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Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump
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Aripiprazole Plasma Concentrations Delivered from Two 2-Month Long-Acting Injectable Formulations: An Indirect

Matthew Harlin1, Craig Chepke2,3, Frank Larsen4

  • 1Quantitative Pharmacology, Clinical Pharmacology, Early Phase & Translational Medicine, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA.

Neuropsychiatric Disease and Treatment
|June 14, 2023
PubMed
Summary
This summary is machine-generated.

Aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) and aripiprazole lauroxil 1064 mg (AL 1064) are long-acting injectable formulations. Both maintained therapeutic aripiprazole plasma concentrations over a 2-month dosing interval in schizophrenia patients.

Keywords:
antipsychoticbipolar I disorderlong-acting injectableschizophrenia

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Psychiatric Pharmacotherapy
  • Long-Acting Injectable Formulations

Background:

  • Aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) and aripiprazole lauroxil 1064 mg (AL 1064) are novel long-acting injectable (LAI) formulations designed for extended-release aripiprazole delivery.
  • These LAI formulations offer a 2-month dosing interval, potentially improving treatment adherence for schizophrenia and bipolar I disorder.
  • Understanding the comparative pharmacokinetic profiles is crucial for optimizing therapeutic outcomes and managing patient care.

Purpose of the Study:

  • To conduct an indirect comparison of aripiprazole plasma concentrations between Ari 2MRTU 960 and AL 1064 following multiple administrations.
  • To evaluate if these LAI formulations maintain aripiprazole plasma concentrations above the established minimum therapeutic concentration (Cmin) of ≥95 ng/mL over the 2-month dosing interval.

Main Methods:

  • Utilized clinical trial data from patients receiving either Ari 2MRTU 960 (n=96) or AL 1064 (n=28) for four administrations.
  • Determined key pharmacokinetic parameters, including average steady-state plasma concentration (Cavg,ss) and maximum plasma concentration (Cmax).
  • Compared pharmacokinetic parameters against a minimum therapeutic aripiprazole concentration (Cmin) of ≥95 ng/mL and consensus guidelines (100-350 ng/mL).

Main Results:

  • Following four administrations, Ari 2MRTU 960 achieved a mean Cavg,ss of 263 (133) ng/mL and a mean Cmax of 342 (157) ng/mL.
  • AL 1064 achieved a mean Cavg,ss of 140.7 (57.3) ng/mL and a mean Cmax of 188.8 (79.8) ng/mL.
  • Both formulations demonstrated mean aripiprazole plasma concentrations that remained above the minimum therapeutic concentration throughout the 2-month dosing interval.

Conclusions:

  • This indirect comparison indicates that both Ari 2MRTU 960 and AL 1064 effectively maintain therapeutic aripiprazole plasma levels over a 2-month period.
  • The findings support the utility of these LAI formulations in managing schizophrenia and potentially bipolar I disorder, warranting further clinical evaluation.
  • Maintaining concentrations above the Cmin is associated with a reduced risk of relapse, highlighting the importance of consistent drug exposure.