Sublingual Research Articles

Comparative study between misoprostol and lidocaine before intrauterine contraceptive device insertion

Background Intrauterine contraceptive device (IUCD) is a safe, extremely effective and long-acting reversible contraceptive method. Misoprostol has definite to be a very pliable and adequate drug because its composition as a tablet that is stable and may be delivered orally, rectally or vaginally, and through the sublingual route. Lidocaine is a common local anesthetic and antiarrhythmic drug. Aims The objective of the present study was to compare between sublingual administration of misoprostol and lidocaine spray prior to IUCD insertion. Patients and methods This randomized controlled clinical trial was conducted at Department of Family Planning at Tanta University Hospital from February 2021 to March 2022. The study included 150 women into three groups each of them had 50 women. Results The pain scores during IUCD insertion and during uterine sounding were lower in group A, B. There was nonhuge distinction between both groups regarding insertion result (failed, easy or difficult insertion). There was nonhuge distinction between sublingual misoprostol and lidocaine spray regarding Visual Analogue Scale during sounding the uterus and during IUCD insertion. There was nonhuge distinction between studied groups as regard of medication related side effect except misoprostol group significant increase abdominal cramps. Conclusions The study concluded that the use of sublingual misoprostol and lidocaine before IUCD insertion reduces Visual Analogue Scale scores (pain scores) during sounding the uterus and during IUCD insertion.

Assessment of the endothelial glycocalyx state in patients with axial spondyloarthritis associated with Crohn’s disease

BACKGROUND: Epithelial barrier dysfunction, including their permeability increment, is supposed to be a pathogenetic link in the development of various immunoinflammatory diseases, including Crohn’s disease and axial spondyloarthritits. Endothelial permeability regulation is provided by both intercellular contacts and endothelial glycocalyx. AIM: To study the microcirculatory state by measuring the endothelial glycocalyx thickness in patients with axial spondyloarthritits associated with Crohn’s disease. To identify an association between the endothelial glycocalyx thinning and the epithelial permeability severity in patients with Crohn’s disease, axial spondyloarthritits and their combination. MATERIALS AND METHODS: 12 patients with axial spondyloarthritits associated with Crohn’s disease (group A), 22 patients with idiopathic axial spondyloarthritits (group B), 24 patients with Crohn’s disease (group C) and 16 healthy individuals (group D) were examined. The endothelial glycocalyx thickness was assessed in the sublingual region using dark-field microscopy. Fecal calprotectin and fecal zonulin was studied. RESULTS: A statistically significant increase in the perfused boundary region high flow was found (p = 0.001), as well as the MicroVascular Health Score (p = 0.004) in group A compared with the control. In Group A, a positive correlation between perfused boundary region high flow and scores Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Metrology Index 10 (p 0.05) was found; perfused boundary region 5–9 mµ correlated positively with the fecal calprotectin (p = 0.007). Perfused boundary region high flow measurement provides 77.1% accuracy for correct classification of axial spondyloarthritits associated with Crohn’s disease and idiopathic axial spondyloarthritits (p = 0.010). In group C, a positive correlation between fecal zonulin and perfused boundary region 5–9 mµ, 10–19 mµ, 5–25 mµ (p 0.05) was also found. CONCLUSIONS: The findings suggest that the patients with axial spondyloarthritits associated with Crohn’s disease have endothelial glycocalyx impairment; the detection of these abnormalities may be useful in assessing the disease integral activity and in the differential diagnosis of axial spondyloarthritits associated with Crohn’s disease and idiopathic axial spondyloarthritits. Further studies of microcirculation will allow better understanding of spondyloarthritis and inflammatory bowel diseases pathogenesis and improve the management of patients with these diseases.

Formulation and Evaluation of Edoxaban Sublingual Tablets Using HPMC as a Hydrophilic Polymer by Solid Dispersion Method

Formulation and Evaluation of Edoxaban Sublingual Tablets Using HPMC as a Hydrophilic Polymer by Solid Dispersion Method

SQ sublingual immunotherapy tablets for children with allergic rhinitis: A review of phase three trials.

