Effect Of Nonionic Surfactants And HPMC F4M On The Development Of Formulations Of Neuro-EPO As A Neuroprotective Agent

Muñoz-Cernada, A.; Pardo-Ruíz, Zenia; Montero-Alejo, Vivian; Fernández-Cervera, Mirna; Sosa-Testé, I.; Amaro, Daniel; García-Rodríguez, Julio César

doi:10.14302/issn.2328-0182.japst-13-206

Cited by 3 publications

(2 citation statements)

References 28 publications

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“…The nasal formulation of NeuroEPO (PATENTS PCT / cu2006 / 000001 and 20050138 to CIDEM, Havana, Cuba) (11) was prepared by the Research Center for Drug Development (CIDEM) and supplied by the Center for Molecular Immunology (CIM) through the marketer of biopharmaceutical products of this center (Havana, Cuba).…”

Section: Neuroepo Formulationmentioning

confidence: 99%

“…This was diluted in saline buffer phosphate (pH 7.0) at 0.15 mM. The nasal formulation also contains other excipients for the stability of the formulation: benzalkonium chloride as a preservative to avoid microbiological contamination to regulate osmotic pressure (11) . The vehicle was supplied by the Research Center for Drug Development (CIDEM) and contained all substances (excipients) except NeuroEPO.…”

Section: Neuroepo Formulationmentioning

confidence: 99%

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Intranasal administration of NeuroEPO does not affect the structure of respiratory mucosa in Wistar rats.

Suárez

Fernández

Cruz³

et al. 2022

Preprint

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Introduction: Diseases associated with the Central Nervous System (CNS) represent a group of conditions with important social and economic repercussions. New treatment strategies with NeuroEPO offer new opportunities to prevent the onset and progression of these disorders. NeuroEPO administered intranasally can reach the CNS through various mechanisms involving the olfactory and trigeminal nerves, respiratory and olfactory mucosa, nasal vasculature, cerebrospinal fluid, and the lymphatic system. Objective To determine the effect of intranasal administration of NeuroEPO on the histologic structure of the respiratory mucosa and its associated lymphatic tissue in Wistar rats. Material and methods an experimental, descriptive, longitudinal, prospective study was conducted, using the Wistar rat as a biological model. Ten healthy animals were randomly distributed in two groups of five animals each. One of the groups received intranasal NeuroEPO for 28 days at doses of 300 µg/kg. The other group was given a vehicle at a rate of 0.3µl/g. The histological characteristics of the respiratory mucosa were studied. The Mann-Whitney test was used to compare the means Results No alterations in the histological characteristics of the respiratory mucosa and the lymphatic tissue associated with the nasal mucosa were observed in Wistar rats after the administration of NeuroEPO. Conclusion Intranasal administration of NeuroEPO does not cause pathological changes in the histological structure of the respiratory mucosa or the lymphatic tissue associated with the nasal mucosa of Wistar rats in our experimental conditions.

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Section: Neuroepo Formulationmentioning

confidence: 99%

Section: Neuroepo Formulationmentioning

confidence: 99%

Intranasal administration of NeuroEPO does not affect the structure of respiratory mucosa in Wistar rats.

Suárez

Fernández

Cruz³

et al. 2022

Preprint

View full text Add to dashboard Cite

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Intranasal Treatment in Subarachnoid Hemorrhage

Caner

2019

Therapeutic Intranasal Delivery for Stroke and Neurological Disorders

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Nasal administration of the neuroprotective candidate NeuroEPO to healthy volunteers: a randomized, parallel, open-label safety study

et al. 2017

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BackgroundDelivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models. In the current study, the safety of NeuroEPO was evaluated for the first time in humans.MethodsA phase I, randomized, parallel, open-label study was carried out in healthy volunteers. They received, intranasally, 1 mg of NeuroEPO every 8 h during 4 days (Group A) or 0.5 mg of NeuroEPO (Group B) with the same schedule. The working hypothesis was that intranasal NeuroEPO produce <10% of severe adverse reactions in the evaluated groups. Therefore, a rigorous assessment of possible adverse events was carried out, which included tolerance of the nasal mucosa and the effect on hematopoietic activity. Clinical safety evaluation was daily during treatment and laboratory tests were done before and on days 5 and 14 after starting treatment.ResultsTwenty-five volunteers, 56% women, with a mean age of 27 yrs. were included. Twelve of them received the highest NeuroEPO dose. Twenty types of adverse events occurred, with headache (20%) and increase of hepatic enzymes (20%) as the most reported ones. Nasopharyngeal itching was the most common local event but only observed in four patients (16%), all of them from the lowest dose group. About half of the events were very probably or probably caused by the studied product. Most of the events were mild (95.5%), did not require treatment (88.6%) and were completely resolved (81.8%). No severe adverse events were reported. During the study the hematopoietic variables were kept within reference values.ConclusionsNeuroEPO was a safe product, well tolerated at the nasal mucosa level and did not stimulate erythropoiesis in healthy volunteers.Trial registrationCuban Public Registry of Clinical Trials RPCEC00000157, June 10, 2013.

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Effect Of Nonionic Surfactants And HPMC F4M On The Development Of Formulations Of Neuro-EPO As A Neuroprotective Agent

Cited by 3 publications

References 28 publications

Intranasal administration of NeuroEPO does not affect the structure of respiratory mucosa in Wistar rats.

Intranasal administration of NeuroEPO does not affect the structure of respiratory mucosa in Wistar rats.

Intranasal Treatment in Subarachnoid Hemorrhage

Nasal administration of the neuroprotective candidate NeuroEPO to healthy volunteers: a randomized, parallel, open-label safety study

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