Background: Orodispersible film (ODF) is a novel drug delivery system and
most widely used dosage form because of its convenience in terms of self-administration,
compactness, and ease in manufacturing. Lutein (Carotenoid) is an antioxidant, belongs to
class II (High permeability and Low solubility) under BCS classification. To enhance the
solubility, a solid dispersion of Lutein was prepared and then it has been successfully fabricated
into ODF to increase its pre-gastric absorption, reduce its first pass effect and
avoid further degradation in gastric acid.
Objective: The objective of the present research work was to prepare a solid dispersion of
Lutein in order to increase its solubility and formulate its ODF to improve its bioavailability.
Method: The solid dispersion of Lutein was prepared by a solvent evaporation method
using Soluplus as a carrier. The orodispersible films of Lutein were prepared separately
using different concentrations of Ethocel E 15 and Aerosil 200 pharma grade by a solvent
Results: The prepared films were evaluated for various parameters such as folding endurance,
drug content, disintegration time, in vitro drug release etc. The formulation F3 containing
150 mg of Ethocel E 15 and 20 mg of Aerosil 200 showed rapid disintegration
time and in vitro drug release.
Conclusion: ODF of Lutein has been successfully formulated. The developed formulation
can be used for the treatment of age-related macular degeneration.