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Zolmitriptan delivery with ADAM
provided rapid and reproducible zolmitriptan in this phase I trial.
ADAM is an intracutaneous drug administration device which provides intracutaneous delivery of Zolmitriptan and thus providing more rapid absorption than orally administered triptans.
Although there are multiple treatment options available, need for assured treatment approach persists. Orally administered medications are user-friendly and first-line treatment but may have side effects like nausea, vomiting, difficulty in swallowing or retaining oral formulations prolong gastric emptying. Other available migraine medications are injectables and intranasal formulations of Sumatriptan and Zolmitriptan nasal spray. But these also have some limitations like needle aversion and poor palatability of nasal formulations. This device circumvents these limitations by providing intracutaneous delivery of Zolmitriptan.
It comprises of a 3 cm2 disposable array of drug-coated titanium micro projections on an adhesive backing. A low cost, reusable, handheld applicator is used to apply the same. After application, its micro projections penetrate the stratum corneum and the drug is delivered proximal to capillaries causing no pain or least pain. The pharmacokinetics of Zolmitriptan delivery using ADAM was evaluated in phase I study in 20 healthy volunteers, aged 18–60 years. Median tmax was <20 min, comparable to subcutaneous Sumatriptan.
It was found that intracutaneous absorption was faster than
oral Zolmitriptan, with higher exposure in the first 2 h. Most adverse events
were consistent with those seen in previous triptan trials. Site reactions on
application were generally mild and resolved within 24 h. To conclude, ADAM
Zolmitriptan shows a promising pharmacokinetic profile for migraine treatment.
Pain Manag. 2017 Jul 25.
Rapid systemic delivery of zolmitriptan using an adhesive dermally applied microarray
Donald J Kellerman, Kellerman et al.
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