Nasal Mometasone Furoate Research Articles

O-PTIR spectroscopy for characterizing active pharmaceutical ingredient specific particle size distributions of nasal spray suspension products

Evaluation of the particle size distribution (PSD) of active pharmaceutical ingredients (APIs) in nasal suspension products is challenging due to the presence of both API and excipients. To characterize these intricate formulations, it is essential to have sophisticated analytical methods that offer high spatial resolution and the ability to chemically pinpoint and map out the presence of API particles. However, such advanced techniques have not been documented for nasal formulations yet.In this proof-of-concept study, we investigated the utility of optical photothermal infrared spectroscopy (O-PTIR) to analyze the PSD of commercially available Nasonex® and its generic Azonaire® nasal mometasone furoate (MM) suspensions. Simultaneous O-PTIR and Raman spectra, as well as IR chemical maps, were collected from the particles in both formulations. Spatially resolved spectra from the particles confirmed the presence of peaks related to MM (1727 cm−1, 1661 cm−1, and 1122 cm−1) and excipient microcrystalline cellulose (MCC) (1061 cm−1). The PSD of MM particles was characterized using chemical maps specific to MM (1661 cm−1) and automated imaging. Results confirmed that the PSD of both formulations were comparable. Spectral analysis also revealed the presence of free MM, free MCC, and particles containing co-localized MM and MCC.For suspension-based nasal products, O-PTIR enables the measurement of API PSD, which is critical for formulators in developing nasal suspension products. This approach holds potential as an innovative complimentary analytical tool that could diminish the need for extensive clinical endpoint bioequivalence studies when evaluating the comparability of generic and brand-name nasal suspension products.

The impact of nasal use of azelastine and mometasone furoate on drug-induced sleep endoscopy.

Endoscopic evaluation becomes difficult when excessive secretion/hypersalivation occurs in the upper airway. Intranasal corticosteroids and antihistamines reduce symptoms of rhinorrhea and nasal congestion. For this reason, in our study, we aimed to examine the effects of mometasone furoate and azelastine on both the amount of secretion and upper airway obstruction in terms of possible benefits during drug-induced sleep endoscopy (DISE). A total of 92 patients participated in the study [69 (75%) were males and 23 (25%) were females]. Three groups in Group 1 used intranasal mometasone furoate for 30 days, Group 2 used intranasal azelastine for 30 days, and Group 3 did not use any nasal spray for 30 days. Then, DISE was performed on all patients on the 30th day. Upper airway obstructions detected in DISE were interpreted according to the VOTE classification. Furthermore, the amount of secretion and patients' tolerance levels observed during DISE were also assessed. Multilevel obstruction was detected in 94.5% of all patients participating in the study. Tolerance was poor in 18 (19.5%) of the patients participating in the study. Better DISE tolerance was determined in the female gender. DISE tolerance was also better in underweight and normal-weight patients (BMI < 25). This study first investigated nasal mometasone furoate and azelastine on DISE. This study showed that prior use of nasal mometasone furoate or azelastine before DISE did not affect the amount of secretion, tolerance level, severity, and configuration of obstruction.

Are nasal steroids effective in children with adenoid hypertrophy?

Objectives: Chronic nasal obstruction is a common disease of childhood. Adenotonsillar hypertrophy plays an important role in obstructive sleep apnea. The topical use of the aerosolized forms of corticosteroids therefore seems the most appropriate route to decrease systemic side effects. The aim of our study is to demonstrate the effect of topical mometasone furoate especially on the adenoid volume in patients without any allergic story. Methods: The study group consisting of 30 males and 25 females was administered topical nasal mometasone furoate steroid treatment. The 20 patients were in the control group where saline solution (0.9% NaCl) treatment was administered consisted of 12 males and 8 females. Nasopharyngeal X-rays before treatment revealed that 25 patients were Grade 2 and 30 patients were Grade 3 according to the Fujioka method. Results: Flexible endoscopy performed before the treatment revealed that 20 patients were Grade 2, 11 patients were Grade 3 and 24 patients were Grade 4. Nasal endoscopies performed after 6 weeks of intranasal topical steroid therapy revealed that 45 patients were Grade 1 and 10 patients were Grade 2. A statistically significant difference was present between endoscopic grades before and after treatment (p &amp;lt; 0.0001). Nasal endoscopies performed after 6 weeks in control group receiving saline solution treatment revealed Grade 2 in 7 patients, Grade 3 in 10 patients and Grade 4 in 3 patients. There was no statistically significant difference between in the prior and later grades of the control group (p = 0.3125). Conclusions: We believe that the use of intranasal steroids (mometasone furoate) for 6 weeks in patients with pediatric chronic nasal obstruction due to adenoid hypertrophy may be an effective treatment modality in alleviating symptoms and decreasing adenoid volume without causing systemic side effects.

