Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study

Davidson, Michael; Emsley, Robin; Kramer, Michelle; Ford, Lisa; Pan, Guohua; Lim, Pilar; Eerdekens, Mariëlle

doi:10.1016/j.schres.2007.03.003

Cited by 220 publications

(209 citation statements)

References 19 publications

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“…Due to its pharmacological profile as a dopamine D2-receptor antagonist, paliperidone ER was found to elevate mean serum prolactin levels to upper than the normal limit in the 6-week studies (26)(27)(28). risperidone group and reported rates from previous studies.…”

Section: Discussionmentioning

confidence: 83%

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

Albayrak¹,

Ünsal²,

Beyazyüz³

et al. 2014

JMOOD

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Section: Discussionmentioning

confidence: 83%

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

Albayrak¹,

Ünsal²,

Beyazyüz³

et al. 2014

JMOOD

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“…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%

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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“…By comparison, the newer antipsychotic agents, aripiprazole and ziprasidone, are associated with minimal weight gain (Leucht et al, 2009). The paliperidone extended release, the active metabolite of risperidone, has the same weight gain profile as its parent drug (M. Davidson et al, 2007).…”

Section: Treatments Exacerbate Cardiometabolic Risk Factorsmentioning

confidence: 99%

The Impact of Cardiometabolic Risk in Patients with Severe Mental Illness: From Evidence to Clinical Management

Sciascio¹,

Calò²

2011

Psychiatric Disorders - Worldwide Advances

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Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study

Cited by 220 publications

References 19 publications

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

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

The Impact of Cardiometabolic Risk in Patients with Severe Mental Illness: From Evidence to Clinical Management

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