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Buccal midazolam (buc MDL) is the first buccal mucosal delivery formulation applied for status epilepticus in Japan. Herein, we aimed to investigate the effectiveness and adverse events of buc MDL as a pre-hospital treatment for epileptic seizures in real-world clinical practice. This study involved a retrospective review based on medical records. We included children who received buc MDL as pre-hospital treatment for epileptic seizures and were subsequently transported to the emergency department between April 2021 and November 2023. This study included 26 patients (136 episodes). The overall efficacy rate, which was defined as seizure cessation within 10 min after buc MDL administration with no recurrence within 30 min, was 43 %. Moreover, 70 % of the episodes did not require additional medications. None of the episodes required bag-mask ventilation or intubation following seizure cessation with buc MDL alone. The efficacy was decreased when buc MDL was administered longer than 15 min from seizure onset. Furthermore, the efficacy did not decrease as long as it was within 0.2–0.5 mg/kg, even if the dose was smaller than the appropriate dose for the specific age. The response rate was significantly higher in episodes where buc MDL was administered within 15 min. Additionally, there was no concern regarding respiratory depression with buc MDL alone. [ABSTRACT FROM AUTHOR]

Objective Combining pharmacologic agents with mechanical ripening achieves the shortest labor duration, yet there is no clear evidence on route of drug administration in obese individuals. The use of buccal misoprostol has shown greater patient acceptance but remains understudied. Our objective was to evaluate the difference in time to delivery of buccal compared with vaginal misoprostol in combination with a Foley catheter (FC) for induction of labor (IOL) in the obese population. Study Design This was a secondary analysis of a randomized controlled trial comparing identical dosages (25 μg) of buccal and vaginal misoprostol in combination with a FC. The parent trial was an institutional review board-approved, randomized clinical trial conducted from June 2019 through January 2020. Labor management was standardized among participants. Women undergoing IOL at ≥37 weeks with a singleton gestation and cervical dilation ≤2 cm were included. Body mass index (BMI, kg/m 2) was stratified. The primary outcome was time to delivery. Results A total of 215 participants were included. Demographic characteristics were similar between the three groups. Vaginal drug administration achieved a faster median time to delivery than the buccal route among patients with a body mass index greater than or equal to 30 kg/m 2 (vaginal misoprostol–FC: 21.3 hours vs. buccal misoprostol–FC: 25.2 hours, p = 0.006). There was no difference in the cesarean delivery rate between the two groups. Furthermore, patients with a BMI greater than or equal to 30 kg/m 2 receiving vaginal misoprostol delivered 1.2 times faster than women who received buccal misoprostol after censoring for cesarean delivery and adjusting for parity (hazard ratio: 1.2, 95% confidence interval: 1.1–1.7). There were no significant differences in maternal and neonatal outcomes. Conclusion We found that vaginal misoprostol was superior to buccal misoprostol when combined with a FC among individuals with a BMI greater than or equal to 30 kg/m 2. Vaginal misoprostol should be the preferred route of drug administration for term IOL in this population. Key Points Vaginal misoprostol was superior to buccal route among patients with obesity. There was no difference in the cesarean delivery rate between the two groups. Vaginal misoprostol should be the preferred route of administration among patients with obesity. [ABSTRACT FROM AUTHOR]

The goal of mucoadhesive drug delivery systems (MDDS) is to improve drug delivery effectiveness by adhering to the body's mucosal tissues. The material used in this approach adheres to mucosal surfaces, including those in the mouth, gastrointestinal system, nasal passages, and vaginal walls. The most important goal is to extend the medication's residence duration at the absorption site in order to improve drug absorption and provide a more regulated and prolonged release. Mucoadhesion refers to the adhesion between two materials, one of which is biological, through interfacial forces over an extended period. This characteristic provides an effective solution to challenges in traditional drug delivery systems, such as avoiding first-pass metabolism and facilitating localized delivery of biomolecules, including proteins, peptides, and oligonucleotides. It holds significant promise for delivering compounds via routes like ocular, nasal, vaginal, and buccal administration This study addresses the introduction, benefits, drawbacks, mechanisms, and theories of mucoadhesion in addition to polymer categorization, mucoadhesive dosage forms, assessment, and factors affecting mucoadhesion and several kinds of mucoadhesive dosage forms. [ABSTRACT FROM AUTHOR]

Needle-free buccal anesthesia improves dental treatment outcomes for both patients and dentists. In this study, we report on an assessment of the enhancement effects of α-bisabolol on the in vitro transmucosal permeation of prilocaine hydrochloride (PCl) and lidocaine hydrochloride (LCl) from needleless buccal films. We also evaluated the mechanical properties of the film, which consisted of Methocel™ K100 LV as the film-forming polymer (3% m·m−1), PEG 400 as a cosolvent (15% m·m−1 based on drug loading), α-bisabolol (15 and 30% m·m−1 based on drug loading), and the drugs combined at a 1:1 ratio (15 mg·unit−1). The porcine esophageal epithelium was used as a membrane barrier, and artificial saliva was the release medium. After a 1 h experiment at 25 ± 2 °C, α-bisabolol significantly decreased, rather than enhanced, the permeation fluxes (five-fold), permeability coefficients (seven-fold), and retentions (two-fold) of both PCl and LCl through the epithelium, regardless of the concentration. Moreover, the resistance and flexibility of the films markedly decreased compared to those without α-bisabolol. Therefore, under the experimental conditions, using α-bisabolol as a buccal permeation enhancer for the hydrophilic local anesthetics PCl and LCl from buccal films is not feasible. [ABSTRACT FROM AUTHOR]

Benzodiazepines are the recommended first-line treatment of acute seizures. We wished to compare the efficacy, side effects, and satisfaction after midazolam administration by the buccal, intranasal, or intramuscular route in the treatment of acute seizures in children at homes and in emergency room (ER). A prospective, randomized, controlled trial was performed in children aged one month to 17 years with acute seizures lasting longer than five minutes. The primary end point was seizure cessation within 10 minutes of drug administration and no seizure recurrence within 30 minutes. In the home group, 67 patients received midazolam via buccal route, 60 via intranasal route, and 69 via intramuscular route, whereas in the ER group, 37 patients received buccal, 34 received intranasal, and 34 received intramuscular midazolam. The primary end point was achieved in 94.2% and 85.3% after intramuscular midazolam in the home and ER groups, respectively. The intranasal midazolam was successful in stopping seizures in 93.3% in the home group and 88.2% in the ER group. The buccal route was effective in 91% in the home group and 78.4% in the ER group. There were no significant differences in efficacy between all groups (P = 0.763 and P = 0.509) among the home and ER groups, respectively. There were no significant cardiorespiratory events in all groups. Intramuscular, intranasal, and buccal doses of midazolam resolved most seizures in prehospital and emergency settings. Our results indicate that there is no statistically significant difference detected between different routes of midazolam. Intranasal route showed the highest satisfaction rate among caregivers. [ABSTRACT FROM AUTHOR]

