Abstract
Solid dosage forms of biopharmaceuticals such as therapeutic proteins could provide enhanced bioavailability, improved storage stability, as well as expanded alternatives to parenteral administration. Although numerous drying methods have been used for preparing dried protein powders, choosing a suitable drying technique remains a challenge. In this review, the most frequent drying methods, such as freeze drying, spray drying, spray freeze drying, and supercritical fluid drying, for improving the stability and bioavailability of therapeutic proteins, are discussed. These technologies can prepare protein formulations for different applications as they produce particles with different sizes and morphologies. Proper drying methods are chosen, and the critical process parameters are optimized based on the proposed route of drug administration and the required pharmacokinetics. In an optimized drying procedure, the screening of formulations according to their protein properties is performed to prepare a stable protein formulation for various delivery systems, including pulmonary, nasal, and sustained-release applications.
Highlights
The intrinsic instability of protein molecules is currently the predominant challenge for biopharmaceutical scientists [1,2,3]
This study indicated that the combination of trehalose and dextran has an additive effect owing to the interaction potential of trehalose and enhanced Tg of dextran
The development of therapeutic proteins has increased rapidly owing to their high therapeutic efficacy
Summary
The intrinsic instability of protein molecules is currently the predominant challenge for biopharmaceutical scientists [1,2,3] Because of their higher molecular weights and diversity of composition, therapeutic proteins have much more complicated structures than conventional chemical drugs [3,4,5]. Dried therapeutic protein powders have shown good storage stability at room temperature (≤25 ◦C), and dehydration is an easy and economical approach [19,20]. Numerous reviews of drying strategies have been published [23,24] Most of these reviews focus on small molecules, and reviews of using drying methods to improve stability or pharmacokinetic properties of therapeutic proteins are relatively few [25,26]. Stabilizers for protein formulations and applications of dried-powder formulations to local or systemic drug delivery are highlighted
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