcarriers followed by evaporative or solvent exchange-based crystallization. These three routes yield composites with tailored microstructure, tunable crystal size, and drug release profiles, in addition to enhanced powder flow properties. The precision and flexibility afforded by the proposed suite of technologies, which is a departure from the conventional crystal engineering paradigm, allows for drug products with tighter specifications, finely tuned dosage forms, increased quality control/safety, and distributed manufacturing.