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Design, characterization, and evaluation of intranasal delivery of ropinirole-loaded mucoadhesive nanoparticles for brain targeting

Jafarieh O, Md S, Ali M, Baboota S, Sahni JK, Kumari B, et al.

Drug Dev Ind Pharm, 2015;41(10):1674-81.
PMID: 25496439 DOI: 10.3109/03639045.2014.991400

Parkinson disease (PD) is a common, progressive neurodegenerative disorder, characterized by marked depletion of striatal dopamine and degeneration of dopaminergic neurons in the substantia nigra.

Matched MeSH terms: Administration, Intranasal
Fulltext An open-label randomised controlled trial on the efficacy of adding intranasal fentanyl to intravenous tramadol in patients with moderate to severe pain following acute musculoskeletal injuries

Chew KS, Shaharudin AH

Singapore Med J, 2017 Oct;58(10):601-605.
PMID: 27193080 DOI: 10.11622/smedj.2016096

INTRODUCTION: The use of intranasal fentanyl as an alternative type of analgesia has been shown to be effective in paediatric populations and prehospital settings. There are a limited number of studies on the use of intranasal fentanyl in adult patients in emergency settings.
METHODS: An open-label study was conducted to evaluate the effectiveness of the addition of 1.5 mcg/kg intranasal fentanyl to 2 mg/kg intravenous tramadol (fentanyl + tramadol arm, n = 10) as compared to the administration of 2 mg/kg intravenous tramadol alone (tramadol-only arm, n = 10) in adult patients with moderate to severe pain due to acute musculoskeletal injuries.
RESULTS: When analysed using the independent t-test, the difference between the mean visual analogue scale scores pre-intervention and ten minutes post-intervention was 29.8 ± 8.4 mm in the fentanyl + tramadol arm and 19.6 ± 9.7 mm in the tramadol-only arm (t[18] = 2.515, p = 0.022, 95% confidence interval 1.68-18.72 mm). A statistically significant, albeit transient, reduction in the ten-minute post-intervention mean arterial pressure was noted in the fentanyl + tramadol arm as compared to the tramadol-only arm (13.35 mmHg vs. 7.65 mmHg; using Mann-Whitney U test with U-value 21.5, p = 0.029, r = 0.48). There was a higher incidence of transient dizziness ten minutes after intervention among the patients in the fentanyl + tramadol arm.
CONCLUSION: Although effective, intranasal fentanyl may not be appropriate for routine use in adult patients, as it could result in a significant reduction in blood pressure.

Matched MeSH terms: Administration, Intranasal
Comparative study of immunopathophysiological responses induced by B. melitensis and its lipopolysaccharide in mouse model infected via intranasal route of exposure

Osman AY, Saharee AA, Jesse FF, Kadir AA

Microb Pathog, 2017 Sep;110:365-374.
PMID: 28710016 DOI: 10.1016/j.micpath.2017.07.014

In this study, we developed a mouse model and characterized the effects of intranasal inoculation of virulent Brucella melitensis strain 16M and its lipopolysaccharide (LPS). The effects of the exposure were compared with respective control groups. Both Brucella melitensis-infected and LPS-infected groups showed no significant clinical presentation with minor relevance in the mortality associated with the infection. In Brucella melitensis-infected group, significant histopathological changes in comparison to the LPS infected group with increase bacterial burden in the lungs, reproductive and reticuloendothelial organs were observed. However, both infected groups showed elevated levels of pro-inflammatory cytokine expression (IL-1β and IL6) and antibody production (IgM an IgG) as early as 3 days post-infection with predominance in LPS infected group. In contrast, low levels of sex related hormonal changes was recorded in both infected groups throughout the experimental period. This is the first detailed investigation comparing the infection progression and host responses in relation to the immunopathophysiological aspects in mouse model after intranasal inoculation with B. melitensis and its lipopolysaccharide. The study revealed a significant difference between infected and control groups with overlap in clinical, pathological, and immunological responses as well as sex related hormonal changes resulting from the infections.

Matched MeSH terms: Administration, Intranasal/methods*
Quality of life assessment in patients with moderate to severe allergic rhinitis treated with montelukast and/or intranasal steroids: a randomised, double-blind, placebo-controlled study

Goh BS, Ismail MI, Husain S

J Laryngol Otol, 2014 Mar;128(3):242-8.
PMID: 24618303 DOI: 10.1017/S002221511400036X

This study investigated improvements in quality of life associated with eight weeks of montelukast and/or intranasal steroid treatment for moderate to severe allergic rhinitis.

Matched MeSH terms: Administration, Intranasal
Fulltext Pre and post treatment mucociliary function in allergic rhinitis in three different treatment modalities

Lee LM, Gendeh BS

Med J Malaysia, 2003 Mar;58(1):17-20.
PMID: 14556322

Allergic rhinitis causes an impairment of the mucociliary function in the nose. It is hoped that treatment of perennial allergic rhinitis would be able to revert mucociliary function to normal. This study aims to compare pre and post treatment mucociliary transport time in 3 different treatment modalities. Ninety-two newly diagnosed patients with allergic rhinitis were randomised into 3 groups and started on different treatment regimes. At the end of 8 weeks, the group treated with only intranasal beclomethasone showed some, though not significant, improvement in the mucociliary function. There were no changes in the mucociliary function in the other two groups treated with beclomethasone and loratidine or loratidine alone.

