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Rajesh Patel, Jonathan L Palmer, Shashidhar Joshi, Alejandro Di Ció Gimena, Florencia Esquivel
Two bioavailability/bioequivalence studies were carried out to evaluate the pharmacokinetics of candesartan cilexetil 16mg tablet formulations. A pilot study was used to optimise the formulation and manufacturing process prior to conducting the definitive study. The pilot study was a single dose, randomised two period crossover and the definitive study was a single dose randomised three period, 6 sequence cross over study in healthy adults. In the pilot study the test formulation was 24% and 18% greater for Cmax and AUC compared to the innovator product...
October 18, 2016: Clinical Pharmacology in Drug Development
Fawzia A Ibrahim, Amina M Elbrashy, Jenny Jeehan M Nasr, Mostafa M Badr El-Dien
Three different spectrophotometric and two spectrofluorimetric methods have been developed and validated for the determination of vincamine (VN) and naftidrofuryl oxalate (NF) in tablets. The spectrophotometric methods depend on charge transfer complex formation between each of VN and NF with 7,7,8,8-tetracyano-quinodimethane (TCNQ), 2,6-dichloroquinone-4-chloroimide (DCQ) and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) at 843, 580 and 588 nm, respectively. The spectrofluorimetric methods are based on the formation of charge transfer complex between each of the two drugs and TCNQ, with measurement of the fluorophore formed at 312/375 and 284/612 nm, respectively, or with DDQ at 400/475 and 284/396 nm, respectively...
October 18, 2016: Luminescence: the Journal of Biological and Chemical Luminescence
G Varela-Fascinetto, C Benchimol, R Reyes-Acevedo, M Genevray, D Bradley, J Ives, H T Silva
This multicenter, open-label study evaluated the tolerability of extended prophylaxis with valganciclovir in pediatric kidney transplant recipients at risk of CMV disease. Fifty-six patients aged 4 months to 16 years received once-daily valganciclovir oral solution and/or tablets, dosed by BSA and renal function, for up to 200 days. The most common AEs on treatment were upper respiratory tract infection (33.9%), urinary tract infection (33.9%), diarrhea (32.1%), leukopenia (25.0%), neutropenia (23.2%), and headache (21...
October 17, 2016: Pediatric Transplantation
Lisa G Rosas, Deborah Salvo, Sandra J Winter, David Cortes, Juan Rivera, Nicole M Rodriguez, Abby C King
Middle- and low-income countries bear 80 % of the global chronic disease burden. Population-level, multi-sectoral approaches to promoting healthful lifestyles that take into local physical, socioeconomic, and sociocultural characteristics of both the environment and the population are needed. The "Nuestra Voz (Our Voice)" is one such approach that involves neighborhood residents acting as "citizen scientists" to systematically gather information on the barriers and facilitators of physical activity in their neighborhoods and then use their data to collectively advocate for local environmental- and policy-level changes to support active living...
October 17, 2016: Journal of Urban Health: Bulletin of the New York Academy of Medicine
Adam J Singer, Eric J Morley, Haney Mallemat
No abstract text is available yet for this article.
September 2016: Clin Exp Emerg Med
Mehta Bharati
Introduction: Medical undergraduates are heavily burdened by their curriculum. The females, in addition, suffer from vivid affective or somatic premenstrual syndrome (PMS) symptoms such as bloating, mastalgia, insomnia, fatigue, mood swings, irritability, and depression. The present study was proposed to attenuate the symptoms of PMS by simple lifestyle measures like yoga and/or oral calcium. Methods: 65 medical female students (18-22 years) with a regular menstrual cycle were asked to self-rate their symptoms, along with their severity, in a validated questionnaire for two consecutive menstrual cycles...
September 2016: Journal of Caring Sciences
Muhammad Irfan, Sumeira Rabel, Quratulain Bukhtar, Muhammad Imran Qadir, Farhat Jabeen, Ahmed Khan
Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs. Out of those, drug delivery system being very eminent among pediatrics and geriatrics is orally disintegrating films (ODFs). These fast disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability...
