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International Journal of Pharmaceutics

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https://www.readbyqxmd.com/read/28104406/a-novel-methodology-for-the-study-of-polymodal-particle-size-distributions-produced-during-continuous-wet-granulation
#1
Carlota Mendez Torrecillas, Gavin W Halbert, Dimitrios A Lamprou
It is important during powder granulation to obtain particles of a homogeneous size especially in critical situations such as pharmaceutical manufacture. To date, homogeneity of particle size distribution has been defined by the use of the d50 combined with the span of the particle size distribution, which has been found ineffective for polymodal particle size distributions. This work focuses on demonstrating the limitations of the span parameter to quantify homogeneity and proposes a novel improved metric based on the transformation of a typical particle size distribution curve into a homogeneity factor which can vary from 0 to 100%...
January 16, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28104405/insights-on-in-vitro-models-for-safety-and-toxicity-assessment-of-cosmetic-ingredients
#2
REVIEW
Andreia Almeida, Bruno Sarmento, Francisca Rodrigues
According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients...
January 16, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28099877/use-of-the-channel-fill-level-in-defining-a-design-space-for-twin-screw-wet-granulation
#3
L J Gorringe, G S Kee, M F Saleh, N H Fa, R G Elkes
Twin screw wet granulation is a key process in the continuous manufacture of oral solid dosage forms. Previous research has qualitatively suggested that the channel fill level influences the granules produced. In this paper a quantitative measure of the total volumetric fraction of the conveying element channels of the screw filled with powder (φ) was used. Experimental results are shown which demonstrate that very similar particle size distributions can be obtained at the same φ with the same material and screw configuration but radically different solids feed rates and screw speeds...
January 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28093327/amorphous-solid-dispersion-of-cyclosporine-a-prepared-with-fine-droplet-drying-process-physicochemical-and-pharmacokinetic-characterization
#4
Hiroki Suzuki, Tatsuru Moritani, Tadahiko Morinaga, Yoshiki Seto, Hideyuki Sato, Satomi Onoue
The present study aimed to develop an amorphous solid dispersion (ASD) of cyclosporine A (CsA) by a fine droplet drying (FDD) process for improvement in oral absorption of CsA. CsA and hydroxypropyl cellulose-SSL were dissolved in 1,4-dioxane, and the solution was powdered by the FDD process to obtain the ASD formulation of CsA (ASD/CsA). The ASD/CsA was characterized in terms of morphology, particle size distribution, crystallinity, dissolution behavior, physicochemical stability, and pharmacokinetic behavior in rats...
January 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28093326/in-vivo-pharmacokinetic-studies-and-intracellular-delivery-of-methotrexate-by-means-of-glycine-tethered-plga-based-polymeric-micelles
#5
Madhwi, Rajendra Kumar, Pramod Kumar, Bhupinder Singh, Gajanand Sharma, Om Prakash Katare, Kaisar Raza
Methotrexate is a widely used drug for the treatment of various kinds of cancers. However, numerous challenges are associated with MTX like poor aqueous solubility, dose-dependent side effects and poor-bioavailability. With an aim to explore the potential benefits in drug delivery of MTX, it was intended to fabricate glycine-PLGA-based polymeric micelles. Glycine was chemically linked to PLGA and the linkage was confirmed by FT-IR, and NMR-Spectroscopy. The developed polymeric micelles offered substantial loading to MTX with a pH-dependent drug release profile...
January 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28093325/gold-nanostar-polymer-hybrids-for-sirna-delivery-polymer-design-towards-colloidal-stability-and-in-vitro-studies-on-breast-cancer-cells
#6
Carla Sardo, Barbara Bassi, Emanuela F Craparo, Cinzia Scialabba, Elisa Cabrini, Giacomo Dacarro, Agnese D'Agostino, Angelo Taglietti, Gaetano Giammona, Piersandro Pallavicini, Gennara Cavallaro
To overcome the low bioavailability of siRNA (small interfering RNA) and to improve their transfection efficiency, the use of non-viral delivery carriers is today a feasible approach to transform the discovery of these incredibly potent and versatile drugs into clinical practice. Polymer-modified gold nanoconstructs (AuNCs) are currently viewed as efficient and safe intracellular delivery carriers for siRNA, as they have the possibility to conjugate the ability to stably entrap and deliver siRNAs inside cells with the advantages of gold nanoparticles, which can act as theranostic agents and radiotherapy enhancers through laser-induced hyperthermia...
