Mometasone Research Articles

Olopatadine/Mometasone (Ryaltris) for Allergic Rhinitis

The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old.

Skin permeation and penetration of mometasone furoate in the presence of emollients: An ex vivo evaluation of clinical application protocols.

Topical corticosteroids (TCS) and emollients are developed independently by the pharmaceutical industry but are often used together in practice. There is potential for the TCS and emollient formulations to interact on the skin surface affecting TCS absorption into the skin. Clinical guidelines acknowledge this issue but lack an evidence base and differ in their recommendations. There is a current clinical need to establish whether the application protocol employed for TCS and emollient products can impact delivery of TCS to the skin. To investigate whether the sequence of application of a TCS and emollient and the time between their application can affect TCS skin absorption. The delivery of mometasone furoate (MF) to ex vivo human skin was evaluated following the application of Elocon cream either 5 or 30min, before and after three different emollients. Mechanistic explanation of the changes in drug absorption was provided by modelling the skin permeation data and Raman microscopy of mixed Elocon cream and emollient formulations. A circa fivefold difference in MF absorption was observed depending on the emollient and application protocol. Applying Elocon cream at short intervals in relation to Hydromol intensive significantly increased MF absorption regardless of the application protocol. In contrast, applying Elocon cream after Diprobase cream or ointment significantly reduced MF absorption relative to Elocon cream alone or when Elocon cream was applied before these emollients. The changes in drug absorption observed were attributed to the presence of emollients altering Elocon cream formulation performance through different mechanisms, including introduction of penetration enhancing excipients and inducing drug crystallization in the mixed TCS emollient layer on the skin surface. Emollients can affect MF absorption in different ways depending on the emollient and sequence of administration. Using a 30min gap between product applications may not be sufficient to mitigate emollient effects on TCS absorption.

Development of affinity polymeric particles for the removal of 4-dimethylaminopyridine (DMAP) from active pharmaceutical ingredient crude streams using a green technology

Polymeric particles with affinity for 4-dimethylaminipyridine (DMAP) were developed by molecular imprinting using supercritical carbon dioxide (scCO2) technology, for cleanup of this potentially genotoxic impurity from crude mixtures of Active Pharmaceutical Ingredients (APIs). DMAP-molecularly imprinted polymer (DMAP-MIP) and the respective control, the non-molecularly imprinted polymer (NIP) were produced by free radical polymerization using methacrylic acid as monomer, ethylene glycol dimethacrylate as crosslinker and AIBN as free-radical initiator in scCO2. The materials were obtained in high yield and were characterized chemically, physically and morphologically. Their extraction efficiency was evaluated by dynamic binding experiments using two solutions: i) a solution containing 104 ppm DMAP solution; ii) model pharmaceutical mixture containing 104 ppm of DMAP and 1018 ppm of Mometasone furoate (API). Particles were able to remove 18.3 µmol DMAP/g polymer from a 104 ppm DMAP solution (i) and 1004.6 µmol DMAP/g API (ii). In addition, high recoveries of both DMAP and API were obtained, above 99%.

Efficacy of mometasone furoate nasal spray in the treatment of acute rhinosinusitis

BackgroundAcute rhinosinusitis (ARS) refers to a group of disorders characterized by inflammation of the respiratory epithelium of the nose and paranasal sinuses lasting from 7 to 28 days. In the treatment of ARS in addition to an antibiotic, intranasal corticosteroids hasten the clearance of bacteria, decrease the frequency and severity of disease recurrence, and reduce the duration of infection. The purpose is to compare the efficacy of the combination of mometasone furoate nasal spray (MFNS) with amoxicillin and amoxicillin alone in the treatment of acute rhinosinusitis. A total of 120 patients (≥ 12 years) were randomized into 2 groups: group A (N: 60) receiving amoxicillin 500 mg thrice daily alone and group B (N: 60) receiving amoxicillin 500 mg thrice daily and MFNS 200 μg twice daily for 7 days. Patients were followed up after 7 days. The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire was taken before and after. The total score of SNOT-22 was compared between the groups.ResultsThere was a reduction in the mean total SNOT score in both groups from 21.32 ± 11.29 to 9.37 ± 6.55 in group A and from 26.68 ± 11.97 to 3.07 ± 3.46 in group B which were statistically significant (p < 0.001) in both groups. The posttreatment mean score with the amoxicillin group was 9.31 ± 6.55 and that of the amoxicillin and mometasone furoate group was 3.07 ± 3.46, and their mean difference was 6.3 ± 0.95. In comparison, MFNS with amoxicillin was significantly (p < 0.001) superior than amoxicillin alone.Conclusion Patients receiving amoxicillin alone or amoxillin with MFNS, both showed improvement of symptoms in ARS. However, amoxicillin with MFNS showed significantly higher improvement and relief of symptoms in ARS than amoxicillin alone.

