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Abstract Background Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants. Objective This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS. Method An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18. Results Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p

Yueying Niu,1 Mengqing Cao,1 Shumin Li,1 Juanfen Mo,2 Ziyi Zhu,1 Haiqin Wang1 1Department of Respiratory Medicine, The Second Hospital of Jiaxing, Jiaxing, Zhejiang, People’s Republic of China; 2The Key Laboratory, The Second Hospital of Jiaxing, Jiaxing, Zhejiang, People’s Republic of ChinaCorrespondence: Haiqin Wang; Ziyi Zhu, Department of Respiratory Medicine, The Second Hospital of Jiaxing, 1518 Huanchen North Road, Jiaxing, Zhejiang, 314000, People’s Republic of China, Email w_haiqin@163.com; zhuziyi1986@163.comObjective: To retrospectively study the effects of budesonide inhalation combined with conventional symptomatic treatment on serum inflammatory factor expression levels and pulmonary function in patients with cough variant asthma (CVA) and to evaluate treatment efficacy.Methods: This retrospective cohort study included 200 patients diagnosed with CVA at the Second Hospital of Jiaxing between January 2022 and June 2023 and given conventional symptomatic treatment plus budesonide inhalation were included in this study. Patients were divided into a no remission group, a partial remission group and a complete remission group based on treatment effect. The expression levels of serum inflammatory factors, cough symptom scores, and small airway function indicators in the three groups of patients at different time points were compared.Results: In the three groups of CVA patients, after receiving budesonide inhalation combined with conventional symptomatic treatment, the expression levels of serum IL-5, IL-6, IL-8, TNF-α, TGF-β 1, and IgE and number of eosinophils significantly decreased (P < 0.05). There were statistically significant differences in the IL-6 and TGF-β 1 levels among the three groups of CVA patients at T1, T2 and T3. There were statistically significant differences in IgE levels, number of eosinophils, cough symptom scores, and small airway function indicators between T2 and T3 (P< 0.05). The receiver operating characteristic (ROC) curve prediction analysis revealed significant differences in the expression of IL-6 and TGF-β 1 at T1, T2, and T3.Conclusion: Budesonide inhalation combined with conventional symptomatic treatment can significantly reduce the levels of serum inflammatory factors in patients with CVA to reduce inflammation and the allergic response, thereby reducing the cough symptom score, improving pulmonary function, and improving therapeutic efficacy. In addition, IL-6 and TGF-β 1 can be used as early predictors of budesonide inhalation efficacy.Keywords: budesonide, cough variant asthma, cytokines, IL-6, TGF-β 1

BackgroundNeratinib is an irreversible pan-HER tyrosine kinase inhibitor approved for HER2-positive early-stage and metastatic breast cancer. Diarrhea is the most frequent side effect and the most common reason for early discontinuation. The phase II CONTROL trial investigated antidiarrheal prophylaxis or neratinib dose escalation (DE) for prevention of diarrhea. We present complete study results including final data for two DE strategies.MethodsPatients who completed trastuzumab-based adjuvant therapy received neratinib 240 mg/day for 1 year. Early cohorts investigated mandatory prophylaxis with loperamide, then additional budesonide or colestipol. Final cohorts assessed neratinib DE over the first 2 (DE1) or 4 weeks (DE2). The primary endpoint was incidence of grade ≥3 diarrhea. Health-related quality of life (HRQoL) was assessed using FACT-B and EQ-5D-5L.Results563 patients were enrolled into six cohorts. All strategies reduced grade ≥3 diarrhea with the lowest incidence in DE1 (DE1 13%; colestipol + loperamide [CL] 21%, DE2 27%; budesonide + loperamide [BL] 28%; loperamide [L] 31%; colestipol + loperamide as needed [CL-PRN] 33%). Diarrhea-related discontinuations occurred early and were lowest in DE1 (DE1 3%; CL 4%; DE2 6%; CL-PRN 8%; BL 11%; L 20%). More patients stayed on neratinib for the prescribed period versus historical controls. Prior pertuzumab use did not affect rates of grade ≥3 diarrhea, diarrhea-related discontinuations, or treatment duration. Early transient reductions in HRQoL scores were observed.ConclusionsThese complete results from CONTROL show improved neratinib tolerability with proactive management at the start of therapy. Two-week neratinib DE with loperamide as needed was particularly effective.ClinicaltrialsGov registration numberNCT02400476.