To provide paediatricians with a summary of efficacy and safety of SQ sublingual immunotherapy (SLIT) tablets from phase three, randomised, double-blind, placebo-controlled trials in children and adolescents with allergic rhinitis or rhinoconjunctivitis, with and without asthma. PubMed searches were conducted and unpublished data were included if necessary. Of the 93 publications, 12 were identified reporting 10 trials. One trial was excluded as paediatric-specific efficacy data were unavailable. The nine eligible trials evaluated grass, house dust mite, ragweed and tree SLIT tablets. Consistent reductions in allergic rhinitis or rhinoconjunctivitis symptoms and medication use were observed with SQ SLIT tablets versus placebo. In a five-year trial, sustained reduction of allergic rhinoconjunctivitis symptoms, asthma symptoms and medication use were observed with SQ grass SLIT tablet versus placebo. The number-needed-to-treat to prevent asthma symptoms and medication use in one additional child during follow-up was lowest in younger children. SQ SLIT tablets were generally well tolerated across trials. Evidence supports use of SQ SLIT tablets in children and adolescents with allergic rhinitis or rhinoconjunctivitis, with and without asthma. Long-term data demonstrate disease-modifying effects of SQ grass SLIT tablet and suggest the clinical relevance of initiating allergy immunotherapy earlier in the disease course.

Bioequivalence of zolpidem hemitartrate: new formulations of 5 mg SL, 10 mg and 12.5 mg XR and comparison of their bioavailabilities

Objective: To evaluate pharmaceutical bioequivalence between two formulations of 5 mg zolpidem hemitartrate sublingual and, 10 and 12.5 mg extended-release formulations tablets in healthy subjects under fasting and fed conditions. Methods: An open label, monocentric, randomized, 2 x 2 crossover study in 40 healthy adults under fasting conditions comparing two formulations of zolpidem 5mg sublingual tablets. Analyte concentrations in human plasma were determined using a validated liquid chromatography with a tandem mass spectrometer detector method (LC-MS/MS). The same design was utilized to evaluate the other formulations.
 Results: Statistical analysis has determined geometric mean of test / reference ratio, confidence intervals, and power of the test to the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞. The geometric mean ratio (90%CI) of the test drug/reference drug for zolpidem 5mg were 99.89 to 113.57% for Cmax, 97.15% to 108.40% for AUC0-t, and 97.22% to 108.13% for AUC0-∞. Power of the test was 99.35% for Cmax and 100% AUC0-t, and AUC0-∞. Conclusion: Both test and reference are bioequivalent for all formulations and, therefore, they are interchangeable, according to the Brazilian criteria (Anvisa resolution RE nº 1170/2006), since confidence intervals for Cmax and AUC0-t ratios were within 80% and 125%.

Cannabidiol usage, efficacy, and side effects: analyzing the impact of health conditions, medications, and cannabis use in a cross-sectional online pilot study.

Products containing cannabidiol (CBD) are attracting attention because of their potential therapeutic benefits and positive impacts on well-being and mental health. Although additional research is needed to understand their effectiveness in treating mental disorders, cross-sectional studies may help identify the factors influencing CBD use patterns. This study examined the impact of variables such as health status, medication use, medical supervision, gender, age, and cannabis use on CBD consumption patterns. A self-selected sample (n =267) of current or former CBD users was recruited via social media and participated in an online survey designed to collect data on basic demographics, health status, cannabis use, and CBD usage patterns. The sample (n = 267) consisted of 68.5% women with an average age of 30.21 years, of which 25.8% reported diagnosed psychiatric disorders and 49.4% reported cannabis use. The top five reasons for using CBD were self-reported stress (65.3%), sleep problems (51.7%), overall improvement in well-being (52.5%), improved mood (44.9%), and anxiety relief (40.9%). Our findings suggest that individuals with psychiatric disorders and those taking psychotropic medications are more likely to use CBD to relieve stress and anxiety. Overall, nearly 70% of the individuals found CBD products to be effective. Sublingual administration was more popular among non-cannabis users, while cannabis users preferred smoking and vaping to CBD administration. Our results indicate that individuals using CBD for health and wellness reasons believe that it has potential health benefits. Further research using rigorous longitudinal designs is needed to delve deeper into the effectiveness of low-dose CBD and to better understand the therapeutic potential of CBD.

