Abstract
The demand for orally disintegrating tablets of lamotrigine has been growing during the last decade especially for the geriatric and pediatric patients. Lamotrigine is a recognized drug for epilepsy, so development of an ODT of lamotrigine and to evaluate the effect of various superdisintegrants on its disintegration time and release profile was the prime objective of this research work. Tablets were prepared by direct compression technique using 3 different superdisintegrants. Sodium starch glycolate, Croscarmellose sodium and Crosspovidone XL-10 were used as superdisintegrants in combinations to achieve optimum release profile, disintegration time and hardness. Direct compression process was selected for this formulation of ODT tablets, because porous nature is more in direct compression blend than wet granulation blend, so it will give faster disintegration. Microcrystalline cellulose was used as diluent and mannitol, mint flavor and sodium saccharin were used to enhance the organoleptic properties of tablets. The tablets were evaluated for weight variation, hardness, friability, in-vitro disintegration time and drug release characteristics. Hardness and friability data indicated good mechanical strength around 3 kg/cm2 for all the batches. The results of in-vitro disintegration time indicated that the tablets dispersed rapidly in mouth within 8 s. Dissolution study revealed release rate of drug from the tablets was comparable with marketed tablet formulation of lamotrigine. It was concluded that superdisintegrants addition technique is a useful method for preparing orally disintegrating tablets by direct compression method. Key words: Orally disintegrating tablets, superdisintegrants, Lamotrigine, direct compression.
Highlights
Most of the oral pharmaceutical dosage forms like conventional tablets and capsules are formulated to be swallowed or chewed
The in-vitro disintegration time for tablet formulations containing low concentration of 1 mg/tablet for two superdisintegrants in combination was observed to be 8-18 s. similar results have been cited in reference (Avani et al, 2008)
The tablet formulations containing each of 2 mg of sodium starch glycolate and croscarmellose sodium (ODT 3), each of 2 mg of sodium starch glycolate and crosspovidone (ODT 6), each of 2 mg of croscarmellose sodium and crosspovidone (ODT 7), showed 15, 16 and 18 s respectively
Summary
Most of the oral pharmaceutical dosage forms like conventional tablets and capsules are formulated to be swallowed or chewed. Bedridden patients and elderly patients have difficulty in swallowing these dosage forms (Avani et al, 2008). To overcome this drawback novel drug delivery systems like orally disintegrating tablets have been developed which disintegrate/dissolve/ disperse in saliva within few seconds without water. The major advantage of the ODT formulation is that it combines the advantages of both liquid and conventional tablet formulations It provides the convenience of a tablet formulation, and allowing the ease of swallowing provided by the liquid formulation (Rangasamy, 2009)
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