Simple Summary: Guidelines from oncologic societies recommend high-dose systemic corticosteroids as the primary therapy with or without biologics for moderate to severe colitis secondary to immune checkpoint inhibitors; budesonide is a gut selective steroid that undergoes first past metabolism with less systemic adverse events in comparison to systemic steroids, although its use has not been studied or established for colitis secondary to immune checkpoint inhibitors. Budesonide employed for other gastrointestinal diseases, such as inflammatory bowel disease, is associated with decreased infections and metabolic side effects. In our analysis, we observed that budesonide may be an effective strategy to treat and prevent the recurrence of colitis with similar results as systemic corticosteroids in this immunocompromised cancer patient population. Background: Current treatment guidelines for moderate to severe colitis (IMC) secondary to immune checkpoint inhibitors (ICI) recommend systemic corticosteroids as the primary therapy in conjunction with biologics, namely infliximab and/or vedolizumab. We aimed to explore the efficacy and safety of oral budesonide in the treatment of IMC. Methods: We performed a retrospective analysis at MD Anderson Cancer Center of adult cancer patients with a confirmed (based on clinical, radiographic and laboratory assessment) diagnosis of IMC between 1 January 2015 and 31 November 2022, treated with budesonide. Data collection included demographics, oncologic history, IMC-related information and outcomes up to 6 months after the last dose of ICI. Results: Our sample (n = 69) comprised primarily of Caucasian (76.8%) females (55.1%). The majority of patients received combination therapy with anti-PD-1/L1 and anti-CTLA-4 (49.3%), and the most common malignancy treated was melanoma (37.6%). The median grade of diarrhea was 3 and of colitis was 2. Of the 50 patients who underwent endoscopic evaluation, a majority had non-ulcerative inflammation (64%) and active colitis on histology (78%). Budesonide was used as primary treatment at onset of IMC in 56.5% patients, as well as a bridging therapy from systemic corticosteroids in 33.3%. Less than half of the patients (44.9%) required additional therapies such as biologics or fecal microbiota transplant. Additionally, 75.3% of patients achieved full remission of IMC and 24.6% had a recurrence of IMC. ICI was resumed in 31.9% of patients and 17.4% received other forms of cancer therapies. Conclusions: Budesonide may be an effective strategy to treat and prevent the recurrence of IMC. The remission rates observed in our analysis with budesonide alone are comparable to systemic corticosteroids. Patients that require an extended duration of steroid exposure and those with moderate to severe colitis may benefit from budesonide given its lower risk of infection and complications. Furthermore, we observe that budesonide may serve as a successful bridge from systemic corticosteroids with subsequent biologic treatment. Larger prospective studies are necessary to determine the role of budesonide as well as its safety profile. [ABSTRACT FROM AUTHOR]

Background: Budesonide high-volume saline irrigations (HVSIs) are routinely used to treat chronic rhinosinusitis (CRS) due to improved sinonasal delivery and efficacy compared to intranasal corticosteroid sprays. The off-label use of budesonide is assumed to be safe, with several studies suggesting the systemically absorbed dose of budesonide HVSI is low. However, the actual budesonide dose retained in the sinonasal cavity following HVSI is unknown. The objective of this study was to quantify the retained dose of budesonide after HVSI. Methods: Adult patients diagnosed with CRS who had undergone endoscopic sinus surgery (ESS) and were prescribed budesonide HVSI were enrolled into a prospective, observational cohort study. Patients performed budesonide HVSI (0.5 mg dose) under supervision in an outpatient clinic, and irrigation effluent was collected. High-performance liquid chromatography was employed to determine the dose of budesonide retained after HVSI. Results: Twenty-four patients met inclusion criteria. The average corrected retained dose of budesonide across the cohort was 0.171 ± 0.087 mg (37.9% of administered budesonide). Increased time from ESS significantly impacted the measured retained dose, with those 3 months post-ESS retaining 27.4% of administered budesonide (P =.0004). Conclusion: The retained dose of budesonide in patients with CRS after HVSI was found to be significantly higher than previously estimated and decreased with time post-ESS. Given that budesonide HVSI is a cornerstone of care in CRS, defining the retained dose and the potential systemic implications is critical to understanding the safety of budesonide HVSI. [ABSTRACT FROM AUTHOR]

This practice point summarizes recommendations from the Canadian Thoracic Society's 2021 "Guideline update: Diagnosis and management of asthma in preschoolers, children, and adults." New recommendations include: a decrease in the frequency of daytime symptoms and reliever use to ≤2 per week in the asthma control criteria; assessing for risk of asthma exacerbation; not using as-needed short-acting beta-agonists alone in patients at higher risk for exacerbation; and the option of as-needed budesonide/formoterol (bud/form) in those ≥12 years old if they are unable to take daily inhaled corticosteroids despite extensive asthma education and support. The preference for daily inhaled corticosteroids to manage mild asthma in children, and the recommendation against intermittent short courses of inhaled corticosteroids, are unchanged. [ABSTRACT FROM AUTHOR]

Objectives: To assess the efficacy and safety of budesonide as an intrapolyp injection in chronic rhinosinusitis with nasal polyps (CRSwNP) in comparison to control and systemic steroids. Method: In a prospective double‐blinded controlled randomized clinical trial, 150 patients with CRSwNP were divided into 3 groups in a ratio 1:1:1 where group (A) was given oral prednisolone 1 mg/kg tapered daily for 2 weeks, group (B) was given budesonide intrapolyp injection weekly for 5 consecutive weeks, and group (C) was given intrapolyp injection with saline as the control group. Patients were assessed upon Sinonasal Outcome Test (SNOT‐22) score, Total Nasal Polyp score (TNPS), Serum IgE, absolute eosinophilic count, and morning cortisol level before treatment, 1 week and 6 months after completing their treatment protocol. Results: SNOT 22 score improved significantly in all groups compared to those at baseline. Reduction in the oral and injection groups was much greater than the control group (P2 < 0.001), (P3 < 0.001), and the same trend concerning TNPS score (P2 < 0.001), (P3 < 0.001) but with no significant change in the control group. Conclusion: Intrapolyp steroid injection is considered a safe and effective method in nasal polyposis with limited side effects in comparison to systemic steroids. Using Budesonide as an agent for intrapolyp injection appears to be promising. It's advisable in patients with multiple relapses or high‐risk patients to avoid repeated courses of oral steroids. Level of Evidence: 2 Laryngoscope, 134:2085–2092, 2024 [ABSTRACT FROM AUTHOR]