House dust mite sublingual allergen immunotherapy tablet is safe and well-tolerated in Dutch clinical practice.

Half (49%) of clinically diagnosed allergic rhinitis (AR) patients are sensitized to house dust mite (HDM). If allergen avoidance and symptomatic medication fail, allergen immunotherapy may be indicated. We investigated safety and tolerability of HDM-sublingual immunotherapy by HDM-SLIT tablets in Dutch daily clinical practice. Daily intake of 12 SQ-HDM SLIT-tablet was investigated in a prospective, multicenter, observational study (EUPAS43753). It comprised 4 consultations in 1 year. Data on safety, tolerability, treatment satisfaction, symptomatic medication, compliance, and clinical effectiveness (Control of Allergic Rhinitis and Asthma Test; CARAT) were collected. Descriptive and longitudinal regression data analysis were performed. Adult patients (n = 415), mean (SD) age 36.6 (12.2) years, 61.4% female and 36% asthmatic were included. The preponderance (65.1%) experienced adverse events (AEs). These, mostly mild (67%), AEs comprised: oral allergic reactions (58.6%), respiratory (12.4%) and gastrointestinal symptoms (9.4%). Sixty (14.5%) patients stopped due to AEs and 76 (18.3%) for non-AE reasons. CARAT scores improved clinically significant by 6 points and symptomatic medication use decreased from 96.1% to 77.4%. Most patients (74.5%) tolerated the treatment and were compliant (>86.5%). The majority of patients (62.4%) and investigators (69.4%) were satisfied with treatment. HDM SLIT-tablet is a safe and well-tolerated AR treatment. AEs occur often but are mostly mild and decreasing during the first year. CARAT scores improved and symptomatic medication use decreased suggesting better control of AR with treatment. Compliance, tolerability, and treatment satisfaction are good. However, patient follow-up and compliance remain important points of attention when initiating treatment.

A REVIEW ON MOUTH DISSOLVING FILM- A NOVEL APPROACH

The oral route is one of the most important routes for local and systemic drug delivery due to its large surface area, high permeability and blood flow. Mouth dissolving films are the most advanced oral forms as they are simpler and easier to use than other dosage forms such as Oro-soluble tablets, sublingual tablets. Fast dissolving drug delivery system were rapidly developed in the 1970s as an alternative to capsules, syrups, and tablets for adults and adolescents who have difficulty swallowing conventional oral solid dosage form. The Oro- soluble film dissolves and disintegrates in less than a minute when placed in the mouth without drinking water or chewing. This form allows the drug to skip first-pass metabolism, which improve the bioavailability of the drug. This article provides a comprehensive review on mechanism of action, merits, formulation, evaluation and covering the aspects related to novel fast dissolving techniques.

Salivary Therapeutic Monitoring of Buprenorphine in Neonates After Maternal Sublingual Dosing Guided by Physiologically Based Pharmacokinetic Modeling.

