Abstract
The delivery of therapeutic proteins remains a challenge, despite recent technological advances. While the delivery of proteins to the lungs is the gold standard for topical and systemic therapy through the lungs, the issue still exists. While pulmonary delivery is highly attractive due to its non-invasive nature, large surface area, possibility of topical and systemic administration, and rapid absorption circumventing the first-pass effect, the absorption of therapeutic proteins is still ineffective, largely due to the immunological and physicochemical barriers of the lungs. Most studies using spray-drying for the nanoencapsulation of drugs focus on the delivery of conventional drugs, which are less susceptible to bioactivity loss, compared to proteins. Herein, the development of polymeric nanoparticles by spray-drying for the delivery of therapeutic proteins is reviewed with an emphasis on its advantages and challenges, and the techniques to evaluate their in vitro and in vivo performance. The protein stability within the carrier and the features of the carrier are properly addressed.
Highlights
The recent advances in the areas of biotechnology and bioengineering have resulted in the emergence of proteins for various therapeutic applications, such as erythropoiesis stimulation, hemophilia, Gaucher’s disease, glucose regulation, carcinomas, among others [1,2,3]
The aim of this review is to perform a full overview on the spray-drying of protein-loaded polymeric nanoparticles for dry powder inhalation
It is important to notice that the small size of polymeric nanoparticles is not acceptable for direct administration into the lungs, since they may get retained in the upper airways or exhaled without reaching the deep lungs
Summary
The recent advances in the areas of biotechnology and bioengineering have resulted in the emergence of proteins for various therapeutic applications, such as erythropoiesis stimulation, hemophilia, Gaucher’s disease, glucose regulation, carcinomas, among others [1,2,3]. The oral route is generally preferred, but the poor oral bioavailability of therapeutic proteins hinders their oral administration [5]. To overcome these problems, the lungs have been suggested has an appropriate delivery route due to the lungs’ physiologic features [6]. The lung has a large surface area and a well vascularized thin epithelial lining, which provides a noninvasive method for therapeutic proteins delivery, a direct access to systemic circulation and a way to avoid first pass metabolism and degradation by gastrointestinal tract [7,8]. The pulmonary delivery of therapeutic proteins has limitations because of their high molecular weight and difficulty to cross biological membranes, their poor bioavailability due to immune response, enzymatic degradation and lack of specific targeting [9]
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