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Alejandro Ruiz-Picazo, Mª Teresa Martinez-Martinez, Sarin Colon-Useche, Ramon Iriarte, Barbara Sanchez-Dengra, Marta Gonzalez-Alvarez, Alfredo Garcia-Arieta, Isabel Gonzalez Alvarez, Marival Bermejo
The main objective of this investigation was to develop an exploratory two-step level A IVIVC for three Telmisartan oral immediate release formulations, the reference product Micardis and two generic formulations (X1 and X2). Correlation was validated with a third test formulation Y1. Experimental solubility and permeability data was obtained to confirm that Telmisartan is a class II compound under the Biopharmaceutic Classification System. BE studies plasma profiles were combined using a previously published reference scaling procedure...
May 10, 2018: Molecular Pharmaceutics
P Marsella, S Giannantonio, A Scorpecci, F Pianesi, M Micardi, A Resca
This is a prospective randomised study that evaluated the differences arising from a bimodal stimulation compared to a monaural electrical stimulation in deaf children, particularly in terms of auditory-perceptual skills development. We enrolled 39 children aged 12 to 36 months, suffering from severe-to-profound bilateral sensorineural hearing loss with residual hearing on at least one side. All were unilaterally implanted: 21 wore only the cochlear implant (CI) (unilateral CI group), while the other 18 used the CI and a contralateral hearing aid at the same time (bimodal group)...
December 2015: Acta Otorhinolaryngologica Italica
Federica Pianesi, Alessandro Scorpecci, Sara Giannantonio, Mariella Micardi, Alessandra Resca, Pasquale Marsella
OBJECTIVES: To assess when prelingually deaf children with a cochlear implant (CI) achieve the First Milestone of Oral Language, to study the progression of their prelingual auditory skills in the first year after CI and to investigate a possible correlation between such skills and the timing of initial oral language development. METHODS: The sample included 44 prelingually deaf children (23 M and 21 F) from the same tertiary care institution, who received unilateral or bilateral cochlear implants...
March 2016: International Journal of Pediatric Otorhinolaryngology
Jinu Isaac, Swastika Ganguly, Animesh Ghosh
The aim of this study was to enhance the dissolution and bioavailability of telmisartan (TLM), a poorly water soluble drug by co-milling approach. Physical mixtures of TLM and poly(vinyl alcohol) (PVA) were co-milled in a planetary micro mill in a dry condition by varying process parameters such as drug to polymer weight ratio, ball-to-powder weight ratio, and rotational speed. The co-milled products offered cumulative percentage dissolution of TLM above 75% in 30 min (CG 1 and CG2). These samples were characterized using field emission scanning electron microscopy (FE-SEM), powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC) and Raman spectra analysis...
April 2016: European Journal of Pharmaceutics and Biopharmaceutics
Paola Aline Amarante Borba, Marihá Pinotti, Carlos Eduardo Maduro de Campos, Bianca Ramos Pezzini, Hellen Karine Stulzer
The solid dispersion technique is the most effective method for improving the dissolution rate of poorly water-soluble drugs, however it depends on a suitable carrier selection. The work explored the use of the biopolymer sodium alginate (SA) as a potential carrier in solid dispersions (SD). The data demonstrated that SA was able to improve the biopharmaceutical properties of the BCS II drug telmisartan (TEL) of low solubility even using relative small drug:polymer ratio. A solid state grinding process was used to prepare the solid dispersions (SD) during 45 min...
February 10, 2016: Carbohydrate Polymers
Paola Aline Amarante Borba, Marihá Pinotti, George Ricardo Santana Andrade, Nivan Bezerra da Costa, Luiz Renato Olchanheski Junior, Daniel Fernandes, Carlos Eduardo Maduro de Campos, Hellen Karine Stulzer
Telmisartan (TEL) was entrapped into β-cyclodextrin aiming the improvement of its biopharmaceutical properties of low solubility. A solid state grinding process was used to prepare the molecular inclusion complex (MIC) for up to 30min. The inclusion ratio of drug and β-cyclodextrin was established as 1:2 and 1:3 (mol/mol) by phase solubility study and Job Plot. DSC, XRPD and FTIR confirmed the molecular interactions between TEL and β-cyclodextrin. Computer molecular modeling supports the presence of hydrogen bonds between guest and host and demonstrated the most probable complexes configuration...
