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https://www.readbyqxmd.com/read/28214989/exposure-response-analyses-of-blood-pressure-and-heart-rate-changes-for-methylphenidate-in-healthy-adults
#1
Liang Li, Yaning Wang, Ramana S Uppoor, Mehul U Mehta, Tiffany Farchione, Mitchell V Mathis, Hao Zhu
The aim of the study was to evaluate the exposure-response (E-R) relationships of blood pressure (BP) and heart rate (HR) changes in healthy adults taking methylphenidate (MPH). Intensive time profiles of BP and HR from healthy adults in placebo and MPH treatment arms of seven clinical trials from the FDA internal database were utilized for this analysis. The analysis model contains a circadian component for placebo effect and an E-R component to describe drug effect. Internal validation was performed using goodness-of-fit plots and visual predictive check...
February 18, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28214690/safety-and-efficacy-of-a-polyherbal-formulation-for-the-management-of-dyslipidemia-and-hyperglycemia-in-patients-with-advanced-stage-of-type-2-diabetes
#2
Mahdi Zarvandi, Hassan Rakhshandeh, Mohammad Abazari, Reza Shafiee-Nick, Ahmad Ghorbani
The present clinical trial was designed to evaluate the safety and efficacy of a polyherbal formulation (PHF) consisted of Allium sativum, Aloe vera, Nigella sativa, Plantago psyllium, Silybum marianum and Trigonella foenum-graecum for controlling dyslipidemia and hyperglycemia in patients with advanced-stage of type-2 diabetes. An open-label phase I trial was carried out on 30 patients who had hyperlipidemia and hyperglycemia before the beginning of the trial in spite of receiving statins and oral hypoglycemic drugs...
February 16, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28214602/impact-of-fill-level-in-twin-screw-granulation-on-critical-quality-attributes-of-granules-and-tablets
#3
Robin Meier, Klaus-Peter Moll, Markus Krumme, Peter Kleinebudde
In a previous study a change of the fill-level in the barrel exerted a huge influence on the twin-screw granulation (TSG) process of a high drug loaded, simplified formulation. The present work investigated this influence systematically. The specific feed load (SFL) indicating the mass per revolution as surrogate parameter for the fill-level was applied and the correlation to the real volumetric fill level of an extruder could be demonstrated by a newly developed method. A design of experiments was conducted to examine the combined influence of SFL and screw speed on the process and on critical quality attributes of granules and tablets...
February 15, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/28214546/effect-of-cyclophosphamide-on-the-solid-form-of-mannitol-during-lyophilization
#4
Krupaliben Patel, Bhushan Munjal, Arvind K Bansal
Mannitol is a commonly used bulking agent in lyophilized formulations. It can crystallize into multiple solid forms during lyophilization thereby exhibiting phase heterogeneity and variability in product performance. In this manuscript, we studied the effect of cyclophosphamide (CPA), an anticancer drug, on the solid form of mannitol during lyophilization from aqueous solutions. Freeze-concentration studies were performed in the DSC while lyophilization was performed in a lab scale freeze dryer. DSC experiments revealed two-stage crystallization of mannitol (1...
February 15, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28214006/-conduct-of-epidemiologic-studies-in-french-cancer-survivors-methods-difficulties-encountered-and-solutions-provided-lessons-learned-from-the-simonal-study-on-long-term-toxicities-after-non-hodgkin-lymphoma-treatment
#5
Sabine Anthony, Pierre Hebel, André Garrel, Vanina Oliveri, Catherine Thieblemont, Vincent Ribrag, Hervé Tilly, Corinne Haioun, René-Olivier Casasnovas, Franck Morschhauser, Pierre Feugier, Richard Delarue, Loic Ysebaert, Catherine Sebban, Florence Broussais, Gandhi Damaj, Virginie Nerich, Jean-Philippe Jais, Gilles Salles, Michel Henry-Amar, Nicolas Mounier
INTRODUCTION: Since the introduction of targeted therapies, specific lymphoma mortality has decreased. Possible long-term toxicities, however, are not known yet. This article describes the implementation of the SIMONAL study that investigates the hypothesis of an overconsumption of care after lymphoma treatment with a 10-year follow-up. METHODS: After the mandatory regulatory steps (CCTIRS and CNIL) the vital status and address of 5247 patients treated in 131 French centers were retrieved using a secure web portal, in order to send a quality of life after lymphoma questionnaire...
