Assessment of Formulation Factors on the Release Behaviour of BCS Class II Drug from Tablet Dosage form Using DoE
Urmila Sri Syamala, Raman Suresh Kumar, Tambi Anuj Pushkarajan and Kuppuswamy Gowthamarajan
Affiliation: Department of Pharmaceutics, JSS College of Pharmacy (A constituent college of JSS University Mysore) Rocklands, The Nilgiris, Ootacamund.
Keywords: ANOVA, BCS class II drug, design of experiment, F-value, immunosuppressant, R2 value.
A model immunosuppressant BCS Class II drug was selected for the work to assess the formulation variables
on the release rate using design of experiment (DoE) - Stat-Ease software. Surface solid dispersion was prepared with dichloromethane
(DCM) and ethanol mixture (4:1), and converted to tablet by adsorption on a neutral carrier. Different
batches were prepared with DoE full factorial design. The concentrations of Polaxamer 188, Kollidon CL and Magnesium
stearate were found to be the critical factors affecting the performance of the tablets. These parameters were selected as
the independent variables in DoE and the formulated batches were evaluated for their percentage release at 120 minutes.
The actual and predicted plots fall close to the line. ANOVA (partial sum squares-type-III) reveals the model with F-value
of 1417.12 which implies significant. The optimized batch with dissolution profile of 99.6% falls close to the innovator
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