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https://www.readbyqxmd.com/read/29679707/enhanced-delivery-of-fixed-dose-combination-of-synergistic-antichagasic-agents-posaconazole-benznidazole-based-on-amorphous-solid-dispersions
#1
Camila Bezerra Melo Figueirêdo, Daniela Nadvorny, Amanda Carla Quintas de Medeiros Vieira, Giovanna Christinne Rocha de Medeiros Schver, José Lamartine Soares Sobrinho, Pedro José Rolim Neto, Ping I Lee, Monica Felts de La Roca Soares
Posaconazole (PCZ) and benznidazole (BNZ) are known to show synergetic effect in treating the acute and chronic phases of Chagas disease, a neglected parasitic disease. However, as both compounds are poorly water soluble, the development of amorphous solid dispersions (ASDs) of a PCZ/BNZ fixed-dose combination in a water-soluble polymer becomes an attractive option to increase their apparent solubility and dissolution rate, potentially improving their oral bioavailability. The initial approach was to explore solvent evaporated solid dispertion (SD) systems for a PCZ/BNZ 50:50 (wt%) combination at several total drug loading levels (from SD with 10% to 50% drug loading) in water-soluble carriers, including polyvinylpyrrolidone (PVP K-30) and vinylpyrrolidone-vinyl acetate copolymer (PVPVA 64)...
April 18, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29674799/assessment-of-nonsteroidal-anti-inflammatory-drug-use-pattern-using-world-health-organization-indicators-a-cross-sectional-study-in-a-tertiary-care-teaching-hospital-of-chhattisgarh
#2
P R R Vaishnavi, Nitin Gaikwad, S P Dhaneria
OBJECTIVE: The objective of this study is to assess drug utilization pattern of nonsteroidal anti-inflammatory drugs (NSAIDs) in a tertiary care teaching hospital, Raipur, Chhattisgarh. MATERIALS AND METHODS: A prospective, cross-sectional observational study was conducted in the outpatient department during 2-month period. After informed consent, the patients visiting pharmacy shop with a prescription were enrolled in the study. Their demographic details and prescription data were recorded in a case record form...
November 2017: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/29674251/outpatient-transition-to-extended-release-injectable-naltrexone-for-patients-with-opioid-use-disorder-a-phase-3-randomized-trial
#3
Adam Bisaga, Paolo Mannelli, Miao Yu, Narinder Nangia, Christine E Graham, D Andrew Tompkins, Thomas R Kosten, Sarah C Akerman, Bernard L Silverman, Maria A Sullivan
BACKGROUND: Injectable extended-release naltrexone (XR-NTX), approved to prevent relapse to opioid dependence, requires initial abstinence. This multisite outpatient clinical trial examined the efficacy and safety of low-dose oral naltrexone (NTX), combined with a brief buprenorphine (BUP) taper and standing ancillary medications, for detoxification and induction onto XR-NTX. METHODS: Patients (N = 378) were randomized, stratified by primary short-acting opioid-of-use, to one of three regimens: NTX + BUP; NTX + placebo BUP (PBO-B); placebo NTX (PBO-N) + PBO-B...
April 10, 2018: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/29673890/efficacy-and-safety-of-fixed-dose-combination-therapy-with-telmisartan-and-rosuvastatin-in-korean-patients-with-hypertension-and-dyslipidemia-telsta-yu-telmisartan-rosuvastatin-from-yuhan-a-multicenter-randomized-4-arm-double-blind-placebo-controlled-phase
#4
Gyu Chul Oh, Jung-Kyu Han, Ki Hoon Han, Min-Su Hyon, Joon Hyung Doh, Moo Hyun Kim, Jin-Ok Jeong, Jang-Ho Bae, Sang Hyun Kim, Byung-Su Yoo, Sang Hong Baek, Moo-Yong Rhee, Sang-Hyun Ihm, Jung Hoon Sung, Young Jin Choi, Soo-Joong Kim, Kyung-Soon Hong, Byoung Kwon Lee, JangHyun Cho, Eun Seok Shin, Jay Young Rhew, Hyunsu Kim, Hyo-Soo Kim
PURPOSE: Hypertension and dyslipidemia are 2 risk factors of cardiovascular disease that often present simultaneously. Traditionally, treatment of these multiple conditions required separate medications for each disease, which may result in poor compliance and thus lead to possible treatment failure. Fixed-dose combination (FDC) therapy with a single pill may be a solution in these situations. METHODS: This multicenter, 8-week, randomized, double-blind, Phase III study evaluated the efficacy and safety of FDC treatment with telmisartan (80 mg) and rosuvastatin calcium (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia...