February 14, 2017: Bulletin du Cancer
https://www.readbyqxmd.com/read/28213875/vehicle-type-affects-filling-of-fractional-laser-ablated-channels-imaged-by-optical-coherence-tomography
#6
Uffe Høgh Olesen, Mette Mogensen, Merete Haedersdal
Ablative fractional laser (AFXL) is an emerging method that enhances topical drug delivery. Penetrating the skin in microscopic, vertical channels, termed microscopic treatment zones (MTZs), the fractional technique circumvents the skin barrier and allows increased uptake of topically applied drugs. This study aims to elucidate the impact of vehicle type on the filling of MTZs from application of liquid, gel, and cream vehicles. Ex vivo pig skin was exposed to 10,600 nm fractional CO2 laser at 5% density, 120 μm beam diameter, and fluences of 40 and 80 mJ/microbeam (mJ/mb)...
February 17, 2017: Lasers in Medical Science
https://www.readbyqxmd.com/read/28213844/self-nanoemulsified-drug-delivery-system-of-hydrochlorothiazide-for-increasing-dissolution-rate-and-diuretic-activity
#7
Cassiana Mendes, Aline Buttchevitz, Jéssica Henriques Kruger, Thiago Caon, Patricia de Oliveira Benedet, Elenara Lemos-Senna, Marcos Antônio Segatto Silva
Hydrochlorothiazide (HCTZ) is a class IV drug according to the Biopharmaceutical Classification System. This study aimed the development of self-nanoemulsifying drug delivery system (SNEDDS) for HCTZ as an approach to overcome the biopharmaceutical limitations. Pre-formulation screening and ternary phase diagrams were carried out to select the oil phase, the surfactant, and the co-surfactant as the amount of each constituent. The optimized formulations, with reduced amount of surfactant, and composed of medium chain triglycerides, Cremophor EL and Transcutol P did not affect the pH or show drug incompatibilities...
February 17, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28213179/the-dispersion-releaser-technology-is-an-effective-method-for-testing-drug-release-from-nanosized-drug-carriers
#8
Christine Janas, Marc-Philip Mast, Li Kirsamer, Carlo Angioni, Fiona Gao, Werner Mäntele, Jennifer Dressman, Matthias G Wacker
The dispersion releaser (DR) is a dialysis-based setup for the analysis of the drug release from nanosized drug carriers. It is mounted into dissolution apparatus2 of the United States Pharmacopoeia. The present study evaluated the DR technique investigating the drug release of the model compound flurbiprofen from drug solution and from nanoformulations composed of the drug and the polymer materials poly (lactic acid), poly (lactic-co-glycolic acid) or Eudragit(®)RSPO. The drug loaded nanocarriers ranged in size between 185...
February 14, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/28212985/nonsteroidal-anti-inflammatory-drugs-in-clinical-and-experimental-epilepsy
#9
REVIEW
Beatrice Mihaela Radu, Florin Bogdan Epureanu, Mihai Radu, Paolo Francesco Fabene, Giuseppe Bertini
Current antiepileptic drugs have limited efficacy and provide little or no benefits in 30% of the patients. Given that a role for brain inflammation in epilepsy has been repeatedly reported in recent years, the potential of anti-inflammatory drugs should be explored in depth, as they may provide new therapeutical approaches in preventing or reducing epileptogenesis. Here, we review preclinical (both in vivo and in vitro) and clinical epilepsy studies in which nonsteroidal antiinflammatory drugs (NSAIDs), i...
February 9, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28212981/development-of-solid-sedds-vi-effect-of-precoating-of-neusilin%C3%A2-us2-with-pvp-on-drug-release-from-adsorbed-self-emulsifying-lipid-based-formulations
#10
Suhas G Gumaste, Beatryz O S Freire, Abu T M Serajuddin
Adsorption of lipid-based formulations, which are usually liquid, onto silicas has been extensively investigated in the past decade to convert them into solid dosage forms. There are conflicting reports on the ability of commercially available porous silicas, like Neusilin® US2, to release lipid formulations completely, especially after long-term storage. In this study, the release of a model drug, probucol, from different formulations of medium chain lipids and a surfactant, Kolliphor EL (Cremophor EL) or polysorbate 80, were studied after adsorbing them onto Neusilin® US2...
