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Fundamentals in nasal drug delivery
Published in Anthony J. Hickey, Heidi M. Mansour, Inhalation Aerosols, 2019
Zachary Warnken, Yu Jin Kim, Heidi M. Mansour, Robert O. Williams, Hugh D.C. Smyth
The development of various types of nasal drug delivery devices raises interest in intranasal delivery of proteins and peptides. These substances are commonly prepared in the form of solutions, suspensions, emulsions, or dry powders. Aqueous solutions with preservatives are the most frequently used for systemic delivery of peptide-based therapeutics. Dry powder nasal formulations and devices have several advantages over liquid formulations: (1) Dry powder provides chemical stability since drugs are delivered in a powder form without being solubilized in a liquid phase, and (2) nasal irritation may be reduced because preservatives may not be required for dry powder formulations (132). Liquid-based delivery systems include nasal drops, aerosols, gels, squeezed bottle, instillation and rhinyle catheter, vapor inhaler, metered-dose spray pumps, syringe spray, pressurized metered-dose inhaler, and nebulizers. Powder-based delivery systems include dry powder inhalers, insufflators, pressurized metered-dose inhalers, and dry powder sprays (132,133). Optinose, Inc. provides two FDA-approved exhalation delivery systems: ONZETRA® Xsail® (licensed to Avanir Pharmaceuticals, Inc. affiliated with Otsuka Pharmaceutical Co., Ltd.) and XHANCE™ metered nasal spray (www.optinose.com). ONZETRA Xsail is the first nasal dry powder product approved by the FDA in 2016 for the treatment of migraine headache, and it contains sumatriptan succinate. It is supplied as a disposable (single-use) nosepiece with a hypromellose capsule filled with sumatriptan succinate in a dry powder form and a reusable delivery device body. XHANCE was approved by the FDA in late 2017 for the treatment of nasal polyps; it contains fluticasone propionate in a solution form. OPN-300, which combines their exhalation delivery system with oxytocin, is currently in phase 1 clinical trials (www.optinose.com). Another example of a nasal device is the nasal delivery of insulin via the ViaNase™ Electronic Atomizer (Kurve Technology, Inc.), which is also in clinical trials (www.kurvetech.com/devices.asp).
Safety review of current systemic treatments for severe chronic rhinosinusitis with nasal polyps and future directions
Published in Expert Opinion on Drug Safety, 2021
The exhalation delivery system has been shown to improve drug delivery to the posterior and superior sinonasal spaces while reducing deposition in the non-ciliated nasal vestibule [31]. During exhalation, the soft palate elevates due to positive pressure in the oropharynx, which in turn isolates the nasal cavity from the rest of the respiratory system [32]. In theory, this should allow good nasal and sinus distribution while limiting systemic absorption. A 3-month double-blinded RCT reported fluticasone to be well tolerated when delivered through an exhalation device [8]. A 12-month single-arm study evaluating the safety and efficacy of the exhalation system with fluticasone found a number of local adverse events, including epistaxis (11.2%), nasal erythema (17.5%) and acute sinusitis (13.9%) [33]. Ocular examination, including the intraocular pressure, was all normal with no evidence of glaucoma or subcapsular cataracts [33]. A similar 12-month single-arm study suggested a similar safety profile with nasal mucosal disorders (10.2%) and epistaxis (6.8%) noted as the only adverse events [34].
Nanotechnologies for intranasal drug delivery: an update of literature
Published in Pharmaceutical Development and Technology, 2021
Rosamaria Lombardo, Teresa Musumeci, Claudia Carbone, Rosario Pignatello
Dr. Djupesland planned an Exhalation Delivery System (EDS) called Xhance. It is a device containing fluticasone propionate designed to improve the intranasal drug treatment (www.xhance.com). Through Optinose technology, Xhance delivers a liquid drug formulation for the nasal congestion and nasal polyps treatment. This device has two spouts: one to be introduced in the mouth and the other into the nasal cavity. When the patient breathes out the air in the spout the drug is expelled via in the highest part of the nasal cavity, due to the pressure exerted by the expired air, and this movement creates a hermetic hold of the soft palate which isolates the nose from the mouth and lungs. So in this way the delivery of the drug is unidirectional to the brain without despair in other parts (Djupesland 2018). The direct action of the drug to the brain by this EDS has been tested with oxytocin (Quintana et al. 2015, 2016).
A review of clinical safety data for sumatriptan nasal powder administered by a breath powered exhalation delivery system in the acute treatment of migraine
Published in Expert Opinion on Drug Safety, 2018
AVP-825 (sumatriptan nasal powder delivered via a novel Breath Powered® exhalation delivery system [ONZETRA® Xsail®; Avanir Pharmaceuticals, Inc.]) was developed to improve intranasal delivery of sumatriptan and is now available in the United States for the acute treatment of migraine in adults with or without aura [16,17]. AVP-825, unlike conventional liquid nasal sprays, utilizes a powdered form of sumatriptan and a unique breath powered intranasal delivery system. This targets deposition of drug in the posterior nasal cavity, an area lined by a richly vascular mucosal surface that is favorable to rapid drug absorption [16].