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https://www.readbyqxmd.com/read/25869450/mini-tablets-versus-pellets-as-promising-multiparticulate-modified-release-delivery-systems-for-highly-soluble-drugs
#1
Dina M Gaber, Noha Nafee, Osama Y Abdallah
Whether mini-tablets (tablets, diameters ≤6mm) belong to single- or multiple-unit dosage forms is still questionable. Accordingly, Pharmacopoeial evaluation procedures for mini-tablets are lacking. In this study, the aforementioned points were discussed. Moreover, their potential for oral controlled delivery was assessed. The antidepressant venlafaxine hydrochloride (Vx), a highly soluble drug undergoing first pass effect, low bioavailability and short half-life was selected as a challenging payload. In an attempt to weigh up mini-tablets versus pellets as multiparticulate carriers, Vx-loaded mini-tablets were compared to formulated pellets of the same composition and the innovator Effexor(®)XR pellets...
July 5, 2015: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/25822610/modified-regulatory-pathways-to-approve-generic-drugs-in-the-us-and-a-systematic-review-of-their-outcomes
#2
REVIEW
Aaron S Kesselheim, Jennifer M Polinski, Lisa A Fulchino, Danielle L Isaman, Joshua J Gagne
BACKGROUND: Generic drugs are approved on the basis of pharmaceutical equivalence and bioequivalence. Some drug products have unique structural or functional attributes, necessitating modified approaches to bioequivalence determinations. OBJECTIVE: The aim of this systematic review was to identify studies that evaluated laboratory or clinical outcomes of six drugs approved via modified bioequivalence approaches. DATA SOURCES: We conducted a systematic review of articles published through February 2014 in MEDLINE, EMBASE, and International Pharmaceutical Abstracts related to six recent drugs subject to modified regulatory approaches: venlafaxine extended release tablet (Effexor XR), acarbose (Precose), enoxaparin (Lovenox), vancomycin capsules (Vancocin), sodium ferric gluconate (Ferrlecit), and calcitonin salmon nasal spray (Miacalcin NS)...
April 2015: Drugs
https://www.readbyqxmd.com/read/24314785/treatment-of-hidradenitis-supprurativa-associated-pain-with-nonsteroidal-anti-inflammatory-drugs-acetaminophen-celecoxib-gabapentin-pegabalin-duloxetine-and-venlafaxine
#3
REVIEW
Noah Scheinfeld
Hidradenitis Supprurativa is a painful dermatological condition. Although the pain of HS has unique aspects, the pain of HS pain shares common elements with essential pain, fibromyalgia, and pure neuropathic pain syndromes. Futhermore, depression plays an important role in the pain of HS. This paper reviews the potential for use of nonsteroidal anti-inflammatory drug (NSAIDS), acetaminophen, celecoxib, gabpentin, pregabalin, and the serotonin and norepinephrine reuptake inhibitors (SNRIs), duloxetine and venlafaxine, for treating HS related pain...
November 2013: Dermatology Online Journal
https://www.readbyqxmd.com/read/23281074/association-between-reported-venlafaxine-use-in-early-pregnancy-and-birth-defects-national-birth-defects-prevention-study-1997-2007
#4
Kara N D Polen, Sonja A Rasmussen, Tiffany Riehle-Colarusso, Jennita Reefhuis
BACKGROUND: Few epidemiologic studies have investigated the use of venlafaxine (Effexor XR capsules, Product Monograph, Wyeth, Montreal, Canada), an antidepressant used to treat major depression and anxiety disorders in adults, during pregnancy. Our objective was to determine whether use of venlafaxine during pregnancy is associated with specific birth defects. METHODS: We used data from the National Birth Defects Prevention Study (NBDPS), a population-based, case-control study in the United States...
January 2013: Birth Defects Research. Part A, Clinical and Molecular Teratology
https://www.readbyqxmd.com/read/22266529/preparation-and-in-vitro-in-vivo-evaluation-of-sustained-release-venlafaxine-hydrochloride-pellets
#5
COMPARATIVE STUDY
Yang Liu, Yinghua Sun, Jin Sun, Nana Zhao, Mingyu Sun, Zhonggui He
The objective of this study was to prepare different venlafaxine hydrochloride sustained-release products and to elucidate the influence of composition of the coating film on the in vitro drug release profiles and in vivo pharmacokinetics. Pellets were prepared by a standardized process of extrusion/spheronization. A selected fraction size (0.8-1.0 mm diameter) of pellets of each formulation was coated with Eudragit NE30D or ethylcellulose (10 cps). Many efforts have been made to tailor drug release rate by choosing different coating materials, different percent of pore forming components and coating weight variation to achieve a desired sustained-release effect...
