Nasal Preparations Research Articles

Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery: A Randomized Three-Arm Controlled Trial

Abstract Objective Transnasal skull base surgery is a complex and invasive procedure that involves the use of preoperative antiseptic preparations. However, evidence supporting their use in preventing postoperative infectious complications is limited. The aim of this study is to assess the efficacy of preoperative antiseptic techniques in reducing postoperative infectious complications within 30 days of surgery. Methods A multicenter, prospective, randomized, single-blind, three-arm trial was conducted from February 2019 to October 2021. Participants were randomized to either of three antiseptic preparation techniques: external 0.9% NaCl nasal preparation, external 0.05% chlorhexidine gluconate, or intranasal irrigation with 80 mg of gentamicin added to 1,000 mL of 0.9% NaCl plus external nasal preparation with chlorhexidine gluconate 0.05%. A total of 130 adults with skull base pathologies were randomized; 12 were excluded before randomization for failure to meet the inclusion criteria (n = 9) or refusal to participate (n = 3). We excluded patients with evidence of infection adjacent to the surgical site, allergies to preparation methods, those who underwent craniotomy during the same admission, and pediatric patients. Results The mean age of the participants was 43.26 ± 14.45 years. Nine patients developed postoperative infections (meningitis, n = 8; sinusitis, n = 2). Among the factors studied, length of surgery (p = 0.002), perioperative cerebrospinal fluid (CSF) diversion (p = 0.01), chordoma (p = 0.004), extended approach (p = 0.026), and postoperative CSF leak (p = 0.025) were significantly associated with postoperative infections. There were no clinically meaningful or significant differences in the studied intervention groups regarding postoperative infectious complications. Conclusion Preoperative antiseptic techniques failed to prefer one application to prevent postoperative infectious complications in patients who underwent endoscopic transnasal skull base surgery.

Visualization and quantitative evaluation of aerosol deposition using 3D-printed adult nose cavities

Local steroid medication is one of the most important treatment options for chronic rhinosinusitis. Regional deposition has a higher clinical value compared with total deposition in predicting treatment outcomes or evaluating adverse reactions. The goal of this project is to propose an effective technique for visualizing and quantifying aerosol deposition in a three-dimensional adult nasal cavity, and to verify the practicality of this method. Three-dimensional (3D) nasal cavity models were constructed from computed tomography (CT) scans of one post-operative rhinosinusitis subject using imaging software. The nasal cast was coated with a water-indicating paste and deposited with saline; a liquid dressing was added to visualize the progress. The quantity of liquid dressing was evaluated via HPLC and the liquid deposition was analyzed within the nasal cast cavity. Herein, 98.77 % of the particles generated by the nebulizer were over 5 μm, suggesting that most of the aerosol could effectively enter the nasal cavity instead of the lower respiratory system. The liquid dressing was mainly deposited in the nasal cavity, ethmoid sinus, and frontal sinus according to the visualization tests. HPLC results suggested that the main deposits were the frontal sinus (up to 41.80 %) as well as in the sphenoid sinus and ethmoid sinus (14.00 %). The large particle nebulizer (BM-TCA) generally led to better deposition in sinus areas when compared to the smaller particle nebulizer (PARI). This technology allows for in vitro testing of various types of nasal preparations and equipment under various test methods.

Review of Intranasal Active Pharmaceutical Ingredient Delivery Systems.

In recent decades, there has been an increased interest in the development of intranasal delivery systems for active pharmaceutical ingredients (APIs) not only for treating local nasal diseases but also for treating systemic diseases, central nervous system (CNS) disorders, and vaccine delivery. The nasal cavity possesses a unique set of anatomical characteristics for delivering active pharmaceutical ingredients, but there are several limitations that recent research in the field of the intranasal administration of APIs aims to overcome. For the effective delivery of nasal preparations, active pharmaceutical ingredients are incorporated into various micro- and nanosystems. Some of the most commonly encountered API delivery systems in the scientific literature include liposomal systems, polymer particles with mucoadhesive properties, in situ gels, nano- and microemulsions, and solid lipid particles. This article provides a review of research on the development of nasal preparations for treating local nasal cavity diseases (in particular, for antibiotic delivery), systemic diseases (analgesics, drugs for cardiovascular diseases, antiviral and antiemetic drugs), CNS disorders (Alzheimer's disease, Parkinson's disease, epilepsy, schizophrenia, depression), and vaccine delivery. The literature data show that active research is underway to reformulate drugs of various pharmacotherapeutic groups into a nasal form.

Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial

BackgroundOff-label intranasal administration of injectable dexmedetomidine has been widely applied in the pediatric sedation setting. However, the development of an improved drug delivery system that is easy to use is needed. We developed a novel dexmedetomidine nasal spray that can be administered directly without dilution or configuration for pediatric pre-anesthetic sedation. This nasal spray has a fixed dose and is stable during storage. To the best of our knowledge, this is the first licensed nasal spray preparation of dexmedetomidine worldwide.ObjectiveTo evaluate the pre-anesthetic sedation efficacy and safety of the novel dexmedetomidine nasal spray in children.MethodsThe study was conducted at 11 sites in China between 24 November 2021 and 20 May 2022 and was registered in ClinicalTrials.gov (NCT05111431, first registration date: 20/10/2021). Subjects (n = 159) between 2 and 6 years old who were to undergo elective surgery were randomized to the dexmedetomidine group (n = 107) or the placebo group (n = 52) in a 2:1 ratio. The dosage was 30 µg or 50 µg based on the stratified body weight. The primary outcome measure was the proportion of subjects who achieved the desired child-parent separation and Ramsay scale ≥ 3 within 45 min of administration. Safety was monitored via the assessments of adverse events, blood pressure, heart rate, respiratory rate and blood oxygen saturation.ResultsThe proportion of subjects achieving desired parental separation and Ramsay scale ≥ 3 within 45 min was significantly higher in the dexmedetomidine group (94.4%) vs the placebo group (32.0%) (P < 0.0001). As compared with placebo, dexmedetomidine treatment led to more subjects achieving Ramsay scale ≥ 3 or UMSS ≥ 2, and shorter time to reach desired parental separation, Ramsay scale ≥ 3 and UMSS ≥ 2 (all P < 0.0001). Adverse events were reported in 90.7% and 84.0% of subjects in the dexmedetomidine and placebo groups, respectively, and all the events were mild or moderate in severity.ConclusionsThis novel dexmedetomidine nasal spray presented effective pre-anesthetic sedation in children with a tolerable safety profile.

Anesthetic recovery outcomes after 2 methods of nasal mucosal preparation for endoscopic sinus surgery

PurposeOur institution uses two approaches for nasal mucosal preparation during endoscopic sinus surgery (ESS) to improve surgical field visualization: topical epinephrine (TE) versus topical cocaine with injection of lidocaine containing epinephrine (TCLE). We aimed to compare anesthetic outcomes after ESS using these techniques. Methods and materialsWe retrospectively identified adult patients at our institution who underwent ESS from May 2018 through January 2023 under general anesthesia with propofol and remifentanil infusions. Postoperative anesthetic outcomes, including pain and recovery time, were compared between patients who had mucosal preparation with TE versus TCLE using inverse probability of treatment weighting (IPTW) to adjust for potential confounders. ResultsAmong 1449 patients who underwent ESS, 585 had TE, and 864 had TCLE. Compared with TE, during anesthetic recovery, the TCLE group had fewer episodes of severe pain (numeric pain score ≥ 7) (IPTW-adjusted odds ratio, 0.65; 95 % CI, 0.49–0.85; P = .002), less opioid analgesic administration (IPTW-adjusted odds ratio, 0.55; 95 % CI, 0.44–0.69; P < .001), and shorter recovery room stay (IPTW-adjusted ratio of the geometric mean, 0.90; 95 % CI, 0.85–0.96; P = .002). Postoperative nausea and vomiting and postoperative sedation were similar between groups. ConclusionsPatients who received preparation of the nasal mucosa with TCLE, compared with TE, were less likely to report severe pain or receive an opioid analgesic in the postanesthesia recovery room and had faster anesthetic recovery. This observation from our large clinical practice indicates that use topical and local anesthetic during endoscopic sinus surgery may have benefit for ambulatory ESS patients.

