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Ars Pharmaceutica (Internet)

On-line version ISSN 2340-9894


PATHAN, Inayat Bashir; MENE, Harshal  and  BAIRAGI, Shripad. Quality by design (QbD) approach to formulate in situ gelling system for nose to brain delivery of Fluoxetine hydrochloride: Ex-vivo and In-vivo study. Ars Pharm [online]. 2017, vol.58, n.3, pp.107-114. ISSN 2340-9894.


The purpose of the present study is to develop an ion sensitive in situ nasal gel of Fluoxetine hydrochloride for brain delivery. A 32 factorial design was used to investigate effect of independent variable on dependent variables.


Formulations were evaluated for gelation study, viscosity, gel strength, mucoadhesion strength, drug content, ex-vivo drug permeation, in vivo pharmacodynamic and stability study.


The results revealed that as the concentration of gellan gum and HPMC were increased, there was increase in viscosity and mucoadhesive strength and decrease in percent release. The optimized formulation F4 showed highest drug release 94.24 %. In locomotor activity and forced swim test study, the in situ gel treated rats showed significant responses as compared to control group. Histopathological examinations showed no evidence of nasal mucosal damage. The in situ nasal gel was stable after 3 months.


It was concluded that, the in situ nasal formulations of Fluoxetine hydrochloride which enhanced nasal absorption and patient compliance for the treatment of depression.

Keywords : Nasal; Fluoxetine hydrochloride; Pharmacodynamic.

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