February 14, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28212319/a-validated-stability-indicating-hplc-method-for-simultaneous-determination-of-amoxicillin-and-enrofloxacin-combination-in-an-injectable-suspension
#11
Nidal Batrawi, Shorouq Wahdan, Fuad Al-Rimawi
The combination of amoxicillin and enrofloxacin is a well-known mixture of veterinary drugs; it is used for the treatment of Gram-positive and Gram-negative bacteria. In the scientific literature, there is no high-performance liquid chromatography (HPLC)-UV method for the simultaneous determination of this combination. The objective of this work is to develop and validate an HPLC method for the determination of this combination. In this regard, a new, simple and efficient reversed-phase HPLC method for simultaneous qualitative and quantitative determination of amoxicillin and enrofloxacin, in an injectable preparation with a mixture of inactive excipients, has been developed and validated...
February 16, 2017: Scientia Pharmaceutica
https://www.readbyqxmd.com/read/28212300/amorphous-amorphous-phase-separation-in-api-polymer-formulations
#12
Christian Luebbert, Fabian Huxoll, Gabriele Sadowski
The long-term stability of pharmaceutical formulations of poorly-soluble drugs in polymers determines their bioavailability and therapeutic applicability. However, these formulations do not only often tend to crystallize during storage, but also tend to undergo unwanted amorphous-amorphous phase separations (APS). Whereas the crystallization behavior of APIs in polymers has been measured and modeled during the last years, the APS phenomenon is still poorly understood. In this study, the crystallization behavior, APS, and glass-transition temperatures formulations of ibuprofen and felodipine in polymeric PLGA excipients exhibiting different ratios of lactic acid and glycolic acid monomers in the PLGA chain were investigated by means of hot-stage microscopy and DSC...
February 15, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28211640/complexation-of-oxethazaine-with-2-hydroxypropyl-%C3%AE-cyclodextrin-increased-drug-solubility-decreased-cytotoxicity-and-analgesia-at-inflamed-tissues
#13
Andressa R Prado, Fabiano Yokaichiya, Margareth Kazuyo Kobayashi Dias Franco, Camila Morais Gonçalves da Silva, Laura Oliveira-Nascimento, Michelle Franz-Montan, Maria C Volpato, Luís F Cabeça, Eneida de Paula
OBJECTIVES: Oxethazaine (OXZ) is one of the few local anaesthetics that provides analgesia at low pH, but presents poor solubility, cytotoxicity and no parenteral formulations. To address these issues, we aimed to prepare OXZ host-guest inclusion complex with hydroxypropyl-beta-cyclodextrin (HP-β-CD). METHODS: The inclusion complex was formed by co-solubilization, followed by a job plot analysis to determine stoichiometry of complexation and dialysis equilibrium analysis (based on UV/VIS absorption and fluorescence profiles of OXZ)...
February 17, 2017: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28211299/comparison-of-biodistribution-profile-of-monoclonal-antibodies-nanoparticles-and-aptamers-in-rats-with-breast-cancer
#14
Cristal Cerqueira-Coutinho, Sotiris Missailidis, Jéssica Alessandra-Perini, Daniel Escorsim Machado, Jamila Alessandra Perini, Ralph Santos-Oliveira
The use of monoclonal antibodies and aptamers is growing every single day, as the use of nanoparticle systems. Although most of the products are under investigation, there are a few commercialized products available at the market, for human consume. In this study, we have compared three formulations (aptamer anti-MUC1, monoclonal antibody - Trastuzumab and monoclonal antibodies nanoparticles - PLA/PVA/MMT trastuzumab) to identify their profile as also to understand their behavior into an alive biological system...
May 2017: Artificial Cells, Nanomedicine, and Biotechnology
https://www.readbyqxmd.com/read/28211296/recommendations-for-the-medical-management-of-chronic-venous-disease-the-role-of-micronized-purified-flavanoid-fraction-mpff
#15
Ronald Bush, Anthony Comerota, Mark Meissner, Joseph D Raffetto, Steven R Hahn, Katherine Freeman
Scope A systematic review of the clinical literature concerning medical management of chronic venous disease with the venoactive therapy Micronized Purified Flavonoid Fraction was conducted in addition to an investigation of the hemodynamics and mechanism of chronic venous disease. Methods The systematic review of the literature focused on the use of Micronized Purified Flavonoid Fraction (diosmin) which has recently become available in the US, in the management of chronic venous disease. The primary goal was to assess the level of evidence of the role of Micronized Purified Flavonoid Fraction in the healing of ulcers, and secondarily on the improvement of the symptoms of chronic venous disease such as edema...
