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Indian Journal of Pediatrics Feb 2018Vaccines have been successful in reducing the mortality and morbidity, but most of them are delivered by intramuscular or intravenous route. They are associated with... (Review)
Review
Vaccines have been successful in reducing the mortality and morbidity, but most of them are delivered by intramuscular or intravenous route. They are associated with pain to the baby and bring lot of anxiety for the parents. There has been a marked increase in the number of injections required in first two years of life for completing the vaccination schedule. Hence, there is a need to have a painless vaccine delivery system. Numerous new routes of vaccination like, oral, nasal and transdermal routes are being tried. Oral polio and intranasal influenza have already been a success. Other newer approaches like edible vaccines, nasal sprays, dry powder preparations, jet injectors, microneedles and nanopatches are promising in delivering painless vaccines. Many of them are under clinical trials. These vaccine delivery systems will not only be painless but also cost effective, safe and easy to administer in mass population. They may be devoid of the need of cold chain. Painless delivery system will ensure better compliance to vaccination schedule.
Topics: Administration, Cutaneous; Administration, Intranasal; Administration, Oral; Aerosols; Drug Delivery Systems; Humans; Pain; Vaccines
PubMed: 28620730
DOI: 10.1007/s12098-017-2377-2 -
Veterinary Sciences Jun 2023The pilot study aimed to investigate the effects of GAMS on oral microbiota in healthy dog subjects. Thirty-eight dogs were recruited and randomly allocated to the...
The pilot study aimed to investigate the effects of GAMS on oral microbiota in healthy dog subjects. Thirty-eight dogs were recruited and randomly allocated to the placebo ( = 19) and treatment groups ( = 19). The dogs were treated with mouth spray once daily for 42 days. The changes in the gingival index (GI), plaque index (PI), and calculus index (CI) were measured at baseline (day 0) and end of the study (42nd day). The changes in the oral microbial composition of representative dogs (placebo, = 7; and treatment, = 7) were also evaluated at baseline and end of the study. Oral microbial composition was assessed by sequencing. The sequences were annotated using the QIIME 2.0. The GI, PI, and CI indexes were reduced after the GAMS usage. The abundance of the commensal bacterial phylum Actinobacteria and Chloroflexi, genera , and was improved after six weeks of GAMS usage. GAMS reduced the pathogenic bacterial species, including sp., sp., , and Moreover, some pathogenic bacterial abundances were increased at the end of the study. All the microbial variations were observed within the group. The inter-group analysis revealed that the changes were unrelated to GAMS usage. Further studies need to be carried out using more experimental subjects to confirm the effectiveness of GAMS. More metagenomic data are required to evidence the GMAS impact on the oral microbiome of healthy dogs.
PubMed: 37505829
DOI: 10.3390/vetsci10070424 -
Chemical & Pharmaceutical Bulletin Dec 2016The stomatitis caused by anticancer agents and radiation therapy deteriorates patient QOL, potentially causing eating disorders as a result of pain. Although gargling...
The stomatitis caused by anticancer agents and radiation therapy deteriorates patient QOL, potentially causing eating disorders as a result of pain. Although gargling and ointments can be used in the treatment of stomatitis, patients must spit out mouthwash after use, while ointment application requires a finger to be inserted into the oral cavity. In contrast, sprays eliminate these potential compliance problems. Therefore, we developed a stomatitis spray that remains on the oral mucosa. It has been reported that irsogladine maleate (IM) is effective against stomatitis via oral administration. IM is water insoluble; thus, it was dissolved with various cyclodextrins (CDs). Furthermore, we examined combination with gum ghatti (GG), a mucoadhesive polymer. The interaction between mucin and GG was examined by Quartz Crystal Microbalance with Dissipation monitoring. We found that GG exhibited mucoadhesion. Furthermore, we examined the healing effects of IM on stomatitis in a stomatitis model hamster. We found that stomatitis healed after direct application of IM. However, the model used in this experiment is not based on stomatitis caused by anticancer agents. Further study is therefore necessary.
Topics: Animals; Antineoplastic Agents; Disease Models, Animal; Male; Mesocricetus; Oral Sprays; Stomatitis; Triazines
PubMed: 27628929
DOI: 10.1248/cpb.c16-00217 -
Clinical and Experimental Dental... Nov 2016The aim of this study was to evaluate the efficacy, safety, and tolerability of three formulations of DC161 oral spray, a saliva substitute, and a comparator in...