Eosinophilic Esophagitis is an antigen-mediated inflammatory disease characterized by thickening of the esophageal wall, leading to dysphagia, vomiting, reflux, and abdominal pain. This disease can be treated with a therapeutic approach ranging from diet to pharmacological therapy. Jorveza® (budesonide) and Dupixent® (dupilumab) are treatments for Eosinophilic Esophagitis approved by the European Medicines Agency in adults but not in children. Budesonide-based extemporaneous oral liquid suspensions could be prepared for pediatric use. The main limit of this formulation is that budesonide needs a longer residence time on the esophageal mucosa to solubilize and diffuse in it to exert its local anti-inflammatory effect. Herein, we propose the development of an extemporaneous mucoadhesive oral budesonide solution for the pediatric population. A liquid vehicle containing hydroxypropyl-beta-cyclodextrin as a complexing agent and carboxymethylcellulose sodium as a mucoadhesive excipient was used to prepare budesonide-based formulations. A stable solution at a concentration of 0.7 mg/mL was successfully prepared and characterized. The formulation showed rheological and mucoadhesive properties suitable for an Eosinophilic Esophagitis local prolonged treatment. In this way, pharmacists can prepare stable budesonide-based mucoadhesive solutions, providing both patients and physicians with a new therapeutic option for Eosinophilic Esophagitis pediatric treatment. [ABSTRACT FROM AUTHOR]

IgA nephropathy is a common glomerulonephritis consequent to the autoimmune response to aberrant glycosylated immunoglobulin (Ig) A antibodies. Although it has historically been considered a benign disease, it has since become clear that a substantial percentage of patients reach end-stage kidney failure over the years. Several therapeutic attempts have been proposed, with systemic steroids being the most prevalent, albeit burdened by possible serious adverse events. Thanks to the more in-depth knowledge of the pathogenesis of IgA nephropathy, new treatment targets have been identified and new drugs developed. In this narrative review, we summarise the molecules under clinical development for the treatment of IgA nephropathy. As a search strategy, we used PubMed, Google, ClinicalTrials.gov and abstracts from recent international congresses. TRF budesonide and sparsentan are the two molecules at a more advanced stage, just entering the market. Other promising agents are undergoing phase III clinical development. These include anti-APRIL and anti-BLyS/BAFF antibodies and some complement inhibitors. Other new possible strategies include spleen tyrosine kinase inhibitors, anti-CD40 ligands and anti-CD38 antibodies. In an era increasingly characterised by 'personalised medicine' and 'precision therapy' approaches and considering that the potential therapeutic armamentarium for IgA nephropathy will be very broad in the near future, the identification of biomarkers capable of helping the nephrologist to select the right drug for the right patient should be the focus of future studies. [ABSTRACT FROM AUTHOR]

What is this summary about? This summary describes the results of a clinical study called MANDALA that was published in the New England Journal of Medicine in 2022. In the MANDALA study, researchers looked at a new asthma rescue inhaler that contains both albuterol and budesonide in a single inhaler (known as albuterol–budesonide, AIRSUPRA™). This summary describes the results for people aged 18 yearsand older who took part in the study. [ABSTRACT FROM AUTHOR]

Background: Post-operative sore throat (POST) has an incidence ranging from 21 to 80%. To prevent the development of POST, several pharmacological measures have been tried. Aim of this study was to compare the efficacy of preoperative zinc, magnesium and budesonide gargles in reducing the incidence and severity of POST in patients who underwent endotracheal intubation for elective surgeries. Methods: We conducted a prospective, randomized, double-blind, controlled equivalence trial in 180 patients admitted for elective surgical procedures under general anaesthesia. Patients were randomised into three groups; group Z received 40 mg Zinc, group M received 250 mg Magnesium Sulphate and group B received 200 µg Budesonide in the form of 30 ml tasteless and colourless gargle solutions. Sore throat assessment and haemodynamic recording was done postoperatively at immediate recovery (0 h) and 2, 4, 6, 8, 12 and 24 h post-operatively. POST was graded on a four-point scale (0–3). Results: POST score was comparable at all recorded time points i.e. 0,2,4,6,8,12 and 24 h. Maximum incidence was seen at 8 h in group B (33.3%) and the minimum incidence was at 24 h in group Z (10%) (p > 0.05). It was found that the incidence of POST was more in the surgeries lasting longer than 2 h in all groups. This difference was found to be statistically significant in Groups M and B. The incidence of POST was found to be comparable between laparoscopic and open procedures. Conclusion: Magnesium, zinc and budesonide have an equivocal effect in the prevention of POST at different time points. The incidence of sore throat increases significantly in surgeries lasting more than two hours if magnesium or budesonide have been used as premedicant. Duration of surgery is an independent predictor for POST. Trial registration: CTRI/2021/05/033741 Date-24/05/2021(Clinical Trial Registry of India). [ABSTRACT FROM AUTHOR]

