Design and In Vitro Evaluation of Intranasal Diazepam for Treating Acute Repetitive Seizures: a Technical Note
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RESEARCH ARTICLE
Design and In Vitro Evaluation of Intranasal Diazepam for Treating Acute Repetitive Seizures: a Technical Note Sai HS. Boddu 1
&
Sneha Kumari 2
Accepted: 9 November 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract This study aimed to develop and characterize a novel microemulsion-based intranasal diazepam for treating acute repetitive seizures (ARS). The solubility of diazepam was obtained in different solvents. An oil in water microemulsion was prepared with castor oil as oil phase, polyethylene glycol monostearate as surfactant, ethanol as cosurfactant, and water. The formulation was further evaluated for droplet size, zeta potential, pH, in vitro drug release, morphology using transmission electron microscopy (TEM), thermal property using differential scanning calorimetry (DSC), and stability and toxicity in the bovine nasal mucosa. The developed o/w microemulsion system exhibited a droplet size of 51.23 nm with a neutral zeta potential. The pH of microemulsion was close to the pH of nasal secretions. The TEM image revealed the spherical droplet shape, and the DSC thermogram showed conversion of diazepam from a crystalline form to an amorphous/molecular dispersion form. Histological evaluation of the microemulsion showed an intact bovine nasal mucosa without any signs of toxicity and was found to be stable at 25 °C for up to 3 months. To conclude, the reported microemulsion could be further explored as an alternative for treating ARS. Keywords Diazepam . Acute repetitive seizures . Microemulsion . Antiepileptic drug
Introduction An epileptic seizure is considered as a persistent neural condition noticed by the incidence of abrupt and random interruptions of the brain neurons. Acute repetitive seizures (ARS) are described as random episodes of multiple seizures (> 3 episodes) in a day with each episode lasting from a few minutes to hours. The medical community also refers to ARS with other terminology such as recurrent, serial, cluster, and crescendo seizures [1, 2]. ARS can occur due to a variety of reasons such as acute neural conditions (e.g., meningitis, encephalitis, or stroke), low antiepileptic drug levels, febrile seizures, or intractable epilepsy, or they can be the first manifestation of epilepsy [3, 4]. As per the report released by the Centers for Disease Control and Prevention (CDC), epilepsy
* Sai HS. Boddu [email protected] 1
Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates
2
Department of Pharmacy Practice, The University of Toledo, Health Science Campus, 3000 Arlington Ave., Toledo, OH 43614, USA
has affected close to 3,000,000 adults and 470,000 children in the USA. Though only a small percentage of population suffer from ARS, those affected are at risk of several medical complications such as injury, evolution into status epilepticus, and reduced quality of life. Given the substantial risks with ARS, it is necessary to develop appropriate protocols for ide
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