Nasal Spray Research Articles

Allergic fungal rhinosinusitis (AFRS) is a highly recurrent form of chronic allergic rhinosinusitis in immunocompetent patients. This study aims to compare the recurrence rates of AFRS between patients who received nasal steroid spray alone and patients who received a combination of nasal and oral steroids after endoscopic sinus surgery. This was a retrospective chart review of patients who underwent endoscopic sinus surgery for AFRS. The selection of the 39 participants has followed the 5 aspects of Bent and Kuhn criteria. Patients were divided into 2 groups: those discharged on both nasal and oral steroids (combination group) and those discharged on nasal steroids alone (local therapy group). All patients were followed for 3 years post operatively, and multiple assessments done for disease recurrence. One patient from 13 patients in the combination therapy group (7.7 %) and 9 patients from the 26 patients in the local therapy group (34.6 %) had recurrence of the condition and underwent functional endoscopic sinus surgery revision surgery (Fisher Exact Test = 3.30, P = .069). AFRS has recurred more frequently among patients who had bilateral disease (33.3%) compared to those who had unilateral disease (0%) (Fisher Exact Test = 4.03, P value = .045). In the postoperative medical management in ARFS, the combination of a short course of oral prednisolone and nasal steroid spray maybe effective to lower the recurrence rate of the disease when compared to nasal steroid spray alone.

Background Specific immunoglobulin Y (IgY) is widely used in immunotherapy, with expanding applications in body care products. Topically applied influenza-specific antibodies may provide an alternative strategy for preventing respiratory infections. Objective This study aimed to evaluate the stability and biological activity of influenza-specific IgY in various body care products. Methods The biological activity of influenza-specific IgY was evaluated in various body care products at different concentrations. Commercial face mists contained 5% and 10% w/v IgY, face mists and nasal sprays contained 0.5% w/v IgY, lip balm, sunscreen, and hand cream contained 0.1% and 0.25% w/v IgY. The products were stored at room temperature for four weeks, and organoleptic changes were monitored weekly. IgY activity was assessed by enzyme-linked-immunosorbent-assay (ELISA). Results In both face mist products, the aroma gradually became fishy, the color remained stable, and turbidity increased. The biological activity of IgY was still detectable by ELISA at concentrations of 0.5%, 5%, and 10%. In nasal spray, no changes in aroma, color, or turbidity were observed, but IgY activity was not detectable. In lip balm, sunscreen, and hand cream, only slight color changes occurred without any change in aroma, and IgY activity was not detected. Conclusion Influenza-specific IgY retained biological activity in face mist formulations at higher concentrations (≥0.5%) despite observable changes in aroma and turbidity. In contrast, IgY activity was not detected in nasal sprays, lip balm, sunscreen, or hand cream, suggesting that the formulation type and IgY concentration significantly influence its stability and detectability in body-care products.