January 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28093324/synthesis-characterization-and-in-vitro-antitumor-activity-of-the-polyethylene-glycol-350-and-1000-succinate-derivatives-of-the-tocopherol-and-tocotrienol-isomers-of-vitamin-e
#7
Ahmed Abu-Fayyad, Sami Nazzal
Vitamin E refers to a group of saturated tocopherol (T) isomers and the biologically more active unsaturated tocotrienol (T3) isomers. PEGylated α-tocopherol, commercially known as Vitamin E TPGS, has been used as an emulsifier and therapeutic agent for children with vitamin E deficiency. Limited information, however, is available about the PEG conjugates of the tocotrienol isomers of vitamin E. The current work was therefore undertaken to synthesize and characterize the water soluble polyethylene glycol (PEG 350 and 1000) derivatives of T and T3...
January 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28093323/in-vitro-gastric-survival-of-commercially-available-probiotic-strains-and-oral-dosage-forms
#8
Romain Caillard, Nicolas Lapointe
Although the intestinal microbial community is still incompletely understood, there is strong evidence of the benefits of using probiotics to address some medical states or conditions. As a result, the probiotics oral supplements market has exploded during the last few years. However, while their sensitivity to gastric juices, acidic pH and bile is well known, most of these oral forms would not guarantee any survival of the strains in such conditions. In this work, we have studied the resistance to simulated gastric juices of several commercially available probiotics products...
January 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28088639/docosahexaenoic-acid-loaded-lipid-nanoparticles-with-bactericidal-activity-against-helicobacter-pylori
#9
Catarina Leal Seabra, Cláudia Nunes, Maria Gomez-Lazaro, Marta Correia, José Carlos Machado, Inês C Gonçalves, Celso A Reis, Salette Reis, M Cristina L Martins
Docosahexaenoic acid (DHA), an omega-3 polyunsaturated fatty acid present in fish oil, has been described as a promising molecule to the treatment of Helicobacter pylori gastric infection. However, due to its highly unsaturated structure, DHA can be easily oxidized loosing part of its bioactivity. This work aims the nanoencapsulation of DHA to improve its bactericidal efficacy against H. pylori. DHA was loaded into nanostructured lipid carriers (NLC) produced by hot homogenization and ultrasonication using a blend of lipids (Precirol ATO5(®), Miglyol-812(®)) and a surfactant (Tween 60(®))...
January 11, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28087384/epidermal-growth-factor-egf-fragment-guided-anticancer-theranostic-particles-for-ph-responsive-release-of-doxorubicin
#10
Myun Koo Kang, Wei Mao, Jun Bae Lee, Hyuk Sang Yoo
EGF fragment (EGFfr) and doxorubicin were chemically co-decorated on single magnetic nanoparticles (MNPs) for concomitant cancer targeting and treatment. Magnetic nanoparticles were prepared by the precipitation of ferric chloride hydrates in an ammonia solution and subsequent surface-functionalization with amines. The terminal thiol group of the EGF fragment was first conjugated to surface amines of the MNPs using a heterofunctional crosslinker, and doxorubicin was sequentially conjugated to the MNPs via a hydrazone linker, where the degree of subsitution of the surface amines to EGFfr was varied from 1% to 40%...
