Nasal residence time and rheological properties of a new bentonite-based thixotropic gel emulsion nasal spray - AM-301.
Drug Dev Ind Pharm
; 49(1): 103-114, 2023 Jan.
Article
en En
| MEDLINE
| ID: mdl-36852769
ABSTRACT
OBJECTIVE:
The present work provides characterization of rheological properties of a new bentonite-based thixotropic gel emulsion nasal spray (AM-301), its nasal residence time, distribution, safety and tolerability.SIGNIFICANCE:
The nasal epithelium is a portal of entry for allergens and primary infection by airborne pathogens. Non-pharmacological interventions, which enhance physical and biological barriers, protect against allergens and pathogens without drug-related side effects. AM-301 has shown promising efficacy and safety in the nasal epithelium against viruses (in vitro) and pollen (clinical).METHODS:
Technical part (i) spray characterization was performed with a validated droplet size distribution method; evaluation of the rheological properties of the formulation was performed by a validated amplitude sweep method and a validated oscillation, rotation, oscillation; Clinical part (ii) nasal and oropharyngeal endoscopy were used to provide a semi-quantitative evaluation of distribution and residence time of fluorescein-labelled AM-301 in the nose and oropharynx of healthy volunteers; (iii) tolerability and safety.RESULTS:
(i) The non-Newtonian rheological properties of the formulation allow AM-301 to be sprayed and then to revert to a gel to prevent run-off from the nasal cavity; (ii) the formulation remains on the inferior turbinate, septum and oropharynx of volunteers for up to 210 min and on the middle turbinate for up to 60 min; two nasal sprays provide no substantial benefit over a single application with regards to coverage or retention; (iii) the spray is well tolerated.CONCLUSIONS:
Single dose spray delivery of AM-301 provides extended coverage of the nasal mucosa up to the inferior turbinates.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Bentonita
/
Rociadores Nasales
Límite:
Humans
Idioma:
En
Revista:
Drug Dev Ind Pharm
Año:
2023
Tipo del documento:
Article
País de afiliación:
Alemania