Background: Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants. Objective: This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS. Method: An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18. Results: Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05). Conclusion: These findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes. Trial registration: The study was registered at the Iranian Registry of Clinical Trials website under the code IRCT20201222049802N1. https://en.irct.ir/user/trial/48117/view. Registration date: 28/02/2021. Public repository: Data set This research data set link is displayed on the Zanjan-Iran Medical Sciences website: https://repository.zums.ac.ir/cgi/users/login? target=https%3 A%2 F/repository.zums.ac.ir/id/eprint. [ABSTRACT FROM AUTHOR]

Problem: To assess the efficacy of budesonide intrapolyp injection in chronic rhinosinusitis with nasal polyps. Method: Ninety patients were divided into three groups; group A was given oral prednisolone, group B was given budesonide intrapolyp injection weekly for five consecutive weeks and group C was given budesonide as nasal irrigation for one month. Patients were assessed using Sino-Nasal Outcome Test 22 score, total nasal polyp score, serum immunoglobulin E, absolute eosinophilic count, and morning cortisol level before treatment, one week and three months after completing their treatment. Results: Total nasal polyp score decreased significantly in all groups compared to those at baseline. Reduction in the oral and injection groups was greater than the wash group (p 2 = 0.004), (p 3 < 0.001), and the same trend concerning Sino-Nasal Outcome Test 22 score (p 2 < 0.001), (p 3 < 0.001). Conclusion: Budesonide is an effective agent used in intrapolyp injection with no documented systemic or visual side effects that has comparable results with oral steroids. [ABSTRACT FROM AUTHOR]

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The introduction of inhaled corticosteroids (ICSs) changed over a few decades the treatment focus of mild-to-moderate asthma from bronchodilation to reduction in inflammation. This was achieved by inhaling a suitable corticosteroid (CS), giving a high, protracted airway concentration at a low total dose, thereby better combining efficacy and tolerance than oral therapy. Successful trials with the potent, lipophilic "skin" CS beclomethasone dipropionate (BDP) paved the way, suggesting that ICSs require a very low water solubility, prolonging their intraluminal dissolution within airways. The subsequent ICS development, with resulting clinical landmarks, is exemplified here with budesonide (BUD), showing that a similar efficacy/safety relationship is achievable by partly alternative mechanisms. BUD is much less lipophilic, giving it a 100-fold higher water solubility than BDP and later developed ICSs, leading to its more rapid intraluminal dissolution and faster airway and systemic uptake rates. In airway tissue, a BUD fraction is reversibly esterified to intracellular fatty acids, a lipophilic conjugate, which prolongs airway efficacy. Another mechanism is that the rapidly absorbed bulk fraction, via short plasma peaks, adds anti-inflammatory activity at the blood and bone marrow levels. Importantly, these plasma peaks are too short to provoke systemic adverse actions. Controlled clinical trials with BUD changed the use of ICS from a last resort to first-line treatment. Starting ICS treatment immediately after diagnosis ("early intervention") became a landmark for BUD. An established dose response made BUD suitable for the treatment of patients with all degrees of asthma severity. With the development of the budesonide/formoterol combination inhaler (BUD/FORM), BUD contributed to the widely used BUD/FORM maintenance and reliever therapy (MART). Recent studies demonstrated the value of BUD/FORM as a generally recommended as-needed therapy for asthma ("anti-inflammatory reliever", AIR). These abovementioned qualities have all influenced international asthma management and treatment guidelines. [ABSTRACT FROM AUTHOR]

