Author(s): Chappidi Suryaprakash Reddy *, Yiragamreddy Padmanabha Reddy and Nayakanti Devanna
The purpose of the present study was to develop and optimize the pH independent Dalfampridine extended release tablets by employing 3 factors 2 level (2 3 ) factorial design. Combination of hydrophilic polymer and methacrylates as matrix formers and MCC PH 102 as direct compressible diluents were used. The independent variables were the concentration of the matrix formers Eudragit RSPO (X1), Eudragit RLPO (X2), HPMC K100M (X3) whereas the dependent variables were the cumulative % drug release at 1 hr (Y1), 6 hrs (Y2), 12 hrs (Y3) and the time for the 50 % of the drug release (Y4), which were restricted to 10-30 %, 40-70 %, NLT 80 % and NLT 3 hrs respectively. Statistical elucidations of the polynomials were established for all the responses. The formulations were evaluated for the pre-compression and post-compression parameters. The in vitro results revealed that formulations with high concentration of HPMC and RLPO were unable to control the drug release whereas formulations with high concentration of RSPO with other two met the extended release criteria. From the kinetic and mathematical results, the drug release follows the first order and Higuchi’s Fickian diffusion kinetics.