November 20, 2015: Carbohydrate Polymers
Kyeong Hwan Kim, Wan Soo Kim
BACKGROUND: This case report describes a patient with chronic unilateral chemosis, likely due to treatment with amlodipine besylate. CASE PRESENTATION: A 52-year-old man visited the clinic with symptoms of foreign body sensation and puffiness in his right eye, which had persisted for 4 months. There were no other symptoms, such as itching and pain, in his right eye and no specific symptoms in his left eye. He had been treated for hypertension and hyperlipidemia for the previous 5 months with once daily amlodipine besylate/atorvastatin (Caduet) and candesartan cilexetil (Atacand)...
2014: BMC Ophthalmology
Philippe Gosse, Helmut Schumacher
A retrospective pooled analysis of the 'Prospective, Randomized Investigation of the Safety and Efficacy of MICARDIS vs. Ramipril Using ABPM' studies conducted in Europe and South Africa (PRISMA I) and in the United States of America and Canada (PRISMA II) was carried out to investigate the effects of telmisartan and ramipril on dipper status (extreme dippers, dippers, non-dippers, risers/reverse dippers), and blood pressure (BP) variability in 1279 patients (with normal sleeping patterns and valid 24-h ambulatory BP monitoring recordings at baseline and end point)...
February 2014: Hypertension Research: Official Journal of the Japanese Society of Hypertension
I-H Baek, B-Y Lee, E-S Lee, K-I Kwon
Angiotensin II receptor blockers (ARBs) are effective and well-tolerated orally active anti-hypertensive agents. The purpose of this study was to investigate the pharmacokinetic properties of typical ARBs in the dog. 60 beagles were administered a single oral dose of Micardis® 80 mg (telmisartan), Cozaar® 50 mg (losartan), or Diovan® 80- and 160-mg (valsartan). The plasma concentrations of these ARBs were measured using liquid chromatography/tandem mass spectrometry and their pharmacokinetic properties were analyzed using both non-compartmental and compartmental approaches...
July 2013: Drug Research
Yanzhuo Zhang, Jiancheng Wang, Xiaoyu Bai, Tongying Jiang, Qiang Zhang, Siling Wang
We investigate the effects of spherical mesoporous silica nanoparticles (MSNs) as an oral drug delivery system to improve the oral bioavailability of the model drug telmisartan (TEL) and examine their cellular uptake and cytotoxicity. Further, we explore the mechanisms behind the improved oral absorption of poorly soluble drugs promoted by MSNs. An investigation of intestinal epithelial cellular binding, association and uptake was carried out by laser scanning confocal microscopy, transmission electron microscopy and fluorescence activated cell sorting...
March 5, 2012: Molecular Pharmaceutics
Krystyna Czerwińska, Aleksander P Mazurek
Losartan potassium, valsartan, telmisartan, irbesartan, eprosartan mesylate and candesartan cilexitil, the angiotensin II receptor antagonists, were analyzed in bulk substances and in tablets: Lorista tablets 50 mg, Diovan tablets 160 mg, Micardis tablets 20 mg, Aprovel tablets 300 mg, Teveten tablets 600 mg and Blopress tablets 16 mg. The conditions for identification by HPLC method in a gradient system and for determination of those compounds in isocratic systems were developed. The determination was carried out using Zorbax SB-Phenyl column with UV-VIS detector set at 230 nm and the following mobile phases: 0...
November 2011: Acta Poloniae Pharmaceutica
James E Frampton
Telmisartan (Micardis®, Pritor®), a well established angiotensin type 1 receptor antagonist, is indicated in the EU for the reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease (CVD) or type 2 diabetes mellitus with documented target organ damage, as well as for the treatment of hypertension. In the pivotal ONTARGET trial, which enrolled ACE inhibitor-tolerant patients at high vascular risk, telmisartan 80 mg once daily added to existing, proven therapy was noninferior to ramipril 10 mg once daily (the gold standard cardioprotective ACE inhibitor) in terms of CVD prevention...
April 16, 2011: Drugs
I P Tatarchenko, N V Pozdniakova, A G Mordovina, O I Morozova, A V Zaĭtseva
AIM: To study the effects of enalapril and telmisartan on hemodynamic parameters and diastolic function (DF) of the left ventricle (LV) in patients with type 2 diabetes mellitus (DM) concurrent with arterial hypertension (AH). SUBJECTS AND METHODS: The study included 64 patients (mean age 54.3 +/- 5.2 years) with type 2 DM. For the treatment of AH, Group 1 (n = 31) received enalapril and Group 2 (n = 33) took telmisartan (micardis). Their examination comprised 24-hour blood pressure (BP) monitoring, Holter ECG monitoring, and echocardiography...