Background: Etripamil nasal spray is a fast-acting, calcium channel blocker in development for the conversion of paroxysmal supraventricular tachycardia (PSVT) outside of a health-care setting. Studies have demonstrated the favorable safety and efficacy of self-administered etripamil in restoring sinus rhythm (SR) and reducing emergency department visits. Purpose: This report analyzes the efficacy, safety, and test-dose tolerability of etripamil across PSVT clinical studies. Methods: We systemically examined randomized, controlled and open-label trials evaluating etripamil in patients with PSVT. Efficacy measures included the proportion of patients converting from PSVT to SR within 30 minutes and the median times to conversion across all Phase 3 studies. Safety data for treatment-emergent adverse events (TEAEs), serious AEs, and test dose tolerability from Phase 2/3 studies were summarized descriptively. Results: NODE-1, NODE-301 Part 1, NODE-301 Part 2 (RAPID, including RAPID Extension, RAPID Open Label, RAPID Open Label Extension periods), NODE-302, and NODE-303 studies were analyzed (Table 1). The Kaplan-Meier estimate of etripamil exposed patients converting to SR within 30 minutes (n= 622) was 59.6% (range, 53.6% to 64.3%) with a median time to conversion of 18.5 minutes (95% CI, 15.7 to 21.0). The proportions of RCT placebo group patients converting from SVT to SR by 30 minutes ranged from 26.7% to 34.7%. Estimates of conversion of SVT to SR with etripamil at 60 minutes for individual studies ranged from 63.2% to 73.5% (Figure). Combined analysis showed mainly the occurrence of mild, transient TEAEs, primarily nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis (Table 2). 1,107 patients took at least one etripamil test dose while in SR; no significant change in average baseline heart rate or blood pressure was observed within 45 minutes of administration, and test dose failure occurred in only 16 patients (1.4%). Conclusions: Across multiple clinical studies of acute PSVT management, self-administered etripamil consistently demonstrated robust efficacy and a favorable safety profile for acute PSVT management. Safety data and the low rate of test dose failures indicate favorable tolerability, suggesting no need for a pretreatment test dose. These findings support the potential of etripamil as a patient-administered therapy for PSVT, which may reduce reliance on emergency care.

Intranasal delivery of monoclonal antibodies (mAb) offers an attractive approach for preventing or treating respiratory viral infections. Previously, we showed that thin-film freeze-dried powder (TFFD powder) of AUG-3387, an anti-SARS-CoV-2 spike protein mAb, could be sprayed into the posterior nasal cavity region of a nasal cast model using Aptar's unidose powder (UDSp) nasal spray system. This work investigated the feasibility of filling TFFD mAb powders into the UDSp system using drum filling. New TFFD AUG-3387 powders were prepared by including magnesium stearate and/or hydroxypropyl methylcellulose in them. The powders were comminuted and their flow properties measured. A selected powder was filled into UDSp systems using a Harro Höfliger Drum TT benchtop filler or a Quantos hand-held powder dispenser at target fill weights of 0.5 and 1.0mg, and the performance of the filled systems was evaluated. The F8 TFFD AUG-3387 powder was selected for drum filling due to its 'passable' to 'excellent' flowability and its minimal sensitivity to controlled moisture exposure. Drum filling succeeded at both target fill weights, consistently compacting the powder into pucks without ejection failures. The average fill weight was 0.54 ± 0.09mg for the 0.5mg target and 1.11 ± 0.08mg for the 1.0mg target. The drum-filled UDSp systems performed similarly to the Quantos-filled systems in shot weight uniformity, emitted particle size, and deposition in a nasal cast, although differences were observed in certain spray characteristics. It is feasible to drum fill TFFD mAb powder at low fill weights.

Improving the efficacy and targeting of carvedilol for the management of diabetes-accelerated atherosclerosis: An in vitro and in vivo assessment.

Multicomponent nasal spray delivered via penetration-enhancer containing vesicles (PEVs) for antioxidant and antibacterial protection

Progress towards a prodrug/enzyme intranasal delivery system for rapid prevention/reversal of seizure emergency.

Maximising olfactory deposition of a valproic acid (VPA)-loaded nanostructured lipid carriers (NLC) formulation.

Patient-reported preferences for sleep apnoea treatments in an Australian community sample.

