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Journal of Pharmaceutical Sciences

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https://www.readbyqxmd.com/read/27894968/crystallographic-structure-intermolecular-packing-energetics-crystal-morphology-and-surface-chemistry-of-salmeterol-xinafoate-form-i
#1
Alexandru A Moldovan, Ian Rosbottom, Vasuki Ramachandran, Christopher M Pask, Oboroghene Olomukhoro, Kevin J Roberts
Single crystals of salmeterol xinafoate (form I), prepared from slow cooled supersaturated propan-2-ol solutions, crystallise in a triclinic P‾1 symmetry with two closely related independent salt pairs within the asymmetric unit, with an approximately double unit cell volume compared to the previously published crystal structure(1). Synthonic analysis of the bulk intermolecular packing confirms the similarity in packing energetics between the two salt pairs. The strongest synthons, as expected, are dominated by coulombic interactions...
November 25, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27894967/role-of-buffers-in-protein-formulations
#2
REVIEW
Teddy J Zbacnik, Ryan E Holcomb, Derrick S Katayama, Brian M Murphy, Robert W Payne, Richard C Coccaro, Gabriel J Evans, James E Matsuura, Charles S Henry, Mark Cornell Manning
Buffers comprise an integral component of protein formulations. Not only do they function to regulate shifts in pH, they also can stabilize proteins by a variety of mechanisms. The ability of buffers to stabilize therapeutic proteins whether in liquid formulations, frozen solutions or the solid state is highlighted in this review. Addition of buffers can result in increased conformational stability of proteins, whether by ligand binding or by an excluded solute mechanism. In addition they can alter the colloidal stability of proteins and modulate interfacial damage...
November 25, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27890245/mathematical-models-for-controlled-drug-release-through-ph-responsive-polymeric-hydrogels
#3
Ramya D Manga, Prateek K Jha
Hydrogels consisting of weakly charged acidic/basic groups are ideal candidates for carriers in oral delivery, as they swell in response to pH changes in the gastrointestinal tract, resulting in drug entrapment at low pH conditions of the stomach and drug release at high pH conditions of the intestine. We have developed 1-dimensional mathematical models to study the drug release behavior through pH-responsive hydrogels. Models are developed for 3 different cases that vary in the level of rigor, which together can be applied to predict both in vitro (drug release from carrier) and in vivo (drug concentration in the plasma) behavior of hydrogel-drug formulations...
November 24, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27890244/development-and-optimization-of-a-wet-granulation-process-at-elevated-temperature-for-a-poorly-compactible-drug-using-twin-screw-extruder-for-continuous-manufacturing
#4
Anuprabha K Meena, Divyakant Desai, Abu T M Serajuddin
The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water...
November 24, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27889072/if-euhydric-and-isotonic-do-not-work-what-are-acceptable-ph-and-osmolality-for-parenteral-drug-dosage-forms
#5
REVIEW
Dieter Roethlisberger, Hanns-Christian Mahler, Ulrike Altenburger, Astrid Pappenberger
Parenteral products should aim toward being isotonic and euhydric (physiological pH). Yet, due to other considerations, this goal is often not reasonable or doable. There are no clear allowable ranges related to pH and osmolality, and thus, the objective of this review was to provide a better understanding of acceptable formulation pH, buffer strength, and osmolality taking into account the administration route (i.e., intramuscular, intravenous, subcutaneous) and administration technique (i.e., bolus, push, infusion)...
November 23, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27889071/using-x-ray-crystallography-to-simplify-and-accelerate-biologics-drug-development
#6
REVIEW
Mark L Brader, Edward N Baker, Michael F Dunn, Thomas M Laue, John F Carpenter
Every major biopharmaceutical company incorporates a protein crystallography unit that is central to its structure-based drug discovery efforts. Yet these capabilities are rarely leveraged toward the formal higher order structural characterization that is so challenging but integral to large-scale biologics manufacturing. Although the biotech industry laments the shortcomings of its favored biophysical techniques, x-ray crystallography is not even considered for drug development. Why not? We suggest that this is due, at least in part, to outdated thinking (for a recent industry-wide survey, see Gabrielson JP, Weiss IV WF...
