Dose accuracy, parenteral material administration compatibility, surfactant choices, and formulation development in large molecules using quartz crystal microbalance [0.03%]
Joe Weidman,Ligi Mathews,Kedar Gokhale
Joe Weidman
Making positive-impact formulation decisions for antibodies and integrated design of clinical durability creates a better drug product (DP). The goal of this study was to prevent dose loss to surfaces during clinical administration, especia...
Development of in vitro/in vivo correlation for long-acting injectable suspensions via bootstrapping [0.03%]
Bo Wan,Shalini Raj Unnikandam Veettil,Yi Li et al.
Bo Wan et al.
In vitro/in vivo correlation (IVIVC) is of great importance to expedite the development life-cycles for pharmaceutical industry and possibly to reduce the burden for regulatory assessment, especially for long-acting injectable (LAI) drug pr...
Guiyu Huang,Shuhui Chen,Yizhi Zhang et al.
Guiyu Huang et al.
Pain is particularly intolerable for children, and the analgesic regimen must be carefully managed, as systemic delivery may lead to serious side effects to growth and development of children. Therefore, the research and development of pain...
Hydroxypropyl-β-cyclodextrin/hyaluronic acid modified polydopamine nanoparticles co-loaded with BNN6 and epirubicin for synergistic photothermal/gas/chemotherapy of breast cancer [0.03%]
Dexue Liu,Sajid Asghar,Dan Gao et al.
Dexue Liu et al.
Combination therapy, which integrates diverse treatment modalities to induce synergistic anti-tumor effects, has emerged as a promising strategy in oncology. In this study, we developed a near-infrared (NIR) laser-triggered nitric oxide (NO...
Transient pH film model for in vitro powder dissolution of weakly basic drugs into buffer and comparison to conventional film model [0.03%]
Roshni P Patel,James E Polli
Roshni P Patel
The dissolution of ionizable drugs is critically influenced by the pH of the microenvironment at the solid-liquid interface, which in part can be impacted by the dissolving drug itself. For weak bases, dissolution may increase surface pH, t...
Aggregation of monoclonal and bispecific antibodies during pneumatic tube transport of IV bags in a hospital: Mitigation by polysorbate 80, poloxamer 188, and headspace removal [0.03%]
Parham Parnian,Annette M Medina,Nidia Gonzalez Lopez et al.
Parham Parnian et al.
Pneumatic tube systems (PTS) are being increasingly used in hospitals to rapidly transport critical packages, but their mechanical stresses raise concerns for the safe transport of protein therapeutics. This study examined the impact of the...
Preparation and evaluation of 3D-printed tacrolimus tablets based on mesoporous silica solubilization [0.03%]
Yixin Zhang,Xiaolu Han,Zhiqiang Tang et al.
Yixin Zhang et al.
Tacrolimus (FK506) has limited clinical applications due to its poor solubility and narrow therapeutic window. Therefore, strategies to enhance its solubility and enable personalized dosing are highly valuable. Recently, loading drug molecu...
Patrick J McNamara,Joseph Fleishaker,Darius Meiman
Patrick J McNamara
Purpose: To employ a comprehensive Top-Down scaling approach to estimate the impact of alterations in bioavailability (gut wall (FG) and hepatic first pass (FH,)) and clearance pathways (renal (ClR) and hepatic (ClH)) on ...
Industry guidance on container closure integrity strategies for difficult-to-test parenteral products (DTPs) [0.03%]
Klaus Wuchner,David Riesop,Carine Huon et al.
Klaus Wuchner et al.
Innovative modalities, such as antibody-drug conjugates (ADCs), radiopharmaceuticals (RPhs), and cell and gene therapies (CGTs), along with ultrahigh-concentration monoclonal antibody suspensions or high-concentration parenteral products, p...
Dmitry V Beigulenko,Inna V Zhezher,Ekaterina S Kazakova et al.
Dmitry V Beigulenko et al.
Here we describe the synthesis and physicochemical evaluation of a series of paclitaxel-biotin conjugates with systematically varied linker lengths. The structure of the synthesized compounds was confirmed by NMR spectroscopy and HRMS. Elon...