September 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Xueying Tan, Jingbo Hu
Sustained and controlled pellets are considered as one of the ideal dosage forms. Due to the large coverage area of pellets, loaded drugs can be absorbed completely in the body and bioavailability is improved correspondingly. Coated pellets-containing tablet is a special oral formulation consisting of various pellets with different release rate. Desired rate of drug release rate can be achieved by adjusting the proportion of pellets. However, this formulation faces strict requirements in the process of preparation...
September 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Pranav Gupta, Virendra Singh, Sujata Sethi, Arun Kumar
AIM: To compare the efficacy of combined local anesthetic injection with 0.5 % bupivacaine and levosulpiride versus local anesthetic injection alone on outcome measures including levels of pain intensity and depression in the management of myofascial pain syndrome in orofacial region. PATIENTS AND METHODS: This was a prospective, randomized, controlled and open-label comparative clinical study. Seventy-four patients diagnosed to have myofascial pain syndrome and fulfilling the inclusion criteria were enrolled for the study...
September 2016: Journal of Maxillofacial and Oral Surgery
Wenwen Wang, Yanqin Yang, Zhewen Xiong, Jiamin Kong, Xinlu Fu, Feihai Shen, Zhiying Huang
Triptolide (TP), a diterpene triepoxide, is a major active component of Tripterygium wilfordii extracts, which are prepared as tablets and has been used clinically for the treatment of inflammation and autoimmune disorders. However, TP's therapeutic potential is limited by severe adverse effects. In a previous study, we reported that TP induced mitochondria dependent apoptosis in cardiomyocytes. Glycogen synthase kinase-3β (GSK-3β) is a multifunctional serine/threonine kinase that plays important roles in the necrosis and apoptosis of cardiomyocytes...
October 14, 2016: Toxicology and Applied Pharmacology
Hemant R Badwaik, Kalyani Sakure, Kartik T Nakhate, Pranita Kashayap, Hemant Dhongade, Amit Alexander, Ajazuddin, Dulal Krishna Tripathi
The effect of Ca(2+) ion cross-linker on acryalamide grafted carboxymethyl xanthan gum (CMXG-g-PAAm) on the drug release was investigated. Previously, CMXG was synthesized from XG and further grafted to CMXG-g-PAAm to retard the drug release. Once the CaCl2 solution is added to CMXG-g-PAAm, Ca(2+) considerably affected the drug release mechanism mainly by diffusion and erosion. In order to validate the grafted polymer, tablets were prepared using wet granulation and dry granulation methods It has been noticed that the tablets prepared by wet granulation successfully controls the release of the drug over an extended period of time...
October 14, 2016: International Journal of Biological Macromolecules
Artur Carnicer, Oriol Arteaga, Josep M Suñé-Negre, Bahram Javidi
The counterfeiting of pharmaceutical products represents concerns for both industry and the safety of the general public. Falsification produces losses to companies and poses health risks for patients. In order to detect fake pharmaceutical tablets, we propose producing film-coated tablets with gold nanoparticle encoding. These coated tablets contain unique polarimetric signatures. We present experiments to show that ellipsometric optical techniques, in combination with machine learning algorithms, can be used to distinguish genuine and fake samples...
October 1, 2016: Optics Letters
Ahmed Refaat, Magda Sokar, Fatma Ismail, Nabila Boraei
Quetiapine (QT) is a short acting atypical antipsychotic drug effective in schizophrenia and bipolar disorder. This study aims at designing a novel dosage form of sustained release taste-masked QT orally disintegrating tablets (ODTs) based on solid lipid micro-pellets (SLMPs). QT SLMPs were prepared using the hot melt extrusion technique and utilizing three lipid carriers: Compritol, Precirol and white beeswax either alone or in mixtures. They showed sustained QT release and a taste masking effect. The selected QT SLMP was further blended with an aqueous solution containing polyvinylpyrollidone (2...
December 1, 2016: Acta Pharmaceutica
Said A Hassan, Eman S Elzanfaly, Salem Badr A El-Zeany, Maissa Y Salem
Two methods were developed for separation and quantitation of amlodipine (AML) and atorvastatin (ATV) in the presence of their acidic degradation products. The first method was a simple isocratic RP-HPLC method while the second was capillary electrophoresis (CE). Degradation products were obtained by acidic hydrolysis of the two drugs and their structures were elucidated for the first time by IR and MS spectra. Degradation products did not interfere with the determination of either drug and the assays were therefore stability-indicating...
