Advances and Challenges in Nasal Formulation Developments, 2nd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: 30 October 2024 | Viewed by 5940

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Guest Editor
Department of Medical Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan
Interests: nasal formulation; nasal drug delivery; mucosal absorption; CNS drug delivery; brain drug targeting; neuroinflammation; neuropathic pain; neurodegenerative diseases; sleep cycle; chronopharmacology; circadian rhythm
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Special Issue Information

Dear Colleagues,

Intranasal administration has the potential as a targeting system for various tissues (e.g., brain targeting, lymphatic delivery, mucosal vaccination and transmucosal absorption). The development of nasal formulations is difficult due to factors such as the retention time in the nasal cavity, dose restriction, animal species difference and individual variation in nasal drug absorption. This Special Issue will address the advances in various forms of nasal formulations, including in vivo and in vitro evaluations of drug permeation and disposition, drug dissolution from formulations, the development of novel dosage forms and excipients for nasal applications. Additionally, it will include studies on drug targeting from nose to brain/lymphatic tissue, nasal vaccination and mucosal absorption. Original research papers and review articles are welcomed.

Dr. Daisuke Inoue
Guest Editor

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Keywords

  • nasal formulations
  • intranasal dissolution and permeation
  • mucosal absorption
  • excipients for nasal formulations
  • in vitro dissolution system
  • in vivo nasal dissolution and absorption

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Published Papers (4 papers)

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Research

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23 pages, 7853 KiB  
Article
Gold Nanoparticles: Tunable Characteristics and Potential for Nasal Drug Delivery
by Aida Maaz, Ian S. Blagbrough and Paul A. De Bank
Pharmaceutics 2024, 16(5), 669; https://doi.org/10.3390/pharmaceutics16050669 - 16 May 2024
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Abstract
A general procedure to prepare gold nanourchins (GNUs) via a seed-mediated method was followed using dopamine hydrochloride as a reducing agent and silver nitrate salt (AgNO3) as a shape-directing agent. The novelty of this study comes from the successful incorporation of [...] Read more.
A general procedure to prepare gold nanourchins (GNUs) via a seed-mediated method was followed using dopamine hydrochloride as a reducing agent and silver nitrate salt (AgNO3) as a shape-directing agent. The novelty of this study comes from the successful incorporation of the prepared gold urchins as an aqueous suspension in a nasal pressurized metered dose inhaler (pMDI) formulation and the investigation of their potential for olfactory targeting for direct nose-to-brain drug delivery (NTBDD). The developed pMDI formulation was composed of 0.025% w/w GNUs, 2% w/w Milli-Q water, and 2% w/w EtOH, with the balance of the formulation being HFA134a propellant. Particle integrity and aerosolization performance were examined using an aerosol exposure system, whereas the nasal deposition profile was tested in a sectioned anatomical replica of human nasal airways. The compatibility of the gold dispersion with the nasal epithelial cell line RPMI 2650 was also investigated in this study. Colloidal gold was found to be stable following six-month storage at 4 °C and during the lyophilization process utilizing a pectin matrix for complete re-dispersibility in water. The GNUs were intact and discrete following atomization via a pMDI, and 13% of the delivered particles were detected beyond the nasal valve, the narrowest region in the nasal cavity, out of which 5.6% was recovered from the olfactory region. Moreover, the formulation was found to be compatible with the human nasal epithelium cell line RPMI 2650 and excellent cell viability was observed. The formulated GNU-HFA-based pMDI is a promising approach for intranasal drug delivery, including deposition in the olfactory region, which could be employed for NTBDD applications. Full article
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Review

