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https://www.readbyqxmd.com/read/28550603/development-of-novel-high-density-gastroretentive-multiparticulate-pulsatile-tablet-of-clopidogrel-bisulfate-using-quality-by-design-approach
#1
Nilesh Desai, Ravindra Purohit
Myocardial infarction, i.e., heart attack, is a fatal condition which is on the increase all over the world. It is reported that a large number of heart attack occur in morning hours which are attributable to platelet aggregation. Chronotherapy at this stage can be crucial. Clopidogrel bisulfate (CLB) is an antiplatelet agent and has become a drug of choice for prevention of heart attack. It is soluble in acidic pH and has a narrow absorption window. So, its long residence time in stomach is desirable. Therefore, a novel high density tablet was developed comprising multiparticulate pellets with pulsatile release necessary to maintain chronotherapy of heart attack...
May 26, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28549973/targeted-delivery-of-rosmarinic-acid-across-the-blood-brain-barrier-for-neuronal-rescue-using-polyacrylamide-chitosan-poly-lactide-co-glycolide-nanoparticles-with-surface-cross-reacting-material-197-and-apolipoprotein-e
#2
Yung-Chih Kuo, Rajendiran Rajesh
Rosmarinic acid-loaded polyacrylamide-chitosan-poly(lactide-co-glycolide) nanoparticles (RA-PAAM-CH-PLGA NPs) were grafted with cross-reacting material 197 (CRM197) and apolipoprotein E (ApoE) for targeting of the blood-brain barrier (BBB) and rescuing degenerated neurons. The polymeric nanocarriers were prepared by microemulsion, solvent diffusion, grafting, and surface modification, and CRM197-ApoE-RA-PAAM-CH-PLGA NPs were used to treat human brain-microvascular endothelial cells, RWA264.7 cells, and Aβ-insulted SK-N-MC cells...
May 23, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28549972/quality-by-design-approach-for-studying-the-impact-of-formulation-and-process-variables-on-product-quality-of-oral-disintegrating-films
#3
Sonal Mazumder, Naresh Pavurala, Prashanth Manda, Xiaoming Xu, Celia N Cruz, Yellela S R Krishnaiah
The present investigation was carried out to understand the impact of formulation and process variables on the quality of oral disintegrating films (ODF) using Quality by Design (QbD) approach. Lamotrigine (LMT) was used as a model drug. Formulation variable was plasticizer to film former ratio and process variables were drying temperature, air flow rate in the drying chamber, drying time and wet coat thickness of the film. A Definitive Screening Design: of Experiments (DoE) was used to identify and classify the critical formulation and process variables impacting critical quality attributes (CQA)...
May 23, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28549971/tpp-dendrimer-nanocarriers-for-sirna-delivery-to-the-pulmonary-epithelium-and-their-dry-powder-and-metered-dose-inhaler-formulations
#4
Elizabeth Bielski, Qian Zhong, Hamad Mirza, Matthew Brown, Ashura Molla, Teresa Carvajal, Sandro R P da Rocha
The regulation of genes utilizing the RNA interference (RNAi) mechanism via the delivery of synthetic siRNA has great potential in the treatment of a variety of lung diseases. However, the delivery of siRNA to the lungs is challenging due to the poor bioavailability siRNA when delivered intraveneously, and difficulty in formulating and maintaining the activity of free siRNA when delivered directly to the lungs using inhalation devices. The use of non-viral vectors such as cationic dendrimers can help enhance the stability of siRNA and its delivery to the cell cytosol...
May 23, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28549950/spray-stability-of-self-assembled-filaments-for-delivery
#5
Abdullah Mahmud, Takamasa Harada, Karthikan Rajagopal, David A Christian, Praful Nair, Ryan Murphy, Dennis E Discher
Filamentous viruses are common in nature and efficiently deliver - sometimes via aerosol - genetic material, viral proteins, and other factors to animals and plants. Aerosolization can be a severe physicochemical test of the stability of any filamentous assembly whether it is made from natural polymers such as viral proteins or synthetic polymers. Here, worm-like "filomicelles" that self-assemble in water from amphiphilic block copolymers were investigated as aerosolized delivery vehicles. After spraying and drying, fluorophore-loaded filomicelles that were originally ~10-20μm long could be imaged as 2-5μm long fragments that survived rehydration on natural and artificial surfaces (i...