The aim of this study was to evaluate the efficacy, safety, and tolerability of three formulations of DC161 oral spray, a saliva substitute, and a comparator in relieving drug-induced xerostomia. This was an open-label, randomized, 4-period, cross-over study in adult subjects with drug-induced xerostomia and documented hyposalivation. During each of the four 1-day periods, one product (one of three DC161 formulations or the comparator) was applied at T0 and then at T4h (before a meal). Mouth dryness and related symptoms were evaluated by the subject on a 100-mm visual analog scale. The primary efficacy criterion was the area under the curve of the dry mouth evaluation (baseline to T4h) after the first application. The oral mucosa was examined by a dental specialist; tolerability and product acceptability were assessed by the subject. Twenty-four subjects were randomized and completed the study. Despite large variability in data among the products, the selected aqueous formulation - DC161-DP0292 - reduced the intensity of dryness of mouth at least as well as the comparator; DC161-DP0292 provided a fast relief and a long-lasting effect on mouth dryness. Both products improved other symptoms such as swallowing and speaking, even when applied just prior to a meal. DC161-DP0292 was well tolerated and rated by subjects as providing a slightly higher acceptability of taste/aftertaste, texture, and lubricating effect than the comparator. No clinically relevant signs were reported for any product following the oral examination. DC161-DP0292 provides fast and long-acting symptomatic relief and is a relevant new treatment for drug-induced xerostomia.
PubMed: 29744157
DOI: 10.1002/cre2.29 -
BMC Oral Health Jun 2021Removal of oral biofilm from the oral mucosa is essential for preventing risk of respiratory and gastrointestinal infection in elderly people. Currently, no device is...
BACKGROUND
Removal of oral biofilm from the oral mucosa is essential for preventing risk of respiratory and gastrointestinal infection in elderly people. Currently, no device is available which can remove oral biofilm from oral mucosa effectively and safely. Therefore, the effectiveness and safety of the Micro Scale Mist UNIT (MSM-UNIT), a newly developed dental plaque removal device utilizing high speed sprays of fine water droplets, were evaluated for biofilm removal, including the rate and surface roughness for simulated tooth surface and mucous membrane.
METHODS
Simulated tooth and oral mucosa coated with an artificial biofilm of Streptococcus mutans were used for evaluation of effectiveness, with uncoated substrates as the controls. The MSM-UNIT and a conventional air ablation device were operated under recommended instructions. The effectiveness was evaluated from the rate of removal of the biofilm, and the safety was evaluated from the damage observed by scanning electron microscope and surface roughness.
RESULTS
The biofilm removal rate of the MSM-UNIT was significantly higher than that of AIRFLOW. Little damage was observed in the area treated by the MSM-UNIT. The surface roughness of the MSM-UNIT treated area on simulated tooth surface and oral mucosa showed no significant difference to the control area. In contrast, cracks and powder were observed in the area treated by AIRFLOW. In particular, the surface roughness of the AIRFLOW treated area for Toughsilon was significantly larger than that of the control.
CONCLUSIONS
The MSM-UNIT could be used safely and effectively for removing biofilm not only on simulated tooth surfaces but also simulated mucous membrane. The MSM-UNIT has no harmful effect on teeth or oral mucosa, and may be used for comprehensive oral care for patients during nursing care and the perioperative period.
Topics: Aged; Biofilms; Dental Plaque; Humans; Streptococcus mutans; Surface Properties
PubMed: 34088301
DOI: 10.1186/s12903-021-01647-4 -
Dentistry Journal Apr 2024Soft drinks may have a deleterious effect on dental health due to a high titratable acidity and a low pH that could be sufficient to induce tooth demineralization. The...