Over the years, research regarding the Zika virus has been steadily increasing. Early immunization for ZIKV is a priority for preventing complications such as microencephaly and Guillain–Barré syndrome (GBS). Unlike traditional vaccination approaches, oral dissolving films (ODFs) or mucoadhesive film technology is an emerging, exciting concept that can be used in the field of pharmaceuticals for vaccine design and formulation development. This attractive and novel method can help patients who suffer from dysphagia as a complication of a disease or syndrome. In this study, we investigated a microparticulate Zika vaccine administered via the buccal route with the help of thin films or oral dissolving films (ODFs) with a prime dose and two booster doses two weeks apart. In vitro, the ODFs displayed excellent physiochemical properties, indicating that the films were good carriers for vaccine microparticles and biocompatible with the buccal mucosa. In vivo results revealed robust humoral (IgG, subtypes IgG1 and IgG2a) and T-cell responses (CD4+/CD8+) for ZIKV-specific immunity. Both the Zika MP vaccine and the adjuvanted Zika MP vaccine affected memory (CD45R/CD27) and intracellular cytokine (TNF-α and IL-6) expression. In this study, ZIKV vaccination via the buccal route with the aid of ODFs demonstrated great promise for the development of pain-free vaccines for infectious diseases. [ABSTRACT FROM AUTHOR]

Background: Clinical evidence for the rapidity and effectiveness of fentanyl buccal soluble film (FBSF) in reducing pain intensity of breakthrough cancer pain (BTcP) remains inadequate. This study aimed to evaluate the efficacy of FBSF proportional to the around-the‐clock (ATC) opioid regimens in rapidly relieving the intensity of BTcP episodes by determining the percentage of patients requiring further dose titration. Methods: The study procedure included a dose-finding period followed by a 14-day observation period. Pain intensity was recorded with a Numeric Rating Scale (NRS) at onset and 5, 10, 15, and 30 min after FBSF self-administration. Meaningful pain relief was defined as the final NRS score ≤ 3. Satisfaction survey was conducted for each patient after treatment using the Global Satisfaction Scale. Results: A total of 63 BTcP episodes occurred in 30 cancer patients. Only one patient required rescue medication at first BTcP episode and then achieved meaningful pain relief after titrating FBSF by 200 µg. Most BTcP episodes relieved within 10 min. Of 63 BTcP episodes, 30 (47.6%), 46 (73.0%), and 53 (84.1%) relieved within 5, 10, and 15 min after FBSF administration. Only grade 1/2 adverse events were reported, including somnolence, malaise, and dizziness. Of the 63 BTcP episodes, 82.6% were rated as excellent/good satisfaction with FBSF. Conclusion: FBSF can be administrated "on demand" by cancer patients at the onset of BTcP, providing rapid analgesia by achieving meaningful pain relief within 10 min. Trial registration: This study was retrospectively registered 24 December, 2021 at Clinicaltrial.gov (NCT05209906): https://clinicaltrials.gov/study/NCT05209906. [ABSTRACT FROM AUTHOR]

Fluconazole (FZ) is a potential antifungal compound for treating superficial and systemic candidiasis. However, the use of conventional oral drug products has some limitations. The development of buccal film may be a potential alternative to oral formulations for FZ delivery. The present study involved the development of novel FZ-loaded solid lipid nanoparticles (FZ-SLNs) in pectin solutions and the investigation of their particle characteristics. The particle sizes of the obtained FZ-SLNs were in the nanoscale range. To produce pectin films with FZ-SLNs, four formulations were selected based on the small particle size of FZ-SLNs and their suitable polydispersity index. The mean particle sizes of all chosen FZ-SLNs formulations did not exceed 131.7 nm, and the mean polydispersity index of each formulation was less than 0.5. The properties of films containing FZ-SLNs were then assessed. The preparation of all FZ-SLN-loaded pectin films provided the mucoadhesive matrices. The evaluation of mechanical properties unveiled the influence of particle size variation in FZ-SLNs on the integrity of the film. The Fourier-transform infrared spectra indicated that hydrogen bonds could potentially form between the pectin-based matrix and the constituents of FZ-SLNs. The differential scanning calorimetry thermogram of each pectin film with FZ-SLNs revealed that the formulation was thermally stable and behaved in a solid state at 37 °C. According to a drug release study, a sustained drug release pattern with a burst in the initial stage for all films may be advantageous for reducing the lag period of drug release. All prepared films with FZ-SLNs provided a sustained release of FZ over 6 h. The films containing FZ-SLNs with a small particle size provided good permeability across the porcine mucosa. All film samples demonstrated antifungal properties. These results suggest the potential utility of pectin films incorporating FZ-SLNs for buccal administration. [ABSTRACT FROM AUTHOR]

Neonatal hypoglycemia (NH) is broadly defined as a low plasma glucose concentration that elicits hypoglycemia-induced impaired brain function. To date, no universally accepted threshold (reference range) for plasma glucose levels in newborns has been published, as data consistently indicate that neurologic responses to hypoglycemia differ at various plasma glucose concentrations. Infants at risk for NH include infants of diabetic mothers, small or large for gestational age, and premature infants. Common manifestations include jitteriness, poor feeding, irritability, and encephalopathy. Neurodevelopmental morbidities associated with NH include cognitive and motor delays, cerebral palsy, vision and hearing impairment, and poor school performance. This article offers a timely discussion of the state of the science of NH and recommendations for neonatal providers focused on early identification and disease prevention. [ABSTRACT FROM AUTHOR]

Introduction and Objective. The congenital disease Fibrodysplasia Ossificans Progressiva (FOP) is extremely rare, characterized by irreversible and intractable skeletal malformations, with devastating heterotopic ossifications. FOP is associated with a change in the amino acid of the ACVR1 protein at position R206H due to a mutation in its respective genetic code. Previous research has observed distinct gene expression profiles between FOP peripheral blood mononuclear cells (PBMC) versus control cells. However, invasive access to biological material in these FOP patients is an obstacle due to possible collection trauma that can cause flare-ups, with undesirable consequences, such as the formation of ectopic ossification. There is, however, a need to obtain biological specimens for research or monitoring of experimental medications. The aim of the study was to obtain total RNA from buccal mucosa epithelial squamous cell scrapings (BEC) from FOP patients. Materials and Method. BEC samples were collected by scraping the oral mucosa on the inner side of each cheek, using tongue depressor spatulas, followed by stabilization in RNAlater and Trizol extraction of total RNA. The expression profile of eight putative target Genes were analyzed from FOP BEC (n=7) and healthy volunteers (n=5), by mRNA expression through qPCR. Results. The results showed differences in basal mRNA expression of ACVR1, TNF-α and COL1 (p < 0.05) genes in FOP, compared to control, characterizing a distinct phenotypic profile of FOP BEC. Conclusions. The use of BEC may be an innovative non-invasive biological material for further clinical and molecular analyzes in patients with FOP. [ABSTRACT FROM AUTHOR]

Background & Objective: The purpose of this study was to compare the effectiveness of Buccal, Vaginal, and Sublingual misoprostol for induction of labor in term pregnancy. Materials & Methods: The research was done as an RCT from 2017 to 2018. About 300 participants were randomly allocated to obtain 50 µg Buccal, 25 µg Vaginal, and 50 µg Sublingual misoprostol in Kosar Hospital, Qazvin, Iran. The maternal and fetal complications, Bishop score hour 1, and hour 6 were observed. Results: There were no differences between fetal complications (P>0.05) and maternal complications (P>0.05) among the three groups. Bishop score hour 1 (P = 0.146), Bishop Score hour 6 (P = 0.704), and total dose (P = 0.15) also were no differences among these groups. Our study found a difference between the three groups (P = 0.015) in achieving standard vaginal delivery within 24 hours, as Buccal, Sublingual and Vaginal groups were performed respectively. The use of Oxytocin in the Buccal group was higher than that of other groups (P = 0.022). Conclusion: This study found that there is no difference in terms of fetal complications and maternal complications in the three groups, but there was a significant difference in Oxytocin use and vaginal delivery within 24 h from the start of induction. [ABSTRACT FROM AUTHOR]

