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International Journal of Pharmaceutics

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https://www.readbyqxmd.com/read/28939464/milling-solid-proteins-to-enhance-activity-after-melt-encapsulation
#1
Parker W Lee, João Maia, Jonathan K Pokorski
Polymeric systems for the immobilization and delivery of proteins have been extensively used for therapeutic and catalytic applications. While most devices have been created via solution based methods, hot melt extrusion (HME) has emerged as an alternative due to the high encapsulation efficiencies and solvent-free nature of the process. HME requires high temperatures and mechanical stresses that can result in protein aggregation and denaturation, but additives and chemical modifications have been explored to mitigate these effects...
September 19, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28939463/design-and-pharmaceutical-applications-of-a-low-flow-rate-single-nozzle-impactor
#2
Hui Wang, Pallavi Bhambri, James Ivey, Reinhard Vehring
A new low-flow-rate (0.5L/min) single-nozzle impactor for the concentration of dilute aerosol particles with selected pharmaceutical applications is described in this paper. The impactor can be configured up to 11 stages with a wide range of cutoff diameters from 0.6μm to 21.1μm, enabling convenient sampling of inhalable drug particles from inhalation devices and drug production processes. Its unique single-nozzle design and removable impaction plate allow direct sample transfer for subsequent compositional, morphological, solid-state, and other analysis...
September 19, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28939462/enhanced-cell-viability-in-hyaluronic-acid-coated-poly-lactic-co-glycolic-acid-porous-scaffolds-within-microfluidic-channels
#3
Fernanda Zamboni, Marie Keays, Sheri Hayes, Ahmad B Albadarin, Gavin M Walker, Patrick A Kiely, Maurice N Collins
The concept of the present work is to produce porous optimised scaffolds of poly(lactic-co-glycolic acid) (PLGA) coated with hyaluronic acid (HA), to provide a suitable microenvironment for cellular proliferation. Freeze dried scaffolds were produced from PLGA with varying lactic acid and glycolic acid ratios along the polymer backbone, as follows: 50:50 ester terminated, 50:50 carboxylate end-group and 85:15 ester terminated. Subsequently, these scaffolds were immersed in crosslinked HA in order for the coating to enhance biological performance...
September 19, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935258/rifampicin-lipid-polymer-hybrid-nanoparticles-lipomer-for-enhanced-peyer-s-patch-uptake
#4
Sagar S Bachhav, Vikas D Dighe, Darsheen Kotak, Padma V Devarajan
The oral uptake of intact nanocarriers through Peyer's patches is an important uptake pathway. We report Rifampicin Lipid-Polymer hybrid nanoparticles (RIF-LIPOMER) using glyceryl monostearate as lipid and the mucoadhesive polymer, Gantrez, with the objective of balancing hydrophobicity and mucoadhesion for enhanced Peyer's patch uptake. RIF-LIPOMER was optimized for size, hydrophobicity, and mucoadhesion using Box-Behnken. Design RIF-LIPOMER (RIF-LIPO-120) exhibited average particle size in the range 300-400nm with drug loading >12%...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935257/tetrac-conjugated-polymersomes-for-integrin-targeted-delivery-of-camptothecin-to-colon-adenocarcinoma-in-vitro-and-in-vivo
#5
Mona Alibolandi, Rouhollah Rezvani, Sara Amel Farzad, Seyed Mohammad Taghdisi, Khalil Abnous, Mohammad Ramezani
In this study, we prepared tetraiodothyroacetic acid (tetrac) conjugated PEG-PLGA polymersomes for the targeted delivery of camptothecin to colon adenocarcinoma. Tetrac, which binds to integrin αvβ3 with high affinity and specificity, was covalently conjugated to the surface of the PEGylated polymersomal formulation of camptothecin (CPT). The hydrodynamic and morphological properties of the prepared system were evaluated using TEM (transmission electron microscopy), SEM (scanning electron microscopy) and DLS (dynamic light scattering) experiments...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935256/application-of-feedback-control-and-in-situ-milling-to-improve-particle-size-and-shape-in-the-crystallization-of-a-slow-growing-needle-like-active-pharmaceutical-ingredient