January 10, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28089936/biodegradable-lipid-nanoparticles-induce-a-prolonged-rna-interference-mediated-protein-knockdown-and-show-rapid-hepatic-clearance-in-mice-and-nonhuman-primates
#11
Yuta Suzuki, Kenji Hyodo, Takuya Suzuki, Yohei Tanaka, Hiroshi Kikuchi, Hiroshi Ishihara
Lipid nanoparticles based on ionizable lipids have been clinically validated as a means of delivery for RNA interference (RNAi) therapeutics. The ideal properties of RNAi carriers are efficient delivery of oligonucleotides into target cells and rapid elimination after the function is performed. Here, we report that degradable lipid nanoparticles are effective carriers of small interfering RNA (siRNA) and have a high therapeutic index. The newly developed degradable lipid nanoparticles carrying siRNA showed potent gene-silencing activity in mouse hepatocytes (ED50≈0...
January 9, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28089935/synergistic-antimicrobial-potential-of-essential-oils-in-combination-with-nanoparticles-emerging-trends-and-future-perspectives
#12
REVIEW
Mahendra Rai, Priti Paralikar, Priti Jogee, Gauravi Agarkar, Avinash P Ingle, Marcos Derita, Susana Zacchino
The development of resistance to different antimicrobial agents by bacteria, fungi, viruses, parasites, etc. is a great challenge to the medical field for the treatment of infections caused by them, and therefore, there is a pressing need to search for new and novel antimicrobials. The antimicrobial activity of essential oils and biogenic nanoparticles is well known. Recent studies have demonstrated that nanoparticles functionalized with essential oils have significant antimicrobial potential against multidrug- resistant pathogens...
January 9, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28089934/evaluation-of-aggregate-and-silicone-oil-counts-in-pre-filled-siliconized-syringes-an-orthogonal-study-characterising-the-entire-subvisible-size-range
#13
Maryam Shah, Zahra Rattray, Katie Day, Shahid Uddin, Robin Curtis, Christopher F van der Walle, Alain Pluen
Characterisation of particulates in therapeutic monoclonal antibody (mAb) formulations is routinely extended to the sub-visible size-range (0.1-10μm). Additionally, with the increased use of pre-filled syringes (PFS), particle differentiation is required between proteinaceous and non-proteinaceous particles such as silicone-oil droplets. Here, three orthogonal techniques: Raster Image Correlation Spectroscopy (RICS), Resonance Mass Measurements (RMM) and Micro-Flow Imaging (MFI), were evaluated with respect to their sub-visible particle measurement and characterisation capabilities...
January 9, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28077295/improved-mucoadhesive-properties-of-self-nanoemulsifying-drug-delivery-systems-snedds-by-introducing-acyl-chitosan
#14
Nuri Ari Efiana, Arshad Mahmood, Hung Thanh Lam, Ožbej Zupančič, Gintare Leonaviciute, Andreas Bernkop-Schnürch
This study was aimed to improve the mucoadhesive properties of SNEDDS by the incorporation of acyl chitosan including octanoyl chitosan (OC), lauroyl chitosan (LC) and palmitoyl chitosan (PC). SNEDDS and acyl chitosan SNEDDS were characterized regarding droplet size and zeta potential. Their mucoadhesivity on porcine intestinal mucosa was evaluated by falling liquid film technique using Sudan Red G as marker. Degree of substitution of chitosan was determined to be 52.8%, 64.8 and 48.5% for OC, LC and PC, respectively...
January 8, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28069390/continuous-direct-compression-as-manufacturing-platform-for-sustained-release-tablets
#15
B Van Snick, J Holman, C Cunningham, A Kumar, J Vercruysse, T De Beer, J P Remon, C Vervaet
This study presents a framework for process and product development on a continuous direct compression manufacturing platform. A challenging sustained release formulation with high content of a poorly flowing low density drug was selected. Two HPMC grades were evaluated as matrix former: standard Methocel CR and directly compressible Methocel DC2. The feeding behavior of each formulation component was investigated by deriving feed factor profiles. The maximum feed factor was used to estimate the drive command which strongly depended upon the density of the material...
