Formulation and evaluation of doxepin hydrochloride by fast dissolving buccal film

Abstract

Tricyclic antidepressants, as doxepin hydrochloride (DH), may also have analgesic neighborhood effect due to its biochemical mechanism of action. This is commonly performed via drug to be administers directly into the blood flow via the Buccal mucosa through using fast dissolving movie system. The main aim of the study was to formulate and evaluate Doxepin hydrochloride by fast dissolving buccal film. The Doxepin hydrochloride buccal film were prepared by the solvent casting method by using the different polymers (HPMC E15, PVA, and HEC). The FTIR test is conducted by this test there was no interaction between the drug and polymers. Then buccal film were evaluated for weight uniformity, thickness uniformity, folding endurance, disintegration study, drug content uniformity, and invitro drug release. The weight uniformity ranged from 47.00 to 55.33mg, thickness ranged from 0.17 to 0.25nm, folding endurance ranged from 344 to 355mm drug content ranged from 84 to 98% and disintegration study ranged from 42.0 to 54.3. The F9 formulation showed highest drug release i.e., 99.96% within 4 minutes. The IR spectra showed stable properties of doxepin hcl mixture of polymers used and revealed the absence of interaction between drug and selected polymer, stability studies were as per ich guideline and result indicated that the selected formulation was stable.