FLOATING PULSATILE DRUG DELIVERY SYSTEM OF FAMOTIDINE: DESIGN, STATISTICAL OPTIMIZATION, AND IN VITRO EVALUATION
Keywords:
Pulsatile drug delivery, Chronotherapeutics, Nocturnal Acid Breakthrough, FamotidineAbstract
Objective: Pulsatile systems are gaining a lot of significance as they deliver the drug at the right site of action at the right time and in the right amount, thus providing spatial and temporal delivery and increasing patient compliance. These systems are designed according to the circadian rhythm of the body. The aim of the present research work was to design and optimize compression coated floating pulsatile drug delivery system of Famotidine. Floating pulsatile concept was applied to increase the gastric residence of the dosage form having lag phase followed by a burst release.
Methods: Floating pulsatile tablets were prepared by using press coated technology. The prepared system consisted of two parts: a core tablet containing the active ingredient and an erodible outer shell with gas generating agent. The burst release core tablet was prepared by using super disintegrants with the active ingredient. Press coating of optimized burst release core tablets was done by the polymer. A 32 full factorial design was used for optimization. The amount of HPMCE4M and Polyox WSRN60K was selected as independent variables. Lag period, drug release, buoyancy and swelling index were selected as dependent variables.
Results: Floating pulsatile release formulation (FPRF) F4 at level 0 (65 mg) for HPMC E4M and level-1 (75 mg) for Polyox WSR N60K showed lag time of 4 h with>90% drug release. The data were statistically analyzed using ANOVA, and ð‘ƒ<0.05 was statistically significant.
Conclusion: The present research work demonstrates that famotidine could be successfully delivered to provide night-time relief of gastric acidity by formulating floating pulsatile drug delivery system. The press-coated formulation containing HPMCE4M and Polyox WSR N60K at 0,-1 level was in the optimum zone and has the potential for time-controlled pulsatile delivery of Famotidine.
Keywords: Floating pulsatile, Famotidine
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