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Abstract

DEVELOPMENT CHARACTERIZATION AND EVALUTION OF NASAL IN SITU GEL OF TRAZODONE HCl

M. Himabindu and Kopparam Manjunath*

ABSTRACT

In situ hydrogels are instilled as drops in the nasal and undergoes a solution to gel transition, improving nasal bioavailability by increasing the duration of contact, thereby reducing the frequency of administration. In this study, a nasal drug delivery system was developed using two different gelling agents with different mechanisms (pH and ion method) for in situ gelation of Trazodone HCl, an anti-depressant drug. In pH triggered method Carbopol 934 was used as a pH triggered polymer. Different formulations were prepared by varying the concentrations of Carbopol 934 alone and in combination with HPMC K 100. In case of ion activated method, Trazodone HCl in-situ nasal gel (0.1% w/w) were prepared at concentration of Gellan Gum (0.3, 0.4, 0.5 ,0.6% w/v) and HPMC E15 M (0.1, 0.15% w/v). The formulations were evaluated for hydrogel formation, pH, viscosity, in vitro release, drug content. The formulation of (1:1) carbopol 934 with HPMC K100 and gellan gum (0.4%) with HPMC E15 (0.15%) was tested for stability studies. Release kinetics followed zero order (non fickian) model. FTIR study revealed that there was no interaction between drug and polymer. pH of all the formulations were found to be in the range of 3.84-4.29 (pH method) and 4.88-6.39 (ion method) and the drug content for all the prepared formulations was found to be in the range of 84-95% (in pH) and 85-96% (ion activated).The results of in vitro drug release indicated that the optimized formulation F7 and F12 is the most successful formulation of the study, exhibited a sustained drug release of 55.48% – 87.33% (in pH method) and 68.41% – 88.79% (ion method) in 8 hours with viscosity 4.68 (in pH method) and 114.3 (ion method).

Keywords: Nasal in situ gel, Trazodone HCl, pH method, ion dependent method.


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