Feasibility study on the application of pectin as pollen adsorbent to prevent pollinosis

In this study, to investigate the feasibility of applying pectin as an adsorbent to prevent pollinosis, we focused on the two types, low- and high‑methoxy pectin, and investigated its properties for application in nasal mucosa-protective preparations. A film adhesion test was performed, and the number of fluorescent microspheres (FMs) adsorbed to the pectin layer was prepared using a hydrophilic polyvinylidene fluoride filter, and mucin was quantified by fluorescence. High‑methoxy pectin (HMP) caught more FMs than low‑methoxy pectin (LMP)(p < 0.05). The quartz crystal microbalance with dissipation monitoring revealed that HMP adhered more to mucin than LMP. The concentration of HMP did not affect adhesiveness. Furthermore, from evaluating the adsorbency of FMs on pectin and mucin, HMP shows higher adsorbency than LMP (p < 0.05). From these results, it could be concluded that pectin with an HMP had stronger interactions with mucin than LMP and could be applied to the nasal formulation to prevent pollinosis.

IN VITRO PERMEABILITY STUDY OF NASAL MEDICINAL PRODUCT FOR SYSTEMIC ACTION

For systemic medicinal products bioavailability is a fundamental characteristic that determines their efficacy and onset of action. Biopharmaceutical parameters of nasal preparations (physicochemical properties of the active substance such as membrane permeability, solubility, lipophilicity, pKa, polymorphic state, type of finished dosage form, pH, osmolarity, composition and characteristics of excipients), affecting bioavailability, are variable and controllable within pharmaceutical development. Besides the use of components that affect enzymatic activity, mucoadhesion and effective con-tact time, mucociliary clearance and viscosity of mucous secretion, changing the rate and degree of absorption of the active substance is possible by modulation of tight junctions and paracellular transport. These processes can be particularly determined by the osmolarity of the dosage form and the use of permeation enhancers. Taking into account the portfolio of excipients available to scientists used in a wide range of concentrations, and, in addi-tion, the requirements of the target product profile in terms of safety and pharmacokinetic parameters, as well as regulatory recommendations for jus-tification of the composition within pharmaceutical development, with particular emphasis on the selection of functional components and the concen-trations used, it is important to have relevant and reliable screening tools when formulating a drug product. Due to the absence of standard bioavailabil-ity assessment methods for nasal preparations, literature review was conducted and methodology of in vitro permeability study for of nasal medicinal products for systemic action with the use of artificial membranes as well as cell line RPMI 2650 of human nasal epithelium is developed. The use of such sufficiently homogeneous barrier films allows to minimize the variability of test conditions. Permeation study of developed compositions of an-timigraine medicinal product is conducted. The results obtained provide evidence of their qualitative compliance and allow to recommend laboratory permeability study on cellulose membranes for the selection and justification of the composition of pharmaceutical compositions. Bioavailability is a fundamental characteristic of pharmaceutical products for systemic action, which defines efficacy and speed of action. Permeability through biological membranes is defined not only by the properties of active component but also by the particulars of formulation. Due to the absence of standard bioavailability assessment methods for nasal preparations, literature review was conducted and methodology of in vitro permeability study for of nasal medicinal products for systemic action with the use of artificial membranes as well as cell line RPMI 2650 is developed. Permeation study of developed compositions of antimigraine medicinal product is conducted. The results obtained provide evidence of their qualitative compliance and allow to recommend laboratory permeability study on cellulose membranes as a screening tool in pharmaceutical development.

