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https://www.readbyqxmd.com/read/28101128/simultaneous-determination-of-newly-developed-antiviral-agents-in-pharmaceutical-formulations-by-hplc-dad
#1
Nourah Zoman Al-Zoman, Hadir Mohamed Maher, Amal Al-Subaie
BACKGROUND: Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira Pak(®)) are the newest medicines approved for use in the treatment of hepatitis C virus (HCV) and are available in tablet form as an oral combination. Specifically, these agents are indicated in the treatment of HCV in patients with genotype 1 infection. Due to the therapeutic importance and increased use of Viekira Pak, proper methods for its determination in bulk and pharmaceutical formulations must be developed. RESULTS: The present study describes the development and validation of a simple, rapid, selective and economical reverse phase high performance liquid chromatography-diode array detection (HPLC-DAD) method for the simultaneous determination of paritaprevir (PAR), ombitasvir (OMB), dasabuvir(DAS) and ritonavir (RIT) in bulk and pharmaceutical preparations...
2017: Chemistry Central Journal
https://www.readbyqxmd.com/read/28100438/high-dose-rifampicin-moxifloxacin-and-sq109-for-treating-tuberculosis-a-multi-arm-multi-stage-randomised-controlled-trial
#2
Martin J Boeree, Norbert Heinrich, Rob Aarnoutse, Andreas H Diacon, Rodney Dawson, Sunita Rehal, Gibson S Kibiki, Gavin Churchyard, Ian Sanne, Nyanda E Ntinginya, Lilian T Minja, Robert D Hunt, Salome Charalambous, Madeleine Hanekom, Hadija H Semvua, Stellah G Mpagama, Christina Manyama, Bariki Mtafya, Klaus Reither, Robert S Wallis, Amour Venter, Kim Narunsky, Anka Mekota, Sonja Henne, Angela Colbers, Georgette Plemper van Balen, Stephen H Gillespie, Patrick P J Phillips, Michael Hoelscher
BACKGROUND: Tuberculosis is the world's leading infectious disease killer. We aimed to identify shorter, safer drug regimens for the treatment of tuberculosis. METHODS: We did a randomised controlled, open-label trial with a multi-arm, multi-stage design. The trial was done in seven sites in South Africa and Tanzania, including hospitals, health centres, and clinical trial centres. Patients with newly diagnosed, rifampicin-sensitive, previously untreated pulmonary tuberculosis were randomly assigned in a 1:1:1:1:2 ratio to receive (all orally) either 35 mg/kg rifampicin per day with 15-20 mg/kg ethambutol, 20 mg/kg rifampicin per day with 400 mg moxifloxacin, 20 mg/kg rifampicin per day with 300 mg SQ109, 10 mg/kg rifampicin per day with 300 mg SQ109, or a daily standard control regimen (10 mg/kg rifampicin, 5 mg/kg isoniazid, 25 mg/kg pyrazinamide, and 15-20 mg/kg ethambutol)...
January 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28089362/clinical-pharmacokinetics-of-oral-levofloxacin-and-sitafloxacin-in%C3%A2-epididymal-tissue
#3
Takuya Sadahira, Koichiro Wada, Kazuro Ikawa, Norifumi Morikawa, Hiroaki Kurahashi, Takashi Yoshioka, Yuichi Ariyoshi, Yasuyuki Kobayashi, Motoo Araki, Ayano Ishii, Masami Watanabe, Shinya Uehara, Toyohiko Watanabe, Yasutomo Nasu
OBJECTIVES: This study aimed to investigate the penetration of fluoroquinolones into human epididymal tissue. METHODS: The penetration of levofloxacin (LVFX) 500 mg or sitafloxacin (STFX) 100 mg into epididymal tissue was examined. Patients with prostate cancer who were referred for orchiectomy were included. LVFX 500 mg (n = 9) or STFX 100 mg (n = 9) was administered orally 1 h before orchiectomy, and 0.5 g of epididymal tissue and blood samples were collected simultaneously during surgery...
January 11, 2017: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
https://www.readbyqxmd.com/read/28088635/mucoadhesive-amorphous-solid-dispersions-for-sustained-release-of-poorly-water-soluble-drugs
#4
Justin S LaFountaine, Leena Kumari Prasad, Dave A Miller, James W McGinity, Robert O Williams
The oral delivery of mucoadhesive patches has been shown to enhance the absorption of large molecules such as peptides. We hypothesized that this mechanism could have utility for poorly soluble small molecules by utilizing a mucoadhesive polymer as the matrix for an amorphous solid dispersion. Binary dispersions of itraconazole and carbomer (Carbopol 71G) were prepared utilizing a thermokinetic mixing process (KinetiSol Dispersing) and the physicochemical properties were investigated by powder x-ray diffraction, calorimetry, and liquid chromatography...
