ISSN : 2663-2187

23 Ful Factorial Design in the development of Fast Dissolving Films of Doxylamine Succinate using Natural Polymer

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Sumitradevi Choudhary1, Harish K. H1*, Amruth M Sansthanmath1, Prajwal Sunil Kole1, Gouri Santosh Koshti1, Anisha Anandu Shetiya1, Fatima Sanjeri Dasankoppa1, Agadi Hiremath Viswanatha Swamy2
» doi: 10.33472/AFJBS.6.5.2024. 8117-8137

Abstract

Aim and Objective: The aim of the present research work is to design and formulate Fast dissolving buccal films that can rapidly provide relief from sudden allergic reactions. Materials and Methods: Doxylamine succinate films were prepared using natural polymer pullulan through solvent casting technique, using a 23 full factorial design with three factors and two responses. The formulation was optimized using Design Expert software. Compatibility studies were carried out using FTIR spectroscopy. The films were assessed for all the parameter. Results: The results indicated no interaction between the drug and excipients. The optimized batch of fast dissolving films showed a disintegration time of 46 seconds and drug release of 81.3% within 45 minutes. All the physicochemical criteria were satisfied, and ex-vivo studies conducted on buccal mucosa demonstrated a cumulative drug release of 79.5% at 60minutes. Stability test was performed on the optimized formulation according to ICH guidelines for one month at a temperature of 30C±2C and relative humidity of 65%±5%. Conclusion: The concept of fast dissolving dosage forms is becoming popular novel delivery system, due to their ability to enhance therapeutic efficacy, improve bioavailability by reducing dosing frequency while bypassing first-pass metabolism for quicker drug absorption and onset of action.

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