Publication Cover
Xenobiotica
the fate of foreign compounds in biological systems
Volume 49, 2019 - Issue 4
390
Views
5
CrossRef citations to date
0
Altmetric
General Xenobiochemistry

Rats and rabbits as pharmacokinetic screening tools for long acting intramuscular depots: case study with paliperidone palmitate suspension

, , , , , , & show all
Pages 415-421 | Received 10 Mar 2018, Accepted 10 Apr 2018, Published online: 08 May 2018

References

  • Alphs L, Fu DJ, Turkoz I. (2016). Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother 17:871–83.
  • Boom S, Talluri K, Janssens L, et al. (2009). Single- and multiple-dose pharmacokinetics and dose proportionality of the psychotropic agent paliperidone extended release. J Clin Pharmacol 49:1318–30.
  • Brissos S, Veguilla MR, Taylor D, Balanzá-Martinez V. (2014). The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Ther Adv Psychopharmacol 4:198–219.
  • Canuso CM, Battisti WP. (2010). Paliperidone extended-release: a review of efficacy and tolerability in schizophrenia, schizoaffective disorder and bipolar mania. Expert Opin Pharmacother 11:2557–67.
  • Cleton A, Rossenu S, Crauwels H, et al. (2014). A single-dose, open-label, parallel, randomized, dose-proportionality study of paliperidone after intramuscular Injections of paliperidone palmitate in the deltoid or gluteal muscle in patients with schizophrenia. J Clin Pharmacol 54:1048–57.
  • Corena-McLeod M. (2015). Comparative pharmacology of risperidone and paliperidone. Drugs R D 15:163–74.
  • Darville N, van Heerden M, Mariën D, et al. (2016a). The effect of macrophage and angiogenesis inhibition on the drug release and absorption from an intramuscular sustained-release paliperidone palmitate suspension. J Control Release 230:95–108.
  • Darville N, van Heerden M, Erkens T, et al. (2016b). Modeling the time course of the tissue responses to intramuscular long-acting paliperidone palmitate nano-/microcrystals and polystyrene microspheres in the rat. Toxicol Pathol 44:189–210.
  • Darville N, van Heerden M, Vynckier A, et al. (2014). Intramuscular administration of paliperidone palmitate extended-release injectable microsuspension induces a subclinical inflammatory reaction modulating the pharmacokinetics in rats. J Pharm Sci 103:2072–87.
  • González-Rodríguez A, Catalán R, Penadés R, et al. (2015). Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability - a review. Patient Prefer Adherence 9:695–706.
  • Greenberg WM, Citrome L. (2015). Paliperidone palmitate for schizoaffective disorder: a review of the clinical evidence. Neurol Ther 4:81–9.
  • INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension for intramuscular use, approved in USA (2006). Available from: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+SUSTENNA-pi.pdf [last accessed March 10, 2018].
  • Jones A, Jones M. (2016). Reviewing depot injection efficacy in the treatment of schizophrenia. Nurs Stand 30:50–9.
  • Kim S, Solari H, Weiden PJ, Bishop JR. (2012). Paliperidone palmitate injection for the acute and maintenance treatment of schizophrenia in adults. Patient Prefer Adherence 6:533–45.
  • Leng D, Chen H, Li G, et al. (2014). Development and comparison of intramuscularly long-acting paliperidone palmitate nanosuspensions with different particle size. Int J Pharm 472:380–5.
  • Morrissette DA, Stahl SM. (2012). Optimizing outcomes in schizophrenia: long-acting depots and long-term treatment. CNS Spectr 17:10–21.
  • Nanaki S, Tseklima M, Terzopoulou Z, et al. (2017). Use of mesoporous cellular foam (MCF) in preparation of polymeric microspheres for long acting injectable release formulations of paliperidone antipsychotic drug. Eur J Pharm Biopharm 117:77–90.
  • NDA22264. (2009). Clinical Pharmacology and biopharmaceutics review(s): paliperidone palmitate. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264s000clinpharmr.pdf [last accessed March 10, 2018].
  • Novalbos J, López-Rodríguez R, Román M, et al. (2010). Effects of CYP2D6 genotype on the pharmacokinetics, pharmacodynamics, and safety of risperidone in healthy volunteers. J Clin Psychopharmacol 30:504–11.
  • Pani L, Marchese G. (2009). Expected clinical benefits of paliperidone extended-release formulation when compared with risperidone immediate-release. Expert Opin Drug Deliv 6:319–31.
  • Prajapati AR, Wilson J, Maidment I. (2016). Efficacy and safety of second-generation antipsychotic long-acting injections (SGA LAIs) in maintenance treatment of bipolar disorder: protocol for a systematic review and meta-analysis. BMJ Open 6:e010237.
  • Roberto P, Brandt N, Onukwugha E, et al. (2017). Adherence to antipsychotic therapy: association with hospitalization and medicare spending among part D enrolees with schizophrenia. Psychiatr Serv 68:1185–8.
  • Rossenu S, Cleton A, Hough D, et al. (2015). Pharmacokinetic profile after multiple deltoid or gluteal intramuscular injections of paliperidone palmitate in patients with schizophrenia. Clin Pharmacol Drug Dev 4:270–8.
  • Sacchetti E, Grunze H, Leucht S, Vita A. (2015). Long-acting injection antipsychotic medications in the management of schizophrenia. Evidence-Based Psychiatric Care 1:27–36.
  • Samtani MN, Vermeulen A, Stuyckens K. (2009). Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Clin Pharmacokinet 48:585–600.
  • Srinivas NR. (2009). Dodging matrix effects in liquid chromatography tandem mass spectrometric assays-compilation of key learnings and perspectives. Biomed Chromatogr 23:451–4.
  • Srinivas NR. (2014). Dilemma with matrix effect in bioanalysis-perspectives from bioavailability/bioequivalence studies for product registration? Drug Res (Stuttg) 64:335–6.
  • Weiden PJ, Kim E, Bermak J, et al. (2017). Does half-life matter after antipsychotic discontinuation? A relapse comparison in schizophrenia with 3 different formulations of paliperidone. J Clin Psychiatry 78:e813–20.
  • Yang LP, Plosker GL. (2007). Paliperidone extended release. CNS Drugs 21:417–25.
  • Yoo HD, Lee SN, Kang HA, et al. (2011). Influence of ABCB1 genetic polymorphisms on the pharmacokinetics of risperidone in healthy subjects with CYP2D6*10/*10. Br J Pharmacol 164:433–43.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.