Related Experiment Video
Updated: Jun 21, 2026
07:44
Fabrication of Pulsatile Polymeric Microparticles Encapsulating Rabies Antigen
Published on: May 12, 2023
Formulating protein therapeutics into particulate forms
Sixing Yang1, Weien Yuan, Tuo Jin
1Shanghai Jiao Tong University, China. tjin@sjtu.edu.cn
Expert Opinion on Drug Delivery
|August 12, 2009
Summary
Formulating protein drugs into particulate systems presents challenges due to protein denaturation during particle formation. This review critically examines methods for creating stable, effective protein drug delivery systems.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Materials Science
Background:
- Protein therapeutics require specialized formulation for effective delivery.
- Particulate systems offer advantages for protein drug delivery, including inhalation and sustained release.
- Protein denaturation during particle formation is a significant challenge.
Purpose of the Study:
- To critically review and analyze methods for formulating protein drugs into particulate forms.
- To identify challenges and feasible strategies for protein drug encapsulation.
- To evaluate formulation approaches for stability, encapsulation efficiency, and controlled release.
Main Methods:
- Literature review of protein formulation strategies.
- Critical analysis of particle-forming processes and their impact on protein stability.
- Evaluation of methods for protecting proteins during encapsulation.
Main Results:
- Many reported protein formulation methods struggle to maintain protein integrity.
- Key challenges include denaturation from interfaces, shear stress, and crosslinking agents.
- Few methods simultaneously achieve high encapsulation efficiency, controlled release, and storage stability.
Conclusions:
- Developing robust particulate protein drug delivery systems requires careful consideration of formulation processes.
- Further research is needed to optimize methods that protect protein structure and function.
- Feasible strategies must balance protein protection with desired pharmaceutical properties.
Related Concept Videos
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
01:30Production of Pharmaceuticals
Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...