Opioid use disorder (OUD) during pregnancy is associated with high mortality rates and neonatal opioid withdrawal syndrome (NOWS). Buprenorphine, an opioid, is used to treat OUD and NOWS. Buprenorphine active metabolite (norbuprenorphine) can cross the placenta and cause neonatal respiratory depression (EC 50 = 35 ng/mL) at high brain extracellular fluid (bECF) levels. Neonatal therapeutic drug monitoring using saliva decreases the likelihood of distress and infections associated with frequent blood sampling. An adult physiologically based pharmacokinetic model for buprenorphine and norbuprenorphine after intravenous and sublingual administration was constructed, vetted, and scaled to newborn and pregnant populations. The pregnancy model predicted that buprenorphine and norbuprenorphine doses would be transplacentally transferred to the newborns. The newborn physiologically based pharmacokinetic model was used to estimate the buprenorphine and norbuprenorphine levels in newborn plasma, bECF, and saliva after these doses. After maternal sublingual administration of buprenorphine (4 mg/d), the estimated plasma concentrations of buprenorphine and norbuprenorphine in newborns exceeded the toxicity thresholds for 8 and 24 hours, respectively. However, the norbuprenorphine bECF levels were lower than the respiratory depression threshold. Furthermore, the salivary buprenorphine threshold levels in newborns for buprenorphine analgesia, norbuprenorphine analgesia, and norbuprenorphine hypoventilation were observed to be 22, 2, and 162 ng/mL. Using neonatal saliva for buprenorphine therapeutic drug monitoring can facilitate newborn safety during the maternal treatment of OUD using sublingual buprenorphine. Nevertheless, the suitability of using adult values of respiratory depression EC 50 for newborns must be confirmed.

Increase in plasma resveratrol levels and in acid-resistant proteins in the acquired enamel pellicle after use of resveratrol-containing orodispersible tablets

ObjectiveThis study evaluated the effect of administration of trans-resveratrol-containing orodispersible tablets on the protein composition of the AEP and on blood plasma trans-resveratrol concentrations. MethodsTen volunteers participated in two crossover double-blind phases. In each phase, after dental prophylaxis, they received a trans-resveratrol (15 mg) orodispersible tablet, or a placebo tablet (without actives). The AEP formed after 120 min was collected with electrode filter papers soaked in 3 % citric acid. Blood samples were collected 30, 45, 60 and 120 min after the use of the tablet. After protein extraction, AEP samples were analyzed by shotgun labelfree quantitative proteomics and plasma samples were analyzed by high-performance liquid chromatography (HPLC). ResultsEight hundred and two proteins were identified in the AEP. Among them, 336 and 213 were unique to the trans-resveratrol and control groups, respectively, while 253 were common to both groups. Proteins with important functions in the AEP had increased expression in the trans-resveratroltreated group, such as neutrophil defensins, S100 protein isoforms, lysozyme C, cystatin-D, mucin-7, alphaamylase, albumin, haptoglobin and statherin. Trans-resveratrol was detected in the plasma at all the times evaluated, with the peak at 30 min. ConclusionsThe administration of trans-resveratrol in sublingual orodispersible tablets was effective both to increase the bioavailability of the polyphenol and the expression of antibacterial and acid-resistant proteins in the AEP, which might benefit oral and general health.

Assessment of preferable site for temperature measurement using non-contact infra-red temperature among pediatric patients.

Accurate temperature measurement with little or no discomfort that is safe, without risk of hospital-acquired infections or perforations, is the preferred choice of medical professionals in pediatric settings. The objective was to discover the preferable site for body temperature measurement using non-contact infra-red thermometer (NCIT) among pediatric patients. NCIT measurement at mid forehead (F), right temporal region (T), right side of neck-over-carotid artery area (N), jugular notch (J), sternum (S), umbilical region and sublingual region (U) were compared with digital axillary temperature (DAT) in a single attempt in 500 patients, aged between 2 to 5 years with fever. Data was analyzed using Pearson's correlation, paired t-test and Bland-Altman plot to assess the correlation and agreement between the DAT and NCIT sites. The mean temperature of NCIT-T (38.42±0.64 °C) was more agreeable with DAT (38.42±0.63 °C) compared to other body sites. The minimum mean bias of -0.00480 °C was noted for NCIT-F with 95% CI of -0.164-0.15; however, NCIT-F revealed many outliers as compared to NCIT-J. A strong positive correlation existed between DAT and NCIT sites (r value: 0.99-0.98). However, significant difference was found between DAT and NCIT-N, NCIT-F and NCIT-U (P<0.0001). NCIT-J is the most preferable choice for measuring body temperature and can be interchanged with DAT. It will help to deliver fast results with enhanced patient comfort due to its non-invasive nature.

