Interfaces in Protein Drug Delivery: Device Concern

Abstract

Effective oral delivery is difficult for many protein drugs, as high-molecular-weight proteins do not easily cross the mucosal membrane and degradation in the gastrointestinal tract is common. Thus, alternative routes of delivery that often require delivery devices are utilized for administration of protein drug, including injection, inhalation, and implants. The protein may be in contact with the device surface during shipping and storage, as well as through delivery. Mechanical stresses on the protein, such as agitation, will increase the contact of the protein with the device surface, as well as with the air at the air/water interface, potentially leading to increased aggregation and reduced efficacy. In some cases, the device may be treated with lubricants that may also affect protein stability. The various stressors on proteins in devices will be discussed along with potential consequences and mitigation strategies.