#6
Yang Yang, Kanjakha Pal, Andy Koswara, Qingqing Sun, Yuqi Zhang, Justin Quon, Rahn McKeown, Charles Goss, Zoltan K Nagy
Control of crystal size and shape is crucially important for crystallization process development in the pharmaceutical industries. In general crystals of large size and low aspect ratio are desired for improved downstream manufacturability. It can be extremely challenging to design crystallization processes that achieve these targets for active pharmaceutical ingredients (APIs) that have very slow growth kinetics and needle-like morphology. In this work, a batch cooling crystallization process for a GlaxoSmithKline patented API, which is characterized by very slow growth rate and needle morphology, was studied and improved using process analytical technology (PAT) based feedback control techniques and in situ immersion milling...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935255/a-comprehensive-approach-to-qualify-and-validate-the-essential-parameters-of-an-in-vitro-release-test-ivrt-method-for-acyclovir-cream-5
#7
Katrin I Tiffner, Isadore Kanfer, Thomas Augustin, Reingard Raml, Sam G Raney, Frank Sinner
The rate of release of an active pharmaceutical ingredient (API) from a topical semisolid dosage form can be influenced by its physical and structural properties. An In Vitro Release Test (IVRT) is an established method to characterize this rate of API release and compare the underlying sameness in product quality characteristics. The purpose of this work was to validate an IVRT method to compare acyclovir cream, 5% products. However, despite widespread use of the IVRT since 1997, there was no established approach to validate an IVRT method...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935254/design-of-gefitinib-loaded-poly-l-lactic-acid-microspheres-via-a-supercritical-anti-solvent-process-for-dry-powder-inhalation
#8
Qing Lin, Guijin Liu, Ziyi Zhao, Dongwei Wei, Jiafeng Pang, Yanbin Jiang
To develop a safer, more stable and potent formulation of gefitinib (GFB), micro-spheres of GFB encapsulated into poly (L-lactic acid) (PLLA) have been prepared by supercritical anti-solvent (SAS) technology in this study. Operating factors were optimized using a selected OA16 (4(5)) orthogonal array design, and the properties of the raw material and SAS processed samples were characterized by different methods The results show that the GFB-loaded PLLA particles prepared were spherical, having a smaller and narrower particle size compared with raw GFB...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935253/effects-of-nerolidol-and-limonene-on-stratum-corneum-membranes-a-probe-epr-and-fluorescence-spectroscopy-study
#9
Sebastião Antonio Mendanha, Cássia Alessandra Marquezin, Amando Siuiti Ito, Antonio Alonso
The sesquiterpene nerolidol and the monoterpene limonene are potent skin-permeation enhancers that have also been shown to have antitumor, antibacterial, antifungal and antiparasitic activities. Because terpenes are membrane-active compounds, we used electron paramagnetic resonance (EPR) spectroscopy of three membrane spin labels combined with the fluorescence spectroscopy of three lipid probes to study the interactions of these terpenes with stratum corneum (SC) intercellular membranes. An experimental apparatus was developed to assess the lipid fluidity of hydrated SC membranes via the fluorescence anisotropy of extrinsic membrane probes...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935252/in-vitro-dissolution-testing-of-parenteral-aqueous-solutions-and-oily-suspensions-of-paracetamol-and-prednisolone
#10
Mareike Probst, Martin Schmidt, Katharina Tietz, Sandra Klein, Werner Weitschies, Anne Seidlitz
The number of intramuscularly applied dosage forms has been continuously increasing during the last decades. However, up to date no in vitro dissolution test method for parenteral dosage forms has been described in the Ph. Eur. or USP. It was the aim of this study to investigate dissolution test setups based on the compendial flow-through cell and the reciprocating holder for this purpose. Both apparatuses were equipped with dialysis membranes to accommodate the drug formulation. The suitability of the dissolution method was evaluated by comparing release profiles with blood level curves that were obtained previously in an in vivo study in rats by our group...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28935251/leachable-diphenylguanidine-from-rubber-closures-used-in-pre-filled-syringes-a-case-study-to-understand-solid-and-solution-interactions-with-oxytocin
