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Journal of Pharmaceutical Sciences

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https://www.readbyqxmd.com/read/28634122/mapping-the-binding-interface-in-a-non-covalent-size-variant-of-a-monoclonal-antibody-using-native-mass-spectrometry-hydrogen-deuterium-exchange-mass-spectrometry-and-computational-analysis
#1
Yuetian Yan, Hui Wei, Sutjano Jusuf, Stanley R Krystek, Jie Chen, Guodong Chen, Richard T Ludwig, Li Tao, Tapan K Das
Variants of monoclonal antibody containing an extra light chain has been reported in protein products(1-3). Due to potential impact on potency and immunogenicity, it is important to understand the formation mechanism of such variants so that appropriate control strategies can be implemented to assure product quality. In a model monoclonal antibody, we observed a size variant with an extra light chain non-covalently associated with the monomer (later named as "1.2mer"). The interaction between monomer and the extra light chain was characterized by native spray and hydrogen/deuterium exchange mass spectrometry (HDX MS) techniques...
June 17, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28634121/population-pharmacokinetics-of-tobramycin-inhalation-solution-in-pediatric-patients-with-cystic-fibrosis
#2
Xinting Wang, Stephan Koehne-Voss, SivaNaga S Anumolu, Jing Yu
Tobramycin inhalation solution (TOBI) given as a twice-daily inhalation of nebulized aerosols of 300 mg is approved for the treatment of Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients over 6 years of age. To investigate tobramycin pharmacokinetics (PK) after inhalation of TOBI in pediatric CF patients below 7 years, a population PK approach was used to evaluate tobramycin PK data in patients 6 months to 44 years of age from four clinical studies. The final model used a two-compartmental, first-order absorption model with effect of body mass index on the apparent central volume of distribution...
June 17, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28625727/incomplete-loading-of-sls-and-fassif-micelles-within-the-diffusion-layers-of-dispersed-drug-particles-during-dissolution
#3
Kendra Galipeau, Michael Socki, Adam Socia, Paul A Harmon
Poorly water soluble drug candidates have been common in developmental pipelines over the last several decades. This has fueled considerable research around understanding how bile salt and model micelles can improve drug particle dissolution rates and human drug exposure levels. However, in the pharmaceutical context only a single mechanism of how micelles load solute has been assumed, that being the direct loading mechanism put forth by Cussler(1) 40 years ago. In this model micelles load at the particle surface and will be loaded to their equilibrium loading values...
June 15, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28625726/pulmonary-administration-of-soluble-antigen-arrays-is-superior-to-antigen-in-treatment-of-experimental-autoimmune-encephalomyelitis
#4
Christopher Kuehl, Sharadvi Thati, Bradley Sullivan, Joshua Sestak, Michael Thompson, Teruna Siahaan, Cory Berkland
Antigen-specific immunotherapy (ASIT) has been used to hyposensitize patients to allergens and offers an enticing approach for attenuating autoimmune diseases. Applying ASIT to mucosal surfaces such as the lungs may engage unique immune response pathways to improve efficacy. Pulmonary delivery of soluble antigen arrays (SAgAs) was explored in mice with experimental autoimmune encephalomyelitis (EAE), a multiple sclerosis model. SAgAs were designed to impede immune response to autoantigen epitopes and are composed of a hyaluronan backbone with peptides PLP139-151 and LABL, a disease-causing proteolipid peptide epitope and an ICAM-1 ligand, respectively...
June 15, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28625725/closing-the-gap-counting-and-sizing-of-particles-across-submicron-range-by-flow-cytometry-in-therapeutic-protein-products
#5
Liling Zhang, Shuai Shi, Valentyn Antochshuk
Quantification and size distribution characterization of subvisible particles in parenteral biopharmaceutics, present as both proteinaceous and nonproteinaceous particles in the size range from 0.1-100 μm, are important for biopharmaceutical industry due to their potential safety and efficacy implications. While a number of analytical techniques are available to count and size subvisible particles, characterization of particles ≤ 2 μm remains a significant challenge due to technical limitations of existing particle counting instruments...