Background: Acyclovir is a widely used anti-viral drug that has low bioavailability when administered orally and is also difficult to administer parenterally due to its inherent solubility limitations. Buccal administration of Acyclovir with the aid of absorption enhancers can improve the permeability of the poorly permeable anti-viral drug. Materials and Methods: Acyclovir-loaded buccal films were prepared by solvent casting method using piperine or zingiberene as herbal bioenhancers. The films were characterized for weight, thickness, folding endurance, surface pH, drug content, swelling index, tensile strength, mucoadhesion time and mucoadhesive strength. They were also evaluated for in vitro drug release and ex vivo permeation using porcine mucosa. Results: The buccal films were found to be smooth and elegant with thicknesses ranging from 0.13 mm to 0.16 mm indicating the uniformity in thickness among the films. All the formulated films demonstrated excellent folding endurance of more than 200 and also the tensile strength ranged from 0.8 kg/cm2 to 3.33 kg/cm2 indicating the robustness of the buccal films. Ex vivo mucoadhesion studies revealed that the films had a mucoadhesion time of more than 100 min. In vitro drug release showed that films released the drug in a prolonged manner for more than 350 min due to the presence of chitosan in the formulation. The drug permeation from all the piperine and zingiberene-incorporated buccal films was found to be more than two-fold compared to those without the permeation enhancers. Conclusion: Acyclovir loaded buccal films containing bioenhancers were able to successfully permeate the buccal mucosa thus achieves better bioavailability. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Mucoadhesive dosage forms, which are used for topical application in the oral cavity, are currently a very intensively developing field in pharmaceutical technology. Considering the physiological conditions of the oral cavity, the formulation of these mucoadhesive forms is still a challenge. Various types and forms of polymers are used in the experiments, in combination with a large number of drugs, while the achieved effect can be local or systemic and the release rate can be controlled. For many drugs, buccal application is one of the ways to increase their bioavailability. [ABSTRACT FROM AUTHOR]

Purpose: Limited research has been conducted on the prevalence of non-medical opioid use (NMOU) in Korean cancer patients who have received prescription opioids (PO). This study aimed to identify the potential proportion of NMOU in cancer patients who had been prescribed opioids in Korea. Methods: A retrospective cohort analysis was conducted on 14,728 patients who underwent cancer-related treatment between January 2009 and December 2019, using electronically collected data from a tertiary hospital in Korea. Information regarding the type and duration of opioid use was gathered. A detailed review of medical charts was carried out, focusing on patients who had been prescribed opioids for over 60 days beyond a 12-month period following the completion of their cancer treatment (long-term PO users). Results: Out of the 5,587 patients who were prescribed PO and followed up for at least 12 months, 13 cases of NMOU were identified, representing 0.23% of the patient population. Among the 204 long-term PO users, the rate was 6.37% (13/204). The most commonly misused opioids were oxycodone and fentanyl. For the group confirmed to have NMOU, the median duration of prescription was 1,327 days in total. Of the 13 patients diagnosed with NMOU, 9 reported withdrawal symptoms, 3 exhibited craving behavior for opioids, and 1 experienced both symptoms. Conclusion: This study found that 0.23% of cancer patients who had been prescribed opioids in Korea demonstrated NMOU. Despite this relatively low rate, careful monitoring is necessary to minimize the risk of NMOU in this population, especially among long-term PO users. [ABSTRACT FROM AUTHOR]

Objective: To determine the changes in orthodontists’ interest in various orthodontic appliances during the coronavirus disease-2019 (COVID-19) pandemic. Methods: A questionnaire probing respondents’ interest in orthodontic appliances and techniques, including standard buccal metal brackets, self-ligating brackets, standard ceramic brackets, lingual brackets, clear aligners, orthodontic facemasks, removable functional appliances, fixed functional appliances, orthognathic surgery, orthodontic miniscrews, and lingual retainers, was prepared using Google Forms and then sent to the Turkish Orthodontic Society to invite all members of the society to participate in the survey. Of the 1903 members invited, 230 (response rate, 12.08%) orthodontists completed the questionnaire. Results: The respondents’ interest in brackets did not change among 70% of the respondents (standard buccal metal bracket 80%, self-ligating bracket 72.2%, standard ceramic bracket 77%, and lingual bracket 76.5%). A significant difference was observed between the genders only about the interest in standard metal brackets and fixed functional appliances (p<0.05 for both). Interest in standard metal brackets decreased as respondents’ work experience increased (p<0.05). The interest in self-ligating brackets was higher among respondents with 1-5 years of experience than among other respondents (p<0.05). Interest in self-ligating brackets increased more among lecturers and residents than among clinicians (p<0.05). Conclusion: The interest of orthodontists in clear aligners showed the highest increase during the COVID-19 pandemic among all orthodontic appliances, whereas their interest in other appliances, particularly standard buccal metal brackets, did not change. [ABSTRACT FROM AUTHOR]

Objectives: This study was designed as a prospective randomized single-blind clinical trial to compare the anesthetic efficacy of inferior alveolar nerve block (IANB), IANB plus buccal infiltration, and IANB plus lingual infiltration of 4% articaine with 1:100,000 epinephrine in mandibular molars with irreversible pulpitis. Method and materials: Sixty healthy volunteers who had a first or second mandibular molar diagnosed with irreversible pulpitis participated in the present study. This study was composed of three arms for the first molar and three arms for the second molar. Subjects in test arm A received two IANB injections (3.6 mL). Subjects in test arm B received 1.8 mL IANB injection plus 1.8 mL buccal infiltration. Subjects in test arm C received 1.8 mL IANB injection plus 1.8 mL lingual infiltration. Articaine (4%) with 1:100,000 epinephrine was used for all injections. The subject's pain during access preparation and pulp extirpation was recorded on the Heft-Parker visual analog scale. Success was defined as "none" or "mild" pain during treatment. Kruskal-Wallis test was used to compare pain categories in three groups of interventions for each mandibular molar. Results: IANB with a supplemented buccal infiltration provided more success than IANB alone or IANB plus lingual infiltration, in first molars (P = .019). There were no significant differences between the three injection techniques in second molars (P = .795). Conclusions: Adding a supplemental buccal infiltration to a standard IANB was more successful in providing pain-free treatment for patients experiencing irreversible pulpitis in mandibular first molars. [ABSTRACT FROM AUTHOR]

Objective: To compare and evaluate the efficacy, hemodynamic changes, and postoperative complications of 4% articaine using buccal infiltration and 2% lidocaine using inferior alveolar nerve block in mandibular primary molars of children aged 6 to 8 years. Method and materials: 100 participants were randomly distributed to receive either 4% articaine using infiltration anesthesia or 2% lidocaine using inferior alveolar nerve block on each side of the mandibular arch, in two different appointments, after a 1-week interval. The pain perception was evaluated using visual analog scale (VAS) and Wong-Baker Faces pain rating scale (WBFPRS). In both the appointments, the efficacy and onset of anesthesia were evaluated using an electric pulp tester. Hemodynamic parameters, which included pulse rate and oxygen saturation levels, were evaluated using a pulse oximeter. Postoperative complications were evaluated at 24-hour follow-up. Results: Pain score recorded with block was more painful compared to infiltration (P < .05). Anesthetic success was observed with both the local anesthetic agents, with no significant differences (P > .05). Shorter onset of action was observed with articaine (P < .05). Statistically significant differences between groups were noted with regard to heart rate (P < .05). Oxygen saturation levels did not show significant differences (P > .05). When postoperative complications were evaluated with either 4% articaine or 2% lidocaine, very few adverse effects were recorded (P > .05). Conclusion: Buccal infiltration using 4% articaine has the potential to replace 2% lidocaine using inferior alveolar nerve block in children. [ABSTRACT FROM AUTHOR]