January 11, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/28074420/efficacy-of-systemic-diclofenac%C3%A2-sodium-on%C3%A2-intravitreal-concentration
#5
Yunes Panahi, Mostafa Naderi, Khosrow Jadidi, Hadise Hoseini, Mojtaba Abrishami
BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs), as an alternative, are replacing corticosteroids in ocular inflammatory diseases. Diclofenac has been used mainly topically, and recent focus has been on intravitreal delivery. Both of these methods have been shown to have complications in long-term application. PURPOSE: To assess the efficacy of slow release oral diclofenac sodium on intravitreal concentration in experimental model of chemically injured eyes...
January 10, 2017: International Ophthalmology
https://www.readbyqxmd.com/read/28074348/challenges-and-opportunities-in-the-development-of-hiv-medications-in-pediatric-patients
#6
Gueorgui Dubrocq, Natella Rakhmanina, B Ryan Phelps
Successful management of pediatric HIV disease requires high therapeutic efficacy and adherence, which can be achieved by providing affordable, easy to store, and palatable antiretrovirals. Current challenges in pediatric antiretroviral drug development include poor palatability, large pill size, limited oral liquid formulations, and few incentives for development by drug manufacturers as the number of children with HIV continues to decline due to successful worldwide preventive interventions and improved access to antiretrovirals...
January 10, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28074334/saliva-versus-plasma-bioequivalence-of-azithromycin-in-humans-validation-of-class-i-drugs-of-the-salivary-excretion-classification-system
#7
Nasir Idkaidek, Tawfiq Arafat, Hazim Hamadi, Salim Hamadi, Ibrahim Al-Adham
AIM: The aim of this study was to compare human pharmacokinetics and bioequivalence metrics in saliva versus plasma for azithromycin as a model class I drug of the Salivary Excretion Classification System (SECS). METHODS: A pilot, open-label, two-way crossover bioequivalence study was done, and involved a single 500-mg oral dose of azithromycin given to eight healthy subjects under fasting conditions, followed by a 3-week washout period. Blood and unstimulated saliva samples were collected over 72 h and deep frozen until analysis by a validated liquid chromatography with mass spectroscopy method...
January 10, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28069690/development-of-solid-phase-extraction-and-hplc-method-for-simultaneous-estimation-of-ilaprazole-and-glimepiride-in-rat-plasma-application-to-pharmacokinetic-studies
#8
A P Dewani, A S Tripathi, P G Shelke, R L Bakal, D S Mohale, A V Chandewar
A novel, simple and mass spectrometry (MS) compatible high-performance liquid chromatography (HPLC) method is reported for the simultaneous estimation of ilaprazole (ILA) and glimepiride (GLM) in rat plasma. The bio-analytical procedure involves extraction of ILA, GLM and internal standard (IS) from rat plasma with a solid-phase extraction (SPE) process. The chromatographic analysis was performed on Waters-600 system using an isocratic mobile phase comprising methanol:water (80:20 % v/v) with pH of water modified to three using formic acid at a flow rate of 1...
January 8, 2017: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/28062204/impact-of-formulation-properties-and-process-parameters-on-the-dispensing-and-depositioning-of-drug-nanosuspensions-using-micro-valve-technology
#9
Bastian Bonhoeffer, Arno Kwade, Michael Juhnke
Flexible manufacturing processes with continuously adjustable dose strengths are considered particularly innovative and interesting for applications in personalized medicine, continuous manufacturing or early drug development. A piezo-actuated micro-valve has been investigated for the dispensing and depositioning of drug nanosuspensions onto substrates to facilitate the manufacturing of solid oral dosage forms. The investigated micro-valve has been characterized regarding dispensing behavior, mass flow, accuracy and robustness...
January 3, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28053507/riluzole-5-mg-ml-oral-suspension-for-optimized-drug-delivery-in-amyotrophic-lateral-sclerosis
#10
Ann Margaret Dyer, Alan Smith
The aim of the present work is to extensively evaluate the pharmaceutical attributes of currently available riluzole presentations. The article describes the limitations and risks associated with the administration of crushed tablets, including the potential for inaccurate dosing and reduced rate of absorption when riluzole is administered with high-fat foods, and the advantages that a recently approved innovative oral liquid form of riluzole confers on amyotrophic lateral sclerosis (ALS) patients. The article further evaluates the patented and innovative controlled flocculation technology used in the pseudoplastic suspension formulation to reduce the oral anesthesia seen with crushed tablets, resulting in optimized drug delivery for riluzole...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28044413/identification-of-metabolites-of-palmatine-in-rats-after-oral-administration-using-ultra-high-performance-liquid-chromatography-quadrupole-time-of-flight-mass-spectrometry
#11
Kun Wang, Liwei Chai, Liqin Ding, Feng Qiu
RATIONALE: Palmatine (PAL), a protopalmatine alkaloid, is an active constituent in a number of medicinal plants. In order to obtain a comprehensive and systematic metabolic profile of PAL, we investigated its metabolites in plasma, liver tissue, bile, urine, and feces samples after intragastrical administration to sprague-dawly rats with a dose of 100 mg/kg/day. METHODS: In this study, a rapid and sensitive method by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC/Q-TOF/MS), and metabolynx(TM) software with mass defect filter (MDF) technique was developed for screening and identification of the metabolites...