Effectiveness of Intranasal Mometasone Furoate vs Saline for Sleep-Disordered Breathing in Children

Obstructive sleep-disordered breathing (SDB) in children is characterized by snoring and difficulty breathing during sleep. SDB affects at least 12% of otherwise healthy children and is associated with significant morbidity. Evidence from small clinical trials suggests that intranasal corticosteroids improve SDB as measured by polysomnography; however, the effect on symptoms and quality of life is unclear. To determine whether intranasal mometasone furoate is more effective than intranasal saline for improving symptoms and quality of life in children with SDB. The MIST trial was a multicenter, randomized, double-blind, placebo-controlled trial, recruiting participants from June 8, 2018, to February 13, 2020. Children aged 3 to 12 years who were referred to a specialist for significant SDB symptoms were included; exclusions were previous adenotonsillectomy, body mass index greater than the 97th percentile, and severe SDB. Randomization was stratified by site, and data were analyzed on an intention-to-treat basis from October 28, 2020, to September 25, 2022. Participants were randomly assigned to receive mometasone furoate, 50 μg, or sodium chloride (saline), 0.9%, 1 spray per nostril daily, dispensed in identical bottles. The primary outcome was resolution of significant SDB symptoms (ie, reduction to a level no longer requiring referral to a specialist as per the American Academy of Pediatrics guidelines) at 6 weeks, measured by parental report of symptoms using the SDB Score. A total of 276 participants (mean [SD] age, 6.1 [2.3] years; 146 male individuals [53%]) were recruited, 138 in each treatment arm. Resolution of significant SDB symptoms occurred in 56 of 127 participants (44%) in the mometasone group and 50 of 123 participants (41%) in the saline group (risk difference, 4%; 95% CI, -8% to 16%; P = .51) with 26 participants lost to follow-up and missing values managed by multiple imputation. The main adverse effects were epistaxis, affecting 12 of 124 participants (9.7%) in the mometasone group and 18 of 120 participants (15%) in the saline group, and nasal itch/irritation, affecting 12 of 124 participants (9.7%) in the mometasone group and 22 of 120 participants (18%) in the saline group. Results of this randomized clinical trial suggest that there was no difference in treatment effect between intranasal mometasone and saline for the management of SDB symptoms. The results suggest that almost one-half of children with SDB could be initially managed in the primary care setting and may not require referral to specialist services, as is currently recommended. Australian New Zealand Clinical Trials Registry: ANZCTRN12618000448246.

Is Mometasone Effective in Treating Otitis Media with Effusion?

Otitis media with effusion (OME) is the long-term deposition of mucus in the middle ear cleft. It is the leading cause of childhood hearing loss and a common childhood infection. It can impair communication and life quality. OME's direct and indirect costs are also crucial. Improving OME care is crucial. This study examines intranasal mometasone's efficacy in treating otitis media with effusion. A clinical trial study was conducted during a period from January 2021 to June 2022. It included 80 patients suffering from otitis media with effusion bilaterally (160 ears) who had an intact tympanic membrane and tympanometry type B. These patients were included only if they had a hearing change or loss noted by the parents or by the patient if he or she could complain for three months or more. These patients were split into two groups. Group A had 80 ears (40 patients) who got one puff of mometasone furoate nasal spray in each nostril every day for three months, and Group B had 80 ears (40 patients) who got one puff of seawater nasal spray in each nostril every day for the same period. On the first visit, otoscopic findings were recorded, and all patients had pure-tone audiometry and tympanometry performed. All of the above-mentioned measures were repeated and compared to the records from the first visit at the end of the three months of treatment. After treatment, 75% of ears in Group A changed from type B to type A tympanometry. This was significantly higher than in Group B, where only 15% of ears changed from type B to type A tympanometry. Regarding retraction, 75% of ears in Group A showed no retraction after treatment with mometasone furoate, while in Group B, it was 40%. The average pure-tone audiometry score in Group A improved after therapy. Corticosteroids are effective in the treatment of otitis media with effusion and safer when used as topical intranasal steroids than systemic preparations.

