The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.
Absorption, Metabolism, and Excretion of Paliperidone, a New Monoaminergic Antagonist, in Humans
Abstract
Absorption, metabolism, and excretion of paliperidone, an atypical antipsychotic, was studied in five healthy male subjects after a single dose of 1 mg of [(14)C]paliperidone oral solution ( approximately 16 microCi/subject). One week after dosing, 88.4 to 93.8% (mean 91.1%) of the administered radioactivity was excreted: 77.1 to 87.1% (mean 79.6%) in urine and 6.8 to 14.4% (mean 11.4%) in the feces. Paliperidone was the major circulating compound (97% of the area under the plasma concentration-time curve at 24 h). No metabolites could be detected in plasma. Renal excretion was the major route of elimination with 59% of the dose excreted unchanged in urine. About half of the renal excretion occurred by active secretion. Unchanged drug was not detected in feces. Four metabolic pathways were identified as being involved in the elimination of paliperidone, each of which accounted for up to a maximum of 6.5% of the biotransformation of the total dose. Biotransformation of the drug occurred through oxidative N-dealkylation (formation of the acid metabolite M1), monohydroxylation of the alicyclic ring (M9), alcohol dehydrogenation (formation of the ketone metabolite M12), and benzisoxazole scission (formation of M11), the latter in combination with glucuronidation (M16) or alicyclic hydroxylation (M10). Unchanged drug, M1, M9, M12, and M16 were detected in urine; M10 and M11 were detected in feces. The monohydroxylated metabolite M9 was solely present in urine samples of extensive CYP2D6 metabolizers, whereas M10, another metabolite monohydroxylated at the alicyclic ring system, was present in feces of poor metabolizers as well. In conclusion, paliperidone is not metabolized extensively and is primarily renally excreted.
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“Paliperidone is primarily renally cleared and not extensively metabolized in the liver; 59% of a single dose is excreted in the urine unchanged [43, 77].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [43]
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“No differences were observed in the paliperidone exposure and clearance between extensive or poor metabolizers of CYP2D6 substrates in population pharmacokinetic analyses [50,51].”
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“By using an osmotically controlled release system, the ER paliperidone formulation has a slowly ascending concentration-time profile, such that a therapeutically active dose may be initiated without the need for titration [38, 48, 49].”
BackgroundOsmotic-Controlled Release Oral Delivery System (OROS) Paliperidone-Related Pruritic Rash
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“A previous study of paliperidone showed that no metabolites were detected in plasma and that renal excretion was the major route of elimination, with 59% of the nonmetabolized dose excreted in urine.(2) Therefore, it is unlikely that paliperidone is metabolized in the body and that paliperidone distribution is influen…”
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“Paliperidone extended release (ER) is an atypical antipsychotic that, unlike other antipsychotics, is not extensively metabolised in the liver.(7) A pharmacokinetic analysis in patients with moderate hepatic impairment and healthy volunteers showed that unbound plasma concentrations of paliperidone ER were similar bet…”
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“Second, unlike risperidone, the oral form of paliperidone is provided in a sustainedrelease formulation providing consistent plasma concentration allowing for once-daily dosing.(48) Lastly, paliperidone tends to have fewer extrapyramidal symptoms compared with risperidone.”
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Roughley, M., Mena, C., Howard, R. J., Reeves, S., & Bertrand, J. (2023) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15692 · Cited by 7
“Early studies of 9-OH-risperidone pharmacokinetics suggested that renal clearance was the main route of elimination, with 59% of the dose excreted unchanged in urine.(13) This study, however, only included five healthy male participants.”
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The role of paliperidone extended release for the treatment of bipolar disorder
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“Impaired renal function may increase paliperidone concentrations since 60% of the drug is excreted almost unchanged in the urine via the renal tubules.(14,22) As a result, patients with a creatinine clearance rate (CrCl) $50 mL/min should be initiated at 6 mg daily, while those with CrCl , 50 mL/min should be started…”
LC-MS/MS Method for the Estimation of Paliperidone in Human Plasma
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“Paliperidone does not undergo extensive hepatic metabolism and is largely eliminated via the renal route.([23-25]) Results of in vivo studies have shown that the hepatic enzymes cytochrome P450 (CYP) 2D6 and CYP3A4 are involved to a limited extent only in the overall elimination of paliperidone.”
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“Email: jayleemd@knu.ac.kr hepatic metabolism (Vermeir et al., 2008), it is well tolerated by patients with poor hepatic function and is not susceptible to metabolic drug interactions.”
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“Unlike risperidone, paliperidone avoids extensive hepatic metabolism through CYP enzymes, thereby reducing drug-drug interactions commonly seen with medications metabolized via similar pathways [2, 3].”
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“As PAL exists as a positive ion, MRP, OATs and OATPs, which mainly efflux negative ions, might not influence its penetration into the brain (13).”
InfluentialPaliperidone palmitate intramuscular 6-monthly formulation in schizophrenia: a profile of its use
Blair, H. A. (2022) · Drugs & Therapy Perspectives · doi:10.1007/s40267-022-00931-9 · Cited by 2
“Approximately 80% of the radioactive dose was recovered in the urine and 11% was recovered in the faeces [12].”
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“Information regarding drug interactions involving paliperidone is limited, with renal excretion likely being the primary elimination route [12].”
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“9-hydroxyrisperidone 9-hydroxyrisperidone is then partially (Vermeir et al. 2008) excreted renally in unchanged form, but can also undergo further metabolism to inactive metabolites by CYP3A4 as well as CYP2D6.”
Stability, degradation impurities and decomposition kinetics for paliperidone from osmotic tablets
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“The fact of the low hepatic metabolism of paliperidone palmitate [16] and the advantage of its monthly administration would seem to favour its use in groups of polymedicated participants such as those with ID, since it would reduce drug interactions and improve therapeutic compliance.”
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“Paliperidone does not undergo extensive hepatic metabolism, is largely eliminated via the renal route, and has a terminal elimination half-life of &23 h [7, 11, 16].”
Background조현병 환자에서 Paliperidone Extended Release의 약물만족도와 치료반응을 조사하기 위한 개방형 다기관 전향적 관찰연구
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Metadata
- Authors
- Vermeir, M., Naessens, I., Remmerie, B., Mannens, G., Hendrickx, J., Sterkens, P., Talluri, K., Boom, S., Eerdekens, M., van Osselaer, N., & Cleton, A.
- Affiliations
- Janssen (Belgium) (BE)
- Venue
- Drug Metabolism and Disposition
- Publisher
- Elsevier BV
- Published
- 2008-04
- Volume
- 36
- Issue
- 4
- Pages
- 769-779
- ISSN
- 0090-9556 (ISSN-L)
- OpenAlex
- W2127872656
- Cited by
- 158
- References
- 16
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 6 · 2023: 8 · 2022: 5 · 2021: 7 · 2020: 4 · 2019: 10 · 2018: 9 · 2017: 10 · 2016: 9 · 2015: 8 · 2014: 13 · 2013: 16 · 2012: 14
- FWCI
- 10.02
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Drug Metabolism and Disposition (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
- Keywords
- paliperidone, pharmacokinetics, drug metabolism, renal excretion, atypical antipsychotics, CYP2D6 polymorphism, N-dealkylation, glucuronidation, metabolites
- MeSH terms
- Paliperidone Palmitate, Adult, Feces, Humans, Intestinal Absorption, Isoxazoles, Kidney, Liver, Male, Middle Aged, Pyrimidines, Time Factors, Biogenic Monoamines, Metabolic Networks and Pathways
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