Pre- and postoperative blood neutrophil-to-lymphocyte and eosinophil-to-lymphocyte ratios in patients with sinonasal polyps: A preliminary investigation.

Identifying specific endotypes within the broad picture of chronic rhinosinusitis with nasal polyps (CRSwNP), by using biomarkers for instance, remains a challenge. The prognostic role of the neutrophil-to-lymphocyte ratio (NLR) and the eosinophil-to-lymphocyte ratio (ELR) as potential markers of inflammation has already been discussed. The aim of the present study was to compare NLR and ELR before and after endoscopic sinus surgery (ESS) and nasal mometasone furoate for CRSwNP by stratifying patients by their clinical and histologic features. The study included 115 consecutive patients with CRSwNP treated with ESS and nasal mometasone furoate, with a postoperative follow-up of >12 months. Eosinophilic-type CRSwNP was histopathologically defined after hematoxylin and eosin tissue staining. In the subcohort of patients with an histologic diagnosis of eosinophilic-type CRSwNP, the mean ± standard deviation ELR significantly decreased after surgery (0.22 ± 0.16 versus 0.18 ± 0.12; p = 0.04), whereas, among patients with a histologic diagnosis of noneosinophilic-type CRSwNP, the mean NLR significantly decreased after surgery (1.98 ± 0.98 versus 1.90 ± 0.90; p = 0.04). Different CRSwNP endotypes are characterized by different biohumoral patterns. It is reasonable to assume that surgery enables clearance of the polyps and polypoid mucosa, which reduces the load of antigens that triggers the inflammation. Consistent with the above-mentioned biologic mechanism, ESS could correspond to a reduction in blood ELR values and eosinophil count in eosinophilic-type CRSwNP. Analysis of the data did not demonstrate an added value of measuring pre- versus postoperative ELR compared with measuring the blood eosinophil count. When used after ESS, topical corticosteroids also had more significant anti-inflammatory effects. As for the subcohort of patients with noneosinophilic CRSwNP, the fact that the mean NLR dropped significantly after surgery was definitely an original finding. Unlike eosinophilic inflammation, the inflammatory patterns seen in noneosinophilic CRSwNP are still poorly understood.

Comparison of Histopathological Effects of Thymoquinone and Local Nasal Corticosteroids in Allergic Rhinitis in a Rabbit Model

Background/Aims: In this study, we aimed to evaluate the histopathological effects of thymoquinone treatment of the nasal mucosa in a rabbit model of allergic rhinitis, and we compared its effects with those of nasal mometasone furoate. Methods: A total of 24 male New Zealand rabbits were used. The animals were randomly assigned to one of four groups. Group 1 received no treatment, while group 2 underwent ovalbumin (OVA) sensitization only. Group 3 was the study group; after OVA sensitization, the rabbits were treated with intranasal thymoquinone. The group 4 rabbits received mometasone furoate for 7 days after OVA sensitization. Mucosal structures were stained with hematoxylin and eosin, while toluidine blue was used to stain mast cells. Apoptosis was evaluated using a TUNEL assay. Results: In the positive control groups, including the thymoquinone and intranasal mometasone furoate groups, intraepithelial and submucosal inflammation and goblet cell hypertrophy were significantly decreased compared to group 2 (p < 0.001). The cilial structure was normal, as was the chondrocyte structure in both treatment groups. Conclusion: This is the first study to evaluate the histopathological effects of thymoquinone in an allergic rhinitis model. Thymoquinone reduced allergic inflammation and may be valuable for treating allergic rhinitis. However, additional studies are needed.

Effect of Nasal Corticosteroid on Secretory Immunoglobulin A Measured in Rat Nasal Lavage: Experimental Study.

In this study, we aimed to experimentally investigate the effects of nasal corticosteroids on the levels of secretory immunoglobulin A (sIgA) in nasal mucosa in rats. Prospective, randomized control trial. Research laboratory. Twenty-four male Sprague Dawley rats were included in our study. The rats were randomized into 3 groups. In group 1, nasal mometasone furoate was applied to the rats for 30 days. Saline was applied to group 2 for 30 days. Group 3 was the control group and received no treatment throughout the study period. Nasal lavage was conducted on both nasal openings of all rats in the 3 groups at the beginning of the study and on days 15 and 30, and the lavage solution (distilled water) was collected by aspiration. In group 1, the sIgA value was significantly higher at day 15 than at baseline. No significant difference was found between the sIgA values on day 15 and day 30. In groups 2 and 3, there were no significant differences in sIgA values at baseline, day 15, and day 30. The sIgA value of group 1 on day 15 was significantly higher than the values of groups 2 and 3. The sIgA value of group 1 on day 30 was significantly higher than the values of groups 2 and 3. Topical corticosteroids (mometasone furoate) applied to the nasal mucosa significantly increase nasal sIgA levels.