INFLUENCE OF AMINOCAPRONIC ACID ON THE REGRESSION OF NASAL POLYPS AND NASAL CONGESTION IN PATIENTS WITH POLYPOUS RHINOSINUSITIS

Chronic rhinosinusitis with nasal polyposis (CRS with NP) is a clinical syndrome including several clinical phenotypes and endotypes with differences in pathophysiology and is divided into neutrophilic (non-type 2) and eosinophilic (type 2) according to the dominant endotype, which is the most severe variant associated with therapy resistance and frequent recurrence. Such pheno-endotype requires personalized treatment, and pharmacotherapy based on endotyping is prospective. Aminocapronic acid (ACA) competitively inhibits plasminogen and plasmin formation, inhibits C3a and C5a, which can affect the pathophysiological mechanisms of eosinophilic inflammation and polypous growth, since, in addition to hemostatic properties, it also has desensitizing, anti-enzymatic, and anti-proliferative properties.&#x0D; The aim of the research: to evaluate the influence of additional administration of aminocapronic acid on the degree of regression of nasal polyps in comparison with patients receiving standard therapy of Chronic rhinosinusitis with nasal polyposis according to clinical recommendations.&#x0D; Material and methods. The study included 120 outpatients, divided into two groups: the main (n - 60) and control (n - 60) ones. The average age of the main group was 45.8 years; the control group was 47.0 years. Patients were prescribed basic treatment (irrigation therapy with saline solutions and mometasone furoate), and in the main group – additionally aminocapronic acid (ACA). The evaluation of treatment effectiveness was based on the analysis of the dynamics of nasal congestion and the regression of nasal polyps at V2 (day 5±1), V3 (day 10±1), V4 (day 20±1) and V5 (day 30±1) compared to V0. Indications for surgical treatment were determined at V3.&#x0D; Results. The use of aminocapronic acid in Chronic rhinosinusitis with nasal polyposis contributes to a reliable reduction in the severity of the main clinical symptoms (rhinorrhea, postnasal drip, nasal congestion, reduced sense of smell), nasal congestion starting from V2, regression of polyps – from V3 compared to patients of the control group. This ensured a statistically significant 25% reduction in the number of operated patients: 56.7% in the main group versus 81.7% in the control (p&lt;0.05). Conservative treatment was continued by 43.3% of patients of the main group and by 18.3% of patients of the control group (p&lt;0.05). After the operated patients were removed from the groups, they did not significantly differ in the dynamics of regression of nasal congestion and nasal polyps at V4 and V5 (p&gt;0.05). Differences in the results of treatment are attributed to the clinical effects of Aminocapronic acid (ACA), since the group characteristics of the patients were commensurable.&#x0D; Conclusions:&#x0D; &#x0D; the additional appointment of Aminocapronic acid (ACA) to patients with Chronic rhinosinusitis with nasal polyposis contributes to a faster regression of nasal congestion associated with edematous changes of the mucous membrane of the nasal cavity, compared to the regression of polyps during the fifth day of treatment;&#x0D; there is a significant difference in the severity of symptoms in the main group during the 10th day of treatment compared to patients in the control group;&#x0D; the reliable positive dynamics of clinical symptoms correlates with a reliable, at 25%, decrease in the number of operative interventions in the main group.&#x0D;

Designing of SiO2 mesoporous nanoparticles loaded with mometasone furoate for potential nasal drug delivery: Ex vivo evaluation and determination of pro-inflammatory interferon and interleukin mRNA expression.

The main objective of the current research work was to synthesize mesoporous silica nanoparticles for controlled delivery of mometasone furoate for potential nasal delivery. The optimized sol-gel method was used for the synthesis of mesoporous silica nanoparticles. Synthesized nanoparticles were processed through Zeta sizer, SEM, TEM, FTIR, TGA, DSC, XRD, and BET analysis for structural characterization. The in vitro dissolution test was performed for the inclusion compound, while the Franz diffusion experiment was performed for permeability of formulation. For the determination of expression levels of anti-inflammatory cytokines IL-4 and IL-5, RNA extraction, reverse transcription, and polymerase chain reaction (RT-PCR) were performed. The MTT assay was also performed to determine cell viability. Synthesized and functionalized mesoporous silica nanoparticles showed controlled release of drugs. FT-IR spectroscopy confirmed the presence of the corresponding functional groups of drugs within mesoporous silica nanoparticles. Zeta sizer and thermal analysis confirmed the delivery system was in nano size and thermally stable. Moreover, a highly porous system was observed during SEM and TEM evaluation, and further it was confirmed by BET analysis. Greater cellular uptake with improved permeability characteristics was also observed. As compared to the crystalline drug, a significant improvement in the dissolution rate was observed. It was concluded that stable mesoporous silica nanoparticles with significant porosity were synthesized, efficiently delivering the loaded drug without any toxic effect.