Pharmaceutical films are polymeric formulations used as a delivery platform for administration of small and macromolecular drugs for local or systemic action. They can be produced by using synthetic, semi-synthetic, or natural polymers through solvent casting, electrospinning, hot-melt extrusion, and 3D printing methods, and depending on the components and the manufacturing methods used, the films allow the modulation of drug release. Moreover, they have advantages that have drawn interest in the development and evaluation of film application on the buccal, nasal, vaginal, and ocular mucosa. This review aims to provide an overview of and critically discuss the use of films as transmucosal drug delivery systems. For this, aspects such as the composition of these formulations, the theories of mucoadhesion, and the methods of production were deeply considered, and an analysis of the main transmucosal pathways for which there are examples of developed films was conducted. All of this allowed us to point out the most relevant characteristics and opportunities that deserve to be taken into account in the use of films as transmucosal drug delivery systems. [ABSTRACT FROM AUTHOR]

A promising controlled drug delivery system has been developed based on polymeric buccoadhesive bilayered formulation that uses a drug-free backing layer and a polymeric hydrophilic gel buccoadhesive core layer containing nifedipine. The DSC thermogravimetric analysis confirms the drug's entrapment in the gel layer and reveals no evidence of a potential interaction. Various ratios of bioadhesive polymers, including HPMC K100, PVP K30, SCMC, and CP 934, were combined with EC as an impermeable backing layer to ensure unidirectional drug release towards the buccal mucosa. The polymeric compositions of hydrophilic gel-natured HPMC, SCMC, and CP formed a matrix layer by surrounding the core nifedipine during compression. Preformulation studies were performed for all of the ingredients in order to evaluate their physical and flow characteristics. Ex vivo buccoadhesive strength, surface pH, swelling index, in vitro and in vivo drug release, and ex vivo permeation investigations were performed to evaluate the produced gel-based system. Rapid temperature variations had no appreciable impact on the substance's physical properties, pharmacological content, or buccoadhesive strength during stability testing using actual human saliva. It was clear from a histological examination of the ex vivo mucosa that the developed system did not cause any irritation or inflammation at the site of administration. The formulation NT5 was the best one, with a correlation coefficient of 0.9966. The in vitro and in vivo drug release profiles were well correlated, and they mimic the in vitro drug release pattern via the biological membrane. Thus, the developed gel-based formulation was found to be novel, stable, and useful for the targeted delivery of nifedipine. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of using DentalVibe during injection in comparison with the traditional injection technique, regarding pain and discomfort associated with buccal infiltration anesthesia (BIA) in pediatric patients. Method and materials: This randomized clinical trial included 6- to 12-year-old healthy children currently receiving nonurgent dental treatment on the maxillary arch that required BIA. In the control group, subjects received traditional BIA. In the test group, they received BIA with the aid of DentalVibe. A sample of 30 subjects per group was included. The mean ± SD age of the subjects was 9.18 ± 1.66 years. All the subjects were videotaped, and two trained and calibrated evaluators assessed the children's behaviors during the injection using the face, legs, activity, cry, consolability (FLACC) scale independently. Immediately after anesthesia administration, the subjects were administered the validated Arabic version of the Wong-Baker FACES scale ranging from 0 to 10. Results: Female subjects showed significantly higher mean FLACC and Wong-Baker FACES scale scores (2.20 ± 1.82 and 2.93 ± 3.05) compared with males (1.08 ± 1.37 and 1.12 ± 2.09) (P = .008 and P = .006, respectively). Multiple regression analysis showed that regardless of age and treatment group, females had significantly higher mean scores on the FLACC (ß = 1.63, P = .002) and the Wong-Baker FACES scales (OR = 4.44, P = .004) than males. Conclusion: The use of DentalVibe did not significantly affect pain, discomfort, or time during BIA among pediatric patients compared with the traditional technique. Female children were more likely to report higher pain and discomfort scores during BIA administration regardless of age and anesthesia administration technique. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effectiveness of a single labial infiltration of 4% articaine versus 2% lidocaine for the extraction of mandibular anterior teeth without an additional lingual injection. Patients and methods: A prospective, randomized-controlled, split-mouth clinical study was implemented. Healthy adult patients seeking bilateral extraction of mandibular anterior teeth were included in this study. Teeth extractions were randomly assigned to two equal groups, where one mandibular anterior tooth was extracted using a solitary labial infiltration of either 4% articaine (the study group) or 2% lidocaine (the control group). After 14 days, the other mandibular anterior tooth was extracted using the other local anesthetic agent. The selection of the anesthetic agent injected in the first session was done in a randomized fashion. After 5 min of local anesthetic injection, the tooth was extracted, and each patient was asked to record the intensity of the extraction pain using the Visual Analogue Scale (VAS). Results: Thirty-one patients were included in the study. The efficacy of a single labial injection for mandibular anterior teeth extraction was established by the fact that none of the patients in the study or control group required re-administration of local anesthesia. The mean VAS for pain control during tooth extraction was 1.16 ± 0.93 for the articaine group and 1.71 ± 0.90 for the lidocaine group. The pain score showed a statistically significant decrease in the articaine group compared to that in the lidocaine group (P = 0.017). Conclusion: Although the anesthetic effects of only buccal infiltration of 4% articaine and 2% lidocaine for extraction of mandibular anterior teeth were comparable, the use of 4% articaine would have more effective and predictable outcomes. ClinicalTrials.org: (ID: NCT05223075) 3/2/2022. [ABSTRACT FROM AUTHOR]

The aim and objective of this study was to create mucoadhesive buccal films that contained the multipurpose medical carvedilol, which has a variety of medicinal uses. Materials and methods. The films were equipped using a solvent casting technique and concentrations of natural polymers, including Sweet basil, Lime Basil seeds and Purple basil mucilage. The influence of Carbopol 934 P, a selected natural polymer, was also investigated. The formulation variables were improved by the use of a factorial design of experiments and evaluated for their physico-chemical and in vitro evaluations. Result. These evaluations provided crucial insights into the properties of the buccal films. To evaluate the release profile and release kinetics of carvedilol from the films, in vitro drug release experiments were carried out in a phosphate buffer solution. Ex vivo permeation tests using fresh sheep buccal mucosa were performed to evaluate the drug’s permeation through the buccal membrane. Samples were taken at regular intervals, and a UV Spectrophotometer was used for analysis. With a polymer solution concentration at level “3,” formulation run R20 showed the best optimized buccal formulation. This formulation shows promise for further in vivo research. Conclusions. The results of this study offer important new evidence about the design and efficacy of mucoadhesive buccal films containing carvedilol. The optimization of formulation parameters and the assessment of physicochemical properties and drug release kinetics contribute to the progress of reproducible buccal films. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Hospital Pharmacy / Journal Canadien de la Pharmacie Hospitalière is the property of Canadian Society of Hospital Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Dental caries is the most common oral disease, with high prevalence rates in adolescents and low-income and lower-middle-income countries. This disease originates from acid production by bacteria, leading to demineralization of the dental enamel and the formation of cavities. The treatment of caries remains a global challenge and the development of effective drug delivery systems is a potential strategy. In this context, different drug delivery systems have been investigated to remove oral biofilms and remineralize dental enamel. For a successful application of these systems, it is necessary that they remain adhered to the surfaces of the teeth to allow enough time for the removal of biofilms and enamel remineralization, thus, the use of mucoadhesive systems is highly encouraged. Among the systems used for this purpose, liquid crystalline systems, polymer-based nanoparticles, lipid-based nanoparticles, and inorganic nanoparticles have demonstrated great potential for preventing and treating dental caries through their own antimicrobial and remineralization properties or through delivering drugs. Therefore, the present review addresses the main drug delivery systems investigated in the treatment and prevention of dental caries. [ABSTRACT FROM AUTHOR]