A nasal spray is a liquid medication delivered into the nasal cavity through a spray device for local or systemic therapeutic effects. It is a non-invasive drug delivery system that offers several advantages, including ease of administration, rapid onset of action, avoidance of first-pass metabolism, and improved patient compliance. The nasal cavity has a rich blood supply and a large surface area, which enables quick absorption of drugs directly into the bloodstream. Additionally, nasal sprays can deliver drugs directly to the brain through the olfactory and trigeminal nerve pathways, bypassing the blood–brain barrier. This makes them suitable not only for treating local conditions such as allergic rhinitis, nasal congestion, and sinusitis but also for systemic conditions like migraines, hormonal deficiencies, and certain neurological disorders. Nasal sprays can be formulated as solutions, suspensions, emulsions, or dry powders and often contain excipients to enhance drug absorption, stability, and patient comfort. Their user-friendly design allows for self-administration, making them a convenient and effective alternative to oral or injectable routes of drug delivery. With ongoing advancements in nanotechnology, biotechnology, and formulation science, nasal sprays are expected to play an even larger role in drug delivery. Innovations such as mucoadhesive nanoparticles, thermosensitive gels, and targeted delivery systems are expanding the potential of nasal drug delivery for complex conditions, including neurodegenerative diseases and systemic infections. This review discusses the key parameters influencing nasal spray performance, emphasizing the morphological, physiological, histological characteristics of the nasal cavity, Ideal drug candidates, possible drugs for nasal spray, nasal spray devices that are used to introduced drug into nasal cavity. Components of nasal spray container and that affect drug formulations and pharmacokinetics.

The Immune defence trial documented short term impacts on RTIs for nasal sprays, and a stress-management and physical activity website. To estimate the impact of sprays and the website after 12 months. Four arm parallel randomised controlled trial Setting. Participants with co-morbidities and/or >=3 self-reported recurrent illnesses recruited by mailed invitation. Methods Participants were randomised by online software (stratified by recurrent illness and comorbidities) to i) usual care (n=3451) ii) Vick's First-Defence (VFD) spray (n=3448) (2 sprays/nostril, <=6x/day) iii) isotonic saline spray (n=3450) (same dosing) or iv) a website promoting physical activity and stress-management (n=3450). respiratory illness days. Usual care participants (n=3051) had on average 22 illness days, reduced by VFD ((n=3076; 18 days, adjusted incidence rate ratio (IRR) 0.84, 99% CIs 0.79,0.90; p<0.0001), and saline (n=3142; 18 days, IRR 0.83; 0.78,0.89; p<0.0001), but not the website (n=2811; 20 days, IRR 0.94;0.88,1.01, p=0.03)). The website reduced incident infections (0.96,0.93 to 0.99, p=0.006). All interventions reduced symptom severity and work-days lost, both spray groups reported lower intention to consult and fewer falls, and there were fewer antibiotic courses and practice visits with saline. Among those with recurrent illness saline had the most impact on both recurrence and symptom days (respectively 0.93 (0.87,0.99), 0.70 (0.60,0.82)). Headache were higher for VFD and lower for saline (7.8%, 3.4% respectively; 4.7% usual care). Widely available, inexpensive sprays and a website promoting self-care reduce the incidence, duration and/ or severity of RTIs and impact work-days lost and healthcare use.

Ischaemic stroke (IS) occurs when there is a deprivation of oxygen and nutrients in brain tissue. Diabetes mellitus (DM) is recognised as a possible factor contributing to this illness. Carvedilol exhibits anti-stroke effects; however, its insolubility and short half-life contribute to its ineffectiveness. The goal of this study was to create carvedilol-novasomes (CNF) nanovesicles for nasal spray as a potential DM-associated IS treatment that would increase sustainability, bioavailability, targeting and effectiveness of carvedilol. To optimise different CNF formulations, the Box-Behnken design was utilised. The optimal CNF formulation underwent in vivo evaluation in an experimental rat model of DM-associated IS. The optimal CNF formulation enhanced sustainability, bioavailability and permeability of carvedilol by 71.93%, 5.79-fold and 7.30-fold, respectively. The optimal CNF demonstrated anti-ischaemic effects by significantly enhancing various measures, including flexion, spontaneous motor activity, grip strength and target quadrant location time, with improvements of 93.72%, 88.53%, 96.57% and 353%, respectively, in comparison to the positive control group. The optimal CNF also improved the drug’s targeting to the brain. These results indicate that a nasal spray formulation of the optimal CNF could serve as a promising therapy for DM-associated IS.