Efficacy and Safety Evaluation of Mometasone Furoate in Treating Ocular Inflammation.

Mometasone furoate (MF) is a medium-potency synthetic glucocorticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. However, its role in the treatment of ocular inflammation has not yet been explored. This work investigated the anti-inflammatory activity of MF in ocular tissues. First, the in vivo safety of the intravitreal (IVT) injection of MF (80, 160, and 240 µg) was evaluated via clinical examination (including the assessment of intraocular pressure), electroretinography (ERG), and histopathology. Second, MF was tested in an experimental model of bacillus Calmette-Guérin (BCG)-induced uveitis in Wistar rats. Intraocular inflammation was then evaluated via a slit-lamp and fundus examination, ERG, histopathology, and the quantification of pro-inflammatory markers. Intravitreal MF showed no toxicity in all the investigated doses, with 160 µg leading to attenuated disease progression and improvement in clinical, morphological, and functional parameters. There was a significant reduction in the levels of inflammatory markers (myeloperoxidase, interleukins 6 and 1β, CXCL-1, and tumor necrosis factor-alpha) when compared to the levels in untreated animals. Therefore, MF should be further investigated as a promising drug for the treatment of ocular inflammation.

Inhalable aerosol microparticles with low carrier dosage and high fine particle fraction prepared by spray-freeze-drying

Co-suspension drug-loading technology, namely Aerosphere™, can improve fine particle fraction (FPF) and delivered dose content uniformity (DDCU). However, because of its poor drug-loading efficacy, the phospholipid carrier dosage in Aerosphere™ is usually dozens of times greater than that of the drug, resulting in a high material cost and blockage of the actuator. In this study, spray-freeze-drying (SFD) technology was used to prepare inhalable distearoylphosphatidylcholine (DSPC)-based microparticles for pressurized metered-dose inhalers (pMDI). Water-soluble, low-dose formoterol fumarate was used as an indicator to evaluate the aerodynamic performance of the inhalable microparticles. Water-insoluble, high-dose mometasone furoate was used to investigate the effects of drug morphology and drug-loading mode on the drug delivery efficiency of the microparticles. The results demonstrated that DSPC-based microparticles prepared using the co-SFD technology not only achieved higher FPF and more consistent delivered dose than those of drug crystal-only pMDI, but the amount of DSPC was also reduced to approximately 4% of that prepared using the co-suspension technology. This SFD technology may also be used to improve the drug delivery efficiency of other water-insoluble and high-dose drugs.

Simultaneous determination of mometasone furoate and calcipotriol in a binary mixture by validated HPLC and chemometric-assisted UV spectrophotometric methods and identification of degradation products by LC-MS.

A new binary mixture containing mometasone furoate (MF) and calcipotriol (CP) is suggested to manage psoriasis; since the combined stability profile of these drugs is poorly understood. Herein MF, CP, and their mixtures were subjected to various stress conditions. Also, stability-indicating HPLC was developed and validated according to ICH guidelines with Box-Behnken design. The degradation products (DPs) were predicted in silico and identified using LC-MS. The bioactivity and toxicity of DPs were studied using molecular docking and alamarBlue assay, respectively. Spectroscopic techniques of the first derivative, first-derivative ratio, and the mean-centering of ratio spectra were also used to determine MF and CP in the mixture because of spectra overlapping. The major degradants for MF in alkaline conditions were DP1, DP2, and DP3, while in thermal and UV conditions, only DP1 was generated. CP gave one degradant in all conditions. No new impurity was observed in the MF and CP mixtures. The results of spectrophotometry showed good linearity in the range of 4-50 and 2-20 µg/ml, while linearity for HPLC was in the range of 4-50 and 0.5-2.5 µg/ml for MF and CP, respectively. Recovery was 99.61-100.38% for UV and 100.4% for HPLC methods of MF and 100.6-101.4% for UV and 99.5% for HPLC methods of CP. The developed methods can be used as simple, accurate, precise, and rapid techniques for routine quality control of MF and CP mixtures.