2009: Terapevticheskiĭ Arkhiv
I P Tatarchenko, N V Pozdniakova, A G Mordovina, S A Sekerko, O I Morozova
The study was designed to evaluate effect of enalapril and telmisartan on hemodynamic characteristics and diastolic function (DF) of left ventricle (LV) in patients with type 2 diabetes and arterial hypertension (AH). It included 64 patients aged 54.3 +/- 5.2 years. Those in group 1 (n = 31) were given enalapril (enap), patients of group 2 (n = 33) were treated with telmisartan (micardis). Examination included 24 hour AP monitoring, Holter ECG monitoring, and echocardiography. Compensation of metabolic disorders was evaluated from fasting and postprandial blood glucose and HbAc1 levels...
2009: Klinicheskaia Meditsina
B Williams, Y Lacourcière, H Schumacher, P Gosse, J M Neutel
Cardiovascular risk is subject to circadian variation, with peak morning incidence of myocardial infarction and stroke correlating with the early morning blood pressure (BP) surge (EMBPS). Ideally, antihypertensive therapy should maintain control of BP throughout the 24-h dosing cycle. In two sister studies, Prospective, Randomized Investigation of the Safety and efficacy of Micardis vs Ramipril Using ABPM (ambulatory BP monitoring) (PRISMA) I and II, BP control was compared in patients with essential hypertension (24-h mean baseline ambulatory BP approximately 148/93 mm Hg) randomized to the angiotensin receptor blocker, telmisartan (80 mg; n=802), or the angiotensin-converting enzyme inhibitor, ramipril (5 or 10 mg; n=811), both dosed in the morning...
September 2009: Journal of Human Hypertension
J M Neutel, H Schumacher, P Gosse, Y Lacourcière, B Williams
OBJECTIVES: A post hoc analysis was performed to assess the magnitude of the early morning blood pressure surge (EMBPS), which is associated with peak cardiovascular risk, in untreated hypertensive patients enrolled in two sister studies (Prospective, Randomised Investigation of the Safety and efficacy of MICARDIS vs. ramipril using ambulatory blood pressure monitoring I and II) with identical design. METHODS: In adults with a mild-to-moderate primary hypertension and no significant comorbidities, 24-h ambulatory blood pressure monitoring was conducted after a 2- to 4-week placebo run-in period and before treatment initiation...
November 2008: International Journal of Clinical Practice
Greg L Plosker, William B White
Fixed-dose combinations of telmisartan and hydrochlorothiazide (HCTZ) [Micardis Plus, Micardis HCT, PritorPlus] are available in many countries for the treatment of patients with essential hypertension. Combining the angiotensin II receptor antagonist (angiotensin II receptor blocker [ARB]) telmisartan with the thiazide diuretic HCTZ provides antihypertensive therapy with complementary mechanisms of action. In the US and EU, telmisartan/HCTZ is approved for patients whose hypertension is not adequately controlled with telmisartan monotherapy; US labelling for the fixed-dose combination also includes inadequate control of blood pressure (BP) with HCTZ monotherapy...
2008: Drugs
Lijun Yao, Jianqing Wang, Anguo Deng, Jianshe Liu, Hong Zhao
In current study, the effect of angiotensin receptor blocker Micardis on the localization and expression of aquaporin-2 (AQP2) was investigated in the renal medullary collecting duct of mice with diabetic nephropathy (DN). Mice were divided into three groups: normal group, DN group and Micardis-treated group. Six weeks after establishment of STZ-induced DN model in mice, the expression of AQP2 in renal medulla was detected measured by semiquantitative immunofluorescence histochemistry and Western blot techniques, and the localization of AQP2 by confocal immunofluorescence laser scanning microscopy...
June 2008: Journal of Huazhong University of Science and Technology. Medical Sciences
Sho-ichi Yamagishi, Kazuo Nakamura
There is a growing body of evidence that the renin-angiotensin system (RAS) plays a pivotal role in the pathogenesis of cardiovascular diseases. Indeed, large clinical trials have demonstrated substantial benefit of the blockade of this system for cardiovascular-organ protection. Although several types of angiotensin II type 1 (AT(1)) receptor blockers (ARBs) are commercially available for the treatment of patients with hypertension, we have recently found that telmisartan (Micardis) could have the strongest binding affinity to AT(1) receptor...
January 2006: Recent Patents on Cardiovascular Drug Discovery
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