May 23, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28549907/transformation-of-bcs-class-i-and-iii-drugs-into-ionic-liquids-and-lipophilic-salts-for-enhanced-developability-using-lipid-formulations
#6
Hywel D Williams, Leigh Ford, Shea Lim, Sifei Han, John Baumann, Hannah Sullivan, David Vodak, Annabel Igonin, Hassan Benameur, Colin W Pouton, Peter J Scammells, Christopher J H Porter
Higher lipid solubility of lipophilic salt forms creates new product development opportunities for high-dose liquid-filled capsules. The purpose of this study was to determine if lipophilic salts of BCS Class I amlodipine and BCS Class III fexofenadine, ranitidine and metformin were better lipid formulation candidates than existing commercial salts. Lipophilic salts were prepared from lipophilic anions and commercial HCl or besylate salt forms, as verified by (1)H NMR. Thermal properties were assessed by DSC and hot-stage microscopy...
May 23, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28549906/using-potentiometric-free-drug-sensors-to-determine-the-free-concentration-of-ionisable-drugs-in-colloidal-systems
#7
Thuy Tran, Anjan Chakraborty, Xi Xi, Hugo Bohets, Claus Cornett, Konstantin Tsinman, Thomas Rades, Anette Müllertz
The current study investigates the use of free drug sensors (FDS) to measure free ionized drug concentrations in colloidal systems, including micellar solutions and emulsions and lipid formulations during in vitro lipolysis. Diphenhydramine hydrochloride (DPH) and loperamide hydrochloride (LOP) were selected as model drugs. Self-diffusion nuclear magnetic resonance (NMR) studies were performed and confirmed the entrapment of drugs in micelles in Brij 35 and sodium taurodeoxycholate (TDC)/phosphatidylcholine (PC) micellar solutions...
May 23, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28549905/on-the-use-of-group-sequential-study-designs-for-the-test-of-bioequivalence-for-complicated-products
#8
Rajesh Krishna, Wen-Lin Luo, Patrick J Larson, Paul H Fackler
A novel modeling approach together with a use of group sequential study design for a complicated triple fixed-dose combination was attempted. Probability of success (POS) was used for determining a weighted average power, where weight was based on available information such as data from previous pilot studies or literature. A simulation study was conducted that resulted in the development of the necessary sample size for the studies in addition to identifying a decision algorithm that was prospectively defined in the protocols...
May 23, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28549867/integrated-testing-strategies-can-be-optimal-for-chemical-risk-classification
#9
Marko Raseta, Jon Pitchford, James Cussens, John Doe
There is an urgent need to refine strategies for testing the safety of chemical compounds. This need arises both from the financial and ethical costs of animal tests, but also from the opportunities presented by new in-vitro and in-silico alternatives. Here we explore the mathematical theory underpinning the formulation of optimal testing strategies in toxicology. We show how the costs and imprecisions of the various tests, and the variability in exposures and responses of individuals, can be assembled rationally to form a Markov Decision Problem...
May 23, 2017: Mathematical Biosciences
https://www.readbyqxmd.com/read/28549712/assessment-of-competence-in-evar-procedures-a-novel-rating-scale-developed-by-the-delphi-technique
#10
M Strøm, L Lönn, B Bech, T V Schroeder, L Konge
OBJECTIVE/BACKGROUND: To develop a procedure specific global rating scale for assessment of operator competence in endovascular aortic repair (EVAR). METHODS: A Delphi approach was used to achieve expert consensus. A panel of 32 international experts (median 300 EVAR procedures, range 200-3000) from vascular surgery (n = 21) and radiology (n = 11) was established. The first Delphi round was based on a review of endovascular skills assessment papers, stent graft instructions for use, and structured interviews...
