Drug development and industrial pharmacy · 2026
Development and evaluation of rizatriptan benzoate orally disintegrating tablets for migraine treatment.
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Çelebi Nevin, Tuncay Emine
Аннотация
OBJECTIVE: This study aimed to develop rizatriptan (RZT) benzoate orally disintegrating tablets (ODTs), used in migraine treatment, using various excipients and, in particular, super-disintegrants, through the direct compression method, and to compare them with a commercial product (Maxalt® RPD).
SIGNIFICANCE: Migraine is a common disease that affects quality of life. ODTs are the preferred dosage form due to their rapid effect and patient compliance. In this study, ODTs with rapid disintegration time, rapid release, and high porosity were developed using superdisintegrant for RZT.
METHODS: ODT formulations were prepared by direct compression method using superdisintegrants such as Ludiflash®, Ludipress®, and Pharmaburst™ along with other excipients. Disintegration time and in vitro dissolution tests were performed and compared with Maxalt® RPD. Furthermore, the porosity, water absorption rate, wetting time, and surface morphology of the tablets were also examined. The interactions between RZT and excipients were investigated using DSC and XRD studies.
RESULTS: ODT formulations containing Ludiflash® and Pharmaburst™ were found to be the most suitable according to their disintegration time, dissolution profiles. It was observed from the dissolution profile of the commercial product that 100% of the drug was dissolved within 3 min. This is thought to be due to Maxalt® RPD being manufactured by lyophilization. A highly porous structure was clearly observed on the surface of ODTs. There was no interaction between RZT and excipients.
CONCLUSION: As a result, ODT formulation of RZT, used in the treatment of migraine, has been successfully developed.
SIGNIFICANCE: Migraine is a common disease that affects quality of life. ODTs are the preferred dosage form due to their rapid effect and patient compliance. In this study, ODTs with rapid disintegration time, rapid release, and high porosity were developed using superdisintegrant for RZT.
METHODS: ODT formulations were prepared by direct compression method using superdisintegrants such as Ludiflash®, Ludipress®, and Pharmaburst™ along with other excipients. Disintegration time and in vitro dissolution tests were performed and compared with Maxalt® RPD. Furthermore, the porosity, water absorption rate, wetting time, and surface morphology of the tablets were also examined. The interactions between RZT and excipients were investigated using DSC and XRD studies.
RESULTS: ODT formulations containing Ludiflash® and Pharmaburst™ were found to be the most suitable according to their disintegration time, dissolution profiles. It was observed from the dissolution profile of the commercial product that 100% of the drug was dissolved within 3 min. This is thought to be due to Maxalt® RPD being manufactured by lyophilization. A highly porous structure was clearly observed on the surface of ODTs. There was no interaction between RZT and excipients.
CONCLUSION: As a result, ODT formulation of RZT, used in the treatment of migraine, has been successfully developed.