Pharmacokinetics and safety of deltoid or gluteal injection of aripiprazole lauroxil NanoCrystal Dispersion used for initiation of the long-acting antipsychotic aripiprazole lauroxil.

Background: Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic for the treatment of schizophrenia in adults, can be started with either 21 days of daily oral aripiprazole supplementation or a 1-day initiation regimen consisting of a single injection of a NanoCrystal Dispersion formulation of AL (AL) and a single dose of 30 mg oral aripiprazole. This phase I study assessed the pharmacokinetics and safety of deltoid gluteal AL injections.

Methods: Patients with schizophrenia or schizoaffective disorder ( = 47) were randomized 1:1 to receive a single intramuscular dose of AL in the deltoid or gluteal muscle.

Best Practices for Aripiprazole Lauroxil Administration: From Formulation Development to Injection Technique.

Long-acting injectable (LAI) antipsychotics are an important treatment option for patients with schizophrenia. Advances and variability in formulation technology have provided several LAI antipsychotic treatment options for schizophrenia, with a wide range of doses and dose intervals. However, clinical reviews of LAIs have not focused on formulation development despite its clinical relevance to injection safety and technique.