Intranasal Administration

1994 ◽  
Vol 13 (1) ◽  
pp. 76-78 ◽  
Author(s):  
Shayne C. Gad
Keyword(s):  
Animal Models ◽  
Pharmaceutical Industry ◽  
Intranasal Administration ◽  
Safety Assessment ◽  
Therapeutic Agents ◽  
Intranasal Route ◽  
Safety Concerns ◽  
And Performance

The intranasal route has gained increased popularity in the pharmaceutical industry in recent years, particularly because of the number of new peptide therapeutic agents. This has led to a corresponding increase in both interest in and performance of toxicity (or as they are called in the pharmaceutical industry, safety assessment) studies by this route. This report reviews the considerations specific to the intranasal route: formulations, devices for administration, special safety concerns, and animal models employed.

scholarly journals Pathology Study Design, Conduct, and Reporting to Achieve Rigor and Reproducibility in Translational Research Using Animal Models

ILAR Journal ◽  
2018 ◽  
Vol 59 (1) ◽  
pp. 4-12 ◽  
Author(s):  
Jeffrey I Everitt ◽  
Piper M Treuting ◽  
Cheryl Scudamore ◽  
Rani Sellers ◽  
Patricia V Turner ◽  
...  
Keyword(s):  
Animal Models ◽  
Best Practices ◽  
Translational Research ◽  
Safety Assessment ◽  
Animal Studies ◽  
Animal Experiments ◽  
Study Data ◽  
Track Record ◽  
Preclinical Animal Models

AbstractIn translational research, animal models are an important tool to aid in decision-making when taking potential therapies into human clinical trials. Recently, there have been a number of papers that have suggested limited concordance of preclinical animal experiments with subsequent human clinical experience. Assessments of preclinical animal studies have led to concerns about the reproducibility of data and have highlighted the need for an emphasis on rigor and quality in the planning, conduct, analysis, and reporting of such studies. The incorporation of a wider role for the comparative pathologist using pathology best practices in the planning and conduct of animal model-based research is one way to increase the quality and reproducibility of data. The use of optimal design and planning of tissue collection, incorporation of pathology methods into written protocols, conduct of pathology procedures using accepted best practices, and the use of optimal pathology analysis and reporting methods enhance the quality of the data acquired from many types of preclinical animal models and studies. Many of these pathology practices are well established in the discipline of toxicologic pathology and have a proven and useful track record in enhancing the data from animal-based studies used in safety assessment of human therapeutics. Some of this experience can be adopted by the wider community of preclinical investigators to increase the reproducibility of animal study data.

Bi-functional sterically hindered phenol lipid-based delivery systems as potential multi-target agents against Alzheimer's disease via an intranasal route

Nanoscale ◽  
2020 ◽  
Vol 12 (25) ◽  
pp. 13757-13770
Author(s):  
Evgenia A. Burilova ◽  
Tatiana N. Pashirova ◽  
Irina V. Zueva ◽  
Elmira M. Gibadullina ◽  
Sofya V. Lushchekina ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Intranasal Administration ◽  
Delivery Systems ◽  
Sterically Hindered Phenols ◽  
Intranasal Route ◽  
Sterically Hindered Phenol ◽  
Hindered Phenols ◽  
Hindered Phenol ◽  
Sterically Hindered

New lipid-based nanomaterials based on sterically hindered phenols were developed as potential drugs against Alzheimer's disease via intranasal administration.

A GoldSim Modeling Approach to Safety Assessment of an LILW Repository System

2010 ◽  
Author(s):  
Youn Myoung Lee ◽  
Jongtae Jeong ◽  
Jongwon Choi
Keyword(s):  
Performance Evaluation ◽  
Safety Assessment ◽  
Preferential Flow ◽  
Far Field ◽  
Well Drilling ◽  
Sensitivity Studies ◽  
Nuclide Transport ◽  
And Performance ◽  
Parameter Values ◽  
Flow Pathway

A program for the safety assessment and performance evaluation of a low- and intermediate level waste (LILW) repository system has been developed by utilizing GoldSim [1]. By utilizing this nuclide transport in the near- and far-field of a repository as well as a transport through a biosphere under various natural and manmade disruptive events affecting a nuclide release are modeled and evaluated. To demonstrate its usability, some illustrative cases under the selected scenarios including the influence of degradation of manmade barriers, pumping well drilling, and the natural disruptive events such as a sudden formation of preferential flow pathway have been investigated and illustrated for a hypothetical LILW repository. Even though all the parameter values applied to a hypothetical repository are assumed without any real base, the illustrative cases could be informative especially when seeing the result of the probabilistic calculation or sensitivity studies with various scenarios that possibly happen for nuclide release and further transport.