April 16, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29673551/antiulcer-and-hepatoprotective-effects-of-aqueous-extract-of-plantago-ovata-seed-on-indomethacin-ulcerated-rats
#5
Seyyed Majid Bagheri, Fatemeh Zare-Mohazabieh, Haniyeh Momeni-Asl, Maryam Yadegari, Aghdas Mirjalili, Morteza Anvari
BACKGROUND: The objective of the study was to investigate the protective effects of aqueous extract of Plantago ovata seed (AEPOS) on peptic ulcer induced by indomethacin (IND) in rats. METHODS: Rats (250-300 g) were divided into three groups (5 rats in each group). Gastric ulcer was induced by a single oral gavage of 48 mg/kg IND. The first group received only 5% sodium bicarbonate orally (5 ml/kg) whereas the control (IND) group received only single oral dose of 48 mg/kg IND...
February 2018: Biomedical Journal
https://www.readbyqxmd.com/read/29673442/subchronic-oral-toxicity-of-silica-nanoparticles-and-silica-microparticles-in-rats
#6
Chun Lai Liang, Qian Xiang, Wen Ming Cui, Jin Fang, Na Na Sun, Xiao Peng Zhang, Yong Ning Li, Hui Yang, Zhou Yu, Xu Dong Jia
OBJECTIVE: To investigate the subchronic oral toxicity of silica nanoparticles (NPs) and silica microparticles (MPs) in rats and to compare the difference in toxicity between two particle sizes. METHODS: Sprague-Dawley rats were randomly divided into seven groups: the control group; the silica NPs low-, middle-, and high-dose groups; and the silica MPs low-, middle-, and high-dose groups [166.7, 500, and 1,500 mg/(kg•bw•day)]. All rats were gavaged daily for 90 days, and deionized water was administered to the control group...
March 2018: Biomedical and Environmental Sciences: BES
https://www.readbyqxmd.com/read/29673395/shorter-treatment-for-minimal-tuberculosis-tb-in-children-shine-a-study-protocol-for-a-randomised-controlled-trial
#7
Chishala Chabala, Anna Turkova, Margaret J Thomason, Eric Wobudeya, Syed Hissar, Vidya Mave, Marieke van der Zalm, Megan Palmer, Monica Kapasa, Perumal K Bhavani, Sarath Balaji, Priyanka A Raichur, Anne-Marie Demers, Graeme Hoddinott, Ellen Owen-Powell, Aarti Kinikar, Philippa Musoke, Veronica Mulenga, Rob Aarnoutse, Helen McIlleron, Anneke Hesseling, Angela M Crook, Mark Cotton, Diana M Gibb
BACKGROUND: Tuberculosis (TB) in children is frequently paucibacillary and non-severe forms of pulmonary TB are common. Evidence for tuberculosis treatment in children is largely extrapolated from adult studies. Trials in adults with smear-negative tuberculosis suggest that treatment can be effectively shortened from 6 to 4 months. New paediatric, fixed-dose combination anti-tuberculosis treatments have recently been introduced in many countries, making the implementation of World Health Organisation (WHO)-revised dosing recommendations feasible...
April 19, 2018: Trials
https://www.readbyqxmd.com/read/29670411/formative-usability-evaluation-of-a-fixed-dose-pen-injector-platform-device
#8
Jakob Lange, Tobias Nemeth
Background: This article for the first time presents a formative usability study of a fixed-dose pen injector platform device used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a user population of both naïve and experienced users across a range of ages. The goals of the study were to evaluate whether users could use the devices safely and effectively relying on the instructions for use (IFU) for guidance, as well as to benchmark the device against another similar injector established in the market...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29670404/evaluation-of-vancomycin-therapy-in-the-adult-icus-of-a-teaching-hospital-in-southern-iran
#9
Afsaneh Vazin, Motahare Mahi Birjand, Masoud Darake
Background: Vancomycin resistance in intensive care units (ICUs) accounts for significant morbidity and excess costs. The objective of the present study was to determine the appropriateness of vancomycin use in the various ICUs of Nemazee Hospital, Shiraz, Iran. Methods: This prospective study was performed on 95 critically ill patients (48 males and 47 females) who were treated with vancomycin for at least 3 subsequent doses in 6 ICUs during 12 months. Required demographic, clinical, and paraclinical data were collected by a pharmacist...