DEVELOPMENT OF NASAL PHARMACEUTICAL PRODUCTS FOR SYSTEMIC EXPOSURE: USE OF PERMEATION ENHANCERS TO ACHIEVE TARGET PRODUCT PROFILE

In recent years, special attention has been paid to non-invasive parenteral routes of administration, which are an alternative to injectable drugs, as well as other dosage forms whose effectiveness and safety may be compromised by the administration route. At the same time, there is a paradigm shift in relation to nasal dosage forms: they are no longer considered as primarily drugs exhibiting local effects, and an increasing number of nasal medici-nal products with systemic action are appearing on the market. There is a growing interest to the nasal delivery due to the possibility of maximizing the therapeutic potential of active substances that have proven themselves in clinical practice, for example, by quick targeted action to the site of the pathological process, increased bioavailability of the drug and reduced possible side effects. The nasal cavity as a site for systemic drug absorption has anatomical and physiological features that include a relatively large surface area, a porous endothelial basement membrane, a highly vascularized epithelial layer, high total blood flow, lack of first-pass metabolism, and easy access. Therefore, the development of a convenient (nasal) dosage form of the drug with a rapid onset of action is a promising approach. When developing a new pharmaceutical product, the factors that determine bioavaila-bility should be taken into account and addressed by appropriate formulation and delivery techniques: the use of mucoadhesive components or sub-stances that modulate mucociliary clearance, variation of the viscosity or osmolarity, or selection of an appropriate dosing device. Improving intrana-sal absorption is a promising direction for obtaining drugs with improved consumer properties. In addition to the functional properties of the formula-tions, safety aspects must also be taken into account. The article provides an analysis of the limiting factors for nasal preparations, strategies for in-creasing bioavailability, permeation enhancement mechanisms, and provides examples of the application of permeation enhancers used in developed and commercially available drugs. This review gives an idea on possible to use in nasal formulations permeation enhancers which have different mode of actions.

Brain Targeted Drug Delivery System of Carmustine: Design, Development, Characterization, in vitro, ex vivo Evaluation and in vivo Pharmacokinetic Study

The treatment of gliomas remains difficult task. Carmustine is a drug that is used in the treatment of gliomas. Flexible liposomes embedded in situ thermoreversible nasal gel preparations of Carmustine were studied for in vitro carmustine release, ex vivo carmustine permeation and carmustine release kinetics. The epithelial layers of nasal tissue were found to be intact and undamaged during histological analysis. Intranasal administration of optimized flexible liposomes embedded in a nasal gel showed higher Cmax (Approximately two-fold), AUC0→t (Approximately three-fold), AUC0→∞ (Approximately six-fold), and lower Tmax (1 h) in the brain, compared to intravenous injection of carmustine. The present study demonstrates that the flexible liposome embedded thermoreversible in situ intranasal gel of carmustine improved the targeted uptake of carmustine in the brain through the nasal delivery system and could be a reliable and effective delivery system for carmustine in the treatment of gliomas.

Nasal preparation prior to nasal endoscopy: a comparison of cotton pledget packing versus topical spray

Nasal endoscopy (NE) is an office procedure done to look at the nasal and sinus passages using an endoscope which could be either rigid or flexible. It allows the clinician to characterize the intranasal anatomy better compared to the conventional techniques of headlight, speculum and mirror thus aiding the diagnosis. Therefore its popularity has increased recently and is one of the most frequently performed diagnostic procedures in Otorhinolaryngology and Head and Neck Surgery OPD. A unanimous consensus has not been reached regarding the best method for preparing the patients for NE. This study compares two methods of nasal preparation; cotton pledget packing and topical spray. A total of 100 patients were randomised into two groups of 50 each (A and B). In Group A, the nasal cavity was packed with a cotton pledget soaked in 4% lignocaine and xylometazoline nasal drops. Whereas in Group B, xylometazoline nasal drops were instilled and nasal cavity was sprayed with 10% lignocaine spray. After performing rigid nasal endoscopy, a proforma based on the patients’ and consultant’s response was filled. Patients in the cotton pledget group experienced more discomfort during packing (p=0.04), during the waiting time (p=0.001) and also during the endoscopic procedure. From the clinician’s perspective, the duration for the overall endoscopic procedure was significantly less in the spray group (p&lt;0.001). Visualisation of structures was comparable in both groups. Less bleeding was experienced in the spray group. We concluded that nasal spray is a better alternative to nasal packing for preparation of nose prior to nasal endoscopy.