The Intranasal Route as an Alternative Method of Medication Administration

2018 ◽  
Vol 38 (5) ◽  
pp. 26-31 ◽  
Author(s):  
Calvin Tucker ◽  
Lyn Tucker ◽  
Kyle Brown
Keyword(s):  
Intranasal Administration ◽  
Pediatric Patients ◽  
Medication Administration ◽  
Intravenous Route ◽  
Appropriate Use ◽  
Intranasal Route ◽  
Superior Efficacy ◽  
Invasive Method ◽  
Correct Technique ◽  
Intranasal Drug Administration

Intranasal drug administration is a less invasive method of drug delivery that is easily accessible for adult and pediatric patients. Medications administered by the intranasal route have efficacy comparable to intravenous administration and typically have superior efficacy to subcutaneous or intramuscular routes. The intranasal route is beneficial in emergent situations when the intravenous route is not available. The intranasal route is safe and effective in various indications, and therapeutic systemic concentrations of medication can be attained via this route. As the evidence for and comfort with intranasal administration continue to grow, guidance on correct technique, medications, and dosing is vital for appropriate use. This article reviews the process and practices of appropriate intranasal medication administration.

Motorcycle No Fall Over Kickstand

2019 ◽  
Author(s):  
Muhammad Salman
Keyword(s):  
Fuel Economy ◽  
Cost Effective ◽  
Customer Demand ◽  
Safety Devices ◽  
Safety Concerns ◽  
Mode Of Transportation ◽  
And Performance

Abstract Motorcycles have been a mode of transportation since 1894, when the first batch of motorcycles were manufactured for consumer use by Hildebrand & Wolfmüller. Motorcycles provide a fast and cost effective, specifically fuel economy, way to commute. They are also used in recreational settings such as motocross and performance racing activities. Over the years, there have been many different design generations for the various manufactures and custom shops. The customer demand for motorcycles is always increasing as well. However, the biggest drawback to someone owning and operating a motorcycle has always been safety concerns. One of these safety concerns is the motorcycle falling over and being damaged while being parked. Fall overs occur for a multitude number of reasons, the most common occurrences due to being parked on an uneven level or someone pushing the motorcycle over. Current safety devices to prevent this from occurring are crash bars and center stands. However, these devices are either not applicable to all motorcycle makes and models or do not appeal to the motorcycles look per the owner’s discretion. A “no fall over” automated mechanical kickstand would solve both of these problems and, at the same time, prevent fall over accidents.

scholarly journals Ocular Medical Devices: Histologic Technique and Histopathologic Evaluation of the Biocompatibility and Performance

2018 ◽  
Vol 47 (3) ◽  
pp. 418-425 ◽  
Author(s):  
Elodie Drevon-Gaillot
Keyword(s):  
Animal Models ◽  
Medical Devices ◽  
Evaluation Method ◽  
Short Review ◽  
Preclinical Studies ◽  
Combination Product ◽  
Different Types ◽  
Histopathologic Evaluation ◽  
And Performance ◽  
Histologic Technique

Ocular medical devices (MDs) represent a very wide and promising field of human ophthalmology. In preclinical studies evaluating the safety and/or performance of these ocular MDs, the choice of histologic technique and the focus of the histopathologic evaluation method should take into consideration the following aspects: the specific guidelines possibly associated with the MD or combination product, the ocular compartment in contact with the MD and its specificities, and last the nature of the biomaterial used in the MD. Following a brief overview of animal models, this short review will present the different types of ocular MDs and will present the specificities of the histologic technique and the histopathologic evaluation related to ocular MDs.

scholarly journals The Role of Animal Models in Evaluating Reasonable Safety and Efficacy for Human Trials of Cell-Based Interventions for Neurologic Conditions

