Advances and Challenges in Nasal Formulation Developments, 3rd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: 31 December 2025 | Viewed by 1691

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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 to target 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 their retention time in the nasal cavity, dose restrictions, the difference between animal species, and individual variations in nasal drug absorption. This Special Issue will address the advances being made in various forms of nasal formulations, including in vivo and in vitro evaluations of the permeation and disposition of drugs, drug dissolution from formulations, and the development of novel dosage forms and excipients for nasal applications. Additionally, it will include studies on drug targeting from the nose to brain/lymphatic tissue, nasal vaccination, and mucosal absorption. Original research papers and review articles are welcome.

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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21 pages, 2142 KB  
Review
Advances in Nasal Biopharmaceutics to Support Product Development and Therapeutic Needs
by Ben Forbes, Lucy Goodacre, Alison B. Lansley, Andrew R. Martin, Helen Palmer, Claire Patterson, Chris Roe and Regina Scherließ
Pharmaceutics 2025, 17(10), 1321; https://doi.org/10.3390/pharmaceutics17101321 - 11 Oct 2025
Viewed by 1451
Abstract
Background/Objectives: Nasal biopharmaceutics is the scientific understanding of product and patient factors that determine the rate and extent of drug exposure following nasal administration. The authors considered whether current biopharmaceutics tools are fit for the current and future needs of nasal product development [...] Read more.
Background/Objectives: Nasal biopharmaceutics is the scientific understanding of product and patient factors that determine the rate and extent of drug exposure following nasal administration. The authors considered whether current biopharmaceutics tools are fit for the current and future needs of nasal product development and regulation. Methods: The limitations of current methods were critically assessed, unmet needs were highlighted, and key questions were posed to guide future directions in biopharmaceutics research. Results: The emergence of physiologically based biopharmaceutics models for nasal delivery has the potential to drive the scientific understanding of nasal delivery. Simulations can guide formulation and device development, inform dose selection and generate mechanistic insights. Developments in modeling need to be complemented by advances in experimental systems, including the use of realistic or idealized nasal casts to estimate the regional deposition of nasal sprays and refined in vitro cell culture models to study nasal drug absorption and the influence of mucus. Similarly, improvements are needed to address the practicalities of using animals in non-clinical studies of nasal drug delivery, and greater clinical use of gamma scintigraphy/magnetic resonance imaging is recommended to measure the delivery and nasal retention of different formulations in humans. Conclusions: Nasal drug delivery is a rapidly growing field and requires advances in nasal biopharmaceutics to support product innovation. Key needs are (i) validated clinically relevant critical product attributes for product performance and (ii) established links between how patients administer the product and where in the nose it deposits and dissolves in order to act or be absorbed, leading to its desired clinical effect. Full article
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