Background: Smoking and the use of non-steroidal anti-inflammatory drugs (NSAIDs) acetylsalicylic acid (ASA), proton pump inhibitors (PPIs), serotonin reuptake inhibitors (SSRIs), and statins have been associated with microscopic colitis (MC). Objectives: We investigated whether these factors were associated with repeated budesonide treatments in patients diagnosed with MC. Design: Retrospective observational study. Methods: All patients with a histologically verified diagnosis of MC at our clinic between the years 2006 and 2022 were identified. Baseline factors and drugs prescribed before and after diagnosis were registered. The influence of risk factors on the odds of having a prescription of oral budesonide and the odds of having a second course of budesonide was studied. Results: Patients with MC (n = 183) with a mean age of 62.3 years [standard deviation (SD): 13.3 years] were followed for a median of 5 years (25th–75th percentile 4–10 years) after diagnosis. In all, 138 patients (75%) had at least one prescription of budesonide after diagnosis, and 90 patients (49%) had at least one clinical relapse treated with budesonide. Patients who had been prescribed NSAIDs within 1 year before clinical relapse had higher odds for clinical relapse [odds ratio (OR): 3.70, 95% confidence interval (CI): 1.06–12.9] but there was no increased risk for clinical relapse for the use of ASA (OR: 0.99, 95% CI: 0.39–2.90), PPIs (OR: 1.09, 95% CI: 0.45–2.63), SSRI (OR: 1.41, 95% CI: 0.82–2.44), or statins (OR: 0.83, 95% CI: 0.35–1.99). No association was seen between being a smoker and/or being prescribed NSAID, ASA, PPI, SSRI, and statins at baseline and the odds of having a prescription of oral budesonide within 1 year after diagnosis. Conclusion: The risk of being prescribed a second course of budesonide is associated with receiving a prescription of NSAIDs but not with the use of ASA, PPIs, SSRIs, and statins. Plain language summary: The use of drugs and the odds for patients with microscopic colitis of having a second course of budesonide Microscopic colitis is a common cause of chronic diarrhea. Previous studies have shown that the use of non-steroidal anti-inflammatory drugs, acetylsalicylic acid, proton-pump inhibitors, serotonin reuptake inhibitors and statins are used more often in patients who later develop microscopic colitis. We aimed to study if these drugs also had an association to an increased risk of disease flares treated with budesonide in 183 patients with known microscopic colitis. Oral budesonide for 6-8 weeks are recommended for disease flares of microscopic colitis. In our study, 90 patients (49%) were prescribed a second course of budesonide probably due to a disease flare. We found a higher odds for being prescribed a second course of budesonide in patients with microscopic colitis who were prescribed non-steroidal anti-inflammatory drugs but no higher risk for the other 'risk drugs' for microscopic colitis. [ABSTRACT FROM AUTHOR]

The clinical benefits of using exogenous pulmonary surfactant (EPS) as a carrier of budesonide (BUD), a non-halogenated corticosteroid with a broad anti-inflammatory effect, have been established. Using various experimental techniques (differential scanning calorimetry DSC, small- and wide- angle X-ray scattering SAXS/WAXS, small- angle neutron scattering SANS, fluorescence spectroscopy, dynamic light scattering DLS, and zeta potential), we investigated the effect of BUD on the thermodynamics and structure of the clinically used EPS, Curosurf®. We show that BUD facilitates the Curosurf® phase transition from the gel to the fluid state, resulting in a decrease in the temperature of the main phase transition (Tm) and enthalpy (ΔH). The morphology of the Curosurf® dispersion is maintained for BUD < 10 wt% of the Curosurf® mass; BUD slightly increases the repeat distance d of the fluid lamellar phase in multilamellar vesicles (MLVs) resulting from the thickening of the lipid bilayer. The bilayer thickening (~0.23 nm) was derived from SANS data. The presence of ~2 mmol/L of Ca2+ maintains the effect and structure of the MLVs. The changes in the lateral pressure of the Curosurf® bilayer revealed that the intercalated BUD between the acyl chains of the surfactant's lipid molecules resides deeper in the hydrophobic region when its content exceeds ~6 wt%. Our studies support the concept of a combined therapy utilising budesonide—enriched Curosurf®. [ABSTRACT FROM AUTHOR]

The current budesonide formulations are inadequate for addressing left-sided colitis, and patients might hesitate to use an enema for a prolonged time. This study focuses on developing a single-layer coating for budesonide pellets targeting the descending colon. Pellets containing budesonide (1.5%w/w), PVP K30 (5%w/w), lactose monohydrate (25%w/w) and Avicel pH 102 (68.5%w/w) were prepared using extrusion spheronization technique. Coating formulations were designed using response surface methodology with pH and time-dependent Eudragits. Dissolution tests were conducted at different pH levels (1.2, 6.5, 6.8, and 7.2). Optimal coating formulation, considering coating level and the Eudragit (S + L) ratio to the total coating weight, was determined. Budesonide pellets were coated with the optimized composition and subjected to continuous dissolution testing simulating the gastrointestinal tract. The coating, with 48% S, 12% L, and 40% RS at a 10% coating level, demonstrated superior budesonide delivery to the descending colon. Coated pellets had a spherical shape with a uniform 30 µm thickness coating, exhibiting pH and time-dependent release. Notably, zero-order release kinetics was observed for the last 9 h in colonic conditions. The study suggests that an optimized single-layer coating, incorporating pH and time-dependent polymers, holds promise for consistently delivering budesonide to the descending colon. [ABSTRACT FROM AUTHOR]

Objective: To explore the effects of budesonide combined with Bifidobacteria and Lactobacilli on the lung function and intestinal microbiota of patients with chronic obstructive pulmonary disease (COPD). Methods: Clinical data of 124 COPD patients admitted to Fengcheng Hospital, Fengxian District, Shanghai from February 2021 to February 2023 were retrospectively analyzed. Patients either received budesonide treatment alone (n=59, control group) or budesonide combined with Bifidobacteria and Lactobacilli (n=65, observation group). Levels of lung function indicators, symptom relief time, gut microbiota levels, and quality of life were compared between the two groups before and after the treatment. Results: After two weeks of treatment, the improvement of lung function in the observation group was better than that in the control group (P<0.05). Compared to budesonide treatment alone, combined budesonide, Bifidobacteria, and Lactobacilli treatment were associated with shorter symptom relief time (P<0.05), and with more significant improvement of intestinal microbiota level (P<0.05) and the quality of life (P<0.05). Conclusions: Budesonide combined with Bifidobacteria and Lactobacilli can effectively alleviate clinical symptoms, regulate intestinal microbiota, improve lung function and the quality of life of COPD patients. [ABSTRACT FROM AUTHOR]

