Abstract

FORMULATIO AND EVALUATION OF ZOLMITRIPTAN BILAYER ORAL STRIP

Wissam Salim Mahmod* and Yehia Ismail Khalil

Abstract

Oral strip is one of acceptable and palatable delivery system assist patients in any age to be easily administered. Zolmitriptan is a 5HT receptor agonist used to relief migraine attack was studied to formulate it as a bilayer oral strip, both layers disintegrates within seconds but each layer has its own drug release (the first layer formulate to release drug rapidly while the second layer release its drug in a sustained release manner) the first release to get rapid mask the migraine attack and the second release to prevent recurrent attack for certain time period, this strip formulated by casting and spraying techniques to get bilayer film with sufficient physical and mechanical properties using different hydrophilic and hydrophobic polymers with different plasticizers in different ratios and concentrations and study their effects on the in-vitro disintegration time, the mechanical properties of the film and also the in-vitro release profile, other studied parameters such as drug-excipients compatibility were evaluated. The disintegration time of the optimized formula (Fx10) was 32 sec.; release 50% of the drug within first 15 minutes and the remaining drug released as sustained reach to 4 hours. The fast release profile compared with the marketed zolmitriptan oral dispersible tablet. FTIR and DSC thermogram studies indicate no presence of incompatibility with the excipients either during mixing or during casting

Keywords: Zolmitriptan, Oral Strip, Bilayer, Sustained Release, FTIR, DSC, SEM.