Soft drinks may have a deleterious effect on dental health due to a high titratable acidity and a low pH that could be sufficient to induce tooth demineralization. The use of oral care products immediately after acidic challenge may diminish the erosive potential of soft drinks. We assessed the effect of oral care foams and a spray on salivary pH changes after exposure to Coca-Cola in young adults. Thirty-three consenting eligible patients were recruited in this double-blind, randomized, crossover study performed in six visits. Baseline examination included unstimulated salivary flow rate, stimulated salivary buffer capacity, and the simplified oral hygiene index (OHI-S) assessment. Salivary pH and time for pH recovery were registered after exposure to Coca-Cola alone or that followed by the application of each of the studied products (an oral foam containing hydroxyapatite and probiotics, an oral foam containing amino fluoride, an alkaline oral spray, and tap water). Thirty-two patients completed the entire study protocol and were included in the final analysis. The mean minimum salivary pH and the mean oral clearance rate after rinsing with Coca-Cola were 6.3 and 27 min, respectively. Further rinsing with any one of the tested solutions, including tap water, resulted in a significant improvement in these parameters. When the pH curves were plotted, the oral care products demonstrated a lower area under the curve that differed significantly from the area under the curve for Coca-Cola; tap water did not differ significantly from Coca-Cola and oral care products. Minimum salivary pH correlated positively with salivary buffer capacity and salivation rate, while salivary clearance correlated with OHI-S plaque scores. In conclusion, the effect of oral care foams and a spray on minimum salivary pH and salivary clearance after exposure to Coca-Cola did not differ significantly among the tested products and tap water. Trial registration NCT06148662. Funding: none.
PubMed: 38668005
DOI: 10.3390/dj12040093 -
International Journal of Environmental... May 2021nasal or oral sprays are often marketed as medical devices (MDs) in the European Union to prevent common cold (CC), with ColdZyme/Viruprotect (trypsin/glycerol) mouth...
BACKGROUND
nasal or oral sprays are often marketed as medical devices (MDs) in the European Union to prevent common cold (CC), with ColdZyme/Viruprotect (trypsin/glycerol) mouth spray claiming to prevent colds and the COVID-19 virus from infecting host cells and to shorten/reduce CC symptoms as an example. We analyzed the published (pre)-clinical evidence.
METHODS
preclinical: comparison of in vitro tests with validated host cell models to determine viral infectivity. Clinical: efficacy, proportion of users protected against virus (compared with non-users) and safety associated with trypsin/glycerol.
RESULTS
preclinical data showed that exogenous trypsin enhances SARS-CoV-2 infectivity and syncytia formation in host models, while culture passages in trypsin presence induce spike protein mutants. The manufacturer claims >98% SARS-CoV-2 deactivation, although clinically irrelevant as based on a tryptic viral digest, inserting trypsin inactivation before host cells exposure. Efficacy and safety were not adequately addressed in clinical studies or leaflets (no COVID-19 data). Protection was obtained among 9-39% of users, comparable to or lower than placebo-treated or non-users. Several potential safety risks (tissue digestion, bronchoconstriction) were identified.
CONCLUSIONS
the current European MD regulations may result in insufficient exploration of (pre)clinical proof of action. Exogenous trypsin exposure even raises concerns (higher SARS-CoV-2 infectivity, mutations), whereas its clinical protective performance against respiratory viruses as published remains poor and substandard.
Topics: COVID-19; Common Cold; European Union; Humans; Medical Device Legislation; Mutation; Oral Sprays; SARS-CoV-2; Trypsin
PubMed: 34064793
DOI: 10.3390/ijerph18105066 -
Antioxidants (Basel, Switzerland) Jul 2023leaves have gained notoriety over the past years due to their rich bioactive composition with human pro-healthy effects, particularly in relation to antioxidants....
leaves have gained notoriety over the past years due to their rich bioactive composition with human pro-healthy effects, particularly in relation to antioxidants. Nevertheless, antioxidants are well known for their chemical instability, making it necessary to develop suitable delivery systems, such as microparticles, to provide protection and ensure a controlled release. The aim of this work was to produce polymeric particles of leaves extract by spray-drying that may improve the oral mucositis condition. Microparticles were characterized by size, shape, antioxidant/antiradical activities, swelling capacity, moisture content, and effect on oral cells (TR146 and HSC-3) viability, with the aim to assess their potential application in this oral condition. The results attested the microparticles' spherical morphology and production yields of 41.43% and 36.40%, respectively, for empty and leaves extract microparticles. The leaves extract microparticles obtained the highest phenolic content (19.29 mg GAE/g) and antioxidant/antiradical activities (FRAP = 81.72 µmol FSE/g; DPPH = 4.90 mg TE/g), being perceived as an increase in moisture content and swelling capacity. No differences were observed between empty and loaded microparticles through FTIR analysis. Furthermore, the exposure to HSC-3 and TR146 did not lead to a viability decrease, attesting their safety for oral administration. Overall, these results highlight the significant potential of leaves extract microparticles for applications in the pharmaceutical and nutraceutical industries.