Review on Sublingual Tablet

Abstract: Objective: As sublingually given dose forms avoid hepatic metabolism, sublingual medication delivery can be an alternate and superior method to oral drug delivery. For some medications, particularly those prescribed for the treatment of acute diseases, a quick onset of pharmacological activity is frequently required. Sublingual pills dissolve quickly, and the major saliva available is typically enough to achieve dosage form disintegration along with enhanced dissolving and increased bioavailability. Findings: Comparing sublingual pills to traditional dosage forms, it was discovered that the former had superior qualities. Due to their rapid breakdown, tablets taken sublingually had more bioavailability, a quicker onset of action, and improved dissolving characteristics. Rapid disintegration was made possible by the addition of super-disintegrants, and this method can be applied to the treatment of urgent or acute disorders. Conclusion: To make sure a quick onset of action, higher patient compliance, and increased bioavailability, sublingual tablets or any sublingual dosage form might be used. Drugs that undergo significant first pass metabolism or degradation in the GIT can be administered sublingually. When compared to normal oral tablets, drugs given sublingually typically have improved bioavailability, which leads to dose reduction.

Effect of single-administration of d-sorbitol pretreatment on the bitterness and continued willingness to take asenapine: a randomized, single-blind, placebo-controlled, crossover trial

BackgroundAsenapine has unique orally-related side effects, such as a bitter taste induced by sublingual administration, which often results in discontinuation of the medication. While the FDA has approved black-cherry-flavored asenapine, several countries have prescribed only unflavored versions. Specifically, Asians commonly report experiencing the bitterness of asenapine because they are more sensitive to bitter tastes than other ethnic groups. In this study, with the aim of improving adherence by reducing the bitterness of asenapine, we investigated the effects of d-sorbitol, which reduced the bitterness parameters of taste sensors in our previous basic study on the bitterness and continuity of asenapine among patients with schizophrenia.MethodsTwenty adult patients with schizophrenia were included in this single-blind, placebo-controlled, crossover trial. Participants rinsed their mouths with single-administration of d-sorbitol or a placebo prior to each administration of asenapine. We then conducted the questionnaires and assessed changes in the bitterness of asenapine (primary end point) and willingness to continue its use (secondary end point).Resultsd-sorbitol significantly improved the bitterness of asenapine (p = 0.038). Although it did not significantly increase the willingness to continue asenapine (p = 0.180), it did show improvement over the placebo in enhancing willingness to continue, especially in patients who were not accustomed to its taste.ConclusionOur findings indicate that single-administration of d-sorbitol significantly reduces the bitterness of asenapine. In countries where flavored asenapine is not available, this finding could benefit patients who were not accustomed to its bitter taste.Trial registrationThis study was registered in the Japan Registry of Clinical Trials (jRCTs041210019) on May 14, 2021.

Myopericytoma of the mouth floor: The diagnostic and therapeutic challenge—A case report and literature review

AbstractMyopericytoma is defined as a rare benign myxoid tumour that is usually found in distal extremities. However, it may rarely affect the oral cavity. Few cases of oral myopericytoma were reported in the literature. A 56‐year‐old female patient presented with a mouth floor lesion. A wedge biopsy performed from the lesion revealed an atypical round cell proliferation, which may be plasmablastic lymphoma or plasmacytoma. Post‐contrast neck MRI described a well‐defined lobulated lesion at the right sublingual region measuring 14 × 21 mm. Transoral wide local excision of the ulcer was performed, and reconstruction of the defect was done using an inferiorly‐based nasolabial flap. Microscopic examination of the excised swelling revealed a tumour proliferation formed of bland‐looking spindle cells alternating with fibroblasts and intervening vascular spaces. No detected mitosis or necrosis in the examined material. IHC staining of the tumour cells was positive for Caldesmon and alpha smooth muscle actin, while Ki67 was positive in 3% of cellularity. Desmin, ALK, B‐catenin, ERG, CD31, and CD138 showed a negative reaction. This led to the diagnosis of bland spindle cell proliferation suggestive of oral myopericytoma with free all surgical margins. Myoepricytoma is a rare benign tumour that rarely affects the oral cavity. Surgical excision is the mainstay of treatment. Local flaps constitute a good choice for the reconstruction of the resection defect.