2018: Drug, Healthcare and Patient Safety
https://www.readbyqxmd.com/read/29670397/effectiveness-of-fixed-site-high-frequency-transcutaneous-electrical-nerve-stimulation-in-chronic-pain-a-large-scale-observational-study
#10
Xuan Kong, Shai N Gozani
Objective: The objective of this study was to assess the effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) in a real-world chronic pain sample. Background: There is a need for nonpharmacological treatment options for chronic pain. FS-TENS improved multisite chronic pain in a previous interventional study. Large observational studies are needed to further characterize its effectiveness. Methods: This retrospective observational cohort study examined changes in chronic pain measures following 60 days of FS-TENS use...
2018: Journal of Pain Research
https://www.readbyqxmd.com/read/29670344/cost-effectiveness-analysis-of-a-fixed-dose-combination-of-indacaterol-and-glycopyrronium-as-maintenance-treatment-for-copd
#11
Ming-Cheng Chan, Elise Chia-Hui Tan, Ming-Chin Yang
Objective: The aim of this study was to evaluate the cost-effectiveness of the long-acting beta-2 agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilator indacaterol/glycopyrronium (IND/GLY) as a maintenance treatment for COPD patients from the perspective of health care payer in Taiwan. Patients and methods: We adopted a patient-level simulation model, which included a cohort of COPD patients aged ≥40 years. The intervention used in the study was the treatment using IND/GLY, and comparators were tiotropium or salmeterol/fluticasone combination (SFC)...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29669668/pharmacokinetics-of-intranasal-mometasone-in-the-fixed-dose-combination-gsp301-versus-two-monotherapy-intranasal-mometasone-formulations
#12
Piyush Patel, Anne Marie Salapatek, Ravi S Talluri, Sudeesh K Tantry
BACKGROUND: GSP301 is a fixed-dose combination (FDC) of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate developed as a single nasal spray (NS). OBJECTIVE: To assess the relative bioavailability of mometasone administered as GSP301 FDC versus two mometasone monotherapy NS formulations. METHODS: In this single-dose, open-label, crossover study, healthy adults (age range, 18-65 years) were randomized equally to one of six treatment sequences for three 72-hour treatment periods with GSP301 (olopatadine 665 μg-mometasone 50 μg), the mometasone furoate monotherapy component of GSP301 (MF-sponsor, 50 μg), and U...
May 1, 2018: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29669667/pharmacokinetics-of-intranasal-olopatadine-in-the-fixed-dose-combination-gsp301-versus-two-monotherapy-intranasal-olopatadine-formulations
#13
Piyush Patel, Anne Marie Salapatek, Ravi S Talluri, Sudeesh K Tantry
BACKGROUND: GSP301 is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate developed as a single nasal spray. OBJECTIVE: To assess the relative bioavailability of olopatadine administered as GSP301 versus two olopatadine monotherapy nasal spray formulations. METHODS: In this single-dose, open-label, crossover study, healthy adults (18-65 years old) were equally randomized to one of six treatment sequences for three 48-hour treatment periods with GSP301 (olopatadine 665 μg-mometasone 50 μg), the olopatadine monotherapy component of GSP301 (OLO-sponsor; 665 μg) and U...
May 1, 2018: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29668577/the-use-of-a-novel-non-steroidal-mineralocorticoid-receptor-antagonist-finerenone-for-the-treatment-of-chronic-heart-failure-a-systematic-review-and-meta-analysis
#14
Hui Pei, Wei Wang, Di Zhao, Lei Wang, Guo-Hai Su, Zhuo Zhao
BACKGROUND: The non-steroidal mineralocorticoid receptor antagonist finerenone (BAY 94-8862) has been used to treat chronic heart failure (CHF) with reduced ejection fraction (HFrEF). However, conflicting results were reported for its efficacy and safety. The study aimed to compare the efficacy and safety of finerenone versus spironolactone or eplerenone in patients with chronic heart failure. METHODS: Electronic databases including MEDLINE, EMBASE, and CENTRAL were searched from inception to December 2017 for randomized controlled trials assessing finerenone treatment in patients with chronic heart failure...