January 3, 2017: Rapid Communications in Mass Spectrometry: RCM
https://www.readbyqxmd.com/read/28043992/direct-oral-anticoagulants-and-heparins-laboratory-values-and-pitfalls-in-bridging-therapy
#12
Thomas Eller, Tobias Flieder, Vanessa Fox, Tatjana Gripp, Marcus Dittrich, Joachim Kuhn, Susanne Alban, Cornelius Knabbe, Ingvild Birschmann
OBJECTIVES: The three direct oral anticoagulants (DOACs) dabigatran, apixaban and rivaroxaban are now widely used in clinical practice. For patients requiring perioperative interruption of DOACs, heparin bridging is still under discussion. Here we show, for the first time, the influence of concomitantly used DOACs and heparins on laboratory assays. METHODS: For spiking experiments, 10 healthy donors and nine patients treated with DOACs were investigated. The measurement of DOACs and heparins was performed with routine methods on the ACL TOP [HEMOCLOT(®) direct thrombin inhibitor (CoaChrom Diagnostica, Austria), COAMATIC(®) Heparin (Chromogenix, USA) calibrated with rivaroxaban, apixaban, unfractionated heparin (UFH) and low molecular weight heparin (LMWH), additionally PT reagent RecombiPlasTin 2G and aPTT reagent SynthASil (Instrumentation Laboratory, Germany)] and the DOACs were additionally quantified with liquid chromatography-mass spectrometry...
January 2, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/28040560/a-systematic-review-of-the-use-of-dosage-form-manipulation-to-obtain-required-doses-to-inform-use-of-manipulation-in-paediatric-practice
#13
REVIEW
Roberta H Richey, Clare Hughes, Jean V Craig, Utpal U Shah, James L Ford, Catrin E Barker, Matthew Peak, Anthony J Nunn, Mark A Turner
This study sought to determine whether there is an evidence base for drug manipulation to obtain the required dose, a common feature of paediatric clinical practice. A systematic review of the data sources, PubMed, EMBASE, CINAHL, IPA and the Cochrane database of systematic reviews, was used. Studies that considered the dose accuracy of manipulated medicines of any dosage form, evidence of safety or harm, bioavailability, patient experience, tolerability, contamination and comparison of methods of manipulation were included...
December 28, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28035764/alpha-pvp-as-an-active-component-of-herbal-highs-in-poland-between-2013-2015
#14
Bogumiła Byrska, Roman Stanaszek, Dariusz Zuba
Alpha-PVP (alpha-pyrrolidinovalerophenone, α-PVP) is a synthetic derivative of cathinone. It has been one of the most frequently detected new psychoactive substances (NPS) available on the drug market in recent years in Poland. The usual routes of administration of the drug include oral, insufflation, injection. Unexpectedly, we dealt with a great number of herbal samples that turned out to contain α-PVP. A total number of 352 herbal samples from 19 cases, in which we detected synthetic cathinones, were investigated in the Institute of Forensic Research (IFR) from 2013 to 2015...
December 30, 2016: Drug Testing and Analysis
https://www.readbyqxmd.com/read/28033584/identification-bioactivity-evaluation-and-pharmacokinetics-of-multiple-components-in-rat-serum-after-oral-administration-of-xian-ling-gu-bao-capsule-by-ultra-performance-liquid-chromatography-coupled-with-quadrupole-time-of-flight-tandem-mass-spectrometry
#15
Zhi-Hong Yao, Zi-Fei Qin, Liang-Liang He, Xin-Luan Wang, Yi Dai, Ling Qin, Frank J Gonzalez, Wen-Cai Ye, Xin-Sheng Yao
The Xian-Ling-Gu-Bao capsule (XLGB) is a famous traditional Chinese medicine prescription (TCMP), which has proven effective in osteoporosis treatment. However, due to the lack of a dynamic XLGB profile, the in vivo pharmacokinetics of multiple bioactive components within this medicine remains unknown. In the present study, ultra-performance liquid chromatography coupled with quadrupole time-of-flight tandem mass spectrometry (UPLC/Q-TOF-MS) identified a total of eighteen prototypes (using reference standards) in rat serum after oral administration of XLGB...
