Use of porous carrier for improvement of solubility and 32 factorial design for pulsatile release of nifedipine from calcium pectin beads: pharmacokinetic studies on Wistar rats

The objective of present investigation was to develop floating-pulsatile drug delivery system using porous calcium silicate (Florite RE®) and LM pectin, for engineered specific drug release of nifedipine (model drug). Florite RE was successfully investigated as duel acting agent for enhancement of solubility and to impart pulsatile release. Nifedipine was adsorbed on FLR by using chloroform and recovered adsorbed product was characterized by FTIR, DSC, PXRD and SEM, and evaluated for saturation solubility and in-vitro dissolution studies. FLR adsorbed product showed positive influence on the solubility of nifedipine due to increase in effective surface area. The pulsatile beads was optimized by 3²  factorial design by considering concentration of FLR adsorbed nifedipine (X₁) and concentration LM pectin (X₂) as independent variables and lag time (R₁) and floating time (R₂) as responses which exert significant effect (P <0.05). The prepared beads were evaluated for various parameters including, entrapment efficiency, average size, mechanical strength, floating time, in-vitro dissolution, in-vivo pharmacokinetic studies etc. The stability study indicated that the prepared beads were sufficiently stable under accelerated and controlled conditions. Thus simple manufacturing process with combined approach proves promising approach for the relief cardiac disorders which follows a circadian rhythm.

Author(s): Rajesh Jagtap

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