Development and evaluation of an oral fast disintegrating anti-allergic film using hot-melt extrusion technology
The main objective of this novel study was to develop chlorpheniramine maleate orally disintegrating films (ODF) using hot-melt extrusion technology and evaluate the characteristics of the formulation using in vitro and in vivo methods. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and the last zone of the barrel was opened to discharge water vapors, which helped to manufacture non-sticky, clear, and uniform films. The film formulations demonstrated rapid disintegration times (6–11 s) and more than 95% dissolution in 5 min. In addition, the films had characteristic mechanical properties that were helpful in handling and storage. An animal model was employed to determine the taste masking of melt-extruded films. The lead film formulation was subjected to a human panel for evaluation of extent of taste masking and disintegration.
European Journal of Pharmaceutics and Biopharmaceutics
Pimparade, M., Vo, A., Maurya, A., Bae, J., Morott, J., Feng, X., Kim, D., & Kulkarni, V. (2017). Development and evaluation of an oral fast disintegrating anti-allergic film using hot-melt extrusion technology. European Journal of Pharmaceutics and Biopharmaceutics, 119, 81-90. https://doi.org/10.1016/j.ejpb.2017.06.004