Formulation And Evaluation of Clomipramine HCL Mucoadhesive Buccal Films

The current study aimed to develop a buccal bioadhesive film for Clomipramine HCl, which reduces the frequency of dosage administration by releasing the drug at an effective concentration over time. Clomipramine HCl exhibits antihistamine, antiadrenergic, antiserotonergic, anticholinergic, sodium channel-blocking, and serotonin-norepinephrine reuptake inhibition properties. This study aims to create a mucoadhesive buccal film of Clomipramine HCl that surpasses the traditional dosage form, improving patient compliance and efficacy. Clomipramine is widely used in treating major depressive disorder (MDD) and psychogenic face pain, although the latter may take up to a year for noticeable results. Formulation F6, containing HPMC K100 polymer, demonstrated the best drug release rate over seven hours, alongside acceptable quality control properties. Based on these findings, formulation F6 was the most promising, with an in-vitro drug release rate of 98.25%. FTIR studies showed no interaction between Clomipramine HCl and the excipients. DSC studies further confirmed the lack of interaction between the polymers and the drug. Stability testing for ninety days, following ICH guidelines, showed the formulation’s stability. These findings suggest that the mucoadhesive buccal film may offer improved patient compliance and efficacy compared to traditional dosage forms.