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...
Overcoming translational barriers in nose-to-brain drug delivery for clinical applications [0.03%]
克服鼻部给药递送药物至大脑以用于临床应用的转化障碍
Xinyue Zhang,Stephanie Chow,Ho Wan Chan et al.
Xinyue Zhang et al.
Recent research has shown an increasing interest in nose-to-brain drug delivery due to its non-invasive nature and ability to transport therapeutics directly to the central nervous system. This approach offers significant advantages over tr...
Explaining the Underlying Causes of Different Tabletability Classifications of Binary Mixtures [0.03%]
解释二元混合物不同压片性分类的内在原因
Pradeep Valekar,Ira S Buckner
Pradeep Valekar
A tabletability classification system has been previously proposed to categorize the range of tabletability behaviors of binary mixtures. 1,2 Although the proposed system has been applied in several subsequent studies, the causes of each be...
A multicompartment stomach physiologically-based pharmacokinetic model capturing gastric reacidification can improve food effect predictions of weak bases [0.03%]
一个生理药代动力学模型可以捕获胃的再次酸化，从而改善弱碱性药物的食物效应预测问题
Lisa Cheng,Po-Chang Chiang,Matthew R Wright et al.
Lisa Cheng et al.
Various changes within the gastrointestinal tract following meal intake may significantly impact oral drug absorption. Physiologically-based pharmacokinetic (PBPK) models are often used to perform early predictions of food effects on oral a...
Application of ion-exchange chromatographic technique using resins to prepare the salts of polar unstable prodrugs and new chemical entities (NCEs) [0.03%]
离子交换色谱技术在制备极性不稳定的前药和新化学实体(NCEs)的盐中的应用
Raja K Rit,V Venkataramasubramanian,V Deepika et al.
Raja K Rit et al.
Prodrugs are inactive and bio-reversible derivatives of drugs or clinical candidates. Prodrugs and New Chemical Entities (NCEs) often do not show good bioavailability primarily due to poor solubility. One of the strategies to overcome this ...
Zahraa Al-Tamimi,Mei Feng,Waleed Elballa et al.
Zahraa Al-Tamimi et al.
Despite significant advancements in peptide drug development, there is still a challenge in formulating and delivering peptide drugs orally. Current oral peptide drugs have very low bioavailability (