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https://www.readbyqxmd.com/read/28331293/risk-assessment-and-experimental-design-in-the-development-of-a-prolonged-release-drug-delivery-system-with-paliperidone
#1
Sonia Iurian, Luana Turdean, Ioan Tomuta
This study focuses on the development of a drug product based on a risk assessment-based approach, within the quality by design paradigm. A prolonged release system was proposed for paliperidone (Pal) delivery, containing Kollidon(®) SR as an insoluble matrix agent and hydroxypropyl cellulose, hydroxypropyl methylcellulose (HPMC), or sodium carboxymethyl cellulose as a hydrophilic polymer. The experimental part was preceded by the identification of potential sources of variability through Ishikawa diagrams, and failure mode and effects analysis was used to deliver the critical process parameters that were further optimized by design of experiments...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28278537/paliperidone-long-acting-plasma-level-monitoring-and-a-new-method-of-evaluation-of-clinical-stability
#2
Massimo Carlo Mauri, Silvia Paletta, Chiara Di Pace, Alessandra Reggiori, Chiara Rovera, Alessio Fiorentini, Carlo Alfredo Altamura
The second generation long-acting antipsychotics can be a pharmacologic strategy, both in the early phase of illness and in the case of low compliance. The aim of the study was to evaluate the clinical efficacy and tolerability of one monthly injection of paliperidone palmitate (PP1M), paliperidone plasma levels (PLs), and the clinical outcome. 21 outpatients, affected by Schizophrenia or Schizoaffective Disorder, were recruited. PP1M started with 150 mg on day 1 and 100 mg on day 8. Following patients were given a dosage ranging from 50 mg to 150 mg every 28 days...
March 9, 2017: Pharmacopsychiatry
https://www.readbyqxmd.com/read/28277864/health-care-resource-use-analysis-of-paliperidone-palmitate-3-month-injection-from-two-phase-3-clinical-trials
#3
Costel Chirila, Isaac Nuamah, Kimberly Woodruff
OBJECTIVE: The objective of this study was to compare occupational status and health care resource use between treatment groups in clinical trials 3012 (PP3M versus placebo) and 3011 (PP3M versus PP1M). METHODS: Occupational status was assessed at each study visit. Logistic regressions modeled the probability of hospitalization during the double-blind phase. RESULTS: At the start of each study, a low percentage of patients were full-time employed or gainfully self-employed (approximately 10% in trial 3012 and 11%-13% in trial 3011)...
February 25, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28265686/inhibition-of-cloned-herg-potassium-channels-by-risperidone-and-paliperidone
#4
Hong Joon Lee, Jin-Sung Choi, Bok Hee Choi, Sang June Hahn
Risperidone and one of its active metabolites, paliperidone, are widely used for the treatment of schizophrenia. We used a patch-clamp study to investigate the effects of paliperidone on hERG potassium channels expressed in HEK cells. Western blot analyses were used to study the effects of risperidone and paliperidone on hERG and hERG 3.1 isoform channel trafficking. Risperidone and paliperidone inhibited the hERG tail currents in a concentration-dependent manner with IC50 values of 0.16 and 0.57 μM, respectively...
March 6, 2017: Naunyn-Schmiedeberg's Archives of Pharmacology
https://www.readbyqxmd.com/read/28264565/dual-modulation-of-human-p-glycoprotein-and-abcg2-with-prodrug-dimers-of-the-atypical-antipsychotic-agent-paliperidone-in-a-model-of-the-blood-brain-barrier
#5
Kelsey Bohn, Allison Lange, Jean Chmielewski, Christine A Hrycyna
Many atypical antipsychotic drugs currently prescribed for the treatment of schizophrenia have limited brain penetration due to the efflux activity of ATP-binding cassette (ABC) transporters at the blood-brain barrier (BBB), including P-glycoprotein (P-gp) and ABCG2. Herein, we describe the design and synthesis of the first class of homodimeric prodrug dual inhibitors of P-gp and ABCG2. These inhibitors are based on the structure of the atypical antipsychotic drug paliperidone (Pal), a transport substrate for both transporters...