May 23, 2017: European Journal of Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/28549603/an-augmented-iterative-method-for-identifying-a-stress-free-reference-configuration-in-image-based-biomechanical-modeling
#11
Manuel K Rausch, Martin Genet, Jay D Humphrey
Continued advances in computational power and methods have enabled image-based biomechanical modeling to become an important tool in basic science, diagnostic and therapeutic medicine, and medical device design. One of the many challenges of this approach, however, is identification of a stress-free reference configuration based on in vivo images of loaded and often prestrained or residually stressed soft tissues and organs. Fortunately, iterative methods have been proposed to solve this inverse problem, among them Sellier's method...
May 5, 2017: Journal of Biomechanics
https://www.readbyqxmd.com/read/28549562/n-o-346-%C3%A3-ge-g%C3%A3-n%C3%A3-sique-avanc%C3%A3-et-fertilit%C3%A3
#12
Kimberly E Liu, Allison Case
OBJECTIFS: Sensibiliser la population à la baisse naturelle de la fertilité avec l'âge, chez les femmes et les hommes, et à l'égard de la reproduction naturelle et des technologies de procréation assistée (TPA); formuler des recommandations de prise en charge; et analyser les méthodes d'évaluation du vieillissement ovarien. OPTIONS: La présente directive clinique passe en revue les options offertes pour l'évaluation de la réserve ovarienne et pour le traitement de l'infertilité faisant appel aux TPA chez les femmes d'âge génésique avancé infertiles...
May 23, 2017: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/28549400/bemfola-%C3%A2-fixed-dose-pens-potentially-reduce-drug-wastage-and-associated-costs-of-infertility-treatment
#13
Graham Foxon, Paul Mitchell, Nikki Turner, Anne McConnell, Helen Kendrew, Julian Jenkins
Bemfola(®) is a recombinant follicle-stimulating hormone (FSH) used during infertility treatment. One main differentiator between FSH products is their delivery device; consisting of multi-dose pens (Gonal-f(®)), vials or multi-dose preparations (Menopur(®)), or adjustable daily disposable dose pens (Bemfola(®)). To determine the potential impact of delivery device on drug wastage during infertility treatment this study retrospectively analysed Gonal-f(®) and Menopur(®) prescription and usage data from five UK clinics...
May 26, 2017: Human Fertility: Journal of the British Fertility Society
https://www.readbyqxmd.com/read/28549386/newly-developed-dilute-russell-s-viper-venom-reagents-for-lupus-anticoagulant-detection-with-improved-specificity
#14
G W Moore, M Peyrafitte, C Dunois, J Amiral
Background Dilute Russell's viper venom time (dRVVT) is indispensible in lupus anticoagulant (LA) detection yet commercial reagents from different suppliers perform variably, no gold standard assays exist and therapeutic anticoagulation interference is problematic. Objective The objective of this study was to compare a new formulation dRVVT with two currently available dRVVTs. Materials and methods Life Diagnostics (LD) dRVVT and Stago PTT-LA were routinely used for lupus anticoagulant detection, plus Taipan snake venom time/ecarin time (TSVT/ET) for patients on warfarin or rivaroxaban...
January 1, 2017: Lupus
https://www.readbyqxmd.com/read/28549033/estrogen-receptor-progesterone-receptor-and-human-epidermal-growth-factor-receptor-2-testing-in-breast-cancer-assessing-the-value-of-repeated-centralized-testing-in-excision-specimens
#15
Nosaibah Hariri, Farnaz Hasteh, Vighnesh Walavalkar, Andres A Roma, Oluwole Fadare
At some tertiary breast care centers, where many patients are referred from other institutions, it is routine to repeat testing for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2/neu) in excision specimens if these tests were performed on the preceding biopsy at the referring facility. The goal of this study is to assess the value of this practice. We documented results from ER, PR, and HER2 testing in 541 consecutive invasive breast cancers excised over a 2...
