Background::
Orally disintegrating tablets (ODTs) have become an excellent choice for
delivering drugs as their palatability is greatly improved. In this work, β-cyclodextrin has been used
to improve the solubility of curcumin by encapsulating it into the hydrophobic cavity for the treatment
of neurodegenerative disorders.
Objective::
The current study aimed to present the design, formulation, and optimisation of fastdissolving
oral tablets of curcumin- β-cyclodextrin molecular inclusion complex using a 32-factorial
design with sodium starch glycolate (SSG) and Neusilin® ULF2 as independent factors.
Methods::
The drug-excipient compatibility was studied by FTIR spectroscopy. The inclusion complex
of curcumin-β-cyclodextrin was prepared using solvent casting and confirmed using XRD studies.
Powder blends were evaluated for flow properties. Tablets prepared by direct compression were
evaluated for post-compression parameters. Further, the effect of formulation variables, such as sodium
starch glycolate (X1) and Neusilin® ULF2 (X2), on various responses, including disintegration
time and dissolution at 2 hours, was studied using statistical models.
Results::
Post-compression parameters, i.e., hardness (4.4-5 kg/cm2), thickness (3.82-3.93 mm),
weight variation (±7.5%), friability (<1%), wetting time (51-85 seconds) and drug content (96.28-
99.32%) were all found to be within the permissible limits and the disintegration time of tablets with
super-disintegrants ranged between 45-58 seconds. The in-vitro dissolution profile of tablets showed
that higher SSG and Neuslin® ULF2 levels promoted drug release. For statistical analysis, the 2FI
model was chosen. Optimised variables for formulation have been determined and validated with the
experimental findings based on the significant desirability factor.
Conclusion::
The current study reveals the validated curcumin-β-cyclodextrin inclusion Complex
fast-dissolving tablets with SSG and Neusilin® ULF2 to be an ideal choice for effectively treating
neurodegenerative disorders.