Formulation and evaluation of mouth dissolving film loaded with antiepileptic drug divalproex sodium

  • Unique Paper ID: 185695
  • Volume: 12
  • Issue: 5
  • PageNo: 2533-2539
  • Abstract:
  • The study aimed to formulate and evaluate mouth dissolving films (MDFs) of divalproex sodium to enhance drug release rate, provide rapid onset of action, and improve patient compliance, especially among individuals with swallowing difficulties. MDFs were prepared using xanthan gum as the film-forming polymer and polyethylene glycol (PEG-400) as the plasticizer through the solvent casting method. A 3² factorial design was employed to optimize polymer and plasticizer concentrations. The prepared films were evaluated for physical characteristics, folding endurance, drug content uniformity, moisture content, disintegration time, dissolution profile, and stability as per ICH guidelines. The results indicated that all formulations exhibited uniform thickness, good mechanical strength, and satisfactory folding endurance. Drug content across all films exceeded 90%, confirming uniform drug distribution. In vitro disintegration occurred within 40 seconds, and more than 90% of the drug was released within 10 minutes. Among all formulations, DF4 showed the best overall performance, with 96.7% drug content and 94% drug release following first order and Higuchi diffusion kinetics. Stability studies confirmed that the optimized film retained its physical integrity and efficacy over 3 months. The developed mouth dissolving film of divalproex sodium offers a promising, patient-friendly delivery system for rapid therapeutic action in epilepsy management.

Copyright & License

Copyright © 2025 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{185695,
        author = {Atul Bopche and Satyam Dubey and Saurav Kumar and Shinu Kumar and Shivam Gupta and Shlok Sharma and Shubham Sharma and Dr. Jagdish C. Rathi},
        title = {Formulation and evaluation of mouth dissolving film loaded with antiepileptic drug divalproex sodium},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {5},
        pages = {2533-2539},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=185695},
        abstract = {The study aimed to formulate and evaluate mouth dissolving films (MDFs) of divalproex sodium to enhance drug release rate, provide rapid onset of action, and improve patient compliance, especially among individuals with swallowing difficulties. MDFs were prepared using xanthan gum as the film-forming polymer and polyethylene glycol (PEG-400) as the plasticizer through the solvent casting method. A 3² factorial design was employed to optimize polymer and plasticizer concentrations. The prepared films were evaluated for physical characteristics, folding endurance, drug content uniformity, moisture content, disintegration time, dissolution profile, and stability as per ICH guidelines. The results indicated that all formulations exhibited uniform thickness, good mechanical strength, and satisfactory folding endurance. Drug content across all films exceeded 90%, confirming uniform drug distribution. In vitro disintegration occurred within 40 seconds, and more than 90% of the drug was released within 10 minutes. Among all formulations, DF4 showed the best overall performance, with 96.7% drug content and 94% drug release following first order and Higuchi diffusion kinetics. Stability studies confirmed that the optimized film retained its physical integrity and efficacy over 3 months. The developed mouth dissolving film of divalproex sodium offers a promising, patient-friendly delivery system for rapid therapeutic action in epilepsy management.},
        keywords = {Divalproex Sodium, Mouth Dissolving Film (MDF), Fast Drug Release, Epilepsy.},
        month = {October},
        }

Cite This Article

  • ISSN: 2349-6002
  • Volume: 12
  • Issue: 5
  • PageNo: 2533-2539

Formulation and evaluation of mouth dissolving film loaded with antiepileptic drug divalproex sodium

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