ObjectiveDescribe time trends during 17.5 years of community-based naloxone distributionMethodsAnalysis of administrative records from a harm reduction program in Pittsburgh, Pennsylvania, USA, collected during encounters for overdose education, naloxone dispensing and refills. Monthly time trends were analyzed using segmented regression. Programmatic context aided interpretation of quantitative findings. We also evaluated impacts of 2014 state legislation loosening naloxone prescribing requirements and providing Good Samaritan protections.ResultsFrom July 2005 to January 2023 there were 16,904 service encounters by 7,582 unique participants, resulting in 70,234 naloxone doses dispensed, with 5,521 overdose response events (OREs), utilizing 8,756 naloxone doses. After legislation, new participants increased from 10.4 to 65.9 per month. New participants tended to be older (46 vs. 37 years), female (58% to 35%), White race, and more likely to be family/friends as opposed to people who use drugs themselves. Consequently, ORE per participant fell from 1.46 to 0.47 in the year after enactment. On average, 1.63 (95% CI: 1.60, 1.65) naloxone doses were administered per ORE, which did not change substantially over 17 years (χ2 = 0.28, 3 df, p = 0.60) during evolution from prescription opioids, to heroin, to illicitly manufactured fentanyl. In 98.0% of OREs the person who experienced overdose “was okay”, i.e., survived. Emergency medical services were called in 16% of OREs overall, but <7% since 2019. There were 106 more emesis events per 1,000 OREs with 4 mg nasal spray compared to intramuscular injection; and 48 per 1,000 more reports of anger. Titration of intramuscular naloxone was associated with lower rates of adverse events.ConclusionsWhile state legislation created the environment for expansion, reaching previously underserved communities required intentional new programmatic development and outreach. Long-term consistency of <2 doses per ORE, high survival rate, and robust utilization all lend confidence in prioritizing naloxone distribution directly to people who use drugs and their social networks.Trial registration: This investigation was pre-registered https://osf.io/b2f4h

Disclosure: M. Kashat: None. L. De Mattei: None. D. Shelden: None.Introduction: Septo-optic dysplasia (SOD) is a rare, congenital brain disorder characterized by a triad of optic nerve hypoplasia, midline brain malformation, and hypothalamic-pituitary axis (HPA) dysfunction, including central diabetes insipidus (CDI). This report describes a patient with CDI, optic nerve hypoplasia, attention-deficit/hyperactivity disorder (ADHD), and other neurological manifestations secondary to SOD in the absence of clinical manifestations of panhypopituitarism. Clinical Case: A 20-year-old female with a history of SOD with CDI presented with polyuria and polydipsia. She was diagnosed with SOD at the age of 2 months due to maternal cytomegalovirus (CMV) transmission. She was previously on Synthroid, hydrocortisone, and growth hormone injections for presumed hypopituitarism. She is only on desmopressin nasal spray. She has regular menses with no symptoms of adrenal insufficiency or hypothyroidism. Water deprivation test showed a copeptin proAVP <2.8, UNa: 37, serum Osm: 314, urine Osm: 149, Na: 150, and Cl:118 consistent with CDI. Thyroid function demonstrated a TSH of 1.47 and free T4 of 0.9 without therapy. FSH, LH, ACTH, and IGF-1 are pending with no hypoglycemia and electrolyte abnormalities. Brain MRI showed an absent septum pellucidum and posterior pituitary bright spot with normal pituitary gland. She was initiated on subcutaneous desmopressin per preference. It is atypical to appreciate a normal pituitary gland in SOD on imaging. Conclusion: Dysfunction of HPA is a classic finding of SOD. Panhypopituitarism is seen in 62% to 80% of SOD cases that can be seen before the age of 2 with optic nerve hypoplasia, absent septic pellucidum and corpus callosum, and hypoplastic or absent pituitary stalk. Growth hormone deficiency, central hypothyroidism, and secondary and tertiary adrenal insufficiencies are common pituitary dysfunctions associated with the condition. Severe cases of panhypopituitarism present with hypoglycemia, genital anomalies, and failure to thrive. In the rarest cases, CDI is observed. Experts recommend screening HPA dysfunction every 4 to 6 months within the first 2 years of life, and every 6 to 12 months between 2 to 8 years, and yearly throughout puberty. There are no formal guidelines on HPA evaluation in SOD after puberty. This case exhibits a variation of SOD which features optic nerve hypoplasia, absent septum pellucidum, and CDI with clinically intact HPA and a normal pituitary gland on imaging.Presentation: Saturday, July 12, 2025