June 15, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28625724/the-binary-system-of-ibuprofen-nicotinamide-under-nanoscale-confinement-from-cocrystal-to-coamorphous-state
#6
Yanping Bi, Deli Xiao, Shuai Ren, Shuyan Bi, Jianzhu Wang, Fei Li
Coamorphous systems have gained success in stabilizing amorphous drugs and improving their solubility and dissolution. Here we proposed to confine a binary mixture of drug and coformer (CF) within nanopores to obtain a nano-confined coamorphous (NCA) system. For proving feasibility of this proposal, a poorly water-soluble drug (ibuprofen, IBP) and a frequently used pharmaceutical CF (nicotinamide, NIC) were loaded into nanopores of mesoporous silica microspheres (MSMs). The solid state of NCA system was characterized by differential scanning calorimetry, X-ray powder diffraction, infrared spectrum and solid state nuclear magnetic resonance...
June 15, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28624420/biophysical-characterization-and-thermal-stability-of-pneumococcal-histidine-triad-protein-d-phtd-in-the-presence-of-zinc-and-manganese
#7
Salvador F Ausar, Kavisha Jayasundara, Lamees Akawi, Cristopher Roque, Anthony Sheung, Jian Hu, Marina Kirkitadze, Nausheen Rahman
The Pneumococcal Histidine Triad Protein D (PhtD) is believed to play a central role in pneumococcal metal ion homeostasis and has been proposed as a promising vaccine candidate against pneumococcal disease. To investigate for potential stabilizers, a panel of physiologically relevant metals was screened using the thermal shift assay and it was found that only Zn(2+) and Mn(2+) were able to increase PhtD melting temperature. Differential Scanning Calorimetry (DSC) analysis revealed a sequential unfolding of PhtD and the presence of at least 3 independent folding domains that can be stabilized by Zn(2+) and Mn(2+)...
June 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28624419/thermo-optical-protein-characterization-for-straightforward-preformulation-development
#8
Randy Wanner, Dennis Breitsprecher, Stefan Duhr, Philipp Baaske, Gerhard Winter
The determination of protein unfolding and aggregation characteristics during preformulation is of major significance for the development of biopharmaceuticals. The aim of this study was to investigate the feasibility of a new immobilization- and label-free thermo-optical approach as an orthogonal method for material and time saving early formulation and drugability screenings. In the experimental setup used, changes in the intrinsic tryptophan fluorescence of the protein were measured during IR-laser induced heating of the samples...
June 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28624418/influence-of-dissolution-media-and-presence-of-alcohol-on-the-in-vitro-performance-of-pharmaceutical-products-containing-an-insoluble-drug
#9
Valeria Friuli, Lauretta Maggi, Giovanna Bruni, Giorgio Musitelli, Ubaldo Conte
The purpose of this investigation is to determine how the dissolution media may influence the release rate of an insoluble drug in in-vitro conditions. Some oral dosage forms containing Ibuprofen, a molecule that shows pH-dependent solubility, are tested. They are evaluated in different media to simulate the gastrointestinal transit at paddle rotation speeds of 50 and 100 rpm. Moreover, the potential effect of different ethanol concentrations on drug release is tested. The dissolution profiles of the tablets show a similar behavior in water, pH 1...
June 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28624417/pharmaceutical-film-coating-catalogue-for-spectral-domain-optical-coherence-tomography
#10
Hungyen Lin, Yue Dong, Daniel Markl, Zijian Zhang, Yaochun Shen, J Axel Zeitler
Optical coherence tomography (OCT) has recently been demonstrated to measure the film coating thickness of pharmaceutical tablets and pellets directly. The results enable the analysis of inter- and intra-tablet coating variability at an off-line and in-line setting. To date, only a few coating formulations have been tried and there is very little information on the applicability of OCT to other coatings. As it is well documented that optical methods including OCT are prone to scattering leading to limited penetration, some pharmaceutical coatings may not be measurable altogether...