April 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29667175/first-line-drugs-for-hypertension
#15
REVIEW
James M Wright, Vijaya M Musini, Rupam Gill
BACKGROUND: This is the first update of a review published in 2009. Sustained moderate to severe elevations in resting blood pressure leads to a critically important clinical question: What class of drug to use first-line? This review attempted to answer that question. OBJECTIVES: To quantify the mortality and morbidity effects from different first-line antihypertensive drug classes: thiazides (low-dose and high-dose), beta-blockers, calcium channel blockers, ACE inhibitors, angiotensin II receptor blockers (ARB), and alpha-blockers, compared to placebo or no treatment...
April 18, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29665705/topogram-based-tube-current-modulation-of-head-computed-tomography-for-optimizing-image-quality-while-protecting-the-eye-lens-with-shielding
#16
Ming-Fang Lin, Chia-Yuen Chen, Yuan-Hao Lee, Chia-Wei Li, Leo E Gerweck, Hao Wang, Wing P Chan
Background Multiple rounds of head computed tomography (CT) scans increase the risk of radiation-induced lens opacification. Purpose To investigate the effects of CT eye shielding and topogram-based tube current modulation (TCM) on the radiation dose received by the lens and the image quality of nasal and periorbital imaging. Material and Methods An anthropomorphic phantom was CT-scanned using either automatic tube current modulation or a fixed tube current. The lens radiation dose was estimated using cropped Gafchromic films irradiated with or without a shield over the orbit...
January 1, 2018: Acta Radiologica
https://www.readbyqxmd.com/read/29665351/neuroendocrine-response-to-gaba-b-receptor-agonism-in-alcohol-dependent-individuals-results-from-a-combined-outpatient-and-human-laboratory-experiment
#17
Mehdi Farokhnia, Mikela B Sheskier, Mary R Lee, April N Le, Erick Singley, Sofia Bouhlal, Timmy Ton, Zhen Zhao, Lorenzo Leggio
Gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the nervous system, plays an important role in biobehavioral processes that regulate alcohol seeking, food intake, and stress response. The metabotropic GABA-B receptor has been investigated as a potential therapeutic target for alcohol use disorder, by using orthosteric agonists (e.g., baclofen) and positive allosteric modulators. Whether and how pharmacological manipulation of the GABA-B receptor, in combination with alcohol intake, may affect feeding- and stress-related neuroendocrine pathways remains unknown...
April 14, 2018: Neuropharmacology
https://www.readbyqxmd.com/read/29665045/high-body-mass-index-is-associated-with-increased-risk-of-treatment-failure-and-surgery-in-biologic-treated-patients-with-ulcerative-colitis
#18
S Kurnool, N H Nguyen, J Proudfoot, P S Dulai, B S Boland, N Vande Casteele, E Evans, E L Grunvald, A Zarrinpar, W J Sandborn, S Singh
BACKGROUND: Though pharmacokinetic studies suggest accelerated biologic drug clearance with increasing body weight, evidence of obesity's impact on clinical outcomes in biologic-treated patients with ulcerative colitis (UC) is inconsistent. AIMS: To evaluate the impact of obesity on real world response to biological therapy in patients with UC. METHODS: In a single-centre retrospective cohort study between 2011-2016 of biologic-treated patients with UC, we evaluated treatment response by baseline body mass index (BMI)...
April 17, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29663959/quality-assurance-of-rifampicin-containing-fixed-drug-combinations-in-south-africa-dosing-implications
#19
R Court, M T Chirehwa, L Wiesner, B Wright, W Smythe, N Kramer, H McIlleron
SETTING: Rifampicin (RMP) drives treatment response in drug-susceptible tuberculosis. Low RMP concentrations increase the risk of poor outcomes, and drug quality needs to be excluded as a contributor to low RMP exposure. OBJECTIVES AND DESIGN: We performed an open-label, three-way cross-over study of three licensed RMP-containing formulations widely used in South Africa to evaluate the bioavailability of RMP in a two-drug fixed-dose combination tablet (2FDC) and a four-drug FDC (4FDC) against a single-drug reference...
May 1, 2018: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/29663947/making-up-the-difference-ensuring-the-bioequivalence-of-fixed-dose-combinations-for-tuberculosis
#20
Gustavo E Velásquez, Geraint R Davies, Carole D Mitnick
No abstract text is available yet for this article.
May 1, 2018: International Journal of Tuberculosis and Lung Disease
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