P.3.a.039 Onset of action of oral paliperidone extended-release tablets in patients with acute schizophrenia: pooled results from three 6-week controlled studies

Abstract Introduction The use of the blonanserin patch (BLO-P) for schizophrenia treatment was approved in Japan in 2019. This systematic review of trials in Japan assessed the efficacy and safety profile of BLO-P compared with other antipsychotics. Methods The systematic review included 6-week, double-blind, randomized, placebo-controlled, phase 3 trials in Japan that included patients with acute schizophrenia. Pooled data for patients receiving BLO-P 40 and 80 mg/day (BLO-P40+80) were compared with pooled data for patients receiving asenapine 10 and 20 mg/day (ASE10+20) and data for those receiving brexpiprazole 2 mg/day (BRE2) and paliperidone extended-release 6 mg/day (PAL-ER6). Results All the investigated treatments were superior to placebo in reducing the Positive and Negative Syndrome Scale (PANSS) total score; the Hedges’ g values (95% confidence interval) for BLO-P40+80, ASE10+20, BRE2, and PAL-ER6 were−0.40 (−0.58,−0.22),−0.61 (−0.79,−0.42),−0.33 (−0.60,−0.07), and−0.69 (−0.93,−0.45), respectively. There were differences among the antipsychotics in the incidence of various individual adverse events. Discussion BLO-P40+80 may have a good efficacy/safety/tolerability profile for the treatment of patients with acute schizophrenia.

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Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics

Expert Opinion on Pharmacotherapy ◽

10.1517/14656566.2014.884071 ◽

2014 ◽

Vol 15 (5) ◽

pp. 593-603 ◽

Cited By ~ 6

Author(s):

Andreas Schreiner ◽

Marjolein Lahaye ◽

Joseph Peuskens ◽

Dieter Naber ◽

Nesrin Dilbaz ◽

...

Keyword(s):

Extended Release ◽

Acute Schizophrenia ◽

Paliperidone Extended Release

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Efficacy and Tolerability of Oral Paliperidone Extended-Release Tablets in the Treatment of Acute Schizophrenia

The Journal of Clinical Psychiatry ◽

10.4088/jcp.v69n0515 ◽

2008 ◽

Vol 69 (5) ◽

pp. 817-829 ◽

Cited By ~ 109

Author(s):

Herbert Y. Meltzer ◽

William V. Bobo ◽

Isaac F. Nuahmah ◽

Rosanne Lane ◽

David Hough ◽

...

Keyword(s):

Extended Release ◽

Acute Schizophrenia ◽

Paliperidone Extended Release

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A Review on Enteric Coated Pellets Composed of Core Pellets Prepared by Extrusion-Spheronization

Recent Patents on Drug Delivery & Formulation ◽

10.2174/1872211313666190212115139 ◽

2019 ◽

Vol 13 (2) ◽

pp. 83-90 ◽

Cited By ~ 1

Author(s):

Hetal Patel ◽

Mukesh Gohel

Keyword(s):

Dosage Form ◽

Extended Release ◽

Rapid Onset ◽

Enteric Coating ◽

Onset Of Action ◽

The Core ◽

Current State ◽

Enteric Coated ◽

Extrusion Spheronization ◽

Acid Labile

Enteric coated dosage form bypasses the stomach and releases the drug into the small intestine. Advantages of enteric coated pellets in comparison with enteric coated tablets are a) Pellets provide rapid onset of action and faster drug release due to the smaller size than tablets and b) Pellets exhibit less residence time of acid-labile drugs in the stomach compared to tablets. Dosage form coat can be damaged by longer resistance time in the stomach. The present review summarizes the current state of enteric coated pellets where core pellets are prepared by extrusion-spheronization technique and the enteric coating is applied in a fluidized bed processor. Two approaches are involved in the preparation of core pellets. In the first approach, a mixture of drug and excipient(s)/co-processed excipient is passed through extruders to prepare core pellets. In the second approach, excipient core pellets are prepared by extrusion technique and the drug is layered onto it before the enteric coating. The excipients present in the core pellets decide immediate or extended release of drug in the intestine. The coprocessed excipient pellets provide less batch variability and provide a platform for layering of many drugs before enteric coating. Some patents included enteric coating pellets [CN105456223 (A), CN105596310 (A), CN105616371 (A), CN105663095 (A), CN101611766B, CN106511862 (A), CN106668018 (A), CN106727381 (A), CN106924222 (A), TW200624127 (A), US 2017/0165248A1, US 2017/0224720A1] are discussed.

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