March 6, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28258365/dosing-and-switching-strategies-for-paliperidone-palmitate-3-month-formulation-in-patients-with-schizophrenia-based-on-population-pharmacokinetic-modeling-and-simulation-and-clinical-trial-data
#6
REVIEW
Mats O Magnusson, Mahesh N Samtani, Elodie L Plan, E Niclas Jonsson, Stefaan Rossenu, An Vermeulen, Alberto Russu
Paliperidone palmitate 3-month formulation (PP3M), a long-acting injectable atypical antipsychotic, was recently approved in the US and Europe for the treatment of schizophrenia in adult patients who have already been treated with paliperidone palmitate 1-month formulation (PP1M) for ≥4 months. This article reviews the pharmacokinetic rationale for the approved dosing regimens for PP3M, dosing windows, management of missed doses and treatment discontinuation, switching to other formulations, and dosing in special populations...
March 4, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28255435/the-effect-of-long-acting-paliperidone-palmitate-once-monthly-on-negative-and-depressive-symptoms-in-patients-with-schizophrenia-switched-from-previous-unsuccessful-treatment-with-oral-aripiprazole
#7
Andreas Schreiner, Paul Bergmans, Pierre Cherubin, Ludger Hargarter
BACKGROUND: The negative symptoms of schizophrenia are generally harder to recognize, more difficult to treat than positive symptoms, and have a significant impact on patient functioning and overall outcomes. Treatment with aripiprazole may be associated with benefits on negative symptoms and functioning given its partial agonism to the dopamine D2 receptor. The aim of this subanalysis was to explore the impact of flexibly dosed, long-acting paliperidone palmitate once monthly (PP1M) on negative and depressive symptoms, disorganized thoughts, anxiety, extrapyramidal symptoms, and patient functioning in nonacute adult patients with schizophrenia previously unsuccessfully treated with oral aripiprazole monotherapy...
February 2017: Therapeutic Advances in Psychopharmacology
https://www.readbyqxmd.com/read/28252452/reduced-sexual-dysfunction-with-aripiprazole-once-monthly-versus-paliperidone-palmitate-results-from-qualify
#8
Steven G Potkin, Jean-Yves Loze, Carlos Forray, Ross A Baker, Christophe Sapin, Timothy Peters-Strickland, Maud Beillat, Anna-Greta Nylander, Peter Hertel, Henrik Steen Andersen, Anna Eramo, Karina Hansen, Dieter Naber
Sexual dysfunction, a common side effect of antipsychotic medications, may be partly caused by dopamine antagonism and elevation of prolactin. In QUALIFY, a randomized study, aripiprazole once-monthly 400 mg (AOM 400), a dopamine D2 receptor partial agonist, showed noninferiority and subsequent superiority versus paliperidone palmitate (PP), a dopamine D2 receptor antagonist, on the Heinrichs-Carpenter Quality-of-Life Scale (QLS) in patients with schizophrenia aged 18-60 years. Sexual dysfunction (Arizona Sexual Experience Scale) and serum prolactin levels were also assessed...
March 1, 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28219485/acute-antipsychotic-treatment-of-children-and-adolescents-with-schizophrenia-spectrum-disorders-a-systematic-review-and-network-meta-analysis
#9
REVIEW
Anne Katrine Pagsberg, Simon Tarp, Dorte Glintborg, Anne Dorte Stenstrøm, Anders Fink-Jensen, Christoph Ulrich Correll, Robin Christensen
OBJECTIVE: To determine the comparative efficacy and safety of antipsychotics for youth with early-onset schizophrenia using network meta-analytic methods combining direct and indirect trial data. METHOD: The authors systematically searched MEDLINE, the Cochrane Library, and clinicaltrials.gov and selected randomized controlled trials allocating youth with schizophrenia spectrum disorders to a (non-clozapine) antipsychotic versus placebo or another antipsychotic...
March 2017: Journal of the American Academy of Child and Adolescent Psychiatry
https://www.readbyqxmd.com/read/28161644/gray-matter-volumes-may-predict-the-clinical-response-to-paliperidone-palmitate-long-acting-in-acute-psychosis-a-pilot-longitudinal-neuroimaging-study
#10
A Carlo Altamura, Giuseppe Delvecchio, Silvia Paletta, Chiara Di Pace, Alessandra Reggiori, Alessio Fiorentini, M Donatella Mirabile, Riccardo A Paoli, Claudia Cinnante, Fabio Triulzi, Massimo C Mauri, Paolo Brambilla
In schizophrenia, paliperidone palmitate (PP) long acting injectable (LAI) has been reported to sustain plasma concentrations and improve clinical symptoms. Moreover, it has also been demonstrated the important role of total gray matter (GM) volumes in predicting the clinical outcome. However, no studies investigating the association between PP-LAI treatment and brain morphometry has been published so far. Therefore, the main aim of our 24 weeks prospective observational exploratory study was to investigate the relation between brain anatomy and clinical outcome in seven patients with acute psychosis treated with PP-LAI...
