FORMULATION AND EVALUATION OF MEDICATED CHEWING GUM OF FLUOXETINE

Jashoda Prajapati*, Dr. Vishal Kumar Modi, Swati Khare, Bansi Zalavadia, Mansi Joshi and Bhakti Shah

ABSTRACT

The purpose of this study to develop medicated chewing gum of Fluoxetine. Fluoxetine is a prescription medicine used in the treatment of depression. The formulation of medicated chewing gum of antidepressant will enhance the patient’s compliance by providing the systemic effect immediately by directly affecting the central nervous system. The crucial aspect in formulation of medicated chewing gum is to mask the bitter taste of drug. Initially the inclusion complex between Fluoxetine and beta cyclodextrin was prepared by kneading method. Different molar ratio of complex is prepared. Complex was characterized using FTIR spectroscopy, differential scanning calorimetry. Medicated chewing gum containing Fluoxetine were prepared using ingredients like Gum base, Mannitol, Aspartame, flavor. The initial compatibility studies between drug and excipients were carried out using DSC and FTIR spectra. The 32 Full Factorial design was selected and the 2 factors were evaluated at 3 levels. The Gum base(mg) [X1] and mannitol(mg) [X2] were selected as independent variables. The hardness [Y1] and % CDR [Y2] were selected as dependent variables. The prepared medicated chewing gum was evaluated for hardness, in vitro drug release, thickness, weight variation, drug content. The results indicated that Gum base(mg) [X1] and Mannitol(mg) [X2] were significantly affected the hardness [Y1] and %CDR [Y2]. Formulation F4 was found to be best formulation with % drug release in 30 min 97.90. There was no drastic change in the results of medicated chewing gum of an optimized batch at end of one month accelerated stability study.

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