April 2017: Phlebology
https://www.readbyqxmd.com/read/28210763/artemisinin-and-its-derivatives-in-cancer-therapy-status-of-progress-mechanism-of-action-and-future-perspectives
#16
REVIEW
Archana Bhaw-Luximon, Dhanjay Jhurry
Since the late 1990s, there has been rapid multiplication of data on the anti-cancer properties of artemisinins. This article reviews the status of progress of artemisinin and its derivatives as anti-cancer agents in clinical trials, case reports, and in vitro/in vivo studies. Particular attention is laid on the combinations of artemisinins and synthetic chemodrugs to enhance the latter's efficacy. An attempt is here made to rationalize the synergistic effects of a few common anti-cancer drugs of the anthracycline, taxane, anti-metabolite, and platinum-based drug families...
February 16, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28210500/drug-release-characteristics-and-tissue-distribution-of-rifapentine-polylactic-acid-sustained-release-microspheres-in-rabbits-after-paravertebral-implantation
#17
Zheng Zhang, Linbo Wu, Haijian Li, Zhicheng Long, Xinghua Song
BACKGROUND: Rates of drug-resistant tuberculosis (TB) and TB associated with human immunodeficiency virus (HIV) infection have increased dramatically, intensifying challenges in TB control. New formulations of TB treatment drugs that control drug release and increase local drug concentrations will have a significant impact on mitigating the toxic side effects and increasing the clinical efficacy of anti-TB drugs. OBJECTIVES: The aim was to observe the sustained release characteristics of rifapentine polylactic acid sustained-release microspheres in vivo and the accumulation of rifapentine in other tissues following paravertebral implantation...
November 2016: Iranian Red Crescent Medical Journal
https://www.readbyqxmd.com/read/28210398/injection-adipolysis-mechanisms-agents-and-future-directions
#18
REVIEW
Shahraam Kamalpour, Keith Leblanc
Noninvasive procedures targeting the elimination of unwanted adipose tissues have recently been developed. injection adipolysis is the term for the injection of cytotoxic substances into these tissues, with the intent of cosmetic improvement by volume reduction. initial attempts in the field utilized intravenous preparations of sodium deoxycholate and soy-derived phosphatidylcholine, approved for the intravenous treatment of fat emboli and dyslipidemias in countries outside the United States. it was initially purported that the active ingredient in these injections was phosphatidylcholine...
December 2016: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/28208662/characterization-molecular-docking-and-in-vitro-dissolution-studies-of-solid-dispersions-of-20-s-protopanaxadiol
#19
Qi Zhang, Yiqiong Pu, Bing Wang, Yuqin Wang, Tina Tingxia Dong, Tao Guo, Tong Zhang, Zhenzhen Cai
In this study, we prepared solid dispersions (SDs) of 20(S)-protopanaxadiol (PPD) using a melting-solvent method with different polymers, in order to improve the solubility and dissolution performance of drugs with poor water solubility. The SDs were characterized via differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), Fourier transform infrared spectroscopy (FTIR), nuclear magnetic resonance (NMR), and molecular docking and dynamics study. DSC and PXRD results indicated that PPD crystallinity in SDs was significantly reduced, and that the majority of PPD is amorphous...
February 11, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28208250/simultaneous-voltammetric-determination-of-acetaminophen-and-isoniazid-hepatotoxicity-related-drugs-utilizing-bismuth-oxide-nanorod-modified-screen-printed-electrochemical-sensing-platforms
#20
Bahaa G Mahmoud, Mohamed Khairy, Farouk A Rashwan, Craig E Banks
To overcome the recent outbreaks of hepatotoxicity-related drugs, a new analytical tool for the continuously determination of these drugs in human fluids is required. Electrochemical-based analytical methods offer an effective, rapid, and simple tool for on-site determination of various organic and inorganic species. However, the design of a sensitive, selective, stable, and reproducible sensor is still a major challenge. In the present manuscript, a facile, one-pot hydrothermal synthesis of bismuth oxide (Bi2O2...
February 7, 2017: Analytical Chemistry
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