Showing papers in "Journal of Pharmaceutical Sciences in 2016"

TL;DR: This review attempts to address the critical molecular and thermodynamic aspects governing the physicochemical properties of amorphous solid dispersion systems and potential advantage of polymers as inert, hydrophilic, pharmaceutical carrier matrices.

TL;DR: Experience with marketed PEGylated products indicates that adverse effects in toxicology studies are usually related to the active part of the drug but not to the PEG moiety, and a trend toward the use of complex PEG architectures and larger PEG polymers, but with very pure and well-characterized PEG reagents is described.

TL;DR: This review provides an overview of the basic immune mechanisms in the context of interactions with protein aggregates, and critically examines the literature with emphasis on the underlying immune mechanisms as they relate to aggregate properties.

TL;DR: The objective of this review is to assemble the knowledge about disintegrants and the measurement of tablet disintegratability so that the information provided could be of help to tablet formulation development.

TL;DR: 3D printing is an applicable method in the production of drug-containing IUS and can open new ways in the fabrication of controlled release implantable devices.

TL;DR: In this article, the authors provided an elaborate characterization of human intestinal fluids (HIF) collected in fasted and fed-state conditions and characterized for pH, bile salts, phospholipids, cholesterol, triacylglycerides (TAG), DAG, monoacyl glycerides, free fatty acids (FFA), pancreatic lipase, and nonspecific esterase activity.

TL;DR: The state of the art is examined, the existing hurdles to overcome are discussed, and developmental strategies necessary to address remaining drug delivery issues are proposed.

TL;DR: The simplicity, flexibility, and efficiency of producing particles at the microscale or nanoscale, with tailored size, shape, morphology, and microstructure, make electrospraying to become one of the most promising and well-practiced approaches to be applied in many biomedical and pharmaceutical fields.

TL;DR: This study provides the first published evidence where the residual host cell protein present in the drug substance was identified and experimentally shown to catalyze the breakdown of PS20 in a protein formulation over time, resulting in free fatty acid particles and PS20 loss.

TL;DR: Results suggest that LPLA2 may play a key role in polysorbate degradation in some antibody preparations, as demonstrated by comparison of elution profiles by liquid chromatography-mass spectrometry.

TL;DR: In general, negligible amounts of aggregates are formed in pure CD solutions, but the aggregate formation is greatly enhanced on inclusion complex formation, and the extent of aggregation increases with increasing CD concentration.

TL;DR: It is concluded that injection volumes higher than 3.5 mL are worth exploring if required for the development of efficacious drug treatments and Studying tissue back pressure, injection site leakage, local tolerability, and injection-related adverse events, such as injection pain, should be considered for theDevelopment of higher SC injection volumes.

TL;DR: In this article, the authors explored the impact of formulation pH and type on the gastrointestinal dissolution, supersaturation and precipitation of posaconazole in humans, and assessed the impact on these processes, and demonstrated for the first time the gastrointestinal behavior of a weakly basic drug administered in different conditions.

TL;DR: The concept of "sink index" that quantifies the magnitude of deviations from perfect sink dissolution conditions in the sink/non-Sink continuum and some considerations of non-sink dissolution testing for marketed drug products are outlined.

TL;DR: An analysis of subvisible particulates using nanoparticle tracking analysis and flow imaging revealed a significantly higher concentration of sub visible particles in the multiuse vial presentation linked to the hypersensitivity cases, illustrating the utility of characterizing sub visible particulates not captured by conventional light obscuration.

TL;DR: This review is intended to address the general status of the pharmaceutical excipients and to describe the safety assessment, and suggests the interest of simplifying the formulations as much as possible and of reducing the number ofexcipients necessary to strictly meet the required functions.

TL;DR: Overall, these findings point out Soluplus nanomicelles as suitable carriers of ALA that may exhibit improved performance compared to currently available eye drop solutions.

TL;DR: The utility and drawbacks of different mouse models used for the development of unwanted immune responses and recommendations for future research utilizing mouse models are provided to improve the understanding of critical factors that may contribute to protein immunogenicity.

TL;DR: In vitro drug release studies found that the PNIPAAm/EC blend nanofibers were able to synergistically combine the properties of the 2 polymers, giving temperature-sensitive systems with sustained release properties.

TL;DR: The results indicate that these peptides can be effectively and selectively used as potential pharmaceutical excipients to improve drug delivery across biological barriers.

TL;DR: The results showed that AS1411 aptamer conjugation on the surface of NP could be a potential treatment strategy for A549 as a nucleolin-overexpressing cell line, suggesting that As1411-GEM-NPs could be potentially used for the treatment of NSCLC.

TL;DR: The utility of the HKCC model system to discern compound-specific effects that may lead to enhanced or mitigate hepatocellular injury due to innate or adaptive immune responses is indicated.

TL;DR: This work studied how the average degree of substitution affects the aggregation behavior, the toxicity, and the solubilizing effect on poorly soluble drugs and found that the products with low average degreeof substitution are more prone to aggregation.

TL;DR: In this paper, the authors discuss aspects of physical and chemical stability of antibody drug conjugates gathered from a survey of the literature and illustrate how investigations into stability enable the development of more effective ADC molecules for the future.

TL;DR: Drying amorphous formulations above Tg′, particularly high protein concentration formulations, is a viable means to achieve significant time and cost savings in freeze-drying processes.

TL;DR: The implication of potential protein-facilitated uptake mechanism(s) on drug distribution in cells under in vivo conditions is discussed, and a refined strategy for potentially performing more accurate quantitative in vitro-to-in vivo extrapolations (IVIVEs) of toxicity at the cellular level from data generated in cell assays is proposed.

TL;DR: The development and validation of a simple, rapid, and accurate method for the quantitation of protein nitrogen, which combines Kjeldahl digestion and ion chromatography with suppressed conductivity detection and requires nanomolar amount of nitrogen in samples, is reported.

TL;DR: Applications of SCH in studying hepatobiliary drug disposition and bile acid-mediated DILI are discussed and an example is presented to show how data generated in the SCH model were used to establish a quantitative relationship between intracellular bile acids and cytotoxicity, and how this information was incorporated into a systems pharmacology model for DilI prediction.

TL;DR: The results demonstrated that these combined hydrogels could become a potential drug delivery system for improving the therapeutic effect of diclofenac sodium and suggested an important technology platform for intra-articular administration.

TL;DR: In vitro experiments with a mathematical model are combined to develop therapeutic soft contact lenses to cure keratitis by extended release of suitable drugs, and vitamin E-loaded lenses retain all critical properties for in vivo use.