The outbreak of the COVID-19 pandemic has adversely affected the most important areas of the modern world. One of the challenges related to counteracting the effects of the pandemic it was necessary to develop methods for the quantitative determination of pharmaceuticals used in the treatment of patients suffering from this disease and its long-term effects. Budesonide (BUD) is a widely available and inexpensive corticosteroid used extensively not only among people suffering from COVID-19, but also asthma and other respiratory diseases. A significant increase in the consumption of drugs containing this component requires the development of new BUD determination methods, especially in real samples. This paper presents a new voltammetric method for BUD determination at renewable silver amalgam film electrode (Hg(Ag)FE). The electrochemical measurements were conduced in the supporting electrolyte containing 80% of methyl alcohol, 0.04 mol L−1 Britton–Robinson buffer (pH 3.0) and 20 mg mL−1 of NaClO4 under optimized differential pulse voltammetry (DPV) parameters. Detailed studies of the behaviour of the BUD on the surface of Hg(Ag)FE demonstrated the quasi-irreversible nature of the diffusion-controlled, two electrons and two protons reduction process. A calibration curve in the range from 1.0 to 290 µg mL−1 shows limit of detection and limit of quantification equal to 0.06 and 0.21 µg mL−1, respectively. The impact of numerous interferences over a wide range of concentrations on BUD signals was analysed and evaluated. The utility of the proposed method was verified by the quantitative analysis of BUD in two pharmaceutical products and the spiked water samples. [ABSTRACT FROM AUTHOR]

IgA nephropathy (IgAN), the most common primary glomerulonephritis worldwide, is characterized by a mesangial IgA deposit and a variety of histological lesions, as described by the Oxford classification system. Despite the well-described "four-hit hypothesis", there are still plenty of less or undescribed mechanisms that participate in the disease pathogenesis, such as B-cell priming, which seems to be initiated by different antigens in the intestinal microbiota. Diagnosis of the disease is currently based on kidney biopsy findings, as the sensitivity and specificity of the many serum and urinary biomarkers described so far do not seem to have diagnostic accuracy. Therapeutic strategies consist of the initial step of non-immune medication, aiming to reduce both the intraglomerular pressure and proteinuria to below 0.5 g/day, followed by systemic corticosteroid administration in patients who remain at high risk for progressive chronic kidney disease despite the maximum non-immune treatment. The 6-month systemic corticosteroid treatment reduces proteinuria levels; however, the increased possibility of adverse events and increased relapse rate after treatment raises the need for a new therapeutic approach. Targeted-release budesonide is a therapeutic modality that aims to inhibit disease pathogenetic pathways at early stages; it has minor systemic absorption and proven beneficial effects on renal function and proteinuria. In the present systemic review, the benefits and adverse events of steroids and budesonide are described, and the possibility of combined treatment is questioned in selected cases with active histologic lesions. [ABSTRACT FROM AUTHOR]

Background: The purpose of this work was to complex budesonide with cyclodextrin-based nanosponges to improve its solubility and stability. The current study focused on polysaccharide systems that have undergone minimal chemical alteration and have been used to target the colon. These targeted delivery and polysaccharide-based complexation methods are anticipated to aid in the creation of medication formulations for disorders affecting the colon, such as colorectal cancer. The goal of the current work was to use a Quality by Design (QbD) strategy to create budesonide-loaded nanosponges. The system consisted of nanosponges loaded with budesonide. Methods: Nanosponges were formulated through microwave-assisted synthesis. Studies on drug release were conducted with a method changing power of hydrogen (pH) with enzyme. Quality by Design-based optimization with a 32 full factorial design was applied for the optimization of the process parameters including the β-cyclodextrin:diphenyl carbonate ratio and the reaction time. Responses were measured for three dependent variables: practical yield, percentage drug release, and percentage drug release at the fifth hour. Results and Conclusions: The optimization model indicated a yield of 76.21%, a percentage drug release at the fifth hour of 24.61%, and a total drug release after 7 hours of 87.58%. The observed responses of the optimized process closely matched the predicted values. The above budesonide-loaded nanosponge formulations provide a targeted medicine for the colon and may be an effective method for treating colonic illness.

