Design and characterization of fast dissolving buccal film of imipramine HCL

Abstract

In depressed individuals, Imipramine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Imipramine hydrochloride having variable bioavailability i.e. ranging from 29-77% due to first pass metabolism, peak plasma concentration is usually attained 2-6 hours. Absorption is unaffected by food. It is freely soluble in water. The objective of this research work is to improve the bioavailability of the drug and fast the onset of action to decrease the depressant activity. The Buccal bioavailability of Imipramine HCL is only 29-77% for this reason drug can be administered into Buccal mucosa using mucoadhesive film. It can be made fast drug release and directly enter into blood circulation through Buccal mucosa and increase the drug bioavailability. Fast dissolving Buccal films were prepared by solvent casting method using various polymers like hydroxyl propyl methyl cellulose E15, PVP, PVA and sodium saccharin, plasticizer and vanillin as flavouring agent. Dissolution profile as studied in USP dissolution apparatus type 1 using pH 6.8 simulated saliva. The influence of variable like polymer type and concentration on Imipramine HCL release profile was studied. The formulation was optimized on the basis of various evaluation parameters like drug content and in vitro drug release. Formulation F3 successfully fast the release of drug within 8 minutes. The IR Spectra revealed the absence of interaction between drug and selected polymer, results of stability studies were as per ICH guide lines and results indicated that the selected formulation was stable.