Preparation and Optimization of Bovine Serum Albumin Nanoparticles as a Promising Gelling System for Enhanced Nasal Drug Administration.

Bovine serum albumin (BSA) has been used extensively as a suitable carrier system for alternative drug delivery routes, such as nasal administration. However, the optimization of BSA nanoparticles with respect to their nasal applicability has not been widely studied. The present study focuses on the characterization of BSA nanoparticles prepared using the desolvation method, followed by a gelation process to facilitate intranasal drug delivery. The results demonstrated that the ratio of BSA and the desolvating agent, ethanol, played a critical role in the nanoparticle characteristics of the BSA nanogel matrices (BSA-NGs). Based on the gelling properties, the formulations of BSA-NG 2, BSA-NG 4, and BSA-NG 6 were selected for further investigation. The Raman spectra confirmed that there were no specific changes to the secondary structures of the BSA. The mucoadhesion studies revealed moderately high mucoadhesive properties, with a mucin binding efficiency (MBE) value of around 67%, allowing the dose to avoid elimination due to rapid mucociliary clearance of the nasal passage. Via studying the nexus of the carrier system, BSA-NGs loaded with dexamethasone as a model drug were prepared and evaluated by differential scanning calorimetry (DSC) and thermal gravimetry (TG), ascertaining that no ethanol remained in the samples after the freeze-drying process. Furthermore, the viscosity measurements exhibited moderate viscosity, which is suitable for nasal liquid preparations. The in vitro release studies performed with a simulated nasal electrolyte solution (SNES) medium showed 88.15-95.47% drug release within 4 h. In conclusion, BSA nanoparticle gelling matrices can offer potential, value-added drug delivery carriers for improved nasal drug administration.

Topical anaesthesia and decongestion in rhinology.

Topical anaesthesia and decongestion of the sinonasal mucosa are used commonly in rhinology practice to facilitate nasal endoscopy, as well as debridement and biopsies. Topical agents used for sinonasal anaesthesia include lignocaine, tetracaine and cocaine. Unlike lignocaine and tetracaine, cocaine also has a decongestant effect. Phenylephrine, oxymetazoline, xylometazoline or adrenaline are usually added to lignocaine and tetracaine to provide decongestion. Several studies have been performed seeking to identify the optimal nasal preparation for nasal endoscopy in the clinic setting. However, there remains no clear consensus in the literature resulting in ongoing wide variation between anaesthetic-decongestant preparations used in clinical practice. Indeed, some authors have argued that no anaesthetic is required at all for flexible nasendoscopy despite the apparent consensus that nasal instrumentation is generally uncomfortable, inferred by the persistence of ongoing research in this area. This review provides a practical summary of local anaesthetic and decongestant pharmacology as it relates to rhinologic practice and summarises the literature to date, with the goal of identifying current gaps in the literature and guiding future research efforts.

DESIGN, CHARACTERIZATION AND EVALUATION OF NOVEL MUCOADHESIVE NASAL INSERTS FOR THE TREATMENT OF MIGRAINE

Recently, nasal administration has gained more attention as a safe way for delivering the active ingredients used to treat migraines. Strategies can be implemented by changing aspects like the medicines, delivery vehicle, and other components to get around the obstacles associated with conventional therapies. This research work aimed to explore the potential of lyophilized nasal inserts of eletriptan hydrobromide for the treatment of migraine attack. Here, the lyophilization technique is used for the nasal inserts preparation. The developed inserts were tested for various characterization studies,such as mucoadhesive examinations, water uptake, in vitro drug release, in vitro cytotoxicity, ex vivo investigations and stability. The inserts showed acceptable pH values, satisfactory mucoadhesion potential and excellent water uptake activity. In vitro release data for the formulations followed first-order kinetics. The cytotoxicity studies showed that there was a reduction in cell toxicity of drug embedded in the inserts when compared to the pure drug. When the prepared nasal inserts were used for treatment, there was no significant impact on the epithelium of nasal mucosa. The novel lyophilized nasal inserts of eletriptan hydrobromide could be a better alternative for the treatment of migraine

