Development of Sustained Release Oral Floating Tablet Formulation of Cinnarizine using 32 factorial design

Abstract

The objective of this research is to develop a single unit capsule containing dual release gastro- retentive floating tablet of cinnarizine using polymers such as HPMC as a matrix forming agent, Ethyl cellulose as release retarding agent and Sodium bicarbonate as gas generating agent. Dual release consists of immediate release dose (IR) (loading dose) 25mg of cinnarizine in powder form and 50mg of sustain release tablet (maintenance dose) that will give drug release up to 12hr. The only target was to increase the gastric residence time by using floating approach, thus leading to increase in bioavailability. The direct compression method was used to create the initial batches of the medication, polymers, gas producing agent, and diluent. 32 factorial design was used to optimize the ingredient level. The optimized batches then were characterized for various parameters such as weight variation, thickness, hardness, Floating lag time, swelling study, FTIR etc. It was found that IR (loading dose) while SR of cinnarizine exhibited more than 80% drug release till 12hr. FTIR studies reveled that the drug was compatible with all other excipients. Through optimization, it was concluded that the amount of polymer and gas generating agent directly affect floating lag time and % drug release. SR tablet of cinnarizine of batch F5 showed drug release more than 99% in 12 hr. Thus, the tablet was then packed in capsule and stored at proper conditions.