November 23, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27887890/non-additive-effects-of-repetitive-administration-of-lipoplexes-in-immunocompetent-mice
#7
Jamie L Betker, Thomas J Anchordoquy
Repetitive administration is routinely used to maintain therapeutic drug levels, but previous studies have documented an accelerated blood clearance of some lipid-based delivery systems under these conditions. To assess the effect of repetitive administration, non-PEGylated lipoplexes (+/- = 0.5) were administered four times via tail vein injection at 3-day intervals to immunocompetent Balb/c mice bearing 4T1 tumors. This study measured the effect of repeat administration of non-targeted lipoplexes on clearance, cytokine/chemokine response, plasmid distribution, reporter gene expression, and liver toxicity...
November 22, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27887889/development-of-intramammary-drug-delivery-systems-novel-in-vitro-release-method
#8
Sanjay Garg, Wen Wang, Yunmei Song, Patricia Eats, Darren J Trott, Stephen W Page, Kiro Petrovski
The aim of this study was to develop an in vitro release model for intramammary drug delivery system (IDDS) evaluation. This study was the first to establish an in vitro-in vivo correlation with investigation of IDDS containing losalocid. Three different methods including standard USP dissolution method with apparatus 2, modified USP method by using a dialysis bag or by using a specific designed enhancer cell system were assessed for the release study. Full cream milk and water were selected as the release media...
November 22, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27887723/synergistic-effect-of-cavitation-and-agitation-on-protein-aggregation
#9
Tetsuo Torisu, Takahiro Maruno, Yoshinori Hamaji, Tadayasu Ohkubo, Susumu Uchiyama
It was recently reported that dropping induces protein aggregation due to the occurrence of cavitation. Agitation also causes protein aggregation. In this study, vials filled with antibody solution were subjected to a cycle of dropping and shaking using the friability testing apparatus to examine the combined effect of cavitation and agitation on protein aggregation. A cycle of dropping and shaking generated a massive amount of subvisible particles. Comparison of aggregation rate at different fill volumes indicated that shaking plays an important role in protein aggregation due to combination stress...
November 22, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27887722/the-effect-of-specific-surface-area-of-chitin-metal-silicate-coprocessed-excipient-on-the-chemical-decomposition-of-cefotaxime-sodium
#10
Suhair S Al-Nimry, Khouloud A Alkhamis, Kawthar Z Alzarieni
Chitin-metal silicates are multifunctional excipients used in tablets. Previously, a correlation between the surface acidity of chitin-calcium and chitin-magnesium silicate and the chemical decomposition of cefotaxime sodium was found but not with chitin-aluminum silicate. This lack of correlation could be due to the catalytic effect of silica alumina or the difference in surface area of the excipients. The objective of this study was to investigate the effect of the specific surface area of the excipient on the chemical decomposition of cefotaxime sodium in the solid state...
November 22, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#11
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27876364/editorial
#12
EDITORIAL
Ronald T Borchardt
No abstract text is available yet for this article.
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27871727/critical-material-attributes-of-strip-films-loaded-with-poorly-water-soluble-drug-nanoparticles-ii-impact-of-polymer-molecular-weight
#13
Scott M Krull, Jennifer Ammirata, Sonia Bawa, Meng Li, Ecevit Bilgili, Rajesh N Davé
Recent work established polymer strip films as a robust platform for delivery of poorly water-soluble drug particles. However, a simple means of manipulating rate of drug release from films with minimal impact on film mechanical properties has yet to be demonstrated. This study explores the impact of film-forming polymer molecular weight (MW) and concentration on properties of polymer films loaded with poorly water-soluble drug nanoparticles. Nanoparticles of griseofulvin, a model Biopharmaceutics Classification System class II drug, were prepared in aqueous suspension via wet stirred media milling...
November 18, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27866687/glibenclamide-nanocrystals-in-a-biodegradable-chitosan-patch-for-transdermal-delivery-engineering-formulation-and-evaluation
#14
Hany S M Ali, Ahmed F Hanafy
Glibenclamide (GBD) nanocrystals (D50 = 429 nm) were engineered by applying combined precipitation and homogenization procedures. GBD crystallinity was maintained during the nanonization process as revealed by differential scanning calorimetry and X-ray analyses. Nanonized and micronized GBD were incorporated into chitosan solutions to fabricate transdermal delivery systems (TDDSs), nano- and micro-GBD, respectively. The fabricated TDDSs displayed satisfactory physicochemical characteristics without substantial aggregation of GBD nanocrystals during the casting and drying procedures...
November 17, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27866686/size-loading-efficiency-and-cytotoxicity-of-albumin-loaded-chitosan-nanoparticles-an-artificial-neural-networks-study
#15
Hadi Baharifar, Amir Amani
When designing nanoparticles for drug delivery, many variables such as size, loading efficiency, and cytotoxicity should be considered. Usually, smaller particles are preferred in drug delivery because of longer blood circulation time and their ability to escape from immune system, whereas smaller nanoparticles often show increased toxicity. Determination of parameters which affect size of particles and factors such as loading efficiency and cytotoxicity could be very helpful in designing drug delivery systems...