January 6, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28069389/layer-by-layer-assembly-of-hierarchical-nanoarchitectures-to-enhance-the-systemic-performance-of-nanoparticle-albumin-bound-paclitaxel
#16
Hima Bindu Ruttala, Thiruganesh Ramasamy, Beom Soo Shin, Han-Gon Choi, Chul Soon Yong, Jong Oh Kim
Although protein-bound paclitaxel (PTX, Abraxane(®)) has been established as a standard PTX-based therapy against multiple cancers, its clinical success is limited by unfavorable pharmacokinetics, suboptimal biodistribution, and acute toxicities. In the present study, we aimed to apply the principles of a layer-by-layer (LbL) technique to improve the poor colloidal stability and pharmacokinetic pattern of nanoparticle albumin-bound paclitaxel (nab-PTX). LbL-based nab-PTX was successfully fabricated by the alternate deposition of polyarginine (pARG) and poly(ethylene glycol)-block-poly (L-aspartic acid) (PEG-b-PLD) onto an albumin conjugate...
January 6, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28063904/a-rational-approach-towards-development-of-amorphous-solid-dispersions-experimental-and-computational-techniques
#17
Paroma Chakravarty, Joseph W Lubach, Jonathan Hau, Karthik Nagapudi
The purpose of this study was to determine the drug-polymer miscibility of GENE-A, a Genentech molecule, and hydroxypropyl methylcellulose-acetate succinate (HPMC-AS), a polymer, using computational and experimental approaches. The Flory-Huggins interaction parameter,χ, was obtained by calculating the solubility parameters for GENE-A and HPMC-AS over the temperature range of 25-100°C to obtain the free energy of mixing at different drug loadings (0-100%) using the Materials Studio modeling and simulation platform (thermodynamic approach)...
January 4, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28063903/distinct-biodistribution-of-doxorubicin-and-the-altered-dispositions-mediated-by-different-liposomal-formulations
#18
Ruijuan Luo, Yan Li, Miao He, Huixia Zhang, Hebao Yuan, Mark Johnson, Maria Palmisano, Simon Zhou, Duxin Sun
The liposomal formulations of doxorubicin produced distinct efficacy and toxicity profiles compared to doxorubicin solution in cancer patients. This study aims to investigate the drug tissue distribution and the driving force for tissue distribution from doxorubicin solution and two liposomal delivery systems, Doxil and Myocet. These three formulations were intravenously administered to mice at a single dose of 5mg/kg. Eleven organs, plasma and blood were collected at different time points. Total doxorubicin concentrations in each specimen were measured with LC-MS/MS...
January 4, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28063902/application-of-aluminum-chloride-phthalocyanine-loaded-solid-lipid-nanoparticles-for-photodynamic-inactivation-of-melanoma-cells
#19
Patrícia L Goto, Marigilson P Siqueira-Moura, Antonio C Tedesco
Cutaneous melanoma is the most aggressive skin cancer and is particularly resistant to current therapeutic approaches. Photodynamic therapy (PDT) is a well-established photoprocess that is employed to treat some cancers, including non-melanoma skin cancer. Aluminum chloride phthalocyanine (ClAlPc) is used as a photosensitizer in PDT; however, its high hydrophobicity hampers its photodynamic activity under physiological conditions. The aim of this study was to produce solid lipid nanoparticles (SLN) containing ClAlPc using the direct emulsification method...
January 4, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28062365/assessment-of-new-generation-high-power-electronic-nicotine-delivery-system-as-thermal-aerosol-generation-device-for-inhaled-bronchodilators
#20
Jérémie Pourchez, Fabien de Oliveira, Sophie Perinel-Ragey, Thierry Basset, Jean-Michel Vergnon, Nathalie Prévôt
PURPOSE: A need remains for alternative devices for aerosol drug delivery that are low cost, convenient and easy to use for the patient, but also capable of producing small-sized aerosol particles. This study investigated the potential of recent high power electronic nicotine delivery systems (ENDS) as aerosol generation devices for inhaled bronchodilators. METHODS: The particle size distribution was measured using a cascade impactor. The delivery of terbutaline sulfate, a current bronchodilator used for asthma or COPD therapy by inhalation, was studied...
January 4, 2017: International Journal of Pharmaceutics
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