International Journal of Pharmaceutics & Drug Research

Susovan Koley*, Rama Shukla, Akhilesh Kumar Singhai

ABSTRACT

The objective of the presented research work was to develop and evaluate fast-dissolving oral film containing solid dispersion of lamotrigine (LM) for improvement of its water solubility, dissolution and oral bioavailability by avoiding the first pass metabolism, providing faster onset of action and avoidance of problem of seizures. First, physical mixture, solid dispersion (SDP) of LM were prepared with PEG 4000, PVP K-90 (as hydrophilic polymeric carrier) in 1:1, 1:2 and 1:3 by using conventional method. The prepared SDP were analyzed for all the physical parameters, drug: carrier interactions like FTIR. Solid dispersions showed a better solubility compared to the pure drugs and among all the other formulations 1:3 ratios shows high % enhancement of solubility i.e. 270.52% and therefore 1:3 ratios were found to be superior and were used for further formulation development. Oral fast dissolving films prepared by solvent casting method using water and 95% ethanol as solvents and HPMC as film forming polymer. PEG 400 was the selected plasticizers, Superdisintegrants such as croscarmellose sodium (CCS) and sodium starch glycolate (SSG) alone and also in combinations was incorporated to achieve the aim. The prepared films were evaluated for the drug content, weight variation, film thickness, disintegration time, folding endurance, percentage of moisture content and in vitro dissolution studies. Among all, the formulation F3 was found to be best formulation which releases 96.65±0.65% of the drug within 15 min and disintegration time is 1.37 min. which was significantly high when compared to other formulation. Stability studies were carried out for optimized formulation F3 at 40±2oC temperature and 75±5% relative humidity for a period 3 months. The % assay of film was found to slightly decrease at higher temperature. Based on the results, it was concluded that fast-dissolving oral film contained SDP of drug may provide the merits of faster onset of action, avoidance of extensive first-pass metabolism, enhanced bioavailability, and improved patient compliance for the delivery of poorly water-soluble drug such as lamotrigine.

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