Development of a nasal cast model to test medicinal nasal devices

Hughes, Robert N.; Watterson, John; Dickens, Colin; Ward, D. T.; Banaszek, Ashley

doi:10.1243/09544119jeim423

Cited by 23 publications

(13 citation statements)

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“…To date, a signifi cant correlation between in vitro analytical tests such as spray pattern and in vivo outcomes has not been established. Because of the importance of deposition, many researchers (Shah et al 2011 ;Shah et al 2013 ;Suman et al 2006 ;Newman et al 2004 ;Laube 2007 ;Aggarwal et al 2004 ;Schroeter, et al 2006 ;Djupesland et al 2006 ;Djupesland and Skretting 2012 ;Cheng et al 2001 ;Foo et al 2007 ;Guo et al 2005 ;Hughes et al 2008 ;Kundoor and Dalby 2010 ) have turned to nasal casts and computational fl uid dynamic (CFD) models to assess the deposition patterns of new nasal devices and/or formulations. Often used in early development, nasal cast studies have become easier to perform with increasing ease in the creation of nasal casts from MRI and CT scans (Fig.…”

Section: Analytical Techniques and Drug Productmentioning

confidence: 99%

Considerations for the Development of Nasal Dosage Forms

Ehrick¹,

Shah²,

Shaw³

et al. 2013

AAPS Advances in the Pharmaceutical Sciences Series

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The anatomy and physiology of the nasal cavity provide unique advantages for accessing targets for local, systemic, and potentially central nervous system drug delivery. This chapter discusses these advantages and the challenges that must be overcome to reach these targets. The chapter then comprehensively reviews nasal dosage forms, analytical testing, and regulatory requirements in the context of existing nasal spray products. Since nasal sprays are moving towards being preservativefree, the chapter covers specialized methods of achieving a sterile product, namely, formulation strategies, manufacturing strategies, and the device landscape that support this upcoming platform. Finally, the chapter reviews various pathways for regulatory approval around the world, for brand and generic, with particular emphasis on the growing acceptance of in vitro data for locally acting nasal spray products.

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Section: Analytical Techniques and Drug Productmentioning

confidence: 99%

Considerations for the Development of Nasal Dosage Forms

Ehrick¹,

Shah²,

Shaw³

et al. 2013

AAPS Advances in the Pharmaceutical Sciences Series

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“…Further, our cast was an earlier generation of the one pictured in Hughes et al 6 and we know that deposition was different. Djupesland and Dr. Mahmoud express concern about the anterior-posterior line.…”

Section: Letter To the Editor: Incorrect Conclusion Regarding Deposimentioning

confidence: 80%

Letter to the Editor: Incorrect conclusions regarding deposition of conventional mometasone furoate (MF) nasal spray

2015

allergy asthma proc

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T he article "Regional deposition of mometasone furoate nasal spray suspension in humans" 1 uses validation in nasal casts, regional deposition of radiolabeled drug in healthy subjects, and a literature review to conclude: "MF [mometasone furoate] aqueous suspension deposited more of its metered dose in humans to the turbinates and middle meatus of the nasal cavity than demonstrated in the literature by other nasal sprays." This prominent conclusion is unsupported and incorrect due to crucial unreported limitations. In this study, the subjects were reportedly trained in the administration "technique described in the package insert"; however, actual administration was by a technician, likely biasing deposition patterns and decreasing variability. 2 Also, as expected with conventional nasal sprays, deposition was concentrated near the nasal valve and head of the inferior turbinate (in casts and in vivo). 2,3 Unfortunately, the implications of this highly concentrated deposition (e.g., Fig. 5) for an accurate estimation of regional deposition are not recognized. When a vertical line that separates the anterior-posterior regions is defined exactly in the area of highest concentration, even minor differences in the line position cause major shifts in relative distribution between as-defined "anterior" and "posterior" segments. 4 We appreciate the authors' use of the method we developed by using a vertical plane at the head of the inferior turbinate visualized by superimposing vertical magnetic resonance imaging sections to delineate anterior-posterior nasal segments. 4 However, this line is more anterior than in many previous studies and most likely more anterior than the corresponding line in the cast (see Figs. 1, 5, and 11, Hughes 2008). 3-5 This renders suspect the comparison of regional deposition in the cast versus humans.With the sensitivity of this "anterior-posterior" result to the dividing line, the unreserved comparative conclusion, "60% of the mometasone furoate spray deposited into the posterior nasal cavity," whereas "most other nasal spray deposition studies showed less than 25% in the posterior nasal cavity, with more than 50% in the anterior regions," would appear at best only weakly supported. 1 Weakness becomes inaccuracy in light of the fact that, in the only human ␥-deposition study that applied the same vertical dividing line (omitted from the article 5 ), the conventional spray pump produced nearly identical anterior (25.4% versus 26.0%) versus posterior (60.1% versus 60.4%) deposition as reported for MF in this study. Lastly, all "posterior" are not the same. Results of previous studies indicate conventional nasal sprays poorly access target regions for deep nasal inflammation, in part, due to inferior (low) deposition of their "posterior" delivery (i.e., the floor of the nasal cavity, not the middle meatus). 2 This could have been, and has been, studied by using both vertical and horizontal segmentation. 2,5 As the authors suggest, upper-posterior regions of the nasal cavity (e.g., the middle ...

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“…A considerable amount of nasally administered dose is deposited on the anterior portion reinforced by skin, which is recognized as a poor site for topical as well as for systemic drugs (Duchateau, 1987;Kimbell et al, 2007;Hughes et al, 2008;Kundoor & Dalby, 2010). The deposition of topical steroids at these sites leads to common adverse effects in the form of irritation, bleeding and crusting.…”

Section: Challenges Related To Delivery Devicesmentioning

confidence: 99%

Nasal-nanotechnology: revolution for efficient therapeutics delivery

2014

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Context: In recent years, nanotechnology-based delivery systems have gained interest to overcome the problems of restricted absorption of therapeutic agents from the nasal cavity, depending upon the physicochemical properties of the drug and physiological properties of the human nose. Objective: The well-tolerated and non-invasive nasal drug delivery when combined with the nanotechnology-based novel formulations and carriers, opens the way for the effective systemic and brain targeting delivery of various therapeutic agents. To accomplish competent drug delivery, it is imperative to recognize the interactions among the nanomaterials and the nasal biological environment, targeting cell-surface receptors, drug release, multiple drug administration, stability of therapeutic agents and molecular mechanisms of cell signaling involved in patho-biology of the disease under consideration. Methods: Quite a few systems have been successfully formulated using nanomaterials for intranasal (IN) delivery. Carbon nanotubes (CNTs), chitosan, polylactic-co-glycolic acid (PLGA) and PLGA-based nanosystems have also been studied in vitro and in vivo for the delivery of several therapeutic agents which shown promising concentrations in the brain after nasal administration. Results and conclusion: The use of nanomaterials including peptide-based nanotubes and nanogels (NGs) for vaccine delivery via nasal route is a new approach to control the disease progression. In this review, the recent developments in nanotechnology utilized for nasal drug delivery have been discussed.

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Development of a nasal cast model to test medicinal nasal devices

Cited by 23 publications

References 0 publications

Considerations for the Development of Nasal Dosage Forms

Considerations for the Development of Nasal Dosage Forms

Letter to the Editor: Incorrect conclusions regarding deposition of conventional mometasone furoate (MF) nasal spray

Nasal-nanotechnology: revolution for efficient therapeutics delivery

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