Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial☆

Kane, John M.; Cañas, Fernando; Kramer, Michelle; Ford, Lisa; Gassmann-Mayer, Cristiana; Lim, Pilar; Eerdekens, Mariëlle

doi:10.1016/j.schres.2006.09.012

Cited by 254 publications

(211 citation statements)

References 44 publications

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“…isoxazol-3-yl)-1-piperidyl]ethyl]-7-hydroxy-4-methyl-1,5-diazabicyclo [4.4.0]deca-3,5-dien-2-one, is the major active metabolite of risperidone (9-hydroxy-risperidone) and is an atypical antipsychotic that belongs to the chemical class of benzisoxazole derivatives [1][2][3][4][5]. The drug was recently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia [6].…”

Section: ) (Rs)-3-[2-[4-(6-fluorobenzo[d]mentioning

confidence: 99%

“…A series of studies have evaluated the pharmacodynamics, efficacy, and tolerability of paliperidone. The results obtained from randomized, double-blinded, placebo-controlled studies indicate that the drug is effective and safe at all doses, resulting in significant improvements in the symptoms of schizophrenia and related disorders [3,[12][13][14][15][16].…”

Section: ) (Rs)-3-[2-[4-(6-fluorobenzo[d]mentioning

confidence: 99%

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Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Barbosa

Mantovani

Garcia

et al. 2012

ISRN Chromatography

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A stability-indicating liquid chromatographic (LC) method was studied for the determination of paliperidone in osmoticcontrolled release oral delivery system (OROS) tablets. A tablet extraction procedure was developed by testing the efficiency of solvents (water, HCl, NaOH, acetonitrile, methanol) and techniques (ultrasonic bath, magnetic stirrer), and evaluating the release of the drug with respect to time. A forced degradation study was conducted to demonstrate the stability-indicating power of the method. Chromatographic separation was achieved using an isocratic elution in a reversed-phase system with a mobile phase prepared from a mixture of phosphate buffer and acetonitrile. The use of an ultrasonic bath demonstrated paliperidone release from OROS tablets in a total time of 60 min. Verifying the efficiency of the chromatographic procedure, the theoretical plates (N = 12634.21) and tailing factor (tf = 1.31) were constant during repeated injections. The retention time of paliperidone was 4.8 min, and the method was validated within the concentration range of 10-50 µg mL −1 (r = 0.9999). Adequate reproducibility (RSD% = 0.30-0.59), interday precision (RSD% = 1.81), and accuracy were obtained. The proposed method was successfully applied to paliperidone determination in the presence of degradation products, and an efficient extraction procedure from the OROS tablets was developed.

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Section: ) (Rs)-3-[2-[4-(6-fluorobenzo[d]mentioning

confidence: 99%

Section: ) (Rs)-3-[2-[4-(6-fluorobenzo[d]mentioning

confidence: 99%

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Barbosa

Mantovani

Garcia

et al. 2012

ISRN Chromatography

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“…Neither data set has properly established the long-term trajectory of hyperprolactinaemia and there are no data to support the concept of regression back to baseline. There are, however, a number of disparate data on comparable rates of hyperprolactinaemia amongst antipsychotics and the largest data sets reporting prolactin include a 6-week paliperidone study in 628 schizophrenia patients (Kane et al, 2007) and a 1-year risperidone and haloperidol in first episode psychosis study in 555 patients (Schooler et al, 2005). Cohort sizes range from <50 to 2725 .…”

Section: Rates Of Hyperprolactinaemia With Individual Antipsychoticsmentioning

confidence: 99%

Prolactin and Schizophrenia, an Evolving Relationship

Bushe¹,

Pendlebury²

2011

Health Management - Different Approaches and Solutions

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“…16 Thus, unvalidated targets are frequently left unpursued by the pharmaceutical industry and, frequently, companies have focused on alterations of existing medications (that is, separating enantiomers or marketing active metabolites; for example 9-OHrisperidone or paliperidone), 17 finding additional compounds that hit known and validated targets ('me too' drugs; for example ORG-5222 or asenapine), 18 and on gaining approval on new indications for already marketed drugs 19 (for example clozapine for suicide in schizophrenia 4 ). These methods, however, cannot continue indefinitely as the number of such possibilities is limited and thus it is critical to find new approaches to drug development.…”

Section: Introductionmentioning

confidence: 99%

The pipeline and future of drug development in schizophrenia

2007

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While the current antipsychotic medications have profoundly impacted the treatment of schizophrenia over the past 50 years, the newer atypical antipsychotics have not fulfilled initial expectations, and enormous challenges remain in long-term treatment of this debilitating disease. In particular, improved treatment of the negative symptoms and cognitive dysfunction in schizophrenia which greatly impact overall morbidity is needed. In this review we will briefly discuss the current pipeline of drugs for schizophrenia, outlining many of the strategies and targets currently under investigation for the development of new schizophrenia drugs. Many of these compounds have great potential as augmenting agents in the treatment of negative symptoms and cognition. In addition, we will highlight the importance of developing new paradigms for drug discovery in schizophrenia and call for an increased role of academic scientists in discovering and validating novel drug targets. Indeed, recent breakthroughs in genetic studies of schizophrenia are allowing for the development of hypothesis-driven approaches for discovering possible disease-modifying drugs for schizophrenia. Thus, this is an exciting and pivotal time for the development of truly novel approaches to drug development and treatment of complex disorders like schizophrenia.

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Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial☆

Cited by 254 publications

References 44 publications

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Prolactin and Schizophrenia, an Evolving Relationship

The pipeline and future of drug development in schizophrenia

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