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Journal of Pharmaceutical Sciences

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https://www.readbyqxmd.com/read/29162424/injectable-hydrogels-for-localized-chemo-and-radio-therapy-in-brain-tumors
#1
Pilar de la Puente, Nicole Fettig, Micah J Luderer, Abbey Jin, Shruti Shah, Barbara Muz, Vaishali Kapoor, Sreekrishna M Goddu, Noha Nabil Salama, Christina Tsien, Dinesh Thotala, Kooresh Shoghi, Buck Rogers, Abdel Kareem Azab
PURPOSE: Overall survival of patients with newly diagnosed glioblastoma (GBM) remains dismal at 16 months with state-of-the-art treatment that includes surgical resection, radiation and chemotherapy. GBM tumors are highly heterogeneous and mechanisms for overcoming tumor resistance have not yet fully been elucidated. An injectable chitosan hydrogel capable of releasing chemotherapy (Temozolomide, TMZ) while retaining radioactive isotopes agents (Iodine, (131)I) was used as a vehicle for localized radiation and chemotherapy, within the surgical cavity...
November 18, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29162423/manipulating-aggregation-behaviour-of-the-uncharged-peptide-carbetocin
#2
Ulrich B Høgstedt, Jesper Østergaard, Torsten Weiss, Helen Sjögren, Marco van de Weert
Peptides are usually administered through subcutaneous injection. For low potency drugs, this may require high concentration formulations increasing the risk of peptide aggregation, especially for compounds without any intrinsic chargeable groups. Carbetocin was used as a model to study the behaviour of uncharged peptides at high concentrations. Manipulation of the aggregation behaviour of 70 mg/ml carbetocin was attempted by selecting excipients which interact with hydrophobic groups in carbetocin, and/or cover hydrophobic surfaces and interfaces...
November 18, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29155235/comparative-assessment-of-miniaturized-screening-approaches-for-selection-of-polymers-for-amorphous-drug-stabilization
#3
Alamelu Banda, Arushi Manchanda, Wei Zhang, Grace May Alba, Karthik Nagapudi
The present work highlights the use of miniaturized approaches to screen and prioritize development of solid dispersions that provide stabilization of the amorphous drug against crystallization and enhanced dissolution over the crystalline form. The approaches evaluated include solvent casting and solvent displacement based techniques. Four compounds were evaluated with both these screening approaches. A dual-pH dilution method using FaSSGF and FaSSIF as media was used to evaluate solubility enhancement ratio in each well of the screen...
November 16, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29154900/alternative-manufacturing-concepts-for-solid-oral-dosage-forms-from-drug-nanosuspensions-using-fluid-dispensing-and-forced-drying-technology
#4
Bastian Bonhoeffer, Arno Kwade, Michael Juhnke
Flexible manufacturing technologies for solid oral dosage forms with a continuous adjustability of the manufactured dose strength, are of interest for applications in personalized medicine. This study explored the feasibility of using micro-valve technology for the manufacturing of different solid oral dosage form concepts. Hard gelatin capsules filled with excipients, placebo tablets and polymer films, placed in hard gelatin capsules after drying, were considered as substrates. For each concept a basic understanding of relevant formulation parameters and their impact on dissolution behavior has been established...
November 15, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29154770/density-and-shape-factor-terms-in-stokes-equation-for-aerodynamic-behavior-of-aerosols
#5
Anthony J Hickey, David A Edwards
Pharmaceutical aerosols are used to treat many pulmonary diseases. The use of low density powders has proven useful to support efficient drug delivery. Measurements must account for the low density, spherical particle features contributing to aerodynamic behavior. Ideally, the aerodynamic particle size distribution (APSD) is measured experimentally. Without formal measurement of APSD, calculations may be performed using surrogate measures such as bulk or tapped density and dynamic shape factor in Stokes' equation...
November 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29133236/prediction-of-apparent-oral-clearance-of-small-molecule-inhibitors-in-pediatric-patients
#6
Yoshihiko Kimura, Yugo Chisaki, Tomohiko Saki, Chikako Matsumura, Hideyuki Motohashi, Masahide Onoue, Yoshitaka Yano
The purpose of this study was to build regression models for the prediction of apparent oral clearance (CL/F) for small-molecule inhibitors in the pediatric population using data obtained from adults. Two approaches were taken; a simple allometric regression model which considers no inter-drug or inter-individual variability and an allometric regression model with mixed-effects modeling (MEM) where some variability parameters are included in the model. Average CL/F values were obtained for 15 drugs at various dosages from 31 literatures (a total of 139 datasets) conducted in adults and for 15 drugs from 26 literatures (62 datasets) conducted in children...
