Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Development of oral fast-disintegrating levothyroxine films for management of hypothyroidism in pediatrics

He Zhang , Mei-Gui Han, Yun Wang, Jie Zhang, Zi-Ming Han, Shu-Jun Li

Department of Pediatrics, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang 453100, China;

For correspondence:- He Zhang Email: zhanghe094@gmail.com Tel:+863734402514

Received: 9 April 2015 Accepted: 31 August 2015 Published: 31 October 2015

Citation: Zhang H, Han M, Wang Y, Zhang J, Han Z, Li S. Development of oral fast-disintegrating levothyroxine films for management of hypothyroidism in pediatrics. Trop J Pharm Res 2015; 14(10):1755-1762 doi: 10.4314/tjpr.v14i10.4

© 2015 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

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 glyc