A Comparative Study of Fluticasone Propionate, Mometasone Furoate, and Saline Nasal Spray in the Treatment of Children with Adenoid Hypertrophy

Introduction: Adenoidectomy is currently considered the treatment of choice for relief of the nasal airway obstruction due to adenoid hypertrophy. Evidence suggests that topical nasal steroid sprays can cause a reduction in adenoid size. We aim to compare the effectiveness of fluticasone propionate, mometasone furoate (MF) and saline nasal sprays in relieving the signs and symptoms of adenoid hypertrophy and in reducing the size of the adenoids. Materials and Methods: We conducted a randomized comparative study on 60 patients divided into three groups A, B, C (20 each). Group A patients treated with fluticasone propionate nasal spray (400 μg/day), Group B patients treated with MF nasal spray (100 μg/day), and Group C patients treated with saline spray (0.65% w/v in purified water which is made isotonic and buffered). Treatment was given up to 12 weeks with follow-up at 4, 8, and 12 weeks and at each follow-up visit assessment was done. Final data were analyzed using SPSS software version 21 and numerical variables associated with different groups were analyzed and analysis of variance test was used. Results: Diagnostic nasal endoscopy and X-ray grades at day 1 among the study groups were not statistically significant, whereas, at 12 weeks results among fluticasone and mometasone groups were significantly better (P &lt; 0.001) as compared to the saline group. There was a significant improvement in the symptoms under all the categories with the use of fluticasone and mometasone. Conclusion: In our study, both fluticasone propionate and MF were able to effectively reduce symptoms and signs of adenoid hypertrophy as well as help in reducing the size of the enlarged adenoid. Both these drugs were well tolerated by the patients.

Meta-analysis and cost-effectiveness analysis of intranasal corticosteroid treatment in allergic rhinitis with ocular symptoms.

Intranasal corticosteroid (INCS) has a beneficial effect on ocular symptoms in allergic rhinitis (AR). To our knowledge, the cost-effectiveness of available INCS for AR with ocular symptoms is yet to be demonstrated. To evaluate the cost-effectiveness of INCSs including Budesonide (BANS), Mometasone furoate (MFNS), Triamcinolone (TANS), and Fluticasone furoate (FFNS) on ocular symptoms associated with AR in the Thai context. The percentage of effectiveness in improving total ocular symptoms score (TOSS) was derived from the result of a meta-analysis that estimated the SMD of each INCS treatment compared to placebo as clinical input parameters. A cost-effectiveness analysis based on a decision-tree model to assess one-year costs and outcomes from a Thai societal perspective. The outcomes were to compare incremental cost-effectiveness ratio (ICER). Probabilistic sensitivity analyses (PSA) were also conducted to capture parameter uncertainties. 13 eligible RCTs with a total of 3,722 patients with SAR were included in the analysis. The percentage of effectiveness of FFNS, MFNS, TANS, and BANS was 59.89%, 45.60%, 24.89%, and 16.00%, respectively. The ICER of FFNS, MFNS, and TANS is THB-6,539.92, 4,593.83, and 1,401.24 compared to BANS. CECA result showed the probability of using FFNS is considered cost-effective in 87.50% of cases from zero value followed by MFNS (0.80%), TANS (5.40%), and BANS (6.30%). With a threshold greater than THB20,000, FFNS is considered a cost-effective strategy. FFNS is a cost-effective option compared to alternative INCSs in Thailand for treating AR with ocular symptoms.

Comparative Study of Montelukast and Mometasone Furoate in the Treatment of Pediatric Obstructive Sleep Apnea Syndrome

Comparative Study of Montelukast and Mometasone Furoate in the Treatment of Pediatric Obstructive Sleep Apnea Syndrome

Long-lasting otic medications may be a rare cause of neurogenic keratoconjunctivitis sicca in dogs.