#11
Ahmed S Zidan, Sabir M Aqueel, Alaadin Alayoubi, Adil Mohammad, Jinhui Zhang, Ziyaur Rahman, Patrick Faustino, Richard T Lostritto, Muhammad Ashraf
Leachables derived from multi-component drug-device syringe systems can result in changes to the quality of drug products. Diphenylguanidine (DPG), a leachable released from styrene butadiene rubber syringe plungers, interacts with Oxytocin to form protein-adducts. This study investigated the mechanism and kinetics of this interaction in both solid and solution states through in-vitro tests and spectroscopic methods For solid state interaction, the protein-adducts with DPG were characterized using SEM, XRD, DSC, FTIR, (13)C ss NMR, and dissolution analysis...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28927842/synthesis-and-preparation-of-biodegradable-hybrid-dextran-hydrogel-incorporated-with-biodegradable-curcumin-nanomicelles-for-full-thickness-wound-healing
#12
Mona Alibolandi, Marzieh Mohammadi, Seyed Mohammad Taghdisi, Khalil Abnous, Mohammad Ramezani
There is a clinical need for a novel, more efficient therapy for full thickness wound healing. In the current study, curcumin encapsulated PEG-PLA [poly(lactide)-block-poly(ethylene glycol)] nanomicelles were incorporated into dextran hydrogel for a full thickness dermal wound healing application. To assess the application of the hydrogel as a therapeutic wound dressing, its morphology, swelling pattern, kinetics of degradation, and capacity to control curcumin release were evaluated. It was found that the prepared hybrid hydrogel had acceptable biocompatibility, incorporation capacity of curcumin nanomicelles, and mechanical properties...
September 16, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28923770/dna-nanostructure-based-drug-delivery-nanosystems-in-cancer-therapy
#13
REVIEW
Dandan Wu, Lei Wang, Wei Li, Xiaowen Xu, Wei Jiang
DNA as a novel biomaterial can be used to fabricate different kinds of DNA nanostructures based on its principle of GC/AT complementary base pairing. Studies have shown that DNA nanostructure is a nice drug carrier to overcome big obstacles existing in cancer therapy such as systemic toxicity and unsatisfied drug efficacy. Thus, different types of DNA nanostructure-based drug delivery nanosystems have been designed in cancer therapy. To improve treating efficacy, they are also developed into more functional drug delivery nanosystems...
September 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28923769/reconstitutable-spray-dried-ultra-fine-dispersion-as-a-robust-platform-for-effective-oral-delivery-of-an-antihyperlipidemic-drug
#14
Mona Basha, Alaa H Salama, Sally El Awdan
The current article highlights the application of spray drying technique to produce an ultra-fine powder encapsulating the antihyperlipidemic drug, atorvastatin calcium (ATV). First, ATV was dissolved in an emulsion formulation, and different carriers (pectin, alginate, chitosan HCl and hydroxypropylmethyl cellulose) in two concentrations (1.5 and 3%) were added. Then, these carrier-containing formulations were subjected to spray drying, whereby ultra-fine ATV-loaded spray dried emulsions were produced (ATV-SDE)...
September 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28923768/applicability-of-low-melting-point-microcrystalline-wax-to-develop-temperature-sensitive-formulations
#15
Kohei Matsumoto, Shin-Ichiro Kimura, Yasunori Iwao, Shigeru Itai
Low-melting-point substances are widely used to develop temperature-sensitive formulations. In this study, we focused on microcrystalline wax (MCW) as a low-melting-point substance. We evaluated the drug release behavior of wax matrix (WM) particles using various MCW under various temperature conditions. WM particles containing acetaminophen were prepared using a spray congealing technique. In the dissolution test at 37°C, WM particles containing low-melting-point MCWs whose melting was starting at approx...
