A comprehensive discussion on analytical method development and validation of a USP type-IV dissolution method for dexamethasone in a combination ophthalmic suspension with povidone-iodine [0.03%]
一种用于含聚维酮碘的十二烷基甲基硫酸钠-氢化可的松组合眼用悬浮液的USP IV溶出度方法的开发与验证的全面讨论
Likhit Mandal,Dr Praveen Kumar Vemuri
Likhit Mandal
Antimicrobial resistance resulting from the widespread use of topical antibiotics has accelerated the need for non-antibiotic strategies in ocular therapy. Povidone-iodine (PVP-I) offers broad antimicrobial activity without inducing resista...
Analysis of the formation of (sub)visual particles in ready-to-administer trastuzumab infusion bags during transport from the hospital pharmacy to patients at home [0.03%]
透析曲妥珠单抗输注袋中(sub)视觉颗粒的形成分析：从医院药房到患者家庭运输过程中
Charlotte Sikking,T Ton Dinh,Mirjam Crul et al.
Charlotte Sikking et al.
For biological drugs, subvisible particle formation can cause loss of efficacy of the drug or trigger immune reactions. Transport of ready-to-administer infusion bags, to enable home treatment of cancer patients, might cause particle format...
Ionic strength mitigates solvent/detergent-induced tertiary expansion of hemopexin [0.03%]
盐强度可减轻溶剂/清洁剂诱导的转铁蛋白受体三级结构扩张效应
Min-Jung Kim,Jae Eun Jung,Jieun Kang et al.
Min-Jung Kim et al.
Hemopexin (Hx) is a plasma glycoprotein that scavenges free heme with sub-nanomolar affinity and under development as a therapeutic. Solvent/detergent treatment (S/D) is routinely applied to plasma-derived manufacturing for viral safety and...
A novel bicyclic peptide-drug conjugate of 3-fluoro-10-hydroxy-evodiamine for targeted colorectal cancer therapy [0.03%]
一种新型二环肽药物缀合物3-氟-10-羟基叶秋碱用于结直肠癌靶向治疗
Siyuan Zhao,Chang Chu,Cuiping Li et al.
Siyuan Zhao et al.
This study aimed to develop a novel peptide-drug conjugate (PDC) by conjugating 3-fluoro-10-hydroxy-evodiamine (FOE) with a bicyclic peptide (BiP) targeting the EphA2 receptor. The goal was to enhance the solubility, tumor selectivity, and ...
Investigating the SNAC-to-drug ratio for the oral absorption of cyanocobalamin in rats [0.03%]
考察氰钴胺在大鼠口服吸收过程中SNAC-药物比例的研究
Po-Chang Chiang,Jia Liu,Karthik Nagapudi et al.
Po-Chang Chiang et al.
The oral route of administration continues to be the preferred and most convenient method for drug delivery among both patients and healthcare professionals. This preference is based not only on its user-friendliness but also on the practic...
Continuous lyophilization of suspended vials with per-vial inline analytics [0.03%]
带有在线分析的连续冷冻干燥悬浮安瓿瓶中的连续冻干技术
Bernhardt L Trout,Steven J Burcat,Rohan P Kadambi et al.
Bernhardt L Trout et al.
Pharmaceutical lyophilization (vacuum freeze-drying) removes water from aqueous drug products to stabilize formulations. This work presents a continuous final-dose pharmaceutical lyophilizer that can integrate with continuous production cha...
Characterization of peristaltic pumps and application to fill & finish operations: Part I [0.03%]
蠕动泵的表征及其在制剂工艺中的应用（一）
Mostafa Nakach,Lionel Bardet,Fabian Voll et al.
Mostafa Nakach et al.
Peristaltic pumps are widely used in fill and finish operations for parenteral drugs, especially biologics. These pumps are believed to work as volumetric pumps and to deliver a constant flow rate. However, this is only true within a limite...
Stability of Therapeutic Monoclonal Antibodies During Infusion with Elastomeric Pumps Intended for Home-Based Therapy [0.03%]
用于家庭治疗的弹性泵在输液过程中对治疗单克隆抗体稳定性的研究
Elham Taherian,Mirjam Crul,Reza Nejadnik
Elham Taherian
The majority of monoclonal antibodies (mAbs) are administered through intravenous infusion, typically in hospitals. A shift towards home-based therapy, initially driven by the COVID-19 pandemic, has been underway in recent years. Elastomeri...
Evaluating the Impact of In-line PES Filters on Subvisible Particle Formation During IV Administration of IgG4 Monoclonal Antibody [0.03%]
评估PES滤器灌注对IgG4单克隆抗体静脉输注过程中亚可见微粒形成的影响
Praval Shah,Maria Fischer,Taylour Treadwell et al.
Praval Shah et al.
Intravenous (IV) administration is a common delivery route for protein therapeutics, especially when used for oncology indications. Typically, multiple components, including IV bags with diluents and infusion sets, are used for IV administr...
Extracellular vesicles from microalgae Pavlova in non-heated condition potently enhance innate immune response as a novel cell-derived immunostimulatory adjuvant [0.03%]
微藻Pavlova分泌的外泌体作为新型免疫刺激佐剂可有效增强固有免疫应答
Masaki Morishita,Kotaro Yamada,Toshio Taira et al.
Masaki Morishita et al.
In vaccine therapy, there is a growing interest in novel immunostimulatory adjuvants derived from food products or dietary supplements with safe profiles. Pavlova is a microalga commonly used as a dietary supplement. Owing to its immune-act...