Cited by 15Schizophrenia research and treatmentPharmacogenetics and Drug MetabolismPharmaceutical studies and practices

Plasma concentrations and dosing of 2 long-acting injectable formulations of aripiprazole

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Salzman, Phyllis, Raoufinia, Arash, Legacy, Susan, Such, Pedro, Eramo, Anna·2017·Neuropsychiatric Disease and Treatment

Abstract

Maintaining therapeutic plasma concentrations of an antipsychotic agent is essential in preventing relapse of symptoms in schizophrenia. Long-acting injectable (LAI) formulations provide extended exposure to antipsychotic therapy and have been useful in addressing treatment nonadherence. Aripiprazole is an atypical antipsychotic used in the treatment of schizophrenia and is available in 2 chemically different (aripiprazole monohydrate and aripiprazole lauroxil [AL]) and pharmaceutically different LAI formulations (aripiprazole once-monthly 400 mg [AOM 400] and AL). The pharmaceutical difference is that AL, unlike AOM 400, is a prodrug that requires additional metabolic steps to form the active drug aripiprazole. We present data demonstrating that aripiprazole plasma concentrations are similar for AOM 400 and the 882 mg dose of AL when administered once every 4 weeks and that both provide similar therapeutic plasma concentrations of aripiprazole when compared with therapeutic oral doses.

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  1. [4]Center for Drug Evaluation and Research Application Number: 202971Orig1s000 Clinical Pharmacology and Biopharmaceutics Review(s) Silver Spring Food and Drug Administration 2011
  2. [14]Center for Drug Evaluation and Research Application Number: 207533Orig1s000 Clinical Pharmacology and Biopharmaceutics Review(s) (Addendum to PBPK, Pharmacometric, Clin Pharm Reviews and Clin Pharm Addendum) and Pharmacometric Review Silver Spring Food and Drug Administration 2015

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Authors
Salzman, P., Raoufinia, A., Legacy, S., Such, P., & Eramo, A.
Affiliations
  • Otsuka (United States) (US)
  • Otsuka Pharmaceutical Development & Commercialization, Inc. (United States) (US)
  • Lundbeck (Denmark) (DK)
  • Lundbeck (United States) (US)
Corresponding author
Raoufinia, Arash
Venue
Neuropsychiatric Disease and Treatment
Published
2017-04
Volume
Volume 13
Pages
1125-1129
ISSN
  • 1176-6328 (ISSN-L)
  • 1178-2021
OpenAlex
W2606184610
Cited by
15
References
10
Citations by year
2025: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 2 · 2019: 1 · 2018: 1 · 2017: 1
FWCI
1.12
Type
journal article
Language
en
Open access
Locations
  • Neuropsychiatric Disease and Treatment (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
Funders
  • Otsuka Pharmaceutical
  • H. Lundbeck A/S
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords
aripiprazole, long-acting injectables, aripiprazole lauroxil, plasma concentration, pharmacokinetics, prodrugs, atypical antipsychotics, schizophrenia, medication adherence

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