This article presents the results of a study on the rheological characteristics of in situ thermosensitive nasal gels based on poloxamer 407 (P407) and their effect on spray angle. The development of new drug delivery systems based on in situ thermosensitive gels can overcome several shortcomings of traditional nasal sprays associated with mucociliary clearance and low mucoadhesion. Using the cold method, samples based on P407 were prepared in pure form, in combination with poloxamer 188 (P188), and with the addition of several mucoadhesive polymers: chitosan, sodium alginate, and hydroxypropyl methylcellulose (HPMC). Analytical studies were carried out for all obtained samples, which showed that the gelling temperature (Tsol–gel) of compositions with P407 was inversely dependent on its concentration, decreasing from 32.71 °C to 24.63 °C. The addition of hydrophilic P188 increased Tsol–gel. The addition of mucoadhesive polymers had varying effects on Tsol–gel: chitosan and HPMC increased the temperature, while sodium alginate decreased it. The addition of mucoadhesive polymers significantly affected the viscosity of the formulations; for example, the addition of sodium alginate resulted in a fivefold increase, making the formulations unsuitable for spraying. A study of the spray angles of Tsol–gel samples in the range of 27–31 °C using the SprayVIEW measuring system revealed an inverse relationship between the viscosity of the formulations and the spray angle. A mathematical model of the solution droplet trajectory was presented, enabling the spray angle to be predicted depending on the formulation composition. The relative error of the computational experiments did not exceed 10%. This approach has the potential to reduce the number of full-scale experiments, and consequently their cost.

Zavegepant is the only calcitonin gene-related peptide antagonist approved as a nasal spray in the United States for acute treatment of migraine in adults with or without aura. This Phase 1, open-label study evaluated the pharmacokinetics, safety, and tolerability of a single intranasal dose of zavegepant 10mg in 12 healthy Chinese adults. Blood samples were collected for pharmacokinetic assessment prior to dosing and from 5 min to 24 h post dose. Geometric mean values for the primary pharmacokinetic parameters were 53.53 ng h/mL for area under the plasma concentration-time curve (AUC) from time zero to infinity, 44.25 ng h/mL for AUC from time zero to time of last quantifiable concentration, and 20.32ng/mL for maximum plasma concentration (Cmax). Secondary parameters included time to Cmax (median, 0.58 h), apparent clearance (geometric mean, 186.8 L/h), apparent volume of distribution (geometric mean, 2943 L), and terminal half-life (arithmetic mean, 11.0 h). Results were comparable to exposures observed previously in non-Asian healthy participants following a single intranasal dose of zavegepant 10mg. Zavegepant demonstrated a favorable safety profile, with no serious or severe adverse events and no clinically relevant findings regarding laboratory tests, vital signs, or electrocardiograms observed.