Background: Buccal mucosa metastasis is rare in breast cancer patients. Case Presentation: A 50-year-old female breast cancer patient with invasive lobular carcinoma (ILC) in his eight years follow-up period presented with a swelling in the right eye. Head and neck MRI was showed soft tissue formation with dimensions of 59x31 mm was detected in the axial plane, extending from the level of the right infratemporal fossa to the right buccinator muscle and right maxillary sinus in front of the alveolar process. In the right periorbital region, there was a thickness increase of up to 1 cm in the thickest part of the globe, which was evident in the anterolateral. In addition, there was no bone destruction in the right infratemporal region in maxillofacial CT, and no additional organ metastasis was detected in PET-CT performed for systemic scanning. In the histopathological examination of the tissue, carcinoma infiltration was detected. Radiotherapy was applied to the right buccal and orbital region of the patient as 30 Gy in 12 fractions (2.5 Gy per fraction) with volumetric modulated arc therapy technique and then 15 Gy in 6 fractions (2.5 Gy per fraction) boost radiotherapy with the adaptive technique were applied. At the follow-up 2 months later, clinical response was observed in the patient, and significant regression of the lesion was observed in facial and orbital MRI. At the 15th month follow-up of the patient, clinical and radiological remission continues. All clinical complaints regressed. Conclusion: ILC is a subtype of breast cancer that is characterized by unusual metastasis. Therefore, during the follow-up of these patients, it is necessary to monitor both laboratory values and clinical complaints very carefully. [ABSTRACT FROM AUTHOR]

The greatest achievement in the advanced drug delivery field should be the optimization of non-invasive formulations for the delivery of high molecular weight compounds. Peptides, proteins, and other macromolecules can have poor membrane permeation, principally due to their large molecular weight. The aim of this work was to explore the possibility of administering fluorescently labeled dextrans (molecular weight 4–150 kDa) across the buccal mucosa. Permeation experiments across pig esophageal mucosa were carried out using fatty acids and bile salts as penetration enhancers. The data obtained show that it is possible to increase or promote the mucosa permeation of high molecular weight dextrans by using caprylic acid or sodium taurocholate as the chemical enhancers. With these enhancers, dextrans with molecular weight of 70 and 150 kDa, that in passive conditions did not permeate, could cross the mucosa in detectable amounts. FD-70 and FD-150 showed comparable permeability values, despite the molecular weight difference. The results obtained in the present work suggest that the buccal administration of high molecular weight compounds is feasible. [ABSTRACT FROM AUTHOR]

In order to mitigate early hypoglycemia in preterm infants, some clinicians have recently explored interventions such as delivery room commencement of dextrose infusions or delivery room administration of buccal dextrose gel. This review aimed to systematically investigate the literature regarding the provision of delivery room (prior to admission) parenteral glucose as a method to reduce the risk of initial hypoglycemia (measured at the time of NICU admission blood testing) in preterm infants. Using PRISMA guidelines a literature search (May 2022) was conducted using PubMed, Embase, Scopus, Cochrane Library, OpenGrey, and Prospero databases. The clinicaltrials.gov database was searched for possible completed/ongoing clinical trials. Studies that included moderate preterm ( ≤ 33+6 weeks) or younger birth gestations or very low birth weight (or smaller) infants, and that administered parenteral glucose in the delivery room were included. The literature was appraised via data extraction, narrative synthesis, and critical review of the study data. A total of five studies (published 2014–2022) were eligible for inclusion (three before-after "quasi-experimental" studies, one retrospective cohort study, and one case-control study). Most included studies used intravenous dextrose as the intervention. Individual study effects (odds ratios) favored the intervention in all included studies. It was felt that the low number of studies, the variability in study design, and the nonadjustment for confounding co-interventions (co-exposures) precluded a meta-analysis. Quality assessment of the studies revealed a spectrum of bias from low to high risk, however, most studies had moderate to high risk of bias, and their direction of bias favored the intervention. This extensive search and systematic appraisal of the literature indicates that there exists few studies (these are low grade and at moderate to high risk of bias) for the interventions of either intravenous or buccal dextrose given in the delivery room. It is not clear if these interventions impact on rates of early (NICU admission) hypoglycemia in these preterm infants. Obtaining intravenous access in the delivery room is not guaranteed and can be difficult in these small infants. Future research should consider various routes for commencing delivery room glucose in these preterm infants and should take the form of randomized controlled trials. [ABSTRACT FROM AUTHOR]

Sedation techniques and drugs are increasingly used in children undergoing imaging procedures. In this systematic review and meta-analysis, we present an overview of literature concerning sedation of children aged 0–8 yr for magnetic resonance imaging (MRI) procedures using needle-free pharmacological techniques. Embase, MEDLINE, Web of Science, and Cochrane databases were systematically searched for studies on the use of needle-free pharmacological sedation techniques for MRI procedures in children aged 0–8 yr. Studies using i.v. or i.m. medication or advanced airway devices were excluded. We performed a meta-analysis on sedation success rate. Secondary outcomes were onset time, duration, recovery, and adverse events. Sixty-seven studies were included, with 22 380 participants. The pooled success rate for oral chloral hydrate was 94% (95% confidence interval [CI]: 0.91–0.96); for oral chloral hydrate and intranasal dexmedetomidine 95% (95% CI: 0.92–0.97); for rectal, oral, or intranasal midazolam 36% (95% CI: 0.14–0.65); for oral pentobarbital 99% (95% CI: 0.90–1.00); for rectal thiopental 92% (95% CI: 0.85–0.96); for oral melatonin 75% (95% CI: 0.54–0.89); for intranasal dexmedetomidine 62% (95% CI: 0.38–0.82); for intranasal dexmedetomidine and midazolam 94% (95% CI: 0.78–0.99); and for inhaled sevoflurane 98% (95% CI: 0.97–0.99). We found a large variation in medication, dosage, and route of administration for needle-free sedation. Success rates for sedation techniques varied between 36% and 98%. [ABSTRACT FROM AUTHOR]