Ethnic rhinoplasty: Preliminary results of our technique in the pursuit of the harmonious nose

According to the American Society of Plastic Surgery, cosmetic surgery procedures for "ethnic patients" are annually increasing. Ethnic rhinoplasty traditionally represents a difficult challenge for plastic surgeons. Herein, we describe our personal technique to ethnic rhinoplasty to achieve a harmonious nose maintaining the characteristics of individual ethnicity and identity. In this study, we retrospectively reviewed ethnic patients treated with rhinoplasty at our institution between January 2019 and October 2022. We described our personal rhinoplasty technique step by step. At a minimum follow-up time of six months, postoperative pictures were taken, and patients were reassessed, evaluating aspects such as global symmetry and shape and contour of the nose. Finally, patient satisfaction was investigated according to rhinoplasty outcomes evaluation (ROE) questionnaire. A total of 1321 patients were included in the study. They reported a significant satisfactory aesthetic result in nasal image, as indicated by the mean postoperative ROE score (92.12). No cases of nasal contracture were recorded. None of the grafts was extruded or collapsed. Wounds healed without reported major infection. This study demonstrated that our approach is a safe procedure that contributes to improved functional outcomes with a high patient satisfaction rate and a low rate of postoperative complication. The creation of a solid base structure, nasal skin preparation, and an integrated patient approach are key elements of this surgery.

Abstract P105: High-throughput Sequence Symmetry Analysis To Detect Angiotensin-converting Enzyme Inhibitors (acei) Induced Prescribing Cascades.

Introduction: ACEIs are the most commonly prescribed antiHTN drugs, but side effects may prompt additional therapy resulting in a prescribing cascade. We aimed to identify potential ACEI-induced prescribing cascades using high throughput sequence symmetry analysis. Methods: Using claims from 5% (2011-15) and 15% (2016-20) national samples of Medicare FFS beneficiaries, we identified new ACEI users aged ≥66 y with continuous enrollment for ≥360 days pre- and ≥180 days post-ACEI initiation. We screened for initiation of 446 other ‘marker’ drug classes (based on WHO Anatomical Therapeutic Classification level 4 codes) within ±90 days of ACE initiation, generating sequence ratios (SRs) representing the proportions of ACEI initiators starting the marker class after, vs before, the ACEI. Adjusted SRs (aSRs), accounting for prescribing trends over time, were calculated with 95% CIs &gt;1 considered statistically significant. Results: We identified 297,410 ACEI initiators (mean ± SD age, 76.1 ± 7.5 y; 59% women, 88% HTN). Of 446 ‘marker’ classes studied, and excluding other antiHTN classes, we identified 110 statistically significant signals indicative of potential prescribing cascades. The 30 strongest prescribing cascade signals (by aSR) are summarized (Figure) and included decongestant nasal preparations and monoamine oxidase B inhibitors. Conclusion: We identified potential prescribing cascade signals reflecting known and possibly underrecognized ACEI adverse events in this Medicare cohort. Additional research is needed to determine impact of these cascades on patient outcomes.

Green easily implemented spectrophotometric methods for concurrent determination of ephedrine hydrochloride and naphazoline nitrate in nasal preparations containing methylparaben.