May 25, 2017: Applied Immunohistochemistry & Molecular Morphology: AIMM
https://www.readbyqxmd.com/read/28548925/immunological-consequences-of-ageing-microvascular-hemodynamic-changes-in-view-of-cancer-development-and-treatment
#16
REVIEW
Jinhyuk Fred Chung, Sang Joon Lee, Anil K Sood
Risk factors of cardiovascular diseases have long been implicated as risk factors for carcinogenesis, but clear explanations for their association have not been presented. In this article, fundamental concepts from carcinogenesis, microvascular hemodynamics, and immunity are collectively reviewed and analyzed in context of the known features of vascular ageing effects, in formulating a theory that suggests reduced microvascular immunity as an important driving factor for carcinogenesis. Furthermore, scientific, preclinical, and clinical evidence that support this new theory are presented in an interdisciplinary manner, offering new explanations to previously unanswered factors that impact cancer risks and its treatment outcome such as chronic drug use, temperature, stress and exercise effects among others...
May 10, 2017: Oncotarget
https://www.readbyqxmd.com/read/28548613/recommendations-for-research-on-suicide-loss-a-commentary
#17
Robert A Neimeyer, Julie Cerel, Myfanwy Maple
As detailed in the lead article in this Special Issue, the Survivors of Suicide Loss Task Force of the National Action Alliance for Suicide Prevention in the United States has recently worked to formulate national guidelines to mitigate the harmful after-effects of suicide in social and family systems. In the present article, we elaborate on one of four strategic directions addressed by the Task Force, namely the development of goals and objectives for surveillance, research and evaluation of the impact of suicide loss...
May 26, 2017: Death Studies
https://www.readbyqxmd.com/read/28548603/beyond-demarcation-care-ethics-as-an-interdisciplinary-field-of-inquiry
#18
Carlo Leget, Inge van Nistelrooij, Merel Visse
BACKGROUND: For many years the body of literature known as 'care ethics' or 'ethics of care' has been discussed as regards its status and nature. There is much confusion and little structured discussion. The paper of Klaver et al. (2014) was written as a discussion article to which we respond. OBJECTIVES: We aim to contribute to the ongoing discussion about the status and nature of care ethics. RESEARCH DESIGN: Responding to 'Demarcation of the ethics of care as a discipline' by Klaver et al...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28548518/density-functional-theory-of-the-fractional-quantum-hall-effect
#19
Jianyun Zhao, Manisha Thakurathi, Manish Jain, Diptiman Sen, J K Jain
A conceptual difficulty in formulating the density-functional theory of the fractional quantum Hall effect is that while in the standard approach the Kohn-Sham orbitals are either fully occupied or unoccupied, the physics of the fractional quantum Hall effect calls for fractionally occupied Kohn-Sham orbitals. This has necessitated averaging over an ensemble of Slater determinants to obtain meaningful results. We develop an alternative approach in which we express and minimize the grand canonical potential in terms of the composite fermion variables...
May 12, 2017: Physical Review Letters
https://www.readbyqxmd.com/read/28548237/simulation-of-non-linear-transient-elastography-finite-element-model-for-the-propagation-of-shear-waves-in-homogeneous-soft-tissues
#20
W Ye, A Bel-Brunon, S Catheline, A Combescure, M Rochette
In this study, visco-hyperelastic Landau's model which is widely used in acoustical physic field is introduced into a finite element formulation. It is designed to model the non-linear behaviour of finite amplitude shear waves in soft solids, typically, in biological tissues. This law is employed in finite element models based on elastography experiments reported in [1], the simulations results show a good agreement with the experimental studyred: it is observed in both that a plane shear wave generates only odd harmonics and a nonplane wave generates both odd and even harmonics in the spectral domain...
May 26, 2017: International Journal for Numerical Methods in Biomedical Engineering
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