Pharmaceutical Technology Interviews Global Highly Potent & Oncology Platform Director Dr. Brittany Hayes after AAPS PharmSci 360 2024 on Oral Solid Dosage drug development & manufacturing, including challenges with the formulation of peptide-based drugs.
The development of oral peptide-based drugs presents unique challenges, specifies Brittany Hayes, PhD, Highly Potent & Oncology Platform Director at CordenPharma, due to the harsh environment of the gastrointestinal tract, highly acidic stomach, and enzymes that degrade peptides. “New manufacturing technologies and formulation techniques have shown to increase bioavailability by a few percentage points,” says Hayes. “But there’s a lot of variability here, including variability from one patient to the next and also in the same patient from one day to the next day. One of the big ones that’s been out there is permeation enhancers.”
Analytics is an important factor for the development of peptide-based drugs, highlights Hayes, because degradation products may be difficult to detect and quantify. “And then, with the use of these permeation enhancers, there needs to be simultaneous dissolution of the permeation enhancer and the peptide,” she says. “So, there may be some challenges here with analytical methods.” She also points out these novel excipients may require more regulatory qualifications and could be treated differently than conventional excipients.
Dr. Brittany L. Hayes
Director, Global Highly Potent & Oncology Platform
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