Spectrophotometric resolution of a mixture of several drugs is considered a cheaper, simpler and more versatile alternate compared to the costly chromatographic instruments. The work aims to resolve the interfering spectra of ephedrine hydrochloride, naphazoline nitrate and methylparaben in nasal preparations using smart spectrophotometric methods. In our work, derivative and dual wavelength methods were combined to eliminate this interference, under the name of derivative dual wavelength method. Other methods, namely successive derivative subtraction and chemometric analysis were also able to eliminate this interference. The methods have proven their applicability as they follow the ICH requirements regarding repeatability, precision, accuracy, selectivity, and linearity. Eco- scale, GAPI and AGREE tools were used to estimate the possible environmental effects of the methods. Acceptable results of repeatability, precision, accuracy, selectivity, and linearity were obtained. LOD values were 2.2 for ephedrine and 0.3 for naphazoline. The correlation coefficients were above 0.999. The methods were proven to be safe for application. The introduced methods are cheap and easily implemented compared to chromatographic techniques. They can be used in purity checking of raw material and estimation of concentrations in market formulations. The replacement of the published chromatographic techniques with our developed methods is usefulwhen saving money, effort and time is needed. The three components of a decongestant nasal preparation were determined using cheap green versatile spectrophotometric methods that keep the advantages of chromatographic techniques including accuracy, reproducibility and selectivity.

Development of Thermoresponsive-Gel-Matrix-Embedded Amoxicillin Trihydrate-Loaded Bovine Serum Albumin Nanoparticles for Local Intranasal Therapy.

A high dose of amoxicillin is recommended as the first-line therapy for acute bacterial rhinosinusitis (ABR). However, oral administration of amoxicillin is connected to many adverse reactions coupled with moderate bioavailability (~60%). Therefore, this study aimed to develop a topical nasal preparation of amoxicillin, employing a thermoresponsive nanogel system to increase nasal residence time and prolong drug release. Rheological investigations revealed that formulations containing 21-23% w/w Poloxamer 407 (P407) were in accordance with the requirement of nasal administration (gelling temperature ~35 °C). The average hydrodynamic diameter (&lt;200 nm), pH (6.7-6.9), and hypertonic osmolality (611-663 mOsmol/L) of the in situ gelling nasal nanogel appeared as suitable characteristics for local rhinosinusitis treatment. Moreover, taking into account the mucoadhesive strength and drug release studies, the 21% w/w P407 could be considered as an optimized concentration for effective nasal delivery. Antibacterial activity studies showed that the ability of amoxicillin-loaded in situ gelling nasal nanogel to inhibit bacterial growth (five common ABR pathogens) preserved its effectiveness in comparison to 1 mg/mL amoxicillin aqueous solution as a positive control. Altogether, the developed amoxicillin-loaded in situ gelling thermoresponsive nasal nanogel can be a potential candidate for local antibiotic therapy in the nasal cavity.

Efficacy of Mouth Rinses and Nasal Spray in the Inactivation of SARS-CoV-2: A Systematic Review and Meta-Analysis of In Vitro and In Vivo Studies.

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) is a global and evolving pandemic associated with heavy health and financial burdens. Considering the oral cavity as the major reservoir for SARS-CoV-2, a systematic review and meta-analysis were conducted to assess the efficacy of mouth rinses and nasal sprays in reducing the salivary viral load of SARS-CoV-2. All in vivo and in vitro studies that assessed the virucidal efficacy of mouth rinses and nasal sprays against SARS-CoV-2 and were published in the English language from December 2019 to April 2022 were considered for analyses. Special Medical Subject Headings terms were used to search Pubmed, Scopus, Embase Ovid, and Web of Science databases. The toxicological data reliability assessment tool (ToxRToool) was used to assess the quality of the included studies. Thirty-three studies (11 in vivo and 22 in vitro) were deemed eligible for inclusion in this analysis. Results of the pooled data showed that povidone-iodine is the most efficacious intervention in vivo in terms of reducing the SARS-CoV-2 salivary viral load, followed by chlorhexidine. The mean difference in the viral load was 86% and 72%, respectively. Similarly, povidone-iodine was associated with the highest log10 reduction value (LRV) in vitro, followed by cetylpyridinium chloride, (LRV = 2.938 (p < 0.0005) and LRV = 2.907 (p = 0.009), respectively). Povidone-iodine-based oral and nasal preparations showed favourable results in terms of reducing SARS-CoV-2 viral loads both in vivo and in vitro. Considering the limited number of patients in vivo, further studies among larger cohorts are recommended.