2008 ◽  
Vol 29 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Alan Regenberg ◽  
Debra JH Mathews ◽  
David M Blass ◽  
Hilary Bok ◽  
Joseph T Coyle ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Animal Models ◽  
Regenerative Medicine ◽  
Therapeutic Agents ◽  
Preclinical Studies ◽  
Safety And Efficacy ◽  
Proper Role ◽  
New Treatments ◽  
Gathering Data

Progress in regenerative medicine seems likely to produce new treatments for neurologic conditions that use human cells as therapeutic agents; at least one trial for such an intervention is already under way. The development of cell-based interventions for neurologic conditions (CBI-NCs) will likely include preclinical studies using animals as models for humans with conditions of interest. This paper explores predictive validity challenges and the proper role for animal models in developing CBI-NCs. In spite of limitations, animal models are and will remain an essential tool for gathering data in advance of first-in-human clinical trials. The goal of this paper is to provide a realistic lens for viewing the role of animal models in the context of CBI-NCs and to provide recommendations for moving forward through this challenging terrain.

Treatment of Migraine Attacks with Intranasal Alniditan: An Open Study

Cephalalgia ◽  
2001 ◽  
Vol 21 (2) ◽  
pp. 140-144 ◽  
Author(s):  
HC Diener ◽  
P Louis ◽  
R Schellens ◽  
F De Beukelaar ◽  
Keyword(s):  
Open Study ◽  
Migraine Headache ◽  
Intranasal Administration ◽  
Receptor Agonist ◽  
Intranasal Route ◽  
Taste Disturbance ◽  
Migraine Headaches ◽  
Nasal Irritation ◽  
Severe Intensity ◽  
Time To Onset

In this open phase-II clinical tolerability trial 17 neurologists enrolled a total of 112 patients and instructed them to administer a maximum of two doses of intranasal alniditan, a 5-HT1B/D receptor agonist, for the treatment of three consecutive migraine attacks of moderate to severe intensity. A second dose of the trial medication was allowed within 1–24 h after the first administration. At 1 h after intranasal administration, 70/103 (68%) patients had responded to treatment (reduction from severe or moderate headache before treatment to mild or no headache) after their first migraine attack, 65/94 (69%) after their second and 52/75 (71%) after their third. In 187/270 (69%) of all attacks, patients were considered responders at 1 h. The median time to onset of effect was 30 min. The migraine headache recurred in 44% (attack 1), 55% (attack 2) and 44% (attack 3) after 4–5 h. Sixty-eight per cent of the patients reported nasal irritation, 19% taste disturbance and 44% throat irritation. Alniditan 2 mg, administered via the intranasal route, was effective in relieving migraine headaches in over two-thirds of the patients at 1 h.

scholarly journals Bioavailability of butorphanol after intranasal administration to horses

2020 ◽  
Vol 23 (4) ◽  
pp. 443-447
Author(s):  
V. Ferreira ◽  
M. Velloso ◽  
M. Landoni
Keyword(s):  
Intranasal Administration ◽  
Peak Plasma ◽  
Peak Plasma Concentration ◽  
Plasma Concentrations ◽  
Volume Of Distribution ◽  
Intravenous Route ◽  
Liquid Chromatography Mass Spectrometry ◽  
Intranasal Route ◽  
Predetermined Time ◽  
Mass Spectrometry Assay

The aim of the present study was to describe butorphanol pharmacokinetics and bioavailability following intranasal administration to horses. Six adult horses received 0.05 mg/kg butorphanol, in a randomised crossover design, by either intravenous or intranasal route. Plasma concentrations of butorphanol were measured at predetermined time points using liquid chromatography/mass spectrometry assay. After intravenous injection, mean ±SD butorphanol steady-state volume of distribution and clearance was 3.20 ± 1.77 l/kg and 3.18 ± 1.47 L/kg/h, respectively. Terminal half-lives for butorphanol after intravenous and intranasal administrations were 0.68 ± 0.17 h and 1.79 ± 1.43 h. For intranasal administration, absorption half-life and peak plasma concentration were 0.43 ± 0.33 h and 1.95 ± 1.7 ng/mL, respectively. Bioavailability was 54.45 ± 20.09%. Intranasal butorphanol administration in horses is practical, not stressful and well tolerated. Therefore, it might be a substitute to the intravenous route in adult horses

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