Development of Oral Fast-Disintegrating Levothyroxine Films for Management of Hypothyroidism in Pediatrics
Purpose: To develop fast disintegrating films of levothyroxine (LVX) using hydrophilic hydroxypropyl methylcellulose (HPMC), croscarmellose sodium (CCS) as superdisintegrant, and propylene glycol (PG) as a plasticizer.
Methods: Fast-disintegrating films were formulated by solvent casting evaporation method using 3-factor, 2-level full factorial design. The films were evaluated for disintegration time, in vitro drug release, physical appearance, thickness, weight variation, folding endurance, drug content uniformity, The effect of concentration of dependent variables (HPMC, CCS and PG) on disintegration time and in vitro drug release was studied.
Results: Suitable fast-disintegrating films were obtained using HPMC, CCS and PG. The minimum disintegration time (DT) was 15 s and maximum drug release (DR) in 1 h was 97.56 %. All independent variables selected for the study were statistically significant (p < 0.5). Increase in the concentrations of independent variables increased DR and DT.
Conclusion: The findings of this study indicate that the developed fast-disintegrating film is suitable for levothyroxine in the management of hypothyroidism in pediatrics.
Keywords: Hypothyroidism, Superdisintegrant, Fast-disintegrating, Levothyroxine, Oral films, Hydroxypropyl methylcellulose, Croscarmelose sodium, Propylene glycol