Journal of Pharmaceutical Sciences
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#1Sonal Bhujbal (Purdue University)H-Index: 4
#2Vaibhav V Pathak (Purdue University)H-Index: 1
Last. Qi Tony Zhou (Purdue University)H-Index: 27
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Abstract This study aims to develop amorphous solid dispersion (ASD) of lumefantrine with a cost-effective approach of spray anti-solvent precipitation. Four acidic polymers, hydroxypropylmethylcellulose phthalate (HPMCP), hydroxypropylmethylcellulose acetate succinate (HPMCAS), poly(methacrylic acid–ethyl acrylate) (EL100) and cellulose acetate phthalate (CAP) were studied as excipients at various drug-polymer ratios. Of the studied polymers, satisfactory physical stability was demonstrated for...
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#1Zhibiao WangH-Index: 2
#2Pu ShanH-Index: 2
Last. Jing XuH-Index: 3
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Abstract Sterile filtration is an effective method to remove any microorganisms present during nanoemulsion preparation. However, it lacks effective control parameters. Here, we established a simple and rapid approach for the process control of nanoemulsion sterile filtration by utilizing optical density detection as a process control parameter. During sterile filtration, the optical density or optical density ratio of the filtrate were continuously monitored to explore the correlation between o...
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#1Peter H. Gilbert (UD: University of Delaware)
#1P. H. Gilbert (UD: University of Delaware)H-Index: 7
Last. Yun Liu (UD: University of Delaware)H-Index: 38
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Abstract Small angle neutron scattering (SANS) studies of a model pharmaceutical formulation reveal how formulation stability depends on the compatibility of individual components. Solutions of two common protein formulation excipients, polysorbate 80 (PS80), a nonionic surfactant that prevents aggregation, and m-cresol, an antimicrobial agent for multi-dose injectable formulations, are investigated. The addition of m-cresol to PS80 solutions leads to solution turbidity and irreversibly alters P...
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#1Ian Roy (Janssen Pharmaceutica)
#2Ashaben Patel (Janssen Pharmaceutica)
Last. Ketan Amin (Janssen Pharmaceutica)H-Index: 1
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Polysorbate (PS) 20 and 80 are the most common surfactants in monoclonal antibody (mAb) drug product (DP) formulations. Residual host cell proteins (HCP) present at extremely low concentrations in DP formulations can maintain enough enzymatic activity to degrade PS surfactants. Over time, the hydrolysis of surfactant causes the accumulation of minimally soluble free fatty acids resulting in precipitation and formation of subvisible and visible particulates. This manuscript summarizes the investi...
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The use of a mixture of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) was investigated for microwave-induced in situ amorphization of celecoxib (CCX) inside compacts. Such amorphization requires the presence of a dipolar excipient in the formulation to ensure heating of the compact by absorption of the microwaves. Previously, the hygroscopic nature of PVP was exploited for this purpose. By exposing PVP-based compacts for set time intervals at defined relative humidity, controlled wate...
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#1Lisa Freerks (University of Greifswald)H-Index: 3
#2Carolin Zielke (University of Greifswald)
Last. Sandra Klein (University of Greifswald)H-Index: 23
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Abstract Since co-administration of dosage forms with food can impact drug exposure, food effect studies became an integral part of oral drug product development. Studies are usually performed in healthy adults and the dosage form is co-administered with a high-fat high-calorie standard breakfast meal to mimic worst-case dosing conditions. A corresponding study design for children is lacking but would be essential for a proper risk-assessment in this vulnerable patient group. To protect healthy ...
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#1Lili Wang (UQ: University of Queensland)H-Index: 3
#2Neville J. Butcher (UQ: University of Queensland)H-Index: 18
Last. Lisa M. Kaminskas (UQ: University of Queensland)H-Index: 31
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Pegylated liposomal doxorubicin (PLD) is widely utilised in cancer chemotherapy, but exhibits large inter-individual pharmacokinetic variability and sex differences in plasma clearance. Population pharmacokinetic modelling has suggested PLD plasma clearance correlates with peripheral monocyte counts, while sex hormones are known to affect endocytosis and phagocytosis in mononuclear cells. This study investigated whether sex hormones affect the uptake of PLD by human monocytes and macrophages in ...
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Abstract The present study aims to formulate all-trans retinoic acid (ATRA) loaded chitosan/tripolyphosphate lipid hybrid nanoparticles (CTLHNs) for enhancing its solubility and oral delivery. This is to improve ATRA therapeutic effect on diabetic nephropathy (DN). CTLHNs were prepared by o/w homogenization, employing stearic acid, to form lipid nanoparticles coated with chitosan that is stabilized against acidic pH via sodium tripolyphosphate crosslinking. Chitosan coated (F7) and naked lipid n...
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#1He Yu (Aston University)
#2Raj K.S. Badhan (Aston University)H-Index: 14
Abstract Gefitinib, a selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, is used to treat non-small-cell lung cancer (NSCLC). Lung cancer rates are high in China and are expected to increase over the next decade. CYP 2D6 intermediate metaboliser (IM) phenotypes are more prevalent in the Chinese population compared to Caucasians; the increased risk of drug-drug interactions (DDI) with chemotherapy polypharmacy may lead to different clinical pharmacokinetics outcom...
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#2Michaela M. LantzH-Index: 1
Last. Yatin R. Gokarn (Alexion Pharmaceuticals)H-Index: 8
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Abstract Monoclonal antibody (mAb)-based drugs are often prone to unfavorable solution behaviors including high viscosity, opalescence, phase separation, and aggregation at the high concentrations needed to enable patient-centric subcutaneous dosage forms. Given that these can have a detrimental impact on manufacturability, stability, and delivery, approaches to identifying, monitoring, and controlling these behaviors during drug development are critical. Opalescence presents a significant chall...
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