Aripiprazole Nanocrystal Impregnated Buccoadhesive Films for Schizophrenia.

Abstract

Aripiprazole is an atypical antipsychotic drug approved worldwide for treatment of acute and long term schizophrenia in adults. Increasingly atypical antipsychotics are playing a key role in the management of schizophrenia. The aim of the present study was to design a mucoadhesive dosage form for buccal delivery of aripiprazole which could provide a rapid drug delivery to the systemic circulation. Nanocrystals of aripiprazole were prepared by nano-precipitation using acid-base neutralization. These nanocrystals were then incorporated into buccoadhesive chitosan films. All the drug loaded films were found to smooth, non-tacky possessing high mechanical strength. Films were characterized for crystallinity of drug, surface pH, thickness, folding endurance, swelling behavior, mucoadhesive strength, drug release and ex-vivo permeation across rabbit cheek mucosa. In-vitro drug release studies indicated distinctly higher drug release from nanocrystal loaded films, FAPZ 13 and FAPZ 14. Permeation studies indicated a higher flux from films FAPZ 14 (442.34 ± 51.08 μg/cm2/h, P < 0.0001) when compared to film FAPZ 12. These promising results indicate that the developed nanocrystal loaded buccal films FAPZ 14 have the potential to provide a faster availability of aripiprazole and the buccoadhesive films offer promising option to patients with schizophrenia especially for geriatric patients.