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16 pages, 2240 KiB  
Review
Maltodextrin-Nanoparticles as a Delivery System for Nasal Vaccines: A Review Article
by François Fasquelle, Angelo Scuotto, Michael Howsam and Didier Betbeder
Pharmaceutics 2024, 16(2), 247; https://doi.org/10.3390/pharmaceutics16020247 - 7 Feb 2024
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Abstract
Nanoparticles are increasingly being studied as antigen delivery systems for immunization with nasal vaccines. The addition of adjuvants is still generally required in many nanoparticle formulations, which can induce potential side effects owing to mucosal reactogenicity. In contrast, maltodextrin nanoparticles do not require [...] Read more.
Nanoparticles are increasingly being studied as antigen delivery systems for immunization with nasal vaccines. The addition of adjuvants is still generally required in many nanoparticle formulations, which can induce potential side effects owing to mucosal reactogenicity. In contrast, maltodextrin nanoparticles do not require additional immunomodulators, and have been shown to be efficient vaccine delivery systems. In this review, the development of maltodextrin nanoparticles is presented, specifically their physico-chemical properties, their ability to load antigens and deliver them into airway mucosal cells, and the extent to which they trigger protective immune responses against bacterial, viral, and parasitic infections. We demonstrate that the addition of lipids to maltodextrin nanoparticles increases their potency as a vaccine delivery system for nasal administration. Full article
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43 pages, 2077 KiB  
Review
Intranasal Drug Delivery by Nanotechnology: Advances in and Challenges for Alzheimer’s Disease Management
by Sayali Dighe, Sunil Jog, Munira Momin, Sujata Sawarkar and Abdelwahab Omri
Pharmaceutics 2024, 16(1), 58; https://doi.org/10.3390/pharmaceutics16010058 - 29 Dec 2023
Cited by 2 | Viewed by 2372
Abstract
Alzheimer’s disease, a progressive neurodegenerative condition, is characterized by a gradual decline in cognitive functions. Current treatment approaches primarily involve the administration of medications through oral, parenteral, and transdermal routes, aiming to improve cognitive function and alleviate symptoms. However, these treatments face limitations, [...] Read more.
Alzheimer’s disease, a progressive neurodegenerative condition, is characterized by a gradual decline in cognitive functions. Current treatment approaches primarily involve the administration of medications through oral, parenteral, and transdermal routes, aiming to improve cognitive function and alleviate symptoms. However, these treatments face limitations, such as low bioavailability and inadequate permeation. Alternative invasive methods, while explored, often entail discomfort and require specialized assistance. Therefore, the development of a non-invasive and efficient delivery system is crucial. Intranasal delivery has emerged as a potential solution, although it is constrained by the unique conditions of the nasal cavity. An innovative approach involves the use of nano-carriers based on nanotechnology for intranasal delivery. This strategy has the potential to overcome current limitations by providing enhanced bioavailability, improved permeation, effective traversal of the blood–brain barrier, extended retention within the body, and precise targeting of the brain. The comprehensive review focuses on the advancements in designing various types of nano-carriers, including polymeric nanoparticles, metal nanoparticles, lipid nanoparticles, liposomes, nanoemulsions, Quantum dots, and dendrimers. These nano-carriers are specifically tailored for the intranasal delivery of therapeutic agents aimed at combatting Alzheimer’s disease. In summary, the development and utilization of intranasal delivery systems based on nanotechnology show significant potential in surmounting the constraints of current Alzheimer’s disease treatment strategies. Nevertheless, it is essential to acknowledge regulatory as well as toxicity concerns associated with this route; meticulous consideration is required when engineering a carrier. This comprehensive review underscores the potential to revolutionize Alzheimer’s disease management and highlights the importance of addressing regulatory considerations for safe and effective implementations. Embracing this strategy could lead to substantial advancements in the field of Alzheimer’s disease treatment. Full article
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Other

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17 pages, 795 KiB  
Systematic Review
The Efficacy and Safety of Intranasal Formulations of Ketamine and Esketamine for the Treatment of Major Depressive Disorder: A Systematic Review
by Ludivine Boudieu, Myriam Mennetrier, Pierre-Michel Llorca and Ludovic Samalin
Pharmaceutics 2023, 15(12), 2773; https://doi.org/10.3390/pharmaceutics15122773 - 13 Dec 2023
Cited by 1 | Viewed by 1423
Abstract
Ketamine and its enantiomers represent an innovative glutamatergic agent as a treatment for individuals with treatment-resistant depression (TRD) and major depressive disorder (MDD) with suicidal ideation and behavior. Intranasal (IN) formulations could allow for quick onset of action on depressive symptoms as well [...] Read more.
Ketamine and its enantiomers represent an innovative glutamatergic agent as a treatment for individuals with treatment-resistant depression (TRD) and major depressive disorder (MDD) with suicidal ideation and behavior. Intranasal (IN) formulations could allow for quick onset of action on depressive symptoms as well as a reduction in side effects by bypassing the blood–brain barrier compared with administration via the intravenous route. The aim of this review was to provide an up-to-date analysis of the data on the efficacy and safety of IN ketamine and IN esketamine for the treatment of MDD. A systematic review following PRISMA guidelines was conducted. Databases (PubMed, Embase, MEDLINE, PsycINFO, and Google Scholar) were searched to capture articles about IN ketamine or IN esketamine for MDD. This systematic review highlighted the interest in IN routes of ketamine and esketamine for MDD patients with TRD or active suicidal ideation. They provide a rapid onset of antidepressant action within the first hours after administration. Nevertheless, the evidence of efficacy is stronger for IN esketamine than for IN ketamine in MDD patients. The safety profile appears to be acceptable for IN esketamine but requires further studies, and a more accurate IN delivery device is required for ketamine. Full article
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