June 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28624416/influence-of-a-small-amount-of-glycerol-on-the-trehalose-bioprotective-action-analyzed-in-situ-during-freeze-drying-of-lyzozyme-formulations-by-micro-raman-spectroscopy
#11
Tatiana Starciuc, Yannick Guinet, Laurent Paccou, Alain Hedoux
Micro-Raman spectroscopy gives the original opportunity to monitor simultaneously the operating process and the protein structure from in-situ investigations along the three stages of the freeze-drying (FD) process. This opportunity was used for determining how a small amount of glycerol enhances the bioprotective efficiency of trehalose during freeze-drying of lysozyme formulations. Three lysozyme formulations were analyzed: lysozyme dissolved in D2O (wt% 1:9), in Trehalose-D2O mixture (wt% 1:1:8) and in the Trehalose-Glycerol-D2O mixture (wt% 1:1:0...
June 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28622951/population-approach-to-efavirenz-therapy
#12
Hélder Duarte, João Paulo Cruz, Natália Aniceto, Ana Clara Ribeiro, Ana Fernandes, Paulo Paixão, Francisco Antunes, José Morais
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor commonly used as first line therapy in the treatment of human immunodeficiency virus, with a narrow therapeutic range and a high between-subject variability which can lead to central nervous system toxicity or therapeutic failure. To characterize the sources of variability and better predict EFV steady state plasma concentrations, a population pharmacokinetic model was developed form 96 HIV positive individuals, using a nonlinear mixed effect method with Monolix® software...
June 13, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28619604/clinical-implementation-of-pharmacogenomics-for-personalized-precision-medicine-barriers-and-solutions
#13
REVIEW
Michelle Elizabeth Klein, Md Masud Parvez, Jae-Gook Shin
Clinical implementation of pharmacogenomics (PGx) leads to personalized medicine, which improves the efficacy, safety, and cost-effectiveness of treatments. Although PGx-based research has been conducted for more than a decade, several barriers have slowed down its widespread implementation in clinical practice. Globally, there is an imbalance in programs and solutions required to empower the clinical implementation of PGx between countries. Therefore, we aimed to review these issues comprehensively, determine the major barriers, and find the best solutions...
June 12, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28619603/water-soluble-combretastatin-a4-phosphate-orally-delivered-via-composite-nanoparticles-with-improved-inhibition-effect-towards-s180-tumors
#14
Yurun Shen, Liping Wu, Liyan Qiu
Combretastatin A4 phosphate (CA4P) is a novel vascular disrupting agent for cancer therapy. However, frequent dosing and negative patient compliance has been encountered over CA4P by injection administration due to its quite short-term action and acute side effects. Therefore, it is significant to develop an oral formulation of CA4P. We established a novel method to prepare CA4P-loaded nanoparticles (CA4P-NPs) for oral administration by combining methoxy poly(ethylene glycol)-b-polylactide (PELA) and poly(D,L-lactic-co-glycolic acid) (PLGA) polymers...
June 12, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28603020/hot-melt-extrusion-hme-as-solvent-free-technique-for-a-continuous-manufacturing-of-drug-loaded-mesoporous-silica
#15
Natalja Genina, Batol Hadi, Korbinian Löbmann
The aim of the study was to explore hot melt extrusion (HME) as a solvent-free drug loading technique for preparation of stable amorphous solid dispersions (ASD) using mesoporous silica (PSi). Ibuprofen (IBU) and carvedilol (CAR) were used as poorly soluble active pharmaceutical ingredients (APIs). Due to the high friction of a API: PSi mixture below the loading limit of the API, it was necessary to add the polymer Soluplus(®) (SOL) in order to enable the extrusion process. As a result the APIs distributed between the PSi and SOL phase after HME...