Background: Prelabour rupture of membranes (PROM) is defined as the membrane rupture at term without spontaneous uterine contractions.1 It is rupture of membranes with at least 2 hours latent period before active labour, latent period being the time elapsing from the time of rupture of membranes to the onset of labour. If rupture of membranes (ROM) occur before 37 weeks of gestation it is termed as the preterm prelabour rupture of membranes (PPROM). OBJECTIVES: * To compare the safety and efficacy of Misoprostol by two different routes of administration i.e., oral and buccal in women with PROM at term. * To achieve a safe vaginal delivery of patients by inducing labour with Misoprostol either by oral or buccal route and to make a clinical study regarding the induction-delivery intervals, maternal and neonatal complications and adverse effects of the drug by the two different routes. MATERIAL & METHODS: Study Design: A prospective comparative study. Study area: Department of Obstetrics and Gynaecology, Integral Institute of Medical Sciences and Research, Lucknow, Uttar Pradesh. Study Period: June 2021 - June 2022.Study population: Cases admitted to labour ward at term with PROM were included in the study. Sample size: study consisted a total of 100 cases. Sampling method: Simple random method. Study tools and Data collection procedure: 100 cases of pregnant women with PROM at term were approached for the study and were divided into two groups of 50 each for 25 microgram Misoprostol for oral and buccal route. Thorough history taking, examination, foetal evaluation by reactive CTG, assessment of cervical status by bishop score was done prior to induction. Informed consent was obtained. The cases were divided into two groups 50 each to receive Misoprostol 25µg(1/4 of 100 µg tablet) 4th hourly either by buccal or oral route. In all patients, the cervical status was assessed by using bishop score prior to induction. Results: In the present study tachysystole was 8% and 2% in women of buccal and oral Misoprostol group respectively. In present study there was no case of hyperstimulation. 10% presently studied women experienced Vomiting. Fever 4%, chills 12% were reported in the overall group. CONCLUSION: From our study, it can be concluded that buccal route of administration of Misoprostol for induction of labour in Term Prelabour rupture of membranes (PROM) is more efficacious compared to the oral route of administration and might be the preferred route. [ABSTRACT FROM AUTHOR]

Statement of the Problem: Natural products have attracted interest as an alternative to synthetic medications for the treatment of oral diseases due to their efficacy and safety. Propolis and pomegranate extracts have both demonstrated efficacy for the treatment of denture stomatitis. However, use of the two compounds together has not been tested for this purpose. Purpose: A comparison was made of the efficacy of a commercially available propolis-pomegranate buccal spray formulation for the treatment of denture stomatitis, compared with miconazole gel, based on stomatitis lesions and Candida spp. concentrations in mouth rinses. Materials and Method: This was an experimental study, characterized as an open-label, parallel twoarmed, non-inferiority randomized clinical trial. Forty elderly adults aged ≥ 60 years with denture stomatitis were randomly allocated to two groups. The patients applied a buccal spray containing 0.5% propolis and 0.9% pomegranate extracts or 2% miconazole gel, a standard treatment recommended in Brazil, to the inner surface of their dentures three times a day for 14 days. They were examined at days 1, 7, 14 and stomatitis lesions were categorized according to Newton’s score. Mouth rinses were made with saline solution at days 1 and 14 and then assessed for Candida spp. Results: Both treatments reduced the Newton’s score, with clinical cure rates of 75 and 40% for the miconazole and propolis-pomegranate groups, respectively. The Candida concentrations in the mouth rinse decreased significantly only in the miconazole group. Conclusion: The propolis-pomegranate spray was less effective than the miconazole treatment. However, clinical improvement was also observed in patients treated with the propolis-pomegranate buccal spray. [ABSTRACT FROM AUTHOR]

Complexes of hen egg white lysozyme (HEWL) with alginate (ALG) and chitosan (CS) (natural biodegradable polysaccharides) are important as antimicrobial agents in oral, intranasal and buccal administration. The HEWL–ALG, HEWL–ALG–Ca, [HEWL–ALG]–CS, and [HEWL–ALG–Ca]–CS complexes have been investigated using a combination of physicochemical methods (fluorescent spectroscopy, circular dichroism, microscopy, turbidimetry, microbiology, in vitro cytotoxicity assay). The complexes obtained were non-toxic negatively charged microparticles with high HEWL entrapment efficiency. The [HEWL–ALG]–CS and [HEWL–ALG–Ca]–CS complexes were found to have the altered tertiary structure of HEWL (and/or changes in the polarity of the microenvironment of Trp residues in HEWL molecules). The HEWL entrapment in all studied complexes was carried out with retention of the HEWL activity. Under the long–term storage conditions (1.5 years at 4 °C), Ca++ cations and CS stabilized HEWL. Under physiological conditions, the [HEWL–ALG]–CS and [HEWL–ALG–Ca]–CS complexes demonstrated sustained release of HEWL and resistance to protease action. The [HEWL–ALG]–CS and [HEWL–ALG–Ca]–CS complexes were highly active against Gram-negative Escherichia coli cells. The data obtained are important in the development of antibacterial drugs based on lytic enzymes. [ABSTRACT FROM AUTHOR]

(S)-ketamine presents potential for the management of acute pain and, more specifically, for the prevention of pain associated with care. However, the administration route can be a source of pain and distress. In this context, a smart formulation of (S)-ketamine was designed for buccal administration. The combination of poloxamer 407 and sodium alginate enables increased contact with mucosa components (mucins) to improve the absorption of (S)-ketamine. In this study, rheological studies allowed us to define the concentration of P407 to obtain a gelling temperature around 32 °C. Mucoadhesion tests by the synergism method were carried out to determine the most suitable alginate among three grades and its quantity to optimize its mucoadhesive properties. Protanal LF 10/60 was found to be the most effective in achieving interaction with mucins in simulated saliva fluid. P407 and alginate concentrations were set to 16% and 0.1%. Then, the impact of P407 batches was also studied and significant batch-to-batch variability in rheological properties was observed. However, in vitro drug release studies demonstrated that this variability has no significant impact on the drug release profile. This optimized formulation has fast release, which provides potential clinical interest, particularly in emergencies. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to determine the success rate of the combination of buccal infiltration (BI) and inferior alveolar nerve block (IANB) injections in irreversible pulpitis in mandibular molars after premedication with ibuprofen. Materials and Methods: From 132 patients participated in the study, 120 patients were included. One hour before root canal treatment, patients with mandibular molars with symptomatic irreversible pulpitis received either a 600 mg ibuprofen capsule or a placebo. All patients received 2% lidocaine with 1:80000 epinephrine and 4% articaine with 1:100000 epinephrine for IANB and BI, respectively. Patients' pain was evaluated using the Heft-Parker visual analog scale during the preparation of access cavity, exposure of pulp, and instrumentation of root canal. The success of anesthesia was defined as the absence of pain or mild pain. The Chi-square and t-test were employed for data analysis. Results: The difference between patient age and gender in the two groups was not significant (P>0.05). The anesthesia success rate was 85% in the premedicated and 70% in the placebo group, with statistically significant results (P=0.049). Conclusion: Based on this triple-blinded randomized clinical study, mandibular molars with irreversible pulpitis were not thoroughly anesthetized by a combination of IANB+BI after premedication with ibuprofen (600 mg), even though anesthesia success was improved significantly by ibuprofen premedication. [ABSTRACT FROM AUTHOR]

Lichen planus is a chronic, inflammatory, immune-mediated dermatosis affecting the patient's skin, scalp, mucous membranes, and nails. Drug-induced lichen planus is described after the administration of antimalarials, ß-blockers, methyldopa, NSAIDs, penicillamines, and sodium aurothiomalate. The use of biologicals such as adalimumab, etanercept, and infliximab has also been linked with the appearance of lichenoid eruptions in the recent past. In this case, we report on a patient developing oral and cutaneous lichen planus after the administration of dupilumab. The lichenoid lesions occurred after 11 months of the drug's administration and involved the buccal walls, trunk, and extremities. Dupilumab had been administered in an effort to counter severe atopic dermatitis exacerbations. Dupilumab is associated with a downregulation of T-helper 2 cell activation by blocking the Interleukin-4/Interleukin-13 pathway, so leading to a TH1/TH2 imbalance. This imbalance may cause a shift toward a TH1-mediated immune response and be an explanation for the drug-induced lichen planus. Dupilumab was discontinued, and the patient was treated with oral corticosteroids and UVB phototherapy, leading to a significant improvement in the lichen planus lesions. [ABSTRACT FROM AUTHOR]