November 17, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27865610/assessment-of-bioequivalence-of-weak-base-formulations-under-various-dosing-conditions-using-physiologically-based-pharmacokinetic-simulations-in-virtual-populations-case-examples-ketoconazole-and-posaconazole
#16
Rodrigo Cristofoletti, Nikunjkumar Patel, Jennifer B Dressman
Postabsorptive factors which can affect systemic drug exposure are assumed to be dependent on the active pharmaceutical ingredient (API), and thus independent of formulation. In contrast, preabsorptive factors, for example, hypochlorhydria, might affect systemic exposure in both an API and a formulation-dependent way. The aim of this study was to evaluate whether the oral absorption of 2 poorly soluble, weakly basic APIs, ketoconazole (KETO) and posaconazole (POSA), would be equally sensitive to changes in dissolution rate under the following dosing conditions-coadministration with water, with food, with carbonated drinks, and in drug-induced hypochlorhydria...
November 16, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27865609/recent-advances-in-lipid-based-vesicles-and-particulate-carriers-for-topical-and-transdermal-application
#17
REVIEW
Shashank Jain, Niketkumar Patel, Mansi K Shah, Pinak Khatri, Namrata Vora
In the recent decade, skin delivery (topical and transdermal) has gained an unprecedented popularity, especially due to increased incidences of chronic skin diseases, demand for targeted and patient compliant delivery, and interest in life cycle management strategies among pharmaceutical companies. Literature review of recent publications indicates that among various skin delivery systems, lipid-based delivery systems (vesicular carriers and lipid particulate systems) have been the most successful. Vesicular carriers consist of liposomes, ultradeformable liposomes, and ethosomes, while lipid particulate systems consist of lipospheres, solid lipid nanoparticles, and nanostructured lipid carriers...
November 16, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27863806/pharmacokinetics-safety-and-tolerability-of-single-and-multiple-doses-of-abt-493-a-first-in-human-study
#18
Chih-Wei Lin, Sandeep Dutta, Armen Asatryan, Yi-Lin Chiu, Haoyu Wang, Jack Clifton, Andrew Campbell, Wei Liu
ABT-493 is a hepatitis C virus nonstructural protein 3/4A protease inhibitor with pangenotypic antiviral activity. This study investigated the pharmacokinetics, safety, and tolerability of single and multiple ascending doses of ABT-493 and the effect of food and ritonavir coadministration on ABT-493 pharmacokinetics in healthy adults. In the blinded, randomized, placebo-controlled phase 1 single- and multiple-dose portions of the study, ABT-493 25-800 mg were evaluated as single doses, and 200, 400, and 800 mg were evaluated as multiple doses...
November 15, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27863805/computational-dehydration-of-crystalline-hydrates-using-molecular-dynamics-simulations
#19
Anders S Larsen, Jukka Rantanen, Kristoffer E Johansson
Molecular dynamics (MD) simulations have evolved to an increasingly reliable and accessible technique and are today implemented in many areas of biomedical sciences. We present a generally applicable method to study dehydration of hydrates based on MD simulations and apply this approach to the dehydration of ampicillin trihydrate. The crystallographic unit cell of the trihydrate is used to construct the simulation cell containing 216 ampicillin and 648 water molecules. This system is dehydrated by removing water molecules during a 2200 ps simulation, and depending on the computational dehydration rate, different dehydrated structures were observed...
November 15, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27855960/polyarginine-nanocapsules-as-a-potential-oral-peptide-delivery-carrier
#20
Giovanna Lollo, Ana Gonzalez-Paredes, Macros Garcia-Fuentes, Pilar Calvo, Dolores Torres, Maria Jose Alonso
We have previously reported the development of novel nanocapsules made of polyarginine (PArg) specifically designed for the delivery of small anticancer drugs into cells. Our goal, in this work, has been to investigate the potential of these nanocarriers for oral delivery of peptide anticancer drugs. To reach this objective, we chose the antitumoral peptide, elisidepsin, and evaluated the characteristics of the PArg nanocapsules in terms of drug loading capacity, stability in simulated intestinal fluids, and ability to interact with the intestinal epithelium both in vitro (Caco-2 model cell line) and in vivo...
November 14, 2016: Journal of Pharmaceutical Sciences
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