December 1, 2016: Acta Pharmaceutica
M Raj, S W Choi, J Platt
Informed consent (IC) struggles to meet the ethical principles it strives to embody in the context of hematopoietic cell transplantation (HCT). Patients often participate in multiple clinical trials making it difficult to effectively inform the participants and fulfill complex regulations. The recent Notice of Proposed Rule Making would make major changes to federal requirements, providing a timely opportunity to evaluate existing practice. Twenty health care professionals within a Midwest Academic Medical Center involved in obtaining IC in the HCT clinic or involved in patient care during or after the IC process were interviewed to understand: (1) how they approached the IC process; (2) how they described a 'successful' IC process; and (3) opportunities for innovation...
October 17, 2016: Bone Marrow Transplantation
Florence van Hunsel, Sonja van de Koppel, Eugène van Puijenbroek
Two 54-year-old women developed abdominal cramps and vaginal hemorrhage as a result of endometrial hyperplasia during treatment with a hop-containing phytotherapeutic product (MenoCool(®)) for post-menopausal complaints. The women used the hop-containing phytotherapeutic product (418 mg of hop per tablet) twice daily (1 and 0.5 tablets by both patient A and B). Patient A developed abdominal cramps and vaginal hemorrhage after 2 months of use. After gynecological examination, she was diagnosed with endometrial hyperplasia...
December 2015: Drug Saf Case Rep
Yusuf Haydar Ertekin, Burkay Yakar, Hülya Ertekin, Ayşegül Uludağ, Murat Tekin
BACKGROUND: Drugs represent one of the etiologic causes of acute rhabdomyolysis (AR) with drug-induced rhabdomyolysis most commonly associated with HMG-CoA reductase inhibitors. AR etiology can also result from the use of diclofenac, a non-steroidal anti-inflammatory drug, and omeprazole, a proton pump inhibitor. Cases of AR triggered by pantoprazole have never before been reported, although it has been observed that its inclusion in multiple drug therapies can result in muscle events...
December 2015: Drug Saf Case Rep
Frank G A Jansman, Heleen A Crommelin, Freek J A H van Hout, Jan Meulenbelt
CONTEXT: Clozapine is used for decennia for the treatment of schizophrenia. Agranulocytosis, diabetic ketoacidosis, gastrointestinal hypomotility, and myocarditis are well-known adverse effects of clozapine, which are sometimes life threatening. Here we report a case of rhabdomyolysis upon an acute overdose of clozapine. CASE: A male patient, 36 years, with elevated creatinine kinase levels (9899 U/l), developed rhabdomyolysis afterafter admission to the emergency department...
December 2015: Drug Saf Case Rep
Claudia Reynoso-von Drateln, Noemí Gómez-Hernández, Norma Rodríguez-Martínez, Carlos Torres-Lozano
An 81-year-old male and a 47-year-old female experienced recurrent severe bullous dermatosis secondary to an intake of drugs and alternative medicines indicated for arthralgias. The first patient had previously presented with Stevens-Johnson/toxic epidermal necrolysis (TEN) overlap syndrome in 2007 secondary to ingestion of trimethoprim/sulfamethoxazole indicated for a urinary tract infection; 6 years later, he presented with the same syndrome 2 days after ingestion of oral naproxen tablets 250 mg twice daily...
December 2016: Drug Saf Case Rep
Hong-Wei Fan, Zhi-Xiang Ma, Jing Chen, Xing-Ye Yang, Jun-Lin Cheng, Ying-Bin Li
INTRODUCTION: Hydroxychloroquine (HCQ), 4-aminoquinoline, is an antimalarial drug and has become a basic therapy for rheumatic disease treatment. It can stabilize the condition of SLE patients and reduce the chances of patient relapse through its immunosuppressive function and antiinflammatory effects. This drug was absorbed completely and rapidly by oral administration, but has a prolonged half-life for elimination. The objective of this study was to evaluate the pharmacokinetic parameters and relative bioequivalence of a new generic (test) formulation with the branded (reference) formulation of HCQ in healthy Chinese male volunteers...
December 2015: Rheumatol Ther
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