Improving the CQAs and Lyophilization Process Efficiency of Freeze-dried Monoclonal Antibody Drug Products Using Controlled Ice Nucleation Technology [0.03%]
运用控制冰核化技术改善冻干单克隆抗体药物产品的关键质量属性及冷冻干燥工艺效率
Yao Chen,Mary Kleppe,Saurav Sharma et al.
Yao Chen et al.
Purpose: The objective of this research was to explore the application of controlled ice nucleation (CN) technology to enhance the critical quality attributes (CQAs) and manufacturing efficiency of freeze-dried monoclonal...
Multifunctional Engineering of Exosomes for Precision Therapeutics: Strategies for Targeted Delivery, Barrier Evasion, and Clinical Translation [0.03%]
多功能工程外泌体的精准治疗策略：靶向递送、屏障规避及临床转化
Shea Riona Mendonca,Pragathi Devanand Bangera,Mahesha Keerikkadu et al.
Shea Riona Mendonca et al.
Exosomes (EXM), cell-secreted nanoscale vesicles, are now used as promising tools for therapeutic protein, nucleic acid, and small molecule delivery. However, various challenges, such as rapid immune system clearance, ineffective cargo load...
Population Pharmacokinetics of Intravenous Levetiracetam in Neurosurgical Patients: Dosage Optimization Based on CrCl and Mannitol Use [0.03%]
神经外科患者的静脉注射左乙拉西坦药代动力学：基于CrCl和甘露醇使用的剂量优化
Jinwei Fan,Jinhui Xu,Xianglong Chen et al.
Jinwei Fan et al.
Objective: Conventional low-dose levetiracetam (LEV) for post-neurosurgical seizure prophylaxis often yields subtherapeutic serum levels. This study characterized the population pharmacokinetics (PPK) of intravenous LEV t...
Evaluation of Mannitol's Crystallization Impact on the Secondary Structure of Spray-Dried recombinant human Growth Hormone (rhGH) Formulations [0.03%]
甘露醇结晶对喷雾干燥重组人生长激素(rhGH)制剂二级结构影响的评估
Ravi Vamsi Peri,Harsh Anchan,Kamal Jonnalagadda et al.
Ravi Vamsi Peri et al.
Objective: The development of protein formulations is grappled by the complexity of maintaining protein integrity during the arduous formulation process. While several excipients have been employed for the stabilization o...
Pharmaceutical 3D Printing for Psychiatric Medications: Advanced Innovations in Taste Masking and Personalized Oral Drug Delivery [0.03%]
精神病药物的制药3D打印：掩味和个性化口服给药的先进创新技术
Praveen H S,Kiran Kumar G B,Prasiddhi Naik et al.
Praveen H S et al.
Purpose: This review aims to examine the impact of three-dimensional (3D) printing technologies on enhancing psychiatric pharmacotherapy through facilitating personalized and patient-centered drug delivery. This research ...
Drum Filling of Thin-Film Freeze-Dried Monoclonal Antibody Powder in UniDose Powder Nasal Spray System [0.03%]
UniDose粉鼻喷雾系统中单克隆抗体冻干粉末薄层的鼓包填充研究
Michael A Sandoval,Miguel O Jara,Thomas Henry et al.
Michael A Sandoval et al.
Purpose: Intranasal delivery of monoclonal antibodies (mAb) offers an attractive approach for preventing or treating respiratory viral infections. Previously, we showed that thin-film freeze-dried powder (TFFD powder) of ...
Co-encapsulation of an AKT Inhibitor Enhances the Tumor-cell Selectivity of STING Agonists in Co-delivery Liposomes [0.03%]
共封装AKT抑制剂可增强共递送脂质体中STING激动剂的肿瘤细胞选择性
Ziyu Ge,Qiang Zhang,Yuming Wang et al.
Ziyu Ge et al.
Objective: The therapeutic potential of STING agonists in cancer immunotherapy is hindered by poor tumor selectivity, resulting in systemic inflammation. Conventional targeted delivery strategies rely on cell-surface mark...
A Proposal for Alternative FDA Bioequivalence Criteria for Narrow Therapeutic Index Drug Products to Support Future Harmonization [0.03%]
一个针对窄治疗指数药物生物等效性标准的替代FDA准则的提议以支持未来的国际协调工作
Wanjie Sun,Donald Schuirmann,Fairouz Makhlouf et al.
Wanjie Sun et al.
Purpose: Establishing bioequivalence (BE) for narrow therapeutic index (NTI) drugs presents unique challenges due to the delicate balance between therapeutic efficacy and toxicity. Recognizing the critical nature of NTI d...
Impact of Pre-Actuation Shaking on the Aerosolization Performance of Easyhaler® Salbutamol Dry Powder Inhaler [0.03%]
预震对Easyhaler沙美特罗干粉吸入剂雾化性能的影响
Ludovica Esposito,Patrick He,Chun Yuen Jerry Wong et al.
Ludovica Esposito et al.
PURPOSE OR OBJECTIVE: Each Easyhaler® Salbutamol 100 μg dry powder inhaler (DPI) uniquely requires pre-actuation shaking, unlike most commercial DPIs. This study aimed to investigate the aerodynamic and functional implications of pre-actu...
Novel orally Disintegrating Edible Films with Ursodeoxycholic Acid for the Treatment of Hepatobiliary Diseases in Pediatric Patients [0.03%]
用于儿科患者治疗肝胆疾病的含鹅脱氧胆酸新型口服速溶可食用膜式制剂
Oriana Boscolo,Sabrina Flor,Camila Olivera et al.
Oriana Boscolo et al.
Purpose: Ursodeoxycholic acid (UDCA) has low toxicity and restores biochemical parameters in cholestatic preschoolers and children. The edible film is a new dosage form included in USP-NF 2023. The objective was to design...