Background: Several studies suggest that exogenous oxytocin nasal spray may enhance placebo analgesia in healthy volunteers and experimental pain models, although the findings remain mixed. The oxytocin placebo hypothesis suggests that increased oxytocin levels trigger a cascade of brain processes that boost positive expectations and augment the placebo response. Since endogenous oxytocin secretion has been found to increase during positive interactions, we hypothesized that changes in endogenous oxytocin levels will affect placebo analgesia in chronic-back-pain patients. Given the role sex has in both placebo analgesia and oxytocin secretion, we hypothesized that the response magnitude will differ by sex. Methods: Chronic-back-pain patients (n = 112) were prospectively recruited and received placebo injections. The placebo response was calculated as the change in the back-pain Visual Analog Score (VAS), and changes between pre- and post-injection salivary oxytocin levels were measured. The effect of sex and changes in oxytocin levels on pain reduction was calculated using two-way analysis of variance (ANCOVA). Results: Oxytocin levels decreased in 62.5% of participants and increased in 37.5%. Increased oxytocin levels were associated with greater pain reduction than decreased oxytocin levels (p = 0.024). Females exhibited greater pain reduction than males (p = 0.034). No interaction between the oxytocin change pattern and sex was observed. Conclusions: This study demonstrates that following a placebo injection, patients suffering from chronic back pain, who exhibited an increase in endogenous oxytocin levels, showed a higher placebo response. Females had a greater placebo response, but this was not associated with an endogenous oxytocin change. These results provide initial support for the oxytocin placebo hypothesis.

This case report discusses a 62-year-old male with treatment-resistant bipolar II depression and hypertension. After poor responses to multiple treatments, an add-on esketamine nasal spray (ESK-NS) was introduced in October 2022. Improvement was seen, and the patient's depressive episode was nearly remitted during the maintenance phase. However, recurrence was noted when ESK-NS frequency was reduced to once every 2 months, indicating that the dosing frequency should be adjusted cautiously. The patient experienced common side effects, including dissociation, dizziness, and transient hypertension. Nifedipine was offered when his systolic blood pressure exceeded 160 mm Hg, accompanied by headache or dizziness. Blood pressure monitoring was essential throughout ESK-NS treatment. This report highlights esketamine's potential for bipolar depression treatment and calls for further studies on its cardiovascular effects and proper management.

BackgroundDexmedetomidine nasal sprays is effective for perioperative sedation, analgesia, and anxiolysis. Nevertheless, its impact on postoperative sleep quality along with the optimal dosage and overall efficacy remains unclear in patients undergoing laparoscopic gynecological surgery.MethodsA total of 150 adult patients undergoing laparoscopic gynecological surgery were enrolled, with 144 included in the final analysis. Patients in the dexmedetomidine (Dex) group received 50 µg of intranasal dexmedetomidine 30 minutes before sleep on the first postoperative night, while the control group received an equivalent volume of saline. Primary outcomes included objective sleep parameters (sleep duration, deep sleep duration, REM sleep duration and light sleep duration) measured via a portable sleep monitor, as well as subjective sleep parameters assessed by Athens Insomnia Scale (AIS) and Numerical Rating Scale (NRS) scores one night before and on the first night after surgery. Secondary outcomes comprised postoperative pain measured by VAS, nausea and vomiting, and average heart rate.ResultsThe sleep duration, deep sleep duration and REM sleep duration of patients in the control group decreased after laparoscopic gynaecological surgery (vs preoperative control group, P=0.021, P<0.001, P=0.005, respectively), whereas the fragmented sleep duration and NRS score increased (vs preoperative control group, P=0.017, P=0.032, respectively) . In contrast, those treated with dexmedetomidine (Dex group) exhibited significantly improved sleep quality postoperatively, with greater sleep duration, deep sleep duration, and REM sleep durations (vs control group, P<0.001, P<0.001, P<0.001, respectively). There were no significant differences in postoperative pain or nausea and vomiting between the two groups.ConclusionDexmedetomidine nasal sprays improved postoperative sleep quality in patients who underwent laparoscopic gynaecological surgery.Trial RegistrationChinese Clinical Trial Registry (clinical trial number: ChiCTR2400080181).

Evaluation of rayleigh jet atomizer for intranasal delivery of lipid nanoparticle-siRNA formulations: stability, deposition, and device performance.