Comparision of Different Techniques Involved in the Development of Ivabradine HCL Floating Pulsatile Multiparticulate Systems for Chronotherapeutic Delivery

摘要

Aims: To develop Ivabradine HCl floating pulsatile multiparticulate (beads/ pellets) dosage forms containing calcium alginate beads/ pellets coated with pH-dependent polymer Eudragit S 100, by ionic gelation, pan coating, fluidized bed coating techniques and optimization of technique by comparing evaluation parameters with statistical data. Study Design: Ionic Gelation, Pan Coating, Fluidized Bed Coating Techniques and comparison and optimization of suitable technique. Place and Duration of Study: Bapatla College of Pharmacy. Bapatla, Guntur (district), Andhra Pradesh, India - 522101. June 2015 to September 2015. Methodology: Multiparticulates were prepared by Ionic gelation, pan coating , fluidized bed coating methods employing 1:5 drug : polymer (sodium alginate5%w/v) ratio ,5%w/v cacl2 as cross-linking agent and further coated with 6% w/w Eudragit S100 dispersed in 10% w/v of oil. These multi particulates were evaluated for % drug entrapment efficiency, Micromeritics, in vitro floating behaviour, in vitro drug release at PH 1.2 and 7.4, Kinetics and statistical analysis of these parameters. Results: Multiparticulates prepared by Ionic gelation technique exhibited very less % drug entrapment efficiency when compared to other two techniques. In pan coating technique lumps were formed and these particles exhibited poor flow properties besides low % of buoyancy when compared to other two techniques. Multiparticulates prepared by fluidized bed coating technique exhibited excellent flow properties, good entrapment efficiency and floating behaviour furthermore these particles also showed lag phase and pulsatile release. Statistical analysis revealed that there was no significant difference between pan and fluidized bed coating techniques in % drug entrapment efficiency. In case of floating lag time significant difference was not exhibited by multiparticulates prepared by ionic gelation technique and fluidized bed coating technique as ( P >.05). Conclusion: The results confirmed that Fluidized bed coating technique was optimized for preparation of floating pulsatile multiparticulates of Ivabradine HCl.