A Prospective, Randomized, Double-Blind Study on the Efficacy of Different Modes of Topical Application of Nasal Anesthetics in the Diagnostic Nasal Endoscopy Procedure.

IntroductionIn the current otorhinolaryngology practice, technology has always been an essential part. Therefore, diagnostic nasal endoscopy (DNE) has become a vital examination in today’s practice. In order to visualize the nasal cavity in a systematic manner without any discomfort to both patient and doctor, the nose should be well anesthetized and decongested.ObjectiveThe study is to compare and evaluate the efficacy of 4% lignocaine-oxymetazoline cotton pledget packing versus topical sprays in the preparation of nasal cavities for DNE.MethodologyThe prospective, randomized, double-blind study was conducted among 246 patients and was divided into two groups. In the first group, the nose was packed with cotton pledgets containing 4% lignocaine-oxymetazoline and another group with 4% lignocaine-oxymetazoline spray. Following DNE, patients and surgeons were questioned on a pre-formed questionnaire to evaluate their experience during the procedure.ResultsIt was observed that the time taken for the pre-endoscopic preparation of the packing group was more than the spray group. A total of 91.9% of the spray group had pain during the pre-endoscopic preparation and more burning and tingling sensation than in the nasal pack (75.6%). A total of 69.9% of the patients among the spray group participants compared to 32.5% of the packing group patients experienced more throat discomfort. In addition, 12% of the packing group had mucosal bleeding during the preparation. A total of 32.5% of the spray group experienced severe pain when compared to 12.2% of the packing group during the endoscopic procedure. Most of the participants from both groups had difficulty visualizing the superior turbinate and sphenoethmoidal recess during the procedure. There was a significant difference seen between both the groups with respect to pain during the pre-endoscopic procedure (p=0.0005), burning/tingling sensation (p<0.0001), throat pain (<0.0001), mucosal bleed (p=0.0003), pain during the procedure (p=0.0001), and discomfort after the procedure (p<0.0001).ConclusionBoth methods of nasal preparation have merits and demerits in terms of discomfort, pain, and visualization of structures. Still, the packing of the nasal cavity with cotton pledgets is better when compared to spraying with 4% lignocaine-oxymetazoline. However, 4% lignocaine-oxymetazoline spray can be used during an emergency situation and with sensitive patients.

Comparison of drug prescribing before and during the COVID-19 pandemic: A cross-national European study.

PurposeThe COVID‐19 pandemic had an impact on health care, with disruption to routine clinical care. Our aim was to describe changes in prescription drugs dispensing in the primary and outpatient sectors during the first year of the pandemic across Europe.MethodsWe used routine administrative data on dispensed medicines in eight European countries (five whole countries, three represented by one region each) from January 2017 to March 2021 to compare the first year of the COVID‐19 pandemic with the preceding 3 years.ResultsIn the 10 therapeutic subgroups with the highest dispensed volumes across all countries/regions the relative changes between the COVID‐19 period and the year before were mostly of a magnitude similar to changes between previous periods. However, for drugs for obstructive airway diseases the changes in the COVID‐19 period were stronger in several countries/regions. In all countries/regions a decrease in dispensed DDDs of antibiotics for systemic use (from −39.4% in Romagna to −14.2% in Scotland) and nasal preparations (from −34.4% in Lithuania to −5.7% in Sweden) was observed. We observed a stockpiling effect in the total market in March 2020 in six countries/regions. In Czechia the observed increase was not significant and in Slovenia volumes increased only after the end of the first lockdown. We found an increase in average therapeutic quantity per pack dispensed, which, however, exceeded 5% only in Slovenia, Germany, and Czechia.ConclusionsThe findings from this first European cross‐national comparison show a substantial decrease in dispensed volumes of antibiotics for systemic use in all countries/regions. The results also indicate that the provision of medicines for common chronic conditions was mostly resilient to challenges faced during the pandemic. However, there were notable differences between the countries/regions for some therapeutic areas.