To characterize the clinical course and long-term prognosis of a suspected novel cause of neurogenic keratoconjunctivitis sicca (nKCS) secondary to florfenicol, terbinafine hydrochloride, mometasone furoate (Claro and Neptra) or florfenicol, terbinafine, betamethasone acetate (Osurnia). 29 client-owned dogs. Online survey and word-of-mouth recruitment were conducted to identify dogs that developed clinical signs of nKCS after application of otitis externa medication containing terbinafine and florfenicol. A retrospective analysis of medical records of dogs meeting inclusion criteria was then conducted. Included dogs had onset of clinical signs of nKCS within 1 day after application of otitis externa medications containing terbinafine and florfenicol and had documentation of low Schirmer tear test value (< 15 mm/min) of affected eyes. 29 dogs with medical records available for review met the inclusion criteria. Documented return of clinically normal tear production was identified in 24 of 29 dogs, with a median time from application of ear medication to documented return of clinically normal tear production of 86 days (range, 19 to 482 days). A corneal ulcer was diagnosed in 68% (20/29). Multivariable Cox regression analysis showed being referred to an ophthalmologist (P = .03) and having a deep ulcer (P = .02) were associated with a longer time to documentation of Schirmer tear test ≥ 15 mm/min. Dogs that developed nKCS within 1 day after application of otitis externa medications containing terbinafine and florfenicol had a good prognosis for return of normal tear production within 1 year.

Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments of Olopatadine Hydrochloride/Mometasone Furoate Monohydrate and Azelastine Hydrochloride/Fluticasone Propionate for Allergic Rhinitis in Australia - An Observational Real-World Clinical Study.

Combination intranasal corticosteroid and antihistamine sprays are a first-line treatment option for allergic rhinitis (AR), of which Azelastine Hydrochloride and Fluticasone Propionate nasal spray (AZE/FLU; Dymista®), and Olopatadine Hydrochloride and Mometasone Furoate Monohydrate nasal spray (OLO/MOM; Ryaltris®) are currently registered in Australia. As it is not known how patients value treatment attributes of current combination nasal sprays, this observational, real-world clinical study aimed to understand patients' satisfaction with, and importance of, treatment attributes of OLO/MOM and AZE/FLU using an Anchored Best-Worst Scaling (ABWS) exercise. Four hundred and twenty-six adults in Australia with moderate to severe AR using either OLO/MOM or AZE/FLU completed an online survey incorporating an ABWS with 11 domains: 7 sensory (immediate taste of medication, aftertaste of medication, smell of medication, irritation to your nose, urge to sneeze, dripping out your nose/down your throat, dryness of your nose/throat) and 4 treatment-related (convenience, fast acting, duration of effect, and AR symptom control). The ABWS involved rescaling individual BWS scores using anchored ratings (0-10) for most and least satisfied/important domains to create a total satisfaction index (TSI) (0-100) to be compared across groups. Statistical comparisons were completed using ANOVA (TSI) and MANOVA (individual domains). Participants using OLO/MOM (M = 68.26, SE = 1.39) had significantly higher TSI than participants using AZE/FLU (M=62.78, SE = 0.70) (p < 0.001), significantly higher satisfaction on 7 of 11 domains and regarded 8 of 11 domains as significantly more important compared to participants using AZE/FLU (all p < 0.05). Preferred domains were predominantly sensory attributes. Current findings showed that participants using OLO/MOM were more satisfied with their overall treatment compared to participants using AZE/FLU, particularly with sensory attributes, thus highlighting the suitability of OLO/MOM for people with AR who value sensory attributes. Prescribers of AR treatments are encouraged to discuss treatment attributes with patients to facilitate shared decision-making.

A New Validated Method for Simultaneous Determination of Aerodynamic Particle Size Distribution of Drug Particles of Mometasone Furoate and Formoterol Fumarate Dihydrate in 200 mcg/5 mcg Inhalation Aerosol

Simultaneous determination of aerodynamic particle size distribution (APSD) of drug particles of mometasone furoate and formoterol fumarate dihydrate – 200 mcg/5 mcg inhalation aerosol (MDI) has been developed and reported in this work. The method was developed in consistent with USP &lt;601&gt; inhalation and nasal drug products e.g. aerosols, sprays and powders. The next generation impactor (NGI) was used and operated at 30 ± 5% L/min. The proposed method was demonstrated for sensitivity, minimum number of actuations, diluent volume optimization, mass balance and precision. The proposed method was found to be robust, accurate, linear and precise.