June 8, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28603019/friability-testing-as-a-new-stress-stability-assay-for-biopharmaceuticals
#16
Tetsuo Torisu, Takahiro Maruno, Saki Yoneda, Yoshinori Hamaji, Shinya Honda, Tadayasu Ohkubo, Susumu Uchiyama
A cycle of dropping and shaking a vial containing antibody solution was reported to induce aggregation. In this study, antibody solutions in glass prefillable syringes with or without silicone oil lubrication were subjected to the combined stresses of dropping and shaking, using a friability testing apparatus. Larger numbers of subvisible particles were generated, regardless of silicone oil lubrication, upon combination stress exposure than that with shaking stress alone. Nucleation of antibody molecules upon perturbation by an impact of the dropping, and/or adsorption of antibody molecules to the syringe surface followed by film formation and antibody film desorption were considered key steps in the particle formation promoted by combination stress...
June 8, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28603018/mechanistic-analysis-of-human-skin-distribution-and-follicular-targeting-of-adapalene-loaded-biodegradable-nanospheres-with-an-insight-into-hydrogel-matrix-influence-in-vitro-skin-irritation-and-in-vivo-tolerability
#17
Marwa Ahmed Sallam, M Teresa Marín Boscá
This work aimed at the development of a biocompatible, non-oily nanomedicine for follicular delivery of adapalene (AD) ameliorating its irritation potential for convenient localized topical treatment of acne vulgaris. AD was efficiently incorporated into poly-Ԑ-caprolactone nanospheres (NS) with an encapsulation efficiency of (84.73± 1.52%), a particle size of (107.5± 8.19 nm), and zeta potential of -13.1 mV demonstrating a sustained release behavior. The AD-NS were embedded in either HPMC or hyaluronate gel (HA)...
June 8, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28601524/rifampin-stability-and-solution-concentration-enhancement-through-amorphous-solid-dispersion-in-cellulose-%C3%AF-carboxyalkanoate-matrices
#18
Hale Çiğdem Arca, Laura I Mosquera-Giraldo, Junia M Pereira, Nammalwar Sriranganathan, Lynne S Taylor, Kevin J Edgar
Tuberculosis (TB) is a deadly infectious disease; approximately 2 billion people are currently latently infected with the causative agent Mycobacterium tuberculosis. Approximately 8 million new active cases and 2 million deaths due to TB are recorded annually(1). Rifampin (Rif) is a vital first line TB treatment drug. Its effectiveness is hampered by the high dose required (600 mg 1x/day) and by its moderate, variable bioavailability. These issues can be explained by Rif instability at gastric pH, limited solubility at neutral pH, polymorphism, and stimulation of its own metabolism...
June 7, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28601523/effect-of-grinding-on-the-solid-state-stability-and-particle-dissolution-of-acyclovir-polymorphs
#19
Federico Magnoni, Maria Rosa Gigliobianco, Dolores Vargas Peregrina, Roberta Censi, Piera Di Martino
The present work investigated the solid state change of four acyclovir polymorphs when ground at room temperature (Method A) and under cryo-grinding in the presence of liquid nitrogen (Method B). Modifications in particle size and shape (evaluated by scanning electron microscopy) and in the water content (evaluated by thermal analysis) were related to transitions at the solid state, as confirmed by X-ray powder diffractometry. Anhydrous Form I was stable under grinding by both methods A and B. The anhydrous Form II was stable during grinding under Method A, while it was progressively converted to the hydrate Form V during grinding under Method B...
June 7, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28600186/effect-of-temperature-on-the-kinetics-of-the-activation-of-treosulfan-and-hydrolytic-decomposition-of-its-active-epoxy-derivatives
#20
Michał Romański, Jakub Mikołajewski, Franciszek K Główka
Treosulfan (TREO) is a prodrug applied in treatment of ovarian cancer and a myeloablative conditioning prior to stem cell transplantation. A sequential activation of TREO to intermediate monoepoxide (S,S-EBDM) and then to (2S,3S)-1,2:3,4-diepoxybutane (S,S-DEB) involves a nonenzymatic intramolecular nucleophilic substitution. The aim of this study was to determine the effect of temperature on the rate constants (k) for the activation of TREO and the hydrolysis of its epoxy-derivatives in a phosphate buffer of pH 7...
June 6, 2017: Journal of Pharmaceutical Sciences
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