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
Abstract
Paliperidone palmitate (PP) is a long‐acting injectable (LAI) antipsychotic, developed for monthly intramuscular (i.m.) administration into deltoid/gluteal muscle, approved for the treatment of schizophrenia in many countries. To assess the options for i.m. injection sites, dose‐proportionality of PP was investigated after injection of a single dose (25–150 mg eq.) of PP in either gluteal (n = 106) or deltoid (n = 95) muscle of schizophrenic patients. Overall, mean (geometric) area under plasma concentration–time curve from time zero to infinity (AUC∞) of paliperidone increased proportionally with increasing PP doses, regardless of injection site. Mean maximum plasma concentration (C max) was slightly less than dose‐proportional for both injection sites at PP doses >50 mg eq. Mean C max was higher after injection in the deltoid compared with the gluteal muscle, except for the 100 mg eq. dose, while AUC∞ for both injection sites was comparable at all doses. Median time to reach C max (t max) ranged from 13–14 days after deltoid and 13–17 days after gluteal injection across all doses. Single PP injections in deltoid and gluteal muscles in the dose range of 25–150 mg eq. were generally tolerable both locally and systemically.
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For PP1M, the observed apparent half-life of 25-49 days allows for once-monthly administration.
“For PP1M, the observed apparent half-life of 25–49 days allows for once-monthly administration [76].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [76]
Peak plasma concentrations of PP1M are achieved at a median of 13 days after a single injection.
“Peak plasma concentrations of PP1M are achieved at a median of 13 days after a single injection [76].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [76]
The LAI formulations of paliperidone are delivered as aqueous nanoparticle suspensions.
“The LAI formulations of paliperidone are delivered as aqueous nanoparticle suspensions [76].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [76]
A study of dose proportionality between maintenance injections of PP1M in the deltoid or gluteal muscles found that geometric mean amount absorbed (AUC∞) increased proportionally with doses regardless of injection site, indicating that maintenance doses of PP1M can be injected into either the deltoid or the gluteal muscle.
“A study of dose proportionality between maintenance injections of PP1M in the deltoid or gluteal muscles found that geometric mean amount absorbed, or AUC from time 0 to infinity (AUC∞), increased proportionally with doses regardless of injection site, indicating that maintenance doses of PP1M can be injected into either the deltoid or the gluteal muscle [76].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [76]
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- Authors
- Cleton, A., Rossenu, S., Crauwels, H., Berwaerts, J., Hough, D., Gopal, S., Eerdekens, M., Vandebosch, A., Remmerie, B., De Meulder, M., & Fernández, C. M. R.
- Affiliations
- Janssen (Belgium) (BE)
- Janssen Research & Development (United States) (US)
- Janssen Research & Development Division of Janssen Pharmaceutica NV Beerse Belgium
- University Hospital of Bellvitge Barcelona Spain
- Venue
- The Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2014-04-03
- Volume
- 54
- Issue
- 9
- Pages
- 1048-1057
- ISSN
- 0021-9754 (ISSN-L)
- 0091-2700
- 1552-4604
- OpenAlex
- W1600870989
- Cited by
- 48
- References
- 31
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 2 · 2023: 2 · 2022: 4 · 2021: 3 · 2020: 4 · 2019: 2 · 2018: 5 · 2017: 5 · 2016: 8 · 2015: 3 · 2014: 1
- FWCI
- 4.32
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Janssen Research and Development
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- paliperidone palmitate, paliperidone, long-acting injectable antipsychotics, intramuscular injection, injection site, deltoid muscle, gluteal muscles, dose proportionality, schizophrenia, pharmacokinetics, AUC, Cmax, Tmax, tolerability
- MeSH terms
- Paliperidone Palmitate, Adult, Buttocks, Female, Humans, Injections, Intramuscular, Isoxazoles, Male, Middle Aged, Psychiatric Status Rating Scales, Pyrimidines, Schizophrenia, Shoulder, Antipsychotic Agents, Muscle, Skeletal
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