Efficacy of different routes of vitamin B12 supplementation for the treatment of patients with vitamin B12 deficiency: A systematic review and network meta-analysis.

This systematic review and network meta-analysis aimed to evaluate the three different administration routes of vitamin B12: oral, intramuscular (IM), and sublingual (SL) routes. We searched four electronic databases (PubMed, Scopus, Web of Science, and Cochrane CENTRAL Register of Controlled Trials). We included only comparative studies. We performed a frequentist network meta-analysis to measure network estimates for the relative outcomes. Moreover, we conducted a pairwise meta-analysis using a random effect model to obtain direct estimates for outcomes. All outcomes were continuous, and the relative treatment effects were pooled as mean difference (MD) with 95% confidence intervals. Thirteen studies were included in the meta-analysis, with a total of 4275 patients. Regarding increasing vitamin B12 levels, the IM route ranked first, followed by the SL route (MD = 94.09 and 43.31pg/mL, respectively) compared to the oral route. However, these differences did not reach statistical significance owing to the limited number of studies. Regarding the hemoglobin level, the pooled effect sizes showed no difference between all routes of administration that could reach statistical significance. However, the top two ranked administration routes were the oral route (78.3) and the IM route (49.6). All IM, oral, and SL routes of administration of vitamin B12 can effectively increase the level of vitamin B12 without significant differences between them, as thought previously. However, the IM route was the top-ranked statistically but without clinical significance. We found no significant difference among studied administrated routes in all other CBC parameters and homocysteine levels.

Ketamine for Adults With Treatment-Resistant Depression or Posttraumatic Stress Disorder: A 2023 Update