Study site: ENT clinic in Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM)
UKM

Matched MeSH terms: Administration, Intranasal
The Relationship Between Long-term Use of Intranasal Corticosteroid and Intraocular Pressure

Mohd Zain A, Md Noh UK, Hussein S, Che Hamzah J, Mohd Khialdin S, Md Din N

J Glaucoma, 2019 04;28(4):321-324.
PMID: 30585941 DOI: 10.1097/IJG.0000000000001164

PURPOSE: The purpose of this study was to investigate the association between long-term intranasal steroid use and intraocular pressure (IOP) elevation.
PATIENTS AND METHODS: In total, 100 eyes from 50 patients on long-term intranasal steroids (>2 y) for allergic rhinitis and 90 eyes from 45 controls were included in this study. Patients on other forms of steroids and risk factors for glaucoma were excluded. IOP was measured and nonmydriatic stereoscopic optic disc photos were taken for each eye. The vertical cup-to-disc ratio and the status of the optic disc were evaluated.
RESULTS: The mean IOP for intranasal steroids group was significantly higher (15.24±2.31 mm Hg) compared to the control group (13.91±1.86 mm Hg; P=0.000). However, there were no significant differences in the vertical cup-to-disc ratio and the status of glaucomatous optic disc changes between the groups.
CONCLUSIONS: Prolonged use of intranasal steroids cause statistical significant increase in IOP in patients with allergic rhinitis although no significant glaucomatous disc changes were seen. We suggest patients on long-term use of intranasal steroid have a yearly eye examination to be monitored for IOP elevation and those with additional risk factors for glaucoma is closely monitored for glaucoma.

Matched MeSH terms: Administration, Intranasal
Intranasal inoculation of recombinant DNA vaccine ABA392 against haemorrhagic septicaemia disease

Kang TL, Chelliah S, Velappan RD, Kabir N, Mohamad J, Nor Rashid N, et al.

Lett Appl Microbiol, 2019 Nov;69(5):366-372.
PMID: 31508837 DOI: 10.1111/lam.13215

We evaluate the efficacy of recombinant DNA vaccine ABA392 against haemorrhagic septicaemia infection through intranasal administration route by targeting the mucosal immunity. The DNA vaccine was constructed and subjected to animal study using the Sprague Dawley (SD) rat. The study was divided into two major parts: (i) active and (ii) passive immunization studies, involving 30 animals for each part. Each group was then divided into five test groups: two test samples G1 and G2 with 50 and 100 µg ml-1 purified DNA vaccine; one positive control G5 with 106 CFU per ml formalin-killed PMB2; and two negative controls, G3 and G4 with normal saline and pVAX1 vector. Both studies were conducted for the determination of immunogenicity by total white blood cell count (TWBC), indirect ELISA and histopathological changes for the presence of the bronchus-associated lymphoid tissue (BALT). Our findings demonstrate that TWBC, IgA and IgG increased after each of the three vaccination regimes: groups G1, G2 and G5. Test samples G1 and G2 showed significant differences (P

Matched MeSH terms: Administration, Intranasal
Preparation, characterization, and optimization of asenapine maleate mucoadhesive nanoemulsion using Box-Behnken design: In vitro and in vivo studies for brain targeting

Kumbhar SA, Kokare CR, Shrivastava B, Gorain B, Choudhury H

Int J Pharm, 2020 Aug 30;586:119499.
PMID: 32505580 DOI: 10.1016/j.ijpharm.2020.119499

The tight junctions between capillary endothelial cells of the blood-brain barrier (BBB) restricts the entry of therapeutics into the brain. Potential of the intranasal delivery tool has been explored in administering the therapeutics directly to the brain, thus bypassing BBB. The objective of this study was to develop and optimize an intranasal mucoadhesive nanoemulsion (MNE) of asenapine maleate (ASP) in order to enhance the nasomucosal adhesion and direct brain targetability for improved efficacy and safety. Box-Behnken statistical design was used to recognize the crucial formulation variables influencing droplet size, size distribution and surface charge of ASP-NE. ASP-MNE was obtained by incorporating GRAS mucoadhesive polymer, Carbopol 971 in the optimized NE. Optimized ASP-MNE displayed spherical morphology with a droplet size of 21.2 ± 0.15 nm and 0.355 polydispersity index. Improved ex-vivo permeation was observed in ASP-NE and ASP-MNE, compared to the ASP-solution. Finally, the optimized formulation was found to be safe in ex-vivo ciliotoxicity study on sheep nasal mucosa. The single-dose pharmacokinetic study in male Wistar rats revealed a significant increase in concentration of ASP in the brain upon intranasal administration of ASP-MNE, with a maximum of 284.33 ± 5.5 ng/mL. The time required to reach maximum brain concentration (1 h) was reduced compared to intravenous administration of ASP-NE (3 h). Furthermore, it has been established during the course of present study, that the brain targeting capability of ASP via intranasal administration had enhanced drug-targeting efficiency and drug-targeting potential. In the animal behavioral studies, no extrapyramidal symptoms were observed after intranasal administration of ASP-MNE, while good locomotor activity and hind-limb retraction test established its antipsychotic activity in treated animals. Thus, it can be concluded that the developed intranasal ASP-MNE could be used as an effective and safe tool for brain targeting of ASP in the treatment of psychotic disorders.

Matched MeSH terms: Administration, Intranasal