January 15, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28032129/first-dose-and-steady-state-pharmacokinetics-of-orally-administered-crizotinib-in-children-with-solid-tumors-a-report-on-advl0912-from-the-children-s-oncology-group-phase-1-pilot-consortium
#16
Frank M Balis, Patrick A Thompson, Yael P Mosse, Susan M Blaney, Charles G Minard, Brenda J Weigel, Elizabeth Fox
PURPOSE: Characterize the pharmacokinetics of oral crizotinib in children with cancer. METHODS: Sixty-four children with solid tumors or anaplastic large-cell lymphoma (ALCL) enrolled on a phase 1/2 trial of the ALK, MET and ROS1 inhibitor, crizotinib, had pharmacokinetic sampling after the first dose (n = 15) or at steady state (n = 49). Dose levels studied were 100, 130, 165, 215, 280 and 365 mg/m(2)/dose administered twice daily. Two capsule and two oral liquid formulations were used over the course of the trial...
December 28, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28029115/development-of-orally-administered-%C3%AE-tocotrienol-gt3-nanoemulsion-for-radioprotection
#17
Grace A Ledet, Shukla Biswas, Vidya P Kumar, Richard A Graves, Demaurian M Mitchner, Taylor M Parker, Levon A Bostanian, Sanchita P Ghosh, Tarun K Mandal
The purpose of this study was two-fold: (1) to formulate γ-tocotrienol (GT3) in a nanoemulsion formulation as a prophylactic orally administered radioprotective agent; and (2) to optimize the storage conditions to preserve the structural integrity of both the formulation and the compound. γ-tocotrienol was incorporated into a nanoemulsion and lyophilized with lactose. Ultra performance liquid chromatography-mass spectroscopy (UPLC-MS) was used to monitor the chemical stability of GT3 over time, the particle size and ζ potential, and scanning electron microscopy (SEM) were used to study the physical stability of the nanoemulsion...
December 24, 2016: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28025523/development-of-a-uplc-tq-ms-approach-for-the-determination-of-eleven-bioactive-components-in-haizao-yuhu-decoction-plus-minus-haizao-and-gancao-drug-combination-after-oral-administration-in-a-rat-model-of-hypothyroidism
#18
Yingchang Ma, Yang Zhang, Yuanjuan Zhai, Zhenhua Zhu, Ying Pan, Dawei Qian, Shulan Su, Xinsheng Fan, Jinao Duan
Haizao Yuhu Decoction (HYD) has been used for approximately 500 years and is well-known in Traditional Chinese Medicine for its efficacy in the treatment of thyroid-related diseases. In this study, a rapid liquid chromatography-tandem mass spectrometry method was developed for the determination of liquiritin, naringin, hesperidin, peimine, liquiritigenin, glycyrrhizic acid, bergapten, nobiletin, osthole, and glycyrrhetinic acid in rat plasma to investigate the pharmacokinetic profile of different HYD prescriptions in a rat model of hypothyroidism...
December 22, 2016: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28012307/a-sensitive-lc-ms-ms-method-for-analysis-of-pericyazine-in-presence-of-7-hydroxypericyazine-and-pericyazine-sulphoxide-in-human-plasma-and-its-application-to-a-comparative-bioequivalence-study-in-chinese-healthy-volunteers
#19
Hua Lin Cai, Yang Deng, Ping Fei Fang, SiSi Cao, Zhen Yan Hou, Yan Qin Wu, Xue Jiao Chen, Miao Yan, BiKui Zhang
A robust and highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of pericyazine in human plasma. The plasma sample was alkalized with sodium hydroxide solution and handled by liquid-liquid extraction with ethyl acetate after adding perphenazine as an internal standard (IS). The analytes were separated on an Ultimate™ AQ-C18 analytical column at 40°C, with a gradient elution consisting of A (aqueous phase: 5mM ammonium acetate buffer solution containing 0...
December 15, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28001462/comparative-pharmacokinetics-between-madecassoside-and-asiaticoside-presented-in-a-standardised-extract-of-centella-asiatica-eca-233-and-their-respective-pure-compound-given-separately-in-rats
#20
Patcharaporn Hengjumrut, Tosapol Anukunwithaya, Mayuree H Tantisira, Boonyong Tantisira, Phisit Khemawoot
1. ECa 233, the standardised extract of Centella asiatica, contains not less than 80% triterpenoid glycosides, in a madecassoside:asiaticoside ratio of 1.5 (±0.5):1. 2. The pharmacokinetic comparison of madecassoside and asiaticoside was performed in rats following intravenous and oral administration of ECa 233, or an equivalent dose of the individual compounds. Blood, tissues, urine and faeces were collected after dosing to determine drug and metabolite levels using liquid chromatography-tandem mass spectrometry...
January 18, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
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