September 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28923767/shrinkage-of-spray-freeze-dried-microparticles-of-pure-protein-for-ballistic-injection-by-manipulation-of-freeze-drying-cycle
#16
Georg Straller, Geoffrey Lee
Spray-freeze-drying was used to produce shrivelled, partially-collapsed microparticles of pure proteins that may be suitable for use in a ballistic injector. Various modifications of the freeze drying cycle were examined for their effects on collapse of the pure protein microparticles. The use of annealing at a shelf temperature of up to +10°C resulted in no visible particle shrinkage. This was because of the high Tg' of the pure protein. Inclusion of trehalose or sucrose led to particle shrinkage because of the plasticizing effects of the disaccharides on the protein...
September 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28923766/development-of-stability-enhanced-ternary-solid-dispersions-via-combinations-of-hpmcp-and-soluplus-%C3%A2-processed-by-hot-melt-extrusion
#17
Ahmad B Albadarin, Catherine B Potter, Mark Davis, Javed Iqbal, Sachin Korde, Sudhir Pagire, Anant Paradkar, Gavin Walker
The aim of this study was to evaluate a novel combination of hydroxypropyl methylcellulose phthalate (HPMCP-HP-50) and Soluplus(®) polymers for enhanced physicochemical stability and solubility of the produced amorphous solid dispersions (ASDs). This was achieved using hot melt extrusion (HME) to convert the crystalline active pharmaceutical ingredient (API) into a more soluble amorphous form within the ternary systems. Itraconazole (ITZ), a Biopharmaceutics Classification System class II (BCS II) API, was utilized as the model drug...
September 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28923765/preparation-and-investigation-of-p28gst-loaded-plga-microparticles-for-immunomodulation-of-experimental-colitis
#18
T H Hoang Thi, P A Priemel, Y Karrout, V Driss, M Delbeke, A Dendooven, M P Flament, M Capron, J Siepmann
The aim of this work was to prepare and characterize (in vitro and in vivo) PLGA-based microparticles loaded with an enzymatic protein derived from the helminth parasite Schistosoma haematobium: glutathione S-transferase P28GST (P28GST). This protein is not only a promising candidate vaccine against schistosomiasis, it also exhibits interesting immunomodulating effects, which can be helpful for the regulation of inflammatory diseases. Helminths express a regulatory role on intestinal inflammation, and immunization by P28GST has recently been shown to be as efficient as infection to reduce inflammation in a murine colitis model...
September 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28919099/development-of-an-abiraterone-acetate-formulation-with-improved-oral-bioavailability-guided-by-absorption-modeling-based-on-in-vitro-dissolution-and-permeability-measurements
#19
Tamás Solymosi, Zsolt Ötvös, Réka Angi, Betti Ordasi, Tamás Jordán, Sándor Semsey, László Molnár, Soma Ránky, Genovéva Filipcsei, Gábor Heltovics, Hristos Glavinas
Particle size reduction of drug crystals in the presence of surfactants (often called "top-down" production methods) is a standard approach used in the pharmaceutical industry to improve bioavailability of poorly soluble drugs. Based on the mathematical model used to predict the fraction dose absorbed this formulation approach is successful when dissolution rate is the main rate limiting factor of oral absorption. In case compound solubility is also a major factor this approach might not result in an adequate improvement in bioavailability...
September 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28855136/ipratropium-is-luminally-recycled-by-an-inter-play-between-apical-uptake-and-efflux-transporters-in-calu-3-bronchial-epithelial-cell-layers
#20
Vijender Panduga, Michael J Stocks, Cynthia Bosquillon
The mechanism by which quaternized anticholinergic bronchodilators permeate the airway epithelium remains controversial to date. In order to elucidate the role of drug transporters, ipratropium bidirectional transport as well as accumulation and release studies were performed in layers of the broncho-epithelial cell line Calu-3 grown at an air-liquid interface, in presence or absence of a range of transporter inhibitors. Unexpectedly, a higher transepithelial permeability was observed in the secretory direction, with an apparent efflux ratio of > 4...
September 15, 2017: International Journal of Pharmaceutics
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