PubMed: 37627491
DOI: 10.3390/antiox12081496 -
AAPS PharmSciTech Jun 2014Aerosol delivery is noninvasive and is effective in much lower doses than required for oral administration. Currently, there are several types of therapeutic aerosol... (Review)
Review
Aerosol delivery is noninvasive and is effective in much lower doses than required for oral administration. Currently, there are several types of therapeutic aerosol delivery systems, including the pressurized metered-dose inhaler, the dry powder inhaler, the medical nebulizer, the solution mist inhaler, and the nasal sprays. Both oral and nasal inhalation routes are used for the delivery of therapeutic aerosols. Following inhalation therapy, only a fraction of the dose reaches the expected target area. Knowledge of the amount of drug actually deposited is essential in designing the delivery system or devices to optimize the delivery efficiency to the targeted region of the respiratory tract. Aerosol deposition mechanisms in the human respiratory tract have been well studied. Prediction of pharmaceutical aerosol deposition using established lung deposition models has limited success primarily because they underestimated oropharyngeal deposition. Recent studies of oropharyngeal deposition of several drug delivery systems identify other factors associated with the delivery system that dominates the transport and deposition of the oropharyngeal region. Computational fluid dynamic simulation of the aerosol transport and deposition in the respiratory tract has provided important insight into these processes. Investigation of nasal spray deposition mechanisms is also discussed.
Topics: Administration, Inhalation; Aerosols; Animals; Chemistry, Pharmaceutical; Computer Simulation; Drug Delivery Systems; Drug Dosage Calculations; Equipment Design; Humans; Models, Anatomic; Models, Biological; Nebulizers and Vaporizers; Pharmaceutical Preparations; Respiratory System; Technology, Pharmaceutical
PubMed: 24563174
DOI: 10.1208/s12249-014-0092-0 -
Journal of Clinical PsychopharmacologyNumerous health authority approvals of esketamine nasal spray, combined with oral antidepressant, to treat depressive symptoms in adults with major depressive disorder... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE/BACKGROUND
Numerous health authority approvals of esketamine nasal spray, combined with oral antidepressant, to treat depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behavior were based on 2 identically designed, double-blind, phase 3 studies.
METHODS/PROCEDURES
Across both ASPIRE studies (NCT03039192, NCT03097133), patients (N = 456) were randomized to esketamine 84 mg or placebo nasal spray twice weekly for 4 weeks plus comprehensive standard of care, including hospitalization and newly initiated or optimized antidepressant(s). In post hoc analyses of pooled data, changes from baseline at 24 hours after the first dose in Montgomery-Åsberg Depression Rating Scale total score and Clinical Global Impression-Severity of Suicidality-Revised, in the full cohort and in subgroups, were analyzed using analysis of covariance.
FINDINGS/RESULTS
Esketamine plus standard of care demonstrated significantly greater improvement in Montgomery-Åsberg Depression Rating Scale total score versus placebo plus standard of care at 24 hours (least square mean difference [95% confidence interval], -3.8 [-5.75 to -1.89]) and at earlier (4 hours: -3.4 [-5.05 to -1.71]) and later time points (day 25: -3.4 [-5.36 to -1.36]). The between-group difference (95% confidence interval) for change in Clinical Global Impression-Severity of Suicidality-Revised at 24 hours was -0.20 (-0.43 to 0.04) for all patients and -0.31 (-0.61 to -0.01) for those with a history of suicide attempt. Common adverse events (≥20%) during esketamine treatment were dizziness, dissociation, nausea, somnolence, and headache.
IMPLICATIONS/CONCLUSIONS
Esketamine plus comprehensive standard of care rapidly reduces depressive symptoms in patients with major depressive disorder who have acute suicidal ideation or behavior, especially in those with a history of suicide attempt, providing a new treatment option for this particularly ill and vulnerable population.
Topics: Administration, Intranasal; Adult; Antidepressive Agents; Depression; Depressive Disorder, Major; Female; Humans; Ketamine; Male; Middle Aged; Nasal Sprays; Suicidal Ideation; Time Factors; Treatment Outcome
PubMed: 34412104
DOI: 10.1097/JCP.0000000000001465