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Abstract

ARIPIPRAZOLE NANOSPONGE: NASAL IN-SITU GEL FORMULATION FOR NOSE TO BRAIN DELIVERY

Rana Zainuddin Ahmed*, Sonal Shaharwale, Jaiprakash Sangshetti and Shaikh Wasim Abdul Gani

Abstract

Aripiprazole offers treatment for schizophrenia but the drug undergoes significant degradation in GI tract leading to poor bioavailablity. The aim of present study is to formulate in-situ nasal gel for nose to brain delivery of Aripiprazole loaded nanosponge (ARP-NS) to achieve better treatment outcomes. Method: Nanosponges (NS) offer the advantage of enhanced dissolution, permeation and drug stability. NS were prepared using β-CD and diphenyl carbonate; parallel reaction synthesizer at temperature 85°C, 1000 rpm. The formulation was optimized for Carbopol 940 and HPMC K100 concentration using 32 factorial designs. The ARP-NS was characterized by FTIR, DSC, XRPD, zeta size and SEM. The formulations were evaluated for parameters such as pH, drug content, viscosity, drug release, mucoadhesion, ex-vivo permeation and stability studies. Results: The PyMOL Molecular Graphics software was used to model β –CD NS and entrapment of Aripiprazole in the cavity, which along with other characterization techniques confirmed drug entrapment. Drug release from formulation and plain drug was found to be 93.85 ± 0.43% and 41.92 ± 0.36% respectively in 6 h. Treatment outcome was better from in-situ gel formulation compared to oral ARP solution on performing locomotor studies on psychosis induced rats. Pharmacokinetic evaluation was performed on Sprauge dawley male rats. Cmax, Tmax & AUC of ARP-NS (in brain) was found to be 4929 ± 21.56 ng/mL, 3 h and 930.35 ± 24.5 ng.h/mL. Conclusion: This study showed that Aripiprazole could be delivered effectively to the brain using nanosponge incorporated in in-situ gel which produced sustained drug release.

Keywords: Nanosponges, nose to brain delivery, Schizophrenia, Pharmacokinetics, locomotor activity.


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