Background: Despite the widespread use and sales of cannabidiol (CBD) products in the United States, there is a paucity of literature to evaluate its effectiveness, safety, or ideal route of administration for postoperative pain. Purpose: To evaluate the potential analgesic effects of buccally absorbed CBD in patients who have undergone arthroscopic rotator cuff repair (ARCR). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This was a US Food and Drug Administration–sanctioned, multicenter, placebo-controlled, randomized, double-blinded trial conducted in patients undergoing ARCR. Patients aged from 18 to 75 years undergoing ARCR were prospectively enrolled and randomized to the control and experimental groups. The experimental group received an oral, buccally absorbed tablet containing 25 mg of CBD 3 times a day if <80 kg, or 50 mg of CBD 3 times a day if >80 kg, for 14 days postoperatively, while the control group received an identical placebo. Patients were followed up on days 1, 2, 7, and 14, and visual analog scale (VAS) for pain scores, opioid consumption, and satisfaction with pain control were recorded. Additionally, liver function tests were conducted on days 7 and 14 to assess safety, and nausea was monitored. P <.05 was considered to be statistically significant. Results: Overall, 100 patients were recruited, with 1 patient being excluded, for a total of 99 patients. There were no significant differences in patient demographics between the 2 groups. On day 1, the VAS pain score was significantly lower in the CBD group than in the control group (4.4 ± 3.1 vs 5.7 ± 3.2, respectively; P =.04), although this difference was no longer present on day 2 (4.7 ± 2.8 vs 5.3 ± 2.6, respectively; P =.32). On both days 1 and 2, patient satisfaction with pain control was significantly higher in the CBD group than in the control group (day 1: 7.0 ± 3.0 vs 5.6 ± 3.7, respectively [ P =.04]; day 2: 7.3 ± 2.5 vs 6.0 ± 3.3, respectively [ P =.03]). The quantity of opioids consumed was low in both groups, and there were no statistically significant differences in opioid consumption (P >.05). On days 7 and 14, there were no statistically significant differences in VAS scores, opioid consumption, or patient satisfaction with pain control between the CBD and control groups (P >.05 for all). There were no significant differences in liver function test results postoperatively (P >.05). Conclusion: Buccally absorbed CBD demonstrated an acceptable safety profile and showed significant promise in the reduction of pain in the immediate perioperative period after ARCR compared with the control. Further studies are currently ongoing to confirm dosing and effectiveness in other orthopaedic conditions. Registration: NCT04672252 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Cytisine (CYT) has emerged as a promising molecule to treat nicotine addiction, since it acts as a partial agonist of nicotinic acetylcholine receptors. However, its unfavorable pharmacokinetic properties lead to multiple administrations per day, reducing the patient's compliance and increasing the side effects. To overcome these drawbacks, CYT buccal administration is here proposed. Firstly, CYT stability in the buccal environment was assessed and its intrinsic ability to permeate/penetrate the tissue was determined by applying CYT solutions at increasing concentrations. Furthermore, a spray-drying method was selected and optimized as it is an eco-friendly, easily scalable and effective technique to obtain uniform and reproducible CYT-loaded (5% w/w) pharmaceutical powders, which were directly compressed, thus obtaining different buccal delivery systems (BDSs). The obtained BDSs were homogeneous and reproducible and embedded CYT in its amorphous form. The mechanism of CYT release was evaluated in vitro and found to be mainly driven by a Fickian diffusion phenomenon. Predominantly, the ex vivo permeation assays highlighted the ability of the BDSs to enhance CYT permeation, also producing high drug fluxes through the mucosa. Speculative mathematical evaluations based on the already-known CYT pharmacokinetic parameters showed that CYT-loaded BDSs could potentially be sufficient to obtain a therapeutic effect, thus making the reported formulations suitable candidates for further in vivo trials. [ABSTRACT FROM AUTHOR]

To date, buccal administration of lipophilic drugs is still a major challenge due to their poor solubility in saliva and limited penetration into mucosal tissues. To overcome these limitations, we developed electrospun patches combining the benefits of mucoadhesive fibers and self-emulsifying drug delivery systems (SEDDS). The fiber system comprises a combination of mucoadhesive thiolated polyacrylic acid fibers and SEDDS-loaded fibers fabricated by parallel electrospinning. The resulting mucoadhesive electrospun SEDDS patches were systemically investigated for fiber characteristics, self-emulsification, mucoadhesion, drug penetration into porcine buccal tissue and biocompatibility. The patches showed high encapsulation efficiency for SEDDS without causing fiber defects or leakage. SEDDS incorporation enhanced the spinning process and reduced the fiber diameter and fiber size distribution. Hydration-dependent self-emulsification provided a controlled release of curcumin being encapsulated in nano-scaled o/w emulsion for over 3 h. Due to the thiolated polyacrylic acid fibers, the buccal residence time of patches was 200-fold prolonged. Further, they promoted a significantly increased drug penetration into buccal tissue compared to fiber patches without SEDDS. Finally, biocompatibility and improved therapeutic effects of curcumin-loaded patches on human keratinocytes and fibroblasts were confirmed. Mucoadhesive electrospun SEDDS patches represent a promising approach to overcome current challenges in the oromucosal delivery of lipophilic drugs to unlock their full therapeutic potential. [Display omitted] • Self-emulsifying drug delivery systems (SEDDS) were electrospun into polymer fibers patches for oromucosal drug delivery. • High loading capacity of the fibers with SEDDS was shown (up to 50% of polymer weight). • 200-fold prolonged buccal patch residence time was achieved by parallel electrospinning of polyacrylic acid thiomer fibers. • SEDDS-loaded fibers ensured prolonged release of curcumin and led to 1200-fold increase in aqueous solubility. • In contrast to conventional fiber patches, SEDDS-loaded mucoadhesive fibers enabled deep mucosal penetration of curcumin. [ABSTRACT FROM AUTHOR]

The IMPROVE study (NCT02408315) compared the efficacy and safety of vaginal and buccal administration of misoprostol for full‐term, uncomplicated labor induction. This report compares the pharmacokinetics of misoprostol between vaginal and buccal routes. Women greater than or equal to 14 years of age undergoing induction of labor greater than or equal to 37 weeks gestation without significant complications were randomized to vaginal or buccal misoprostol 25 μg followed by 50 μg doses every 4 h. Misoprostol acid concentrations were determined using liquid chromatography‐tandem mass spectrometry for the first 8 h in a subgroup of participants. A population pharmacokinetic model was developed using NONMEM. Plasma concentrations (n = 469) from 47 women were fit to a one‐compartment nonlinear clearance model. The absorption rate constant (ka) was dependent on both route and dose of administration: buccal 25 μg 0.724 (95% confidence interval, 0.54–0.92) h−1; 50 μg 0.531 (0.37–0.63) h−1; vaginal 25 μg 0.507 (0. 2–1. 4) h−1; and 50 μg 0.246 (0.103–0.453) h−1. Relative bioavailability for vaginal compared to buccal route was 2.4 (1.63–4.77). There was no effect of body mass index or age on apparent clearance 705 (431–1099) L/h or apparent volume of distribution 632 (343–1008) L. The area under the concentration–time curve to 4 h following the first 25 μg dose of misoprostol was 16.5 (15.4–17.5) pg h/ml for buccal and 34.3 (32.5–36.1) pg h/ml for vaginal administration. The rate of buccal absorption was two times faster than that of vaginal, whereas bioavailability of vaginal administration was 2.4 times higher than that of buccal. Decreased time to delivery observed with vaginal dosing may be due to higher exposure to misoprostol acid compared to buccal. [ABSTRACT FROM AUTHOR]