What Is the Issue?&#x0D; &#x0D; Many drug treatments are available for depression, but 22% of people in Canada with the condition have treatment-resistant depression (TRD). For people with TRD, standard drug treatments do not improve their symptoms or do not work for long, and their depression persists.&#x0D; Posttraumatic stress disorder (PTSD) is a disabling mental health condition that affects about 9% of people in Canada in their lifetime. Few drugs are available for treating PTSD, none of which are considered effective.&#x0D; Ketamine is a hallucinogenic drug used primarily for anesthesia. Ketamine has also been explored for other indications, such as TRD and PTSD, generating questions about whether it could be a treatment option for these conditions.&#x0D; &#x0D; What Did We Do?&#x0D; &#x0D; We conducted a review of the clinical effectiveness, cost-effectiveness, and evidence-based guidelines on the use of ketamine in adults with TRD or PTSD, to help guide decisions on the use of ketamine for managing these conditions.&#x0D; An information specialist conducted a search of peer-reviewed and grey literature sources published in March 2022 or later. One reviewer screened citations and selected and critically appraised the included studies.&#x0D; CADTH engaged a patient with lived experience of TRD who shared their experiences and perspectives on ketamine-assisted psychotherapy. These perspectives helped us to contextualize the literature and appreciate nuances of the experience.&#x0D; &#x0D; What Did We Find?&#x0D; &#x0D; Ketamine could lead to an immediate improvement in depressive symptoms and suicidal ideation compared to placebo or midazolam in adults with TRD. The longest follow-up was 90 days, and the longest lasting effect after a dose was 28 days. Serious side effects of ketamine — such as dissociation — were rare and short-lived, lasting hours, in adults with TRD.&#x0D; It is uncertain if ketamine is an effective and safe treatment for symptoms of PTSD, due to little to no evidence suggesting its effectiveness or safety against placebo, midazolam, or opioids.&#x0D; Most studies evaluated ketamine given intravenously, and we found limited evidence on intramuscular (IM), subcutaneous, and intranasal routes of administration. We found no studies on oral or sublingual administration of ketamine and no studies comparing the different ways that ketamine can be given for TRD or PTSD.&#x0D; An economic evaluation found that IV ketamine was likely to be cost-effective compared to intranasal esketamine in adults with TRD from a health care perspective in the US. However, from a patient perspective, IV ketamine was unlikely to be cost-effective compared to esketamine, due to comparable levels of clinical effectiveness and lower costs of esketamine attributable to commercial insurance coverage and manufacturer assistance programs.&#x0D; A US guideline on TRD suggests ketamine as augmentation to antidepressants. A US guideline on PTSD does not suggest the use of ketamine as therapy.&#x0D; The patient contributor CADTH engaged for this review highlighted the benefits, stigma, and barriers of ketamine therapy, including financial implications.&#x0D; &#x0D; What Does This Mean?&#x0D; &#x0D; There is some clinical effectiveness and cost-effectiveness evidence and a guideline recommendation to support the short-term use of ketamine in adults with TRD.&#x0D; Clinical effectiveness evidence and a guideline recommendation do not support the use of ketamine in adults with PTSD.&#x0D; Future research is necessary to understand the effectiveness and safety of ketamine as therapy for TRD in larger populations over longer periods and for PTSD for any follow-up duration.&#x0D; Decision-makers should consider offering ketamine in an equitable manner.&#x0D;

Large Epidermoid Cyst in Submental Region: A Rare Case Report

Epidermoid cyst, specially in large size is one of the rare lesions of maxillofacial region, affects submental and sublingual region. The cyst develops from the entrapment of pluripotent ectodermal and mesodermal primordia, in the embryonic lines of fusion, when first and second branchial arches of each fuse in the midline, between third and fourth weeks of intrauterine life. After entrapment, this tissue shows gradual proliferation and ultimately transform to a cyst. A 19-year-old-boy presented with such a midline painless large swelling in the submental and sublingual region with diagnosis of epi dermoid cyst. After enucleation, the patient didn’t show any recurrence after 2 years follow up. J Bangladesh Coll Phys Surg 2024; 42: 92-96

Easy assessment of the avidity of polyclonal allergen-specific serum antibodies.

Allergen-specific IgE-blocking IgG antibodies contribute to successful allergen immunotherapy (AIT), however, not much is known about their affinity. Since affinity measurements of polyclonal antibodies in serum are technically challenging we evaluated the applicability of acidic disruption of antibody-allergen complexes by a modified ELISA protocol with monoclonal antibodies (mAbs) specific for the relevant major allergens Betv1 and Mald1. Then, AIT-induced blocking and non-blocking Mald1-specific antibodies in sera from individuals with or without reduced apple allergy were compared. After testing their pH stability coated recombinant allergens were incubated with (i) mAbs diluted in PBS or human serum and (ii) sera from individuals after sublingual administration of Mald1 or Betv1 for 16 weeks. Immune complexes were exposed to buffers in the pH range of 6.4-3.4 and residual antibodies were measured. Avidity indexes (AI), defined as the pH removing 50% of antibodies, were compared to the dissociation constants (KD) of mAbs determined by surface plasmon resonance. The selected pH range was applicable to disrupt allergen complexes with highly affine mAbs without compromising allergen integrity. AIs of mAbs accorded with KD values and were unaffected by epitope specificity or the presence of serum proteins. The inter-assay variability was <4% CV. Protective Mald1-specific IgG antibodies from individuals with reduced apple allergy showed a higher collective binding strength than that of the non-protective antibodies of individuals without reduced apple allergy. Acidic disruption of allergen-antibody complexes may be used to estimate the net-binding force of polyclonal serum antibodies and eases the investigation of affinity-related research questions in AIT.