Rare simultaneous occurrence of two supposedly antagonistic diseases: Vogt-Koyanagi-Harada disease and allergic conjunctivitis

Rare simultaneous occurrence of two supposedly antagonistic diseases: Vogt-Koyanagi-Harada disease and allergic conjunctivitis

The role of topical nasal steroids in the treatment of children with otitis media with effusion and/or adenoid hypertrophy

Topical steroid treatment can be a powerful alternative to surgery in controlling adenoid hypertrophy and otitis media with effusion (OME). A prospective, controlled, randomized, clinical study in an academic tertiary care center. A total of 122 children (3-15-year-old) on the waiting list for an adenoidectomy and/or ventilation tube placement were enrolled into the study and control groups. The study group (67 patients with adenoid hypertrophy, 34 of them with otitis media with effusion) received intranasal mometasone furoate monohydrate 100 mcg/day, and the control group (55 patients with adenoid hypertrophy, 29 of them with otitis media with effusion) was followed up without any treatment. All patients were evaluated at 0 and 6 weeks. The assessment of each patient included history, a symptom questionnaire, a skin prick test, a tympanogram, if possible a pure tone audiogram, and otoscopic and endoscopic examinations. The size of adenoid tissue was graded as a percentage according to obliteration of the choanae. The adenoid/choana ratio (A/C) was recorded for each patient. Symptoms were scored as 0 (absent), 1 (intermittent/periodic), or 2 (continuous). The data were analyzed with the "Statistical Package for the Social Sciences" (SPSS 9.0) using the appropriate nonparametric tests for nominal and ordinal data. Resolution of otitis media with effusion in the study group (42.2%) was significantly higher than that in the control group (14.5%) (p<0.001). Forty-five patients (67.2%) with adenoid hypertrophy in the study group showed a significant decrease in adenoid size according to the endoscopic evaluation compared to the control group (p<0.001). A significant improvement in obstructive symptoms was seen in the study group (p<0.001). The endoscopically measured adenoid/choana ratio and degree of obstructive symptoms showed a significant correlation (r=0.838 p<0.001, r=0.879 p<0.001, r=0.838 p<0.001, r=0.879 p<0.001). The adenoid/choana ratio improved significantly in atopic patients in the study group (p<0.05), whereas in atopic patients in the control group there was no change (p=0.221). Nasal mometasone furoate monohydrate treatment can significantly reduce adenoid hypertrophy and eliminate obstructive symptoms. It is a useful alternative to surgery, at least in the short term, for otitis media with effusion.

Intranasal mometasone furoate reduces late-phase inflammation after allergen challenge

Allergen specific nasal challenge (ASNC) is an optimal model to study the pathophysiologic mechanisms sustaining allergic inflammation, particularly the adhesion molecules promoting cellular infiltration of nasal mucosa. Topical corticosteroids have been accepted as a highly effective anti-inflammatory therapy for allergic rhinitis. The aim of this double-blind, randomized, placebo-controlled study was the evaluation of inflammatory events, during the late-phase, after a 2-week treatment with nasal mometasone furoate (MF), 200 microg daily, or placebo, using the model of ASNC. A total of 42 patients with allergic rhinitis underwent nasal challenge before and after treatment. The following parameters were evaluated at baseline, and 6 hours (late-phase) after ASNC: 1) nasal symptoms (rhinorrhea, itching, sneezing, obstruction); 2) inflammatory cells (eosinophils and neutrophils); 3) eosinophil cationic protein (ECP) and tumor necrosis factor-alpha (TNF-alpha) in nasal lavage; and 4) intercellular adhesion molecule-1 expression on nasal epithelial cells. MF nasal spray was associated with late-phase reductions of: 1) clinical symptoms (P < 0.03); 2) eosinophil (P < 0.004) and neutrophil (P < 0.003) infiltration; 3) ECP (P < 0.001) and TNF-alpha (P < 0.05); and 4) intercellular adhesion molecule-1 expression on nasal epithelial cells (P < 0.001). The present results demonstrate that MF has a significant effect on late-phase events, reducing the cellular influx and activation.