Oral candidiasis has a high rate of development, especially in immunocompromised patients. Immunosuppressive and cytotoxic therapies in hospitalized HIV and cancer patients are known to induce the poor management of adverse reactions, where local and systemic candidiasis become highly resistant to conventional antifungal therapy. The development of oral candidiasis is triggered by several mechanisms that determine oral epithelium imbalances, resulting in poor local defense and a delayed immune system response. As a result, pathogenic fungi colonies disseminate and form resistant biofilms, promoting serious challenges in initiating a proper therapeutic protocol. Hence, this study of the literature aimed to discuss possibilities and new trends through antifungal therapy for buccal drug administration. A large number of studies explored the antifungal activity of new agents or synergic components that may enhance the effect of classic drugs. It was of significant interest to find connections between smart biomaterials and their activity, to find molecular responses and mechanisms that can conquer the multidrug resistance of fungi strains, and to transpose them into a molecular map. Overall, attention is focused on the nanocolloids domain, nanoparticles, nanocomposite synthesis, and the design of polymeric platforms to satisfy sustained antifungal activity and high biocompatibility with the oral mucosa. [ABSTRACT FROM AUTHOR]

A pharmaceutical vehicle based on lyophilized liposomes is proposed for the buccal administration of drugs aimed at systemic delivery through the sublingual mucosa. Liposomes made of egg phosphatidylcholine and cholesterol (7/3 molar ratio) were prepared and lyophilized in the presence of different additive mixtures with mucoadhesive and taste-masking properties. Palatability was assayed on healthy volunteers. The lyophilization cycle was optimized, and the lyophilized product was compressed to obtain round and capsule-shaped tables that were evaluated in healthy volunteers. Tablets were also assayed regarding weight and thickness uniformities, swelling index and liposome release. The results proved that lyophilized liposomes in unidirectional round tablets have palatability, small size, comfortability and buccal retention adequate for sublingual administration. In contact with water fluids, the tablets swelled, and rehydrated liposomes were released at a slower rate than permeation efficiency determined using a biomimetic membrane. Permeability efficiency values of 0.72 ± 0.34 µg/cm2/min and 4.18 ± 0.95 µg/cm2/min were obtained for the liposomes with and without additives, respectively. Altogether, the results point to the vehicle proposed as a liposomal formulation suitable for systemic drug delivery through the sublingual mucosa. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study is to evaluate the potential analgesic effects of buccal-absorbed cannabidiol (CBD) in patients that have undergone arthroscopic rotator cuff repair (ARCR). Methods: This is an FDA sanctioned, multi-center, placebo-controlled, randomized, double-blinded trial conducted in patients undergoing ARCR. Patients from 18 to 75 years of age undergoing an ARCR were prospectively enrolled. Patients were equally randomized to the control and experimental groups. The experimental group post-operatively received 25mg of CBD (Oravexx, Orcosa Pharmaceuticals, USA) TID if < 80kg and 50mg of CBD TID if > 80kg for 14 days, with control groups receiving an identical placebo. Patients were followed-up on Day 1, 2, 7, and 14, and Visual Analog Scale (VAS) for pain, opioid consumption, and satisfaction with pain control were recorded. Additionally, liver function tests (LFT) were done on Days 7 and 14 to assess safety, and nausea was monitored. A priori power analysis was performed based on the VAS score as primary endpoint, which revealed that a minimum of 39 patients would be required in each group to detect a clinically important difference in the VAS score (1.4) with a power of 0.8. A value of p < 0.05 was considered to be statistically significant. Results: Overall, 80 patients were recruited. There were no significant differences in age, sex, or BMI between the two groups. On Day 1, VAS pain score was significantly lower in those receiving CBD (4.1 ± 3.0 vs 6.0 ± 3.1, p = 0.01), which also meets VAS MCID for shoulder arthroscopy (1.2-1.4). Patient satisfaction with pain control trended towards significance favoring the CBD group (72% vs 60%, p = 0.072). However, there were no statistically significant differences in opioid consumption (16.4mme ± 12.7 vs 20.6mme ± 14.4, p = 0.186), which was relatively small in both groups. Notably, patients receiving 50 mg of CBD reported lower VAS scores at day 1 (3.9 ± 3.3 vs 4.6 ±2.5 ± 6.0 ± 3.1, p = 0.0394) and higher satisfaction with pain control at day 1 and 2 (8.1 ± 2.3, 5.8 ± 3.3, 5.9 vs 3.6, p = 0.0175 | 7.8 ± 1.8 vs 6.3 ± 3.0 6.0 ± 3.2, p = 0.05) compared to those receiving 25 mg of CBD and control group respectively. On Day 7 and Day 14, there were no statistically significant differences in VAS score, opioid consumption, or patient satisfaction with pain control (p>0.05 for all). There were no significant differences in nausea or LFTs post-operatively (p > 0.05). Conclusions: CBD is safe and effective in reducing pain in the immediate peri-operative period following ARCR and should be considered in post-operative multimodal pain control. Table 1. Summary of Major Kinematic Effects for LMORT Lesions and Repairs [ABSTRACT FROM AUTHOR]

Introduction: Buccal midazolam treatment is licensed in the European Union for prolonged acute convulsive seizures in children and adolescents, but the buccal pathway is often hampered by jaw clenching, hypersalivation, or uncontrolled swallowing. Midazolam formulations that are more secure, reliable, and faster for use are needed in the acute setting. Pharmacokinetics and comparative bioavailability of intranasally administered midazolam and two midazolam intravenous solutions administered buccally or intravenously in healthy adults were evaluated. Methods: In this phase 1, open-label, randomized, single-dose, three-period, three-sequence crossover study, 12 healthy adults (19–41 years) were randomly assigned to receive 2.5 mg midazolam intranasally; 2.5 mg midazolam intravenously; 2.5 mg midazolam buccally. Blood samples were collected for 10 h post dose to determine pharmacokinetic profiles. Adverse events and vital signs were recorded. Results: Intranasal administration of 2.5 mg midazolam demonstrated a more rapid median time to Cmax compared to buccal administration of midazolam (Tmax, 12.6 min vs. 45 min; Cmax, 38.33 ng/ml vs. 24.97 ng/ml). The antiepileptic effect of intranasal and buccal midazolam treatment lasted less than 4 h and generally did not differ from intravenously administered midazolam. No serious adverse events or deaths were reported, and no treatment-emergent adverse events led to study discontinuation. Conclusion: Intranasal administration of midazolam may be a preferable alternative to the currently approve buccal midazolam treatment for prolonged acute convulsive seizures in children and adolescents. Trial Registration: This study is registered at the Chinese Clinical Trial [http://www.chictr.org.cn] (ChiCTR2000032595) on 3 May, 2020. [ABSTRACT FROM AUTHOR]