January 26, 2017: Psychiatry Research
https://www.readbyqxmd.com/read/28150091/reliability-and-validity-of-the-short-version-of-udvalg-for-kliniske-undersogelser-in-antipsychotic-treatment
#11
Kun-Po Chen, For-Wey Lung
The aim of this study was to develop a reliable and valid short version of the Udvalg for Kliniske Undersogelser (UKU) to efficiently evaluate the side effects of antipsychotics in patients with schizophrenia. This multi-site study included 10 hospitals, which included 331 inpatients and outpatients diagnosed with schizophrenia. UKU, Clinical Global Impression-Severity (CGI-S), Personal and Social Performance (PSP) and dosage of paliperidone were collected. The predictive validity of the UKU-short version, as well as that of the CGI-S, PSP and paliperidone dosages, was analyzed using structural equation modeling (SEM), latent growth models (LGM), and confirmatory factor analysis to test its content and construct validity...
February 1, 2017: Psychiatric Quarterly
https://www.readbyqxmd.com/read/28141623/activating-and-sedating-adverse-effects-of-second-generation-antipsychotics-in-the-treatment-of-schizophrenia-and-major-depressive-disorder-absolute-risk-increase-and-number-needed-to-harm
#12
Leslie Citrome
PURPOSE/BACKGROUND: Activating and sedating adverse effects of antipsychotics can be obstacles to their use. METHODS/PROCEDURES: This study quantified the activating and sedating properties of first-line oral second-generation antipsychotics by examining the rates of adverse reactions as reported in product labeling for the indications of schizophrenia and adjunctive treatment of major depressive disorder. Additional data sources included regulatory documents, study synopses, and published study reports...
April 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28140680/paliperidone-for-the-treatment-of-schizophrenia-and-schizoaffective-disorders-a-drug-safety-evaluation
#13
REVIEW
M C Mauri, A Reggiori, S Paletta, C Di Pace, A C Altamura
Paliperidone, the major active metabolite of risperidone, is a second-generation antipsychotic that has been developed as an extended-release (ER) oral formulation and a long-acting injectable paliperidone palmitate (PP) formulation. Paliperidone has demonstrated efficacy in the reduction of acute schizophrenia symptoms and clinical benefits were maintained also in the long-term treatments. Paliperidone ER and PP are generally well tolerated with a predictable adverse event profile. Areas covered: Data from studies evaluating safety and tolerability in the acute and maintenance treatment of schizophrenia with paliperidone are reviewed...
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28138247/effects-of-paliperidone-extended-release-on-hostility-among-thai-patients-with-schizophrenia
#14
Apichat Jariyavilas, Nuntika Thavichachart, Ronnachai Kongsakon, Sunanta Chantakarn, Suwanna Arunpongpaisal, Vasu Chantarasak, Piyadit Jaroensook, Khanogwan Kittiwattanagul, Osot Nerapusee
OBJECTIVE: This open-label prospective study investigated the effects of paliperidone extended release (ER) on hostility in Thai patients with schizophrenia. BACKGROUND: Patients diagnosed with schizophrenia may be hostile or exhibit aggressive behavior, which can occasion their admission to psychiatric hospital. Antipsychotic medications are often used to treat hostility and aggression in such patients. Paliperidone ER is effective and well tolerated in the treatment of schizophrenia...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28124262/atypical-antipsychotics-and-the-risks-of-acute-kidney-injury-and-related-outcomes-among-older-adults-a-replication-analysis-and-an-evaluation-of-adapted-confounding-control-strategies
#15
Patrick B Ryan, Martijn J Schuemie, Darmendra Ramcharran, Paul E Stang
OBJECTIVE: A recently published analysis of population-based claims data from Ontario, Canada reported higher risks of acute kidney injury (AKI) and related outcomes among older adults who were new users of atypical antipsychotics (AAPs) compared with unexposed patients. In light of these findings, the objective of the current study was to further investigate the risks of AKI and related outcomes among older adults receiving AAPs. METHODS: A replication of the previously published analysis was performed using the US Truven MarketScan Medicare Supplemental database (MDCR) among patients aged 65 years and older...