April 15, 2012: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/19653973/comparison-of-pharmacokinetic-profiles-of-brand-name-and-generic-formulations-of-citalopram-and-venlafaxine-a-crossover-study
#6
RANDOMIZED CONTROLLED TRIAL
Franck Chenu, Lisa A Batten, Gerald Zernig, Elisabeth Ladstaetter, Chantal Hébert, Pierre Blier
BACKGROUND: Generic drugs are lower-cost versions of patent-expired brand-name medications. Bioequivalence is decreed when the 90% confidence intervals for the ratios of the generic to the reference compound for the area under the curve and maximum plasma concentration (C(max)) fall within a 0.80 to 1.25 range. The aim of the present pilot study was to compare the pharmacokinetic profiles of brand-name and generic formulations of citalopram and extended-release venlafaxine. METHOD: Effexor XR/Novo-venlafaxine XR 75 mg and Celexa/Gen-citalopram 40 mg were studied in a randomized crossover design...
July 2009: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/19444618/fabrication-of-triple-layer-matrix-tablets-of-venlafaxine-hydrochloride-using-xanthan-gum
#7
Mukesh C Gohel, Shital H Bariya
The objective of present investigation was to develop venlafaxine hydrochloride-layered tablets for obtaining sustained drug release. The tablets containing venlafaxine hydrochloride 150 mg were prepared by wet granulation technique using xanthan gum in the middle layer and barrier layers. The granules and tablets were characterized. The in vitro drug dissolution study was conducted in distilled water. The tablets containing two lower strengths were also developed using the same percentage composition of the middle layer...
2009: AAPS PharmSciTech
https://www.readbyqxmd.com/read/16096924/future-pain-drugs-8-9-march-2000-london-uk
#8
A Holdcroft
Closing the gaps between product design and delivery of analgesic drugs, and individual patient needs for pain relief was the focus for this meeting. The changes in theories of nociceptive activity, from a mechanistic to a biopsychosocial disorder with diverse systemic modulation, were highlighted by Mark Travers (Janssen-Cilag, Titusville, NJ, USA), including examples from clinical trials where a patient's expectations were not met and high drop-out rates occurred. The need to target drug design and delivery to defined patient groups was clearly an important issue...
June 2000: IDrugs: the Investigational Drugs Journal
https://www.readbyqxmd.com/read/15853535/venlafaxine-in-the-treatment-of-anxiety-disorders
#9
REVIEW
Martin Katzman
Venlafaxine extended-release (Effexor XR, Wyeth-Ayerst Co.) is a novel, dual acting serotonin-norepinephrine reuptake inhibitor antidepressant, which inhibits the synaptic reuptake of both serotonin and norepinephrine. Controlled trials have demonstrated the efficacy and safety of venlafaxine in the treatment of anxiety disorders including social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, panic disorder and obsessive-compulsive disorder. Generally well-tolerated with side effects that usually abate with continued treatment, venlafaxine is an important alternative to the selective serotonin reuptake inhibitors for patients with anxiety disorders...
May 2004: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/15533993/an-open-treatment-trial-of-venlafaxine-for-elderly-patients-with-dysthymic-disorder
#10
D P Devanand, Nicole Juszczak, Mitchell S Nobler, Nancy Turret, Linda Fitzsimons, Harold A Sackeim, Steven P Roose
Treatment response and side effects of venlafaxine were evaluated in an open-label trial of elderly outpatients with dysthymic disorder (DD). Patients received flexible dose (up to 300 mg/d) venlafaxine (Effexor XR) for 12 weeks. Of 23 study patients, 18 completed the trial. Fourteen (60.9%) were responders in intent-to-treat analyses with the last observation carried forward, and 77.8% were responders in completer analyses. Nearly half the sample (47.8%) met criteria for remission. In the intent-to-treat sample, increased severity of depression at baseline was associated with superior response, and the presence of cardiovascular disease was associated with poorer response...
