Advancing Antipsychotic Therapy: Clinical And Formulation Benefits Of A Novel Quetiapine Oral Suspension Formulation

BackgroundQuetiapine is an antipsychotic drug with unique pharmacological properties approved for the treatment of schizophrenia, bipolar disorder, and augmentation for major depressive disorder. In routine clinical practice, it is also frequently prescribed for conditions such as insomnia, anxiety, and psychomotor agitation. Italfarmaco (ITF) Group has developed an innovative oral suspension formulation of quetiapine; its composition, optimized in viscosity and stability, aims to facilitate administration and dosing across a wide range of patient profiles, particularly those requiring low doses or those with difficulty swallowing, limited manual dexterity, or cognitive impairment. ObjectiveThis study aimed to evaluate the pharmacokinetic (PK) profile of this innovative oral suspension formulation of quetiapine compared to the immediate-release tablets. MethodsA single-dose, open-label, randomized, two-sequence, two-treatment, two-period cross-over pivotal study was conducted in 43 healthy subjects under fasting conditions. Volunteers received a single 25 mg dose of quetiapine, administered either as an oral suspension or as an immediate-release film-coated tablet, with an appropriate washout between treatments. The PK performance of the two formulations was compared, maximum plasma concentration (Cmax), time to reach Cmax (tmax), area under the curve (AUC), and overall bioavailability. Plasmatic quetiapine levels were measured by validated high performance liquid chromatography (HPLC) methods blinded to the dosing randomization scheme. ResultsQuetiapine oral suspension demonstrated pharmacokinetic bioequivalence to the reference tablet in terms of Cmax and AUC. It exhibited faster absorption, being detectable in plasma within 10 minutes following oral administration, with a median tmax of 0.75 h compared to 1.02 h for the immediate-release tablet. Calculating the median tmax difference for each subject shows that quetiapine oral suspension reaches peak plasma concentration about 30 minutes faster than the immediate-release tablet. ConclusionThis novel quetiapine oral suspension formulation addresses key unmet needs in psychiatric pharmacotherapy treatment by combining a favorable pharmacokinetic profile with a patient-centered design. It enables precise dose titration of the drug and promotes faster absorption, thereby potentially achieving a more rapid onset of action. This formulation facilitates administration and dosing flexibility, an advantage for all patients, especially for the ones requiring low doses. KEY POINTSO_LIItalfarmaco (ITF) has developed an innovative oral suspension formulation of quetiapine. C_LIO_LIThis novel quetiapine oral suspension formulation enables precise dose titration of the drug and promotes faster absorption, thereby potentially achieving a more rapid onset of action. C_LIO_LIITF quetiapine suspension formulation is intended to address key unmet needs in antipsychotic pharmacotherapy treatment by combining a favorable pharmacokinetic profile with a patient-centered design. C_LI