March 2017: Drugs & Aging
https://www.readbyqxmd.com/read/28119036/one-year-mirror-image-study-using-paliperidone-palmitate-for-relapse-prevention-of-schizophrenia-in-four-university-hospitals-in-canada
#16
Philippe D Vincent, Marie-France Demers, Venessa Doyon-Kemp, Josée Duchesneau, Alex Halme, Violaine Masson
BACKGROUND: Superiority of long acting injectable antipsychotics (LAI) over oral antipsychotics remains controversial and dependent on study design and inclusion criteria. Meta-analysis of 21 RCTs demonstrated no difference in their effectiveness, but meta-analysis of 25 mirror-image studies did. None of these included paliperidone palmitate (PP). METHODS: We challenged efficiency of PP in a multicentric mirror-image study. Primary outcome was total hospitalization days...
January 21, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28112539/long-acting-injectable-antipsychotics-in-children-and-adolescents
#17
Sarah Lytle, Molly McVoy, Martha Sajatovic
OBJECTIVE: While a number of articles have reviewed the use of long-acting injectable antipsychotics (LAIs) in first-episode psychosis, there has been extremely limited focus on LAIs in children and adolescents. This review of the literature evaluated use of LAIs in children and youth under the age of 18. METHODS: We conducted a comprehensive search of the PubMed, PsychINFO, CINAHL, and EMBASE databases using keywords related to LAIs, children, and psychiatric conditions, including schizophrenia, bipolar disorder, and schizoaffective disorder...
February 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28111036/an-lc-ms-ms-method-for-the-simultaneous-determination-of-15-antipsychotics-and-two-metabolites-in-hair-and-its-application-to-rat-hair
#18
Juhyun Sim, Eunmi Kim, Wonkyung Yang, Sanghee Woo, Sangwhan In
In recent years, the inappropriate use of antipsychotics by young Korean men has become a social problem. As military service exemptions are given for mental illness, some men pose as mental health patients to avoid military service. In order to verify the authenticity of mental illnesses, we developed simultaneous analytical methods for the detection of 15 antipsychotics and 2 of their metabolites in hair using liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. The target drugs were modafinil, atomoxetine, aripiprazole, benztropine, buspirone, duloxetine, gabapentin, oxcarbazepine, topiramate, escitalopram, paliperidone, ziprasidone, lamotrigine, clonazepam, levetiracetam, and metabolites of oxcarbazepine and clonazepam...
January 12, 2017: Forensic Science International
https://www.readbyqxmd.com/read/28108226/efficacy-acceptability-and-tolerability-of-8-atypical-antipsychotics-in-chinese-patients-with-acute-schizophrenia-a-network-meta-analysis
#19
REVIEW
Zhihua Bai, Guoqiang Wang, Shangli Cai, Xindi Ding, Weiwei Liu, Depei Huang, Weidi Shen, Juncheng Zhang, Kui Chen, Yuqing Yang, Lili Zhang, Xiaochen Zhao, Qiong Ouyang, Jingping Zhao, Huafei Lu, Wei Hao
OBJECTIVE: We aimed to create hierarchies of the efficacy, acceptability and tolerability of eight atypical antipsychotics in the treatment of Chinese patients with acute schizophrenia. METHOD: We systematically searched for RCT articles published between January 1st 2005 and December 31st 2014 in electronic databases (Medline, Pubmed, Embase, the Cochrane Library and ClinicalTrial.gov for studies in English and the China National Knowledge Infrastructure, Wan Fang, and VIP Information/Chinese Scientific Journals Database for studies in Chinese)...
January 17, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28108225/female-schizophrenia-patients-and-risk-of-breast-cancer-a-population-based-cohort-study
#20
Ana Isabel Wu Chou, Yu-Chiao Wang, Cheng-Li Lin, Chia-Hung Kao
OBJECTIVE: Breast cancer is the most common type of cancer in women. This population-based cohort study aimed to examine the association between breast cancer in female schizophrenia patients and its association with the use of antipsychotics drugs. METHODS: All study subjects were selected from the Taiwan Insurance Claims Data (1998-2008). We compared the risk for breast cancer between female schizophrenia patients receiving antipsychotics (n=29,641) with female patients without any serious mental illnesses nor receiving antipsychotic drugs (n=59,282)...
January 17, 2017: Schizophrenia Research
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