Innovative Superdisintegrant Strategy for the Formulation of Rapidly Disintegrating Lamotrigine Tablets

Abstract

Aims: Lamotrigine (LMG) is a poorly water-soluble antiepileptic drug (0.17 mg/mL at 25°C), commonly prescribed for epilepsy, including secondary generalized tonic-clonic seizures, as well as simple and complex partial seizures. Due to its low solubility and swallowing difficulty in some patients, the present study aimed to enhance its solubility and formulate it as oral disintegrating tablets (ODTs) for rapid onset of action. Methodology: Lamotrigine ODTs were produced via the direct compression technique with varying concentrations of various superdisintegrants such as Pharmaburst 500 (a co-processed excipient containing 95% fructose and 5% starch), Croscarmellose sodium and Crospovidone. Seven formulations were made and assessed for parameters before and after compression. Results: All tablets exhibited satisfactory results in terms of weight variation, hardness (2.8–4.0 kg/cm²), friability (<1%), and in vitro dispersion time (7.62–30 sec). Drug content uniformity ranged from 97.2% to 100%, indicating even distribution. FTIR analysis confirmed no significant interaction between Lamotrigine and the superdisintegrants. In vitro drug release studies conducted over 45 minutes revealed more than 97% drug release in all batches. Among them, formulation F3 containing Pharmaburst 500 demonstrated the highest release of 99.39% within 30 minutes. Conclusion: The study concludes that ODTs of Lamotrigine prepared using Pharmaburst 500 and suitable superdisintegrants effectively enhance solubility and offer a patient-friendly dosage form with faster drug release, potentially improving therapeutic outcomes and patient compliance.