Case Study – Unidose Nasal Spray Pump for Epilepsy

The case study presented is a collaborative effort with Aptar Pharma and a leading Pharmaceutical company, aimed at repurposing midazolam into a form that is easily administrable even by those without medical training. The cornerstone of this initiative is the development of a midazolam nasal spray, designed as a more accessible and user-friendly alternative to intramuscular injections.

The innovative aspect of this project lies in the use of Aptar Pharma’s Unidose Liquid (UDS) system. The UDS system is primeless and intuitive, making it an ideal solution for emergency situations where time and ease of use are crucial. This device has been designed to allow administration by a wide range of potential caregivers, including those who are not medically trained. Its design is particularly beneficial for use on unresponsive patients, a common scenario in cases of severe seizure clusters.

One of the key challenges in the development of this nasal drug delivery system was ensuring effective delivery of the drug from the nose to the brain. The nasal route offers a direct path to the central nervous system, bypassing the blood-brain barrier, which can often impede or slow down drug efficacy. Aptar Pharma played a pivotal role in optimizing the formulation of midazolam for efficient ‘nose-to-brain’ drug delivery. This optimization was crucial in maximizing the effectiveness of the drug when administered through the nasal route.

The collaboration led to the establishment of a first-in-class solution for the treatment of seizure clusters. The resulting nasal spray not only meets an unmet medical need but also stands out as a significant advancement in the field of nasal drug delivery systems. The use of the UDS system in this context is particularly noteworthy, as it demonstrates the potential of nasal drug delivery technology in emergency medical situations.

Moreover, the case study has implications beyond the immediate solution it provides. The development of the midazolam nasal spray has generated valuable intellectual property, potentially opening avenues for further innovation in drug delivery systems. The success of this project could pave the way for similar approaches in the administration of other medications, especially those required in urgent care scenarios.

In summary, the case study of developing a midazolam nasal spray through a collaborative effort with Aptar Pharma Services highlights a significant step forward in addressing the challenges associated with the treatment of seizure clusters in epilepsy. The use of nasal drug delivery systems, exemplified by the UDS drug delivery system, offers a promising new avenue for the administration of emergency medications. This approach not only enhances the accessibility of treatment for seizure clusters but also sets a precedent for future innovations in drug delivery technologies. The project underscores the potential of collaborative efforts in pharmaceutical research and development, especially in creating solutions that address unmet needs in healthcare.