Background and Aim: To control complications in infants with respiratory distress syndrome, surfactants and auxiliary drugs such as budesonide are used to reduce the inflammatory reactions of the airways. The aim of this study is to compare the effect of intratracheal administration of survanta and survanta with budesonide in premature infants with respiratory distress syndrome. Materials and Methods: This clinical trial included 50 premature infants with respiratory distress syndrome, hospitalized in the neonatal intensive care unit in Qazvin Children's Hospital, in 2019. The patients were divided into two groups. One group (25 cases) received intratracheal survanta (1 milliliter) + budesonide (0.25 milligram) and the other group (25 cases) received only intratracheal survanta. Using SPSS 21 software, data were analyzed by descriptive statistics, Fisher's exact and T-test (p

Xu Zuo,1 Yinuo Gu,1 Xiaoping Guo,1 Wenxue Zheng,1 Haoyu Zheng,1 Yiming An,1 Caina Xu,2,3 Fang Wang1,3 1Department of Pathogeny Biology, College of Basic Medical Sciences, Jilin University, Changchun, 130021, People’s Republic of China; 2Department of Biochemistry, College of Basic Medical Sciences, Jilin University, Changchun, 130021, People’s Republic of China; 3Key Laboratory of Pathobiology, Ministry of Education, Jilin University, Changchun, 130021, People’s Republic of ChinaCorrespondence: Caina Xu; Fang Wang, Email xucaina@jlu.edu.cn; wf@jlu.edu.cnPurpose: Inhaled corticosteroids, including budesonide (BUD), are widely employed for the treatment of asthma. However, the frequent use of corticosteroids is associated with numerous adverse effects and poses challenges to ongoing drug therapy and patient adherence. Budesonide liposomal nanoparticles (BUD-LNPs) were developed to improve the bioavailability of the drug and thereby improve the effectiveness of asthma treatment.Methods: BUD-LNPs were prepared via thin-film hydration, and the characterizations, stability, and in vitro release of BUD-LNPs were studied. In vitro cellular uptake was observed by laser-scanning confocal microscope (LSCM) and flow cytometry. And the in vitro anti-inflammatory activity of BUD-LNPs was evaluated by measuring the expression of pro-inflammatory cytokines in activated macrophages. Besides, the accumulation time in the lung of drugs delivered via liposomal carriers and free drugs was compared in vivo. And the in vivo therapeutic efficacy of BUD-LNPs was assessed in OVA-induced asthmatic mice. Finally, in vivo biosafety assessment was performed.Results: The particle size, PDI, and zeta potential of BUD-LNPs were 127.63± 1.33 nm, 0.27± 0.02, and 3.33± 0.13 mV, respectively. BUD-LNPs exhibited excellent biosafety and anti-inflammatory activity in vitro. Furthermore, compared with the free drugs, the utilization of liposomal nano-vehicles for drugs delivery could effectively extend the duration of drugs accumulation in the pulmonary system. Additionally, treatment with BUD-LNPs alleviated airway hyperresponsiveness, reduced airway mucus secretion, and mitigated pulmonary inflammation in OVA-induced asthmatic mice. And the BUD-LNPs demonstrated superior therapeutic efficacy compared to free BUD.Conclusion: BUD-LNPs was successfully prepared with excellent stability and sustained release for 24 h in vitro. The data of anti-inflammatory activity, asthma therapeutic effects and safety studies indicated that drug delivery mediated by liposomal nano-vehicles was a feasible and desirable strategy for medical strategy and showed great promise in the clinical therapy of asthma.Keywords: liposomal nanoparticles, asthma, budesonide, pulmonary delivery, nano-vehicles

Background IgA nephropathy (IgAN) is the most common primary glomerulonephritis in China and worldwide, approximately 25%-30% of patients will progress to end-stage renal disease within 20 years after diagnosis. Currently, there is no effective and safe treatment specifically for IgAN. In recent years, there has been a rapid progress in the research of new drugs for IgAN, among which the targeted delayed-release budesonide capsules is the first allopathic drug for IgAN globally. Objective To investigate the mechanism of corticosteroid budesonide capsules in the treatment of IgAN based on network pharmacology. Methods Chemical Book platform was used to screen the targets of budesonide; GeneCards and CTD databases were utilized to obtain the relevant targets of IgAN. The intersection of budesonide targets and IgAN targets was obtained through a Venn diagram. A protein-protein interaction (PPI) network map was constructed, and gene ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis were performed on the intersecting targets. Results A total of 242 targets for budesonide, 1 443 candidate targets for IgAN, and 146 intersecting targets were selected. The 15 core targets in the PPI network included interleukin-6 (IL-6), tumor necrosis factor (TNF), interleukin-10 (IL-10), vascular endothelial growth factor A (VEGFA), epidermal growth factor receptor (EGFR), interleukin-1B (IL-1B), interleukin-4 (IL-4), interleukin-8 (CXCL8), gene on chromosome 1 (JUN), interleukin-13 (IL-13), interleukin-2 (IL-2), chemokine 2 (CCL2), toll-like receptor 4 (TLR4), colony-stimulating factors (CSF2), and albumin (ALB). Enrichment analysis revealed 1 646 GO enrichment results and 174 KEGG signaling pathways. The biological processes (BP) mainly involved positive regulation of phosphorylation, inflammatory response, and positive regulation of cell movement. The cellular components (CC) mainly involved cytoplasmic vesicle lumen, cyst cavity, and secretory granule lumen. The molecular functions (MF) mainly involved receptor signaling activity, receptor regulator activity, and receptor ligand activity. The KEGG signaling pathways mainly included interleukin 17 signaling pathway, cytokine-cytokine receptor interaction, pathways in cancer, and tumor necrosis factor signaling pathway. Conclusion This study provides preliminary verified that budesonide can treat IgAN by targeting IL-6, TNF, IL-10, VEGFA, EGFR, and other targets, through multiple signaling pathways, like cytokine-cytokine receptor interaction, interleukin-17 signaling pathway, pathways in cancer, and tumor necrosis factor signaling pathway, providing a theoretical basis for further research and clinical practice of budesonide.