Оптимальное лечение инфекционного риносинусита как инструмент профилактики обострений ХОБЛ

Background: many studies report on the association between upper and lower respiratory infections. Various theories explain this association. In particular, some evidence demonstrates that nasal symptoms in diseases of the nasal cavity and paranasal sinuses affect exacerbations of chronic obstructive pulmonary disease (COPD). Therefore, treatment for rhinosinusitis improves the overall health and quality of life of these patients. Aim: to assess the clinical efficacy, tolerability, and safety of a combined antibacterial, anti-inflammatory, and vasoconstrictive drug in mild and moderate acute rhinosinusitis and concomitant COPD. Patients and Methods: this study enrolled 50 male and female patients aged 41–65 years. The primary examination included complaints and history taking, examination, instrumental tests for ENT organs, and pulmonary consultation. All patients underwent digital diaphanoscopy during the first visit to rule out acute exudative rhinosinusitis. In addition, all patients filled out a subjective assessment questionnaire. Treatment continued for 10 days with an interim examination on day 5±1 after starting treatment. Study group patients received a combined drug Polydexa with phenylephrine (1 injection into each nostril 4 times daily for 10 days) and irrigation with isotonic saline. The control group patients received 2 doses of mometasone furoate twice daily into each nostril for 10 days and irrigation with isotonic saline. Topical vasoconstrictors were allowed to be used as needed. Results: significant differences in the improvement of inflammatory symptoms between the groups were reported as early as by the second visit. The effect occurred earlier and was more significant at all treatment steps in the study group. A natural association between upper respiratory infection (acute rhinosinusitis), treatment strategy choice, and COPD exacerbation was revealed. Meanwhile, more COPD exacerbations were detected in the control group than in the study group (7 vs. 4). Conclusion: in mild and moderate acute rhinosinusitis and concomitant COPD, the combined drug Polydexa with phenylephrine reduces the rate and severity of COPD exacerbations. KEYWORDS: rhinosinusitis, nasal symptoms, upper and lower respiratory tract inflammation, Haemophilus influenzae, chronic obstructive pulmonary disease, phenylephrine, neomycin sulfate, polymixin B. FOR CITATION: Ovchinnikov A.Yu., Miroshnichenko N.A., Nikolaeva Yu.O., Zaitsev A.A. Optimal treatment for infectious rhinosinusitis as a tool to prevent COPD exacerbations. Russian Medical Inquiry. 2023;7(8):511–517 (in Russ.). DOI: 10.32364/2587-6821-2023-7-8-6.

Tozinameran (Pfizer-BioNTech COVID-19 vaccine)-induced AGEP-DRESS syndrome

Dear Editor, A 40-year-old woman with scalp psoriasis was maintained on topical mometasone furoate therapy from 2019 with no major psoriatic flares until she presented with one week of an acute generalised pustular eruption and fever in June 2021. Physical examination revealed numerous discrete and confluent pustules studded on her scalp, trunk and limbs, on

Real-life effectiveness of indacaterol/glycopyrronium/mometasone for symptomatic relief of cough after switching from inhaled corticosteroid/long-acting β2-agonist therapy in patients with asthma: REACH study design.

Cough is a major symptom in patients with asthma and poses a significant burden compared with other asthma symptoms. However, there are no approved treatments in Japan, developed to specifically treat cough in patients with asthma. We present the design of REACH, an 8-week real-life study, which will evaluate the efficacy of a combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF) in asthmatic patients with cough refractory to medium-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA). Patients with asthma (age ≥20 to <80 years) with a cough visual analogue scale (VAS) ≥40 mm will be randomised 2:1:1 to receive IND/GLY/MF medium-dose 150/50/80 μg once daily or step-up to a high-dose regimen of fluticasone furoate/vilanterol trifenatate (FF/VI) 200/25 µg once daily or budesonide/formoterol fumarate (BUD/FM) 160/4.5 µg four inhalations twice daily during the 8-week treatment period. The primary objective is to demonstrate the superiority of IND/GLY/MF medium-dose over high-dose ICS/LABA in terms of cough-specific quality of life after 8 weeks. The key secondary objective is to demonstrate the superiority of IND/GLY/MF in terms of subjective assessment of cough severity. Cough frequency (VitaloJAK cough monitor) and capsaicin cough receptor sensitivity will be evaluated in eligible patients. Cough VAS scores, fractional exhaled nitric oxide, spirometry and blood tests, and the Asthma Control Questionnaire-6, Cough and Sputum Assessment Questionnaire, and Japanese version of the Leicester Cough Questionnaire will be evaluated. REACH will provide valuable evidence on whether a switch to IND/GLY/MF medium-dose or step-up to high-dose ICS/LABA is beneficial for patients with persistent cough despite treatment with medium-dose ICS/LABA.