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Population pharmacokinetic modeling as a justification of practical application mode of paliperidone palmitate injectable in three-month formulation

Oleneva E.V., Ryvkin P.V., Ladyzhensky M.Ya.
Federal Medical Research Centre for Psychiatry and Narcology by the name of V.P. Serbsky Minzdrava RF, Russia, Moscow

Summary: In article a series the pharmakokinentic aspects of practical use of a paliperidone palmitate injectable in three-month formulation (PPI3M) both based on results of clinical tests, and formulated as a result of the subsequent pharmacokinetic modeling are surveyed. The final population pharmakokinetic model of PPI3M was developed with data obtained from two clinical trials for the purpose of the description of a pharmacokinetic profile of a paliperidon after PPI3M injection. References on renewal of therapy in cases of admissions of injections of different duration are formulated, different schemes of transition from one dosage form of a paliperidon on another are discussed, and preferable dosage in special populations is defined. The most important results of the clinical trials of PPI3M with pharmakokinetic studying have been reviewed.

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References: 
  • 1. Mosolov S.N. Osnovy psikhofarmakoterapii. – M.: Vostok, 1996. – 288 s.
  • 2. Mosolov S.N. Rezistentnost' k psikhofarmakoterapii i metody ee preodoleniya // Psikhiatriya i psikhofarmakoterapiya. – 2002. – T. 4, № 4. – S. 132–136.
  • 3. Mosolov S.N., Tsukarzi E.E., Alfimov P.V. Algoritmy biologicheskoi terapii shizofrenii // Sovremennaya terapiya psikhicheskikh rasstroistv. – 2014. – № 1. – S. 27–36.
  • 4. Psikhofarmakologicheskie i protivoepilepticheskie preparaty, razreshennye k primeneniyu v Rossii / pod red. S.N. Mosolova. – 2-e izd. – M.: BINOM, 2004. – 301 s.
  • 5. Federal'noe rukovodstvo po ispol'zovaniyu lekarstvennykh sredstv (formulyarnaya sistema) / pod red. A.G. Chuchalina. – 13-e izd. – M.: Ekho, 2012.
  • 6. Klinicheskaya farmakokinetika: teoreticheskie, prikladnye i analiticheskie aspekty: rukovodstvo / pod red. V.G. Kukesa. – M.: Izdatel'skaya gruppa «GEOTAR-Media», 2009. – 432 s.
  • 7. Klinicheskaya farmakologiya / pod red. V.G. Kukesa. – M.: Izdatel'skaya gruppa «GEOTAR-Media», 2004. – 944 s.
  • 8. Shaeva T.V., Bel'chinskii V.V., Pletnev A.V. Izuchenie matematicheskoi modeli farmakokinetiki: metodich. ukazaniya – Voronezh: VGMA, 2013. – S. 9.
  • 9. Ravenstijn P., Remmerie B., Savitz A., et al. Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: a phase-1, single-dose, randomized, open-label study // J Clin Pharmacol. – 2015. [Epub ahead of print]. – DOI: 10.1002/jcph.597.
  • 10. Berwaerts J., Liu Y., Gopal S. et al. Efficacy and safety of the 3 month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial // JAMA Psychiatry. – 2015 [Epub ahead of print]. – DOI: 10.1001/jamapsychiatry.2015.0241.
  • 11. Gopal S., Vermeulen A., Nandy P., Ravenstijn P., at al. Rekomendatsii po primeneniyu PP3M u vzroslykh patsientov, stradayushchikh shizofreniei (per. s angl.) // Currenent Medical Research & Opinion. – 2013. – P. 1–9.
  • 12. Karlsson P, Dencker E, Nyberg S, et al. Pharmacokinetics, dopamine D2 and serotonin 5-HT2A receptor occupancy and safety profile of paliperidone ER in healthy subjects // Schizophrenia Res. – 2006. – Vol. 81 (Suppl. 1). – P. 85–86.
  • 13. Oleneva E.V., Ryvkin P.V., Ladyzhenskii M.Ya. In"ektsionnyi paliperidona pal'mitat trekhmesyachnogo deistviya (Trevikta) – novoe slovo v dlitel'noi terapii bol'nykh shizofreniei // Sovremennaya terapiya psikhicheskikh rasstroistv. – 2017. – № 1. – C. 35–43.
  • 14. Savitz A., Xu H., Gopal S., Nuamah I., Ravenstijn P., Janik A., Schotte A., Hough D., FleischhackerW. Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study // International Journal of Neuropsychopharmacology. – 2016. – Vol. 19 (7). – P. 1–14.
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