【作者】 金拓；

【Author】 Tuo Jin;School of Pharmacy, Shanghai JiaoTong University;

【机构】 上海交通大学药学院；

【摘要】 Developing practically feasible advanced dosage forms of biological medicines requires development of rational production engineering. For example, the current processes to produce sustainedrelease microspheres of peptides has no future as there are merely seven drugs delivered in this form since the first product in the category was launched thirty years ago despite peptide drugs are increasing. Similarly, the hurdles blocking the success of microneedle patches for proteins such as insulin comprise the inefficiency and poor reproducibility in producing them. These dosage forms are therefore regarded as "the most complicated among complicated dosage forms" in the industry because of their tedious production processes. This lecture will demonstrate two newly invented self-regulated production engineering, respectively, for sustained-release microspheres and microneedle patches, the two most promising dosage forms to replace frequent injections for biologic drugs. The microsphere production process involves an extruding-settling mechanism which not only combines formation, solidification, and collection of microspheres into a singleunit operation, but also achieves customizable particle size and nearly 100% peptide encapsulation efficiency. The process to produce microneedle patches involves a highly efficient cryo-3 D printing which "draws" hundreds of microneedles on a hydrogel sheet simultaneously under a condition free of elevated temperature and reactive hazards. Both of the efficient yet protein-friendly production processes may easily be scaled up with no needs of sophisticated equipment.更多还原

【Abstract】 Developing practically feasible advanced dosage forms of biological medicines requires development of rational production engineering. For example, the current processes to produce sustainedrelease microspheres of peptides has no future as there are merely seven drugs delivered in this form since the first product in the category was launched thirty years ago despite peptide drugs are increasing. Similarly, the hurdles blocking the success of microneedle patches for proteins such as insulin comprise the inefficiency and poor reproducibility in producing them. These dosage forms are therefore regarded as "the most complicated among complicated dosage forms" in the industry because of their tedious production processes. This lecture will demonstrate two newly invented self-regulated production engineering, respectively, for sustained-release microspheres and microneedle patches, the two most promising dosage forms to replace frequent injections for biologic drugs. The microsphere production process involves an extruding-settling mechanism which not only combines formation, solidification, and collection of microspheres into a singleunit operation, but also achieves customizable particle size and nearly 100% peptide encapsulation efficiency. The process to produce microneedle patches involves a highly efficient cryo-3 D printing which "draws" hundreds of microneedles on a hydrogel sheet simultaneously under a condition free of elevated temperature and reactive hazards. Both of the efficient yet protein-friendly production processes may easily be scaled up with no needs of sophisticated equipment.更多还原