December 2004: Journal of Geriatric Psychiatry and Neurology
https://www.readbyqxmd.com/read/15449363/an-open-trial-of-venlafaxine-for-the-treatment-of-late-life-atypical-depression
#11
Steven P Roose, Marissa Miyazaki, Dev Devanand, Stuart Seidman, Linda Fitzsimmons, Nancy Turret, Harold Sackeim
OBJECTIVES: The atypical subtype in patients with major depressive disorder is characterized by mood reactivity, significant weight gain or increase in appetite, hypersomnia, leaden paralysis and a long-standing pattern of interpersonal rejection sensitivity. Though atypical depression is well documented in younger patients, little attention has been paid to the atypical subtype in samples of late-life depressed patients. This study reports the patient characteristics and treatment results of an eight-week open-label trial of venlafaxine in a sample of older depressed patients with atypical subtype...
October 2004: International Journal of Geriatric Psychiatry
https://www.readbyqxmd.com/read/14705849/massive-venlafaxine-overdose-resulted-in-a-false-positive-abbott-axsym-urine-immunoassay-for-phencyclidine
#12
G Randall Bond, Paul E Steele, Donald R A Uges
CASE REPORT: A 13-yr-old girl overdosed on 48 x 150 mg venlafaxine (Effexor XR). She was taking venlafaxine regularly for depression. Her only other medications included topical Benzamycin and pyridoxine 50 mg daily for acne. The Abbott AxSYM assay was positive only for phencyclidine, but GC/MS did not confirm the presence of phencyclidine. Toxilab identified only one substance, confirmed by GC/MS as venlafaxine. A serum sample obtained 3 h after her ingestion revealed a venlafaxine concentration of 24460 ng/mL and an O-desmethylvenlafaxine concentration of 3930 ng/mL, confirming the massive acute overdose (therapeutic range of venlafaxine and O-desmethylvenlafaxine together is 250-750 ng/mL)...
2003: Journal of Toxicology. Clinical Toxicology
https://www.readbyqxmd.com/read/12477299/common-treatment-of-polycystic-ovarian-syndrome-and-major-depressive-disorder-case-report-and-review
#13
REVIEW
N L Rasgon, M S Carter, S Elman, M Bauer, M Love, S G Korenman
We present the case of a young woman with treatment-resistant major depression, who presented to the Mood Disorders Clinic with a Hamilton Psychiatric Rating Scale for Depression (HAM-D-21) score of 28, after a year-long treatment with Effexor-XR. The patient also had untreated Polycystic Ovarian Syndrome (PCOS). The resolution of her depressive symptoms resulted from the treatment for PCOS with metformin and spironolactone. The patient remained euthymic 5 months after discontinuation of the antidepressant while continuing therapy for PCOS...
April 2002: Current Drug Targets. Immune, Endocrine and Metabolic Disorders
https://www.readbyqxmd.com/read/12028242/venlafaxine-er-as-a-treatment-for-generalized-anxiety-disorder-in-older-adults-pooled-analysis-of-five-randomized-placebo-controlled-clinical-trials
#14
Ira R Katz, Charles F Reynolds, George S Alexopoulos, David Hackett
OBJECTIVES: Concerns about the safety of benzodiazepines in older adults may have led investigators and clinicians to underestimate the importance of adequately treating generalized anxiety disorder (GAD) in later life. To evaluate the safety and efficacy profile of an alternative treatment in older patients, we conducted a secondary analysis of five randomized, placebo-controlled clinical trials of extended release venlafaxine (venlafaxine ER, Effexor XR) for adult patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of GAD...
January 2002: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/8969980/etrank-a-ranking-procedure-for-handling-missing-data-in-clinical-trials-application-to-venlafaxine-extended-release-depression-clinical-trial
#15
REVIEW
R Entsuah
ETRANK is a statistical software which uses nonparametric (randomization) technique to analyze incomplete repeated measures data, where the pattern of withdrawal is treatment related. This stand alone program is written in C, presently runs in MS-DOS, and a Windows version is in development. The program has been developed based on methods developed by Entsuah (1990). These methods were presented at Statistics and Statistical Graphics Section of the 1991 SAS Users Group International Conference (SUGI-16). They were also presented to the Biometric Division of US Food and Drug Administration (FDA)...
November 1996: Journal of Biopharmaceutical Statistics
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