FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILM OF LAMOTRIGINE BY CRYSTALLO-CO-AGGLOMERATION TECHNIQUE

Registration ID: IJNRD_327096

Published ID: IJNRD2607188

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Ashwini Khandagale, Mr. Vaibhav Changediya

Keywords: Lamotrigine; Mouth dissolving film; Crystallo-co-agglomeration; Solvent casting; Drug dissolution; Fast dissolving oral film; HPMC; Polyvinyl alcohol; Drug release; Stability study.

ABSTRACT: Background: Lamotrigine is a Biopharmaceutical Classification System (BCS) Class II antiepileptic drug with poor aqueous solubility, which limits its dissolution rate and oral bioavailability. The present study aimed to develop mouth dissolving films (MDFs) of Lamotrigine using the crystallo-co-agglomeration technique to enhance drug dissolution and improve patient compliance. Methods: Lamotrigine mouth dissolving films were prepared by the solvent casting method using crystallo-co-agglomerated drug. Nine formulations (F1–F9) were developed by varying the concentrations of hydroxypropyl methylcellulose (HPMC E5), polyvinyl alcohol (PVA), and polyethylene glycol (PEG 400). Preformulation studies, including organoleptic evaluation, solubility, melting point, FTIR, and DSC analyses, were carried out to assess drug characteristics and compatibility. The prepared films were evaluated for weight variation, folding endurance, disintegration time, surface pH, drug content, in vitro drug release, and accelerated stability. Results: Preformulation studies confirmed the purity of Lamotrigine and its compatibility with the selected excipients. All formulations exhibited satisfactory physicochemical properties with uniform weight, acceptable mechanical strength, near-neutral surface pH, and uniform drug content. Formulation F7 demonstrated the best overall performance, showing a folding endurance of 232 ± 6, disintegration time of 24 ± 1.80 s, drug content of 99.82 ± 0.60%, and 100 ± 1.20% drug release within 10 min. Accelerated stability studies conducted for three months revealed no significant changes in the physicochemical characteristics or dissolution profile of the optimized formulation. Conclusion: The combination of crystallo-co-agglomeration and solvent casting successfully produced Lamotrigine mouth dissolving films with improved dissolution characteristics, rapid disintegration, and good stability. The optimized formulation (F7) exhibited desirable pharmaceutical properties and represents a promising oral drug delivery system for improving the dissolution and patient acceptability of Lamotrigine. Further in vivo studies are warranted to confirm its pharmacokinetic and therapeutic advantages.

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Ashwini Khandagale & Mr. Vaibhav Changediya (July-2026). FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILM OF LAMOTRIGINE BY CRYSTALLO-CO-AGGLOMERATION TECHNIQUE. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 11(7), b809-b824. https://ijnrd.org/papers/IJNRD2607188.pdf

Volume 11 Issue 7, July-2026

Pages : b809-b824

Paper Reg. ID: IJNRD_327096

Published Paper Id: IJNRD2607188

Research Area: Pharmacy All

Author Type: Indian Author

Country: Chhatrapati Sambhajinagar, Maharashtra , India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2607188.pdf

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