Preparation and Evaluation of Telmisartan Solid Dispersion as Sublingual Tablets

Background: Telmisartan is an antihypertensive angiotensin II receptor antagonist drug commonly used to treat hypertension and renal disease. Based on the Biopharmaceutical Classification System. It’s a Class II poorly soluble drug. Objective: To prepare a sublingual tablet by increasing the dissolution and solubility of Telmisartan utilizing the solid dispersion method. Methods: Three methods were obtained to prepare the solid dispersion of telmisartan: solvent evaporation, Kneading, and microwave method. Each method uses surplus as a hydrophilic carrier in different ratios of 1%, 2%, and 3%. Preparation of ternary solid dispersion by adding potassium carbonate salt to the binary solid dispersion. After that preparing the sublingual tablets by applying a direct compression method, using different types and ratios of superdisintegrants such as crospovidone, croscarmellose and sodium starch glycolate in 5% and 10%. Study the evaluation tests of sublingual tablets, such as friability, hardness, disintegration time and dissolution time. Results: The solid dispersion showed an improvement in solubility over the pure medication. The best result was obtained with the formula (Telmisartan, soluplus and k2co3 salt at 1:1:0.3 ratio) prepared by microwave method, in this method and the high ratio of soluplus, the solubility increased more than the solvent evaporation and kneading method. The selected tablet is prepared using crospovidone 10% as a superdisintegrant that appears disintegration time in 5 seconds and releases in 1 min in dissolution media. Conclusion: The solubility and dissolution of Telmisartan were improved by microwave-based ternary solid dispersion using hydrophilic carriers and salt in a ratio of 1:1:0.3 (drug: carrier: salt). The analysis exerts the increases in wettability, enhanced solubility, and dissolution due to conversion from crystal to amorphous state. Received May. 2023 Accepted Aug. 2023 Published Jan. 2024

Real-world surveillance of standardized quality (SQ) house dust mite sublingual immunotherapy tablets for 3 years in Japan.

Standardized quality (SQ) house-dust mite (HDM) sublingual immunotherapy tablets (10,000 Japanese allergy units [JAU], equivalent to 6 SQ-HDM in Europe and the United States) are licensed for the treatment of HDMinduced allergic rhinitis (AR) without age restriction, based on 52-week administration clinical trials. There are no large-scale data on the administration of 10,000 JAU for > 1 year in actual clinical practice. To examine the safety and effectiveness of 10,000 JAU during use for up to 3 years at real-world clinical sites in Japan. This survey was a multicenter, observational, prospective study. We assessed the safety and effectiveness of the long-term administration of 10,000 JAU as well as effectiveness after its discontinuation in patients with HDM AR with an observation period of 3 years. The safety analysis included 815 patients, and the effectiveness analysis included 768 patients. Adverse reactionsthat occurred in 144 patients (17.67%) were mainly site-related events that occurred early in the dosing period. Seriousadverse reactions were dyspnea and anaphylactic reaction in one patient each, and both patients recovered. With regard toeffectiveness, compared with scores before the administration of SQ-HDM, nasal symptom scores decreased, depending on theadministration period, from 6 months to 3 years. Overall, 67.34% of the patients had improved quality of life after 6 months, and this improvement continued after 12 months. The proportion of patients with "improved and slightly improved" of overallimprovement exceeded 90% after 2 years. Treatment discontinuation because "symptoms disappeared" occurred in 24.42% of the patients at 3 years. Patients who discontinued 10,000 JAU (n = 39) had a sustained improvement in nasal symptomscores compared with baseline, even 1 year after discontinuing treatment. The real-world safety and effectiveness of 10,000 JAU SQ-HDM sublingual immunotherapy tablets were confirmed in Japanese patients with HDM AR. No new safety and effectiveness precautions were required.