Currently, there is an increase in the incidence of microscopic colitis. There are difficulties in diagnosing this disease due to the variability of histological signs, variability of morphological changes in the mucous membrane of the colon in different parts of the colon, and the combination in one patient of not only various forms of microscopic colitis, but also other intestinal diseases. The article describes the differential diagnosis, an example of its staging and successful treatment of various forms of microscopic colitis with budesonide (two clinical cases presented).

Background/Objectives: Paediatric eosinophilic oesophagitis (EoE) treatment is challenging due to the limited number of age-appropriate formulations. This study aims to develop and evaluate oral viscous suspensions and solid formulations of budesonide (BUD), focusing on their in vitro mucoadhesive properties, to enhance drug delivery and therapeutic outcomes in paediatric EoE. Methods: This study encompasses the development of oral viscous suspensions and orodispersible solid formulations (moulded tablets and 3D-printed dosage forms) containing BUD. The formulations underwent quality control tests as per the European Pharmacopoeia, chemical stability assessments, and an in vitro evaluation of their mucoadhesiveness properties. Results: A validated analytical method enabled accurate BUD quantification and efficient extraction, and all developed formulations demonstrated chemical stability for 30 days, meeting Ph. Eur. quality standards. Three-dimensional printing using SSE successfully produced 1 mg and 0.5 mg BUD printlets, complying with quality tests for conventional tablets. Formulations containing xanthan gum (L2-XG and P1-0.5-XG) exhibited superior mucoadhesive properties. L2-XG showed significantly higher mucoadhesion than L1-MC. Among the solid formulations, P1-0.5-XG demonstrated the highest mucoadhesive properties. Conclusions: This is the first study to develop solid oral dosage forms of BUD at a very low dose, specifically for paediatric use. The results highlight the potential of 3D printing for developing individualised orodispersible BUD formulations with improved bioadhesion for paediatric EoE treatment. The L2-XG formulation and the XG-containing printlets are the most promising formulations in terms of increasing contact time with the oesophageal mucosa, which could translate into improved therapeutic efficacy in this patient population.

Recombinant AAV (rAAV) vectors are increasingly favored for gene therapy due to their useful features of vectorology, such as transfection of dividing and nondividing cells, the presence of tissue-specific serotypes, and biosafety considerations. This study investigates the impact of commonly used therapeutic drugs—acetaminophen, budesonide, and simvastatin—on rAAV transduction efficiency in HEK-293 cells. Cells were transduced with an AAV mosaic vector under the control of a cytomegalovirus (CMV) promoter encoding green fluorescent protein (GFP). Transduction efficiency was assessed by qPCR and fluorescent microscopy. Analysis of functional interactions between genes potentially involved in rAAV transduction in drug-exposed cells was also performed. This study showed a clear effect of drugs on rAAV transmission. Notably, acetaminophen enhanced transduction efficiency by 9-fold, while budesonide and simvastatin showed 2-fold and 3-fold increases, respectively. The gene analysis illustrates the possible involvement of genes related to cell membranes in the potentiation of rAAV transduction induced by the drugs under investigation. Attention should be paid to S100A8, which is a common drug-modified gene for drugs showing anti-inflammatory effects (budesonide and simvastatin), demonstrating an interaction with the gene encoding the receptor for AAV (HGFR). This study underscores the significance of assessing rAAV pharmacokinetics/pharmacodynamics (PKs/PDs) and drug–gene therapy interactions in optimizing gene therapy protocols.

Microbiotically activated ileo-colonic delivery of budesonide from compression coated tablets with considerably reduced carboxymethyl chitosan (CMCH) concentration was designed and investigated. CMCH was synthesized from chitosan dissolved in 20%w/v sodium hydroxide (NaOH) with monochloroacetic at 40 ± 5 °C and characterized by proton NMR, FTIR and Degree of Substitution. The microbiotically activated compression coated tablets (MACC-TABs) were prepared by wet granulation and compression coated with Eudragit S100: HPMC K100M in different ratios for enteric protection and ileo-colon selectivity. Dissolution studies without enzymes and in the presence of enzymes such as pepsin at pH 1.2, diastase and pancreatin at pH 6.8, the F1C3 did not show significant changes. Addition of colonic enzymes at the tenth hour resulted in significant increase in release of budesonide. The % Cumulative Drug Release was 98.49 ± 1.42%, due to the enzymatic triggering (produced by the colonic microflora) leading to the lysis of glycosidic bonds. Scanning electron microscopy revealed the pores formed after dissolution was due to the water-soluble nature of CMCH to release budesonide. The evidence during in-vitro dissolution studies confirmed the pH sensitivity along with microbiotic activation of the MACC-TABs tablets to efficiently and reproducibly release budesonide in the ileo-colon site in the presence of the bacterial enzymes. [ABSTRACT FROM AUTHOR]