Development of Buccal Gel Formulations for the Treatment of Migraine
Project no. 32046 · Status: Kapanmış · 2024
Summary
<p>Migraine is a neurological disorder characterized primarily by recurrent, severe, throbbing pain in the head region, often accompanied by photophobia, phonophobia, nausea, and vomiting. Chronic migraine affects approximately 1.3–5.1% of the global population. Its prevalence can vary depending on several patient-related factors, including gender, age, and sociocultural differences. In Turkey, the prevalence of migraine among individuals aged 15–55 is estimated to be 16.7%, affecting nearly 8 million people. Approximately 75% of migraine patients experience pain lasting four or more days per month. The frequency and severity of this widespread condition significantly increase both the treatment costs and the overall economic burden on society.</p><p>Patients seek fast and effective control of all migraine symptoms to minimize the impact of the disease on their work, family, and social lives. In migraine treatment, triptans are considered first-line options for acute and symptomatic therapy due to their favorable benefit-risk profiles. They are especially preferred for patients who do not respond to non-specific analgesics, suffer from severe pain, and experience nausea, sensitivity to light and sound, and functional impairment during attacks.</p><p>Eletriptan hydrobromide is a highly selective serotonin 5-HT1B/1D receptor agonist, administered orally for the acute treatment of moderate to severe migraine attacks. It is generally well tolerated, allows patients to return quickly to their daily activities, improves quality of life, and represents a cost-effective therapeutic option. Based on this information, eletriptan hydrobromide has been selected as the active pharmaceutical ingredient (API) for our graduation project.</p><p>Studies have shown that 80–88% of migraine patients prefer conventional dosage forms such as tablets, capsules, or orally disintegrating tablets. However, for some patients, nausea and vomiting caused by the pain can hinder medication intake. Moreover, it has been reported that gastrointestinal absorption of orally administered drugs can be significantly impaired during migraine attacks. In light of these findings, the importance of non-conventional dosage forms in migraine treatment becomes increasingly evident.**</p><p>Currently, eletriptan hydrobromide is available on the global and Turkish pharmaceutical markets only in tablet form. While the literature describes alternative formulations such as buccal tablets, orally disintegrating tablets, and films, there is no non-oral dosage form of eletriptan commercially available.</p><p>Within the scope of this graduation project, buccal oleogel, hydrogel, and bijel formulations containing eletriptan hydrobromide will be developed for the treatment of migraine, and in vitro quality control tests will be conducted. Buccal administration offers several advantages, including rapid onset of action, reduced side effects associated with oral therapy, prevention of gastrointestinal issues, ease of use for patients with swallowing difficulties or nausea/vomiting, and the convenience of administration without the need for water.</p><p>It is believed that the development of buccal formulations not only supports the proposal of alternative dosage forms for migraine therapy but also contributes to patient compliance by offering effective and reliable formulations. Furthermore, these novel formulations, incorporating various excipients, are expected to provide new insights and value to the scientific literature.</p>