November 10, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29133235/can-the-cellular-internalization-of-cargo-proteins-be-enhanced-by-fusing-a-tat-peptide-in-the-center-of-proteins-a-fluorescence-study
#7
Xiaochao Chen, Jing Chen, Rong Fu, Pingfan Rao, Richard Weller, Jeremy Brasdshaw, Shutao Liu
Aim to investigate whether the cellular uptake of cargo proteins can be enhanced by fusing a Tat peptide in the center of proteins, GST-Tat-GFP and GST-GFP-Tat proteins were firstly constructed and expressed. The cellular internalization of both proteins was then evaluated and compared in HeLa cells by using fluorescent microscopy and flow cytometry, as well as the transdermal delivery in human skin by using confocal microscopy. Results from in-vitro cell experiments showed that GST-Tat-GFP protein efficiently internalized into HeLa cells when a Tat peptide was fused in the center of proteins, whereas its efficiency is lower than that of GST-GFP-Tat protein with a Tat peptide terminal fused...
November 10, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29133234/-unknown-title
#8
EDITORIAL
Ronald T Borchardt
No abstract text is available yet for this article.
November 10, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29133233/freeze-drying-from-organic-co-solvent-systems-part-1-thermal-analysis-of-co-solvent-based-placebo-formulations-in-the-frozen-state
#9
Claudia Kunz, Sonja Schuldt-Lieb, Henning Gieseler
The use of co-solvent systems has been demonstrated to shorten lengthy freeze drying processes and improve the solubility and stability of certain active pharmaceutical ingredients. The goal of the present study was to evaluate the suitability of two thermal characterization techniques, differential scanning calorimetry and freeze dry microscopy, to identify an optimal co-solvent system. Binary mixtures of a co-solvent (tert-butanol, dimethyl sulfoxide, 1,4-dioxane, acetone or ethanol) and water were investigated...
November 10, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29122582/biorelevant-media-slows-the-solution-mediated-phase-transformation-of-amorphous-spironolactone
#10
Mary S Kleppe, Roy J Haskell, Robin H Bogner
Solution-mediated phase transformation (SMPT) can reduce the high drug concentration expected from amorphous formulations, eliminating the improvement in drug absorption one hoped to gain from this high energy drug state. The differences in SMPT of a supersaturating system were compared in biorelevant media (Fasted State Simulated Intestinal Fluid (FaSSIF) and Fed State Simulated Intestinal Fluid (FeSSIF)) and USP compendial medium, Simulated Intestinal Fluid without pancreatin (SIFsp). Amorphous spironolactone underwent SMPT to the same hydrate of spironolactone in all three media which was confirmed by the decrease in dissolution rates assessed in a flow-through dissolution apparatus, as well as by the appearance of crystals on the amorphous solid surface detected by polarized light microscopy...
November 6, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29113922/current-japanese-regulatory-systems-for-generics-and-biosimilars
#11
Ryosuke Kuribayashi, Kenji Sawanobori
Currently, biosimilar products are being actively developed around the world. One reason for this is the expiry of patents of original biopharmaceutical products with an extremely large market share because the biosimilar companies need to avoid infringing patents. A representative example of this is biosimilar versions of monoclonal antibodies. In Japan, the Ministry of Health, Labour and Welfare is promoting the use of biosimilar products because the market share of such products is currently extremely low compared with that of generic products...
November 4, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29108729/-liquid-crystalline-systems-based-on-glyceryl-monooleate-and-penetration-enhancers-for-skin-delivery-of-celecoxib-characterization-in-vitro-drug-release-and-in-vivo-studies
#12
Mariane de Cássia Lima Dante, Livia Neves Borgheti-Cardoso, Marcia Carvalho de Abreu Fantini, Fabíola Silva Garcia Praça, Wanessa Silva Garcia Medina, Maria Bernadete Riemma Pierre, Marilisa Guimarães Lara
Celecoxib (CXB) is a widely used anti-inflammatory drug that also acts as a chemopreventive agent against several types of cancer, including skin cancer. As the long-term oral administration of CXB has been associated with severe side effects, the skin delivery of this drug represents a promising alternative for the treatment of skin inflammatory conditions and/or chemoprevention of skin cancer. We prepared and characterized liquid crystalline systems based on glyceryl monooleate (GMO) and water containing penetration enhancers which were primarily designed to promote skin delivery of CXB...
November 3, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29102552/predictive-screening-tools-used-in-high-concentration-protein-formulation-development
#13
Melanie Hofmann, Henning Gieseler
This review examines the use of predictive screening approaches in high concentration protein formulation development. In addition to the normal challenges associated with protein formulation development, for high concentration formulations, solubility, viscosity, and physical protein degradation play major roles. To overcome these challenges, multiple formulation conditions need to be evaluated such that it is desirable to have predictive but also low-volume and high throughput methods in order to identify optimal formulation conditions very early in development without time and material consuming setups...
November 1, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29102551/editorial
#14
Ronald T Borchardt
No abstract text is available yet for this article.
