Comparative Study of Bilayered Vs. Trilayered Tablets for Optimized Maxalt Delivery in Migraine Treatment
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Abstract
Migraine is a disabling neurologic disorder that afflicts millions of people globally. Although treatments like Maxalt (rizatriptan benzoate) are available, traditional formulations can produce rapid absorption followed by a rapid decrease in plasma concentration after which therapeutic effects may not be optimal. Preformulation Studies Like other 5-HT1F agonist medications, Maxalt poses challenges due to its relatively low solubility and the potential for premature gastrointestinal absorption. In this study, bilayered and trilayered tablet formulations are compared for optimized delivery of Maxalt. Sustained drug release can be achieved via bilayered tablets, which are composed of two separate layers: a designated protective layer that protects the active pharmaceutical ingredient (API) from destruction in the gastric cavity, and a designated drug-release layer. Trilayered tablets contain an extra intermediate barrier, which may open up for many more well-controlled release profiles. Stacked structure of LbL assembly tablets polymers were selected, such as poly(lactic-co-glycolic acid) (PLGA), chitosan and sodium alginate. Tablets were characterized for physical properties (hardness, friability), morphological studies using scanning electron microscopy (SEM), and crystallinity studied using X-ray diffraction (XRD). The in vitro dissolution studies were performed at simulated gastric (pH 1.2) and intestinal (pH 6.8) conditions and the in vivo pharmacokinetic studies were carried out in Sprague–Dawley rats. These findings demonstrate that trilayered tablets are capable of delivering lower initial burst release and providing a more sustained drug plasma concentration than bilayered formulations and standard immediate-release tablets. These results indicate that bioavailability could be enhanced with a trilayered tablet and controlled Maxalt release could be achieved for acute migraine therapy. Clinical significance and recommendations for future studies are also explored.
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