Formulation and Characterization of Nanostructured Lipid Carrier Intranasal Spray Of Cariprazine using QBD Approach

Abstract

Schizophrenia is a complex, long-lasting mental health condition marked by hallucinations, delusions, disorganised speech or behaviour, and impaired cognitive function. Around 24 million people, or 1 in 300 persons (0.32%), globally suffer with schizophrenia. Cariprazine hydrochloride (CPZ) is a new atypical antipsychotic used to treat schizophrenia. CPZ is a BCS class II drug having low aqueous solubility (0.1159 mg/L). It exhibits oral bioavailability 52%. CPZ has a moderate first-pass effect. Conventional dosage forms of CPZ exhibits adverse effects like insomnia, akathisia, nausea, hyperprolactinemia, EPS, headache, dizziness, tremors, and gastrointestinal disturbances. Many antipsychotics are not suited for oral administration from a pharmacokinetic point of view due to limited bioavailability brought on by gastrointestinal enzymatic degradation, hepatic first-pass effects, and/or gastrointestinal adverse effects. Additionally, due to a lack of aqueous solubility and unfavourable physical/chemical or toxicological qualities, not all medications have injectable drug formulations available. Intranasal delivery of nano lipid carriers enhanced the bioavailability of drug molecules by obviating their first-pass metabolism and delivers them directly to the brain. Objectives The present study was an attempt to systemically deliver Cariprazine HCl, a schizophrenic drug via intranasal route using nanostructured lipid carrier.