November 1, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29102550/a-physiologically-based-pharmacokinetic-modeling-approach-to-predict-drug-drug-interactions-of-buprenorphine-after-subcutaneous-administration-of-cam2038-with-perpetrators-of-cyp3a4
#15
Tao Liu, Jogarao V S Gobburu
CAM2038, FluidCrystral (FC) injection depot, is an extended release formulation of buprenorphine given subcutaneously every 1 week (Q1W) or every 4 weeks (Q4W). The purpose of this research is to predict the magnitude of drug-drug interaction (DDI) after coadministration of a strong CYP3A4 inducer or inhibitor using physiologically based pharmacokinetic (PBPK) modeling. A PBPK model was developed for CAM2038 based on the previously published buprenorphine PBPK model after intravenous (IV) and sublingual (SL) administration and the PK profiles after SC administration of CAM2038 from two Phase I clinical trials...
November 1, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29102549/lipidic-nanoparticles-comprising-of-phosphatidylinositol-mitigate-immunogenicity-and-improve-efficacy-of-recombinant-human-acid-alpha-glucosidase-in-a-murine-model-of-pompe-disease
#16
Jennifer L Schneider, Robert K Dingman, Sathy V Balu-Iyer
Enzyme replacement therapy with recombinant human acid α-glucosidase (rhGAA) is complicated by the formation of anti-rhGAA antibodies, a short circulating half-life, instability in the plasma, and limited uptake into target tissue. Previously, we have demonstrated that phosphatidylinositol (PI) containing liposomes can reduce the immunogenicity and extend plasma survival of Factor VIII (FVIII) in a mouse model of Hemophilia A. In this manuscript we investigate the ability of PI liposomes to be used as a delivery vehicle to overcome the issues that complicate therapy with rhGAA...
November 1, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29100864/sustained-simultaneous-delivery-of-metronidazole-and-doxycycline-from-polycaprolactone-matrices-designed-for-intravaginal-treatment-of-pelvic-inflammatory-disease
#17
Meenakshi Pathak, Allan G A Coombes, BoMi Ryu, Peter J Cabot, Mark S Turner, Cheryn Palmer, Dongjie Wang, Kathryn J Steadman
Poly(ɛ-caprolactone) (PCL) intra-vaginal matrices were produced for local delivery of a combination of antibacterials, by rapidly cooling a mixture of drug powders dispersed in PCL solution. Matrices loaded with different combinations of metronidazole (10, 15 and 20% w/w) and doxycycline (10% w/w), were evaluated in vitro for release behavior and antibacterial activity. Rapid 'burst release' of 8-15% of the doxycycline content and 31-37% of the metronidazole content occurred within 24 h when matrices were immersed in simulated vaginal fluid (SVF) at 37°C...
October 31, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29097226/understanding-the-differences-between-cocrystal-and-salt-aqueous-solubilities
#18
Katie L Cavanagh, Chinmay Maheshwari, Naír Rodríguez-Hornedo
This work challenges the popular notion that pharmaceutical salts are more soluble than cocrystals. There are cocrystals that are more soluble than salt forms of a drug and vice-versa. It all depends on the interplay between the chemistry of both the solid and solution phases. Aqueous solubility, pHmax, and supersaturation index (SA =SCC or Ssalt/SD) of cocrystals and salts of a basic drug, Lamotrigine (LTG), were determined, and mathematical models that predict the influence of cocrystal/salt Ksp and Ka were derived...
October 30, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29107791/complexes-of-felodipine-nanoparticles-with-zein-prepared-using-a-dual-shift-technique
#19
Fuzheng Ren, Jinping Fu, Hui Xiong, Lin Cui, Guobin Ren, Haiying Guan, Qiufang Jing
To improve the dissolution of felodipine, felodipine-zein complexes were prepared using a dual shift technique, with zein as both stabilizer and carrier. The complexes were characterized by particle size, zeta potential, morphology, crystalline properties and release behavior. The complexes could be prepared in high yield and showed good redispersibility. The mean diameters of the felodipine particles in complexes were 150-300 nm, with negative zeta potentials of -30 mV to -25 mV after re-hydration, and the particle sizes of the complexes were in the range 10-80 μm...
October 28, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29107790/the-selection-of-a-pharmaceutical-salt-the-effect-of-the-acidity-of-the-counterion-on-its-solubility-and-potential-biopharmaceutical-performance
#20
Yan He, Edward Orton, Donglai Yang
A roadmap for the selection of a pharmaceutical salt form for a development candidate is presented. The free base of the candidate did not have sufficient chemical stability for development. The initially selected salt form turned out to be undevelopable because it was unstable during scale-up synthesis and storage. The rationale for the new solid form screening and the criteria for selection are discussed. Prior to the final selection, the pH solubility profiles of the two new salts, a benzoate and a besylate, were compared...
October 28, 2017: Journal of Pharmaceutical Sciences
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