Syrup In Children Research Articles

Clinical and Stability Assessment of Chloral Hydrate Syrup for Sedation in Pediatrics

To develop a stable chloral hydrate (CH) syrup and to test its clinical efficacy in inducing painless sedation during diagnostic imaging examinations in children under 4 years of age. For the physico-chemical tests, the vials were stored at + 5 and + 25°C and the analysis was carried out for 60 days. The microbiological tests were performed in 4 days of analysis. The prospective clinical study was conducted in 33 infants and children after receiving CH syrup orally for sedation prior to magnetic resonance imaging (MRI). After two months of storage, the average concentrations in all tests were greater than 95% of the initial chloral hydrate concentration. No microbiological growth was noted after 60 days of storage. The clinical use of syrup in children resulted in effective sedation in 100% of children and rare side effects. Compared to midazolam, chloral hydrate is more effective for sedating children under 5 years of age and is significantly less expensive. The prescription of 5% CH syrup for sedation prior to imaging diagnosis has well-established efficacy. However, the safe use of chloral hydrate in infants and children under 5 years of age should be in accordance with international recommendations.

Efficacy and Safety of Shenqu Xiaoshi Oral Liquid Compared With Domperidone Syrup in Children With Functional Dyspepsia

Background: Treatment of functional dyspepsia (FD) in children is generally symptomatic and unsatisfactory. Traditional Chinese medicines, such as Shenqu Xiaoshi Oral Liquid (SXOL), have been recommended to alleviate dyspeptic symptoms. However, evidence of their safety and efficacy remains limited to date. AIM: To assess whether 2 weeks of therapy with SXOL was non-inferior to domperidone syrup in children with FD. Methods: In this randomized, double-blind, double-simulated, non-inferiority, multi-center clinical trial, we recruited children (3–14 years) with FD according to the Rome IV criteria from 17 tertiary medical centers across China. Patients were randomly allocated (1:1) to receive SXOL or domperidone syrup for 2 weeks. We compared the participants’ clinical scores from both groups based on the severity and frequency of dyspepsia symptoms according to Rome IV criteria (0, 1, 2, and 4 weeks after randomization). The primary endpoint was the total response rate, which was defined as the proportion of patients with a decrease of 30% or more in the FD symptoms clinical score from baseline, at the end of the 2-weeks treatment. A non-inferiority margin of -10% was set. Secondary endpoints and adverse events were assessed. This trial is registered with www.Chictr.org.cn, number ChiCTR1900022654. Results: Between February 2019 and March 2021, a total of 373 patients were assessed for eligibility, and 356 patients were enrolled and randomized. The clinical response rate at week two was similar for SXOL [118 (83.10%) of 142] and domperidone [128 (81.01%) of 158]; difference 2.09; 95% CI −6.74 to 10.71, thereby establishing non-inferiority. The total FD symptom scores were significantly improved in the two groups at 1-, 2-, and 4-weeks follow-up periods (p < 0.005). The decrease in symptom score compared with the baseline were similar between these two groups. Over the total study period, 10 patients experienced at least one treatment-related adverse event [six (3.37%)] in the SXOL group, four [(2.25%) in the domperidone group], although no serious adverse event was noted. Conclusion: Treatment with SXOL effectively improves dyspeptic symptoms and is well tolerated. In addition, it is not inferior to domperidone syrup and leads to sustained improvement in Chinese children with FD.

Acceptability of small-sized oblong tablets in comparison to syrup and mini-tablets in infants and toddlers: A randomized controlled trial

ObjectiveThere is limited evidence for the acceptability of various drug formulations holding the potential to improve medicines administration to children. Suitable formulations need to meet the requirements of pediatric patients. Previous studies have demonstrated the acceptance of mini-tablets. Oblong tablets may carry more active ingredient content per unit than mini-tablets and could be an important alternative when the drug substance requires administration of higher doses.The primary objective was to demonstrate non-inferiority of acceptability of oblong tablets in comparison to 3 ml glucose syrup in children aged 1 to 5 years. Secondary objectives were investigation of acceptability, swallowability and palatability of mini-tablets, oblong tablets and glucose syrup in children between 1 and 5 years. MethodsAn open, randomized, single dose two-way cross-over design in two parallel study arms was applied. 280 children were stratified to one of five age groups and randomized to receiving one oblong tablet (2.5 × 6 mm) in comparison either to 3 ml glucose syrup or to three mini-tablets (2 × 2 mm). Acceptability and swallowability were assessed according to pre-defined evaluation criteria. The application of the formulations was video documented to evaluate the palatability. ResultsAs primary objective, non-inferiority was observed regarding acceptability of the oblong tablet compared to syrup in all age groups (84.4% vs 80.1%, difference 4,29% points with 95% CI of −3.00%,11.57%). For swallowability, superiority of the oblong tablet compared to syrup could be shown (74.5% vs. 53.2%, difference 21.26% points, 95% CI of 11.29%, 31.23%). Regarding palatability, <10% of children demonstrated unpleasant reaction after intake of the oblong tablet or mini-tablets as graded by both raters, however, in contrast up to 40% of children after intake of syrup. ConclusionOblong tablets are a promising, safe alternative to liquid drug formulations and administration of multiple mini-tablets in children.

Relief of acute cough by cough syrup with mucoprotection

Two randomised, blind, controlled, multicentre studies investigated the therapeutic effect of a chemical and mechanical barrier in the upper airways produced by polysaccharide-resin-honey based cough syrup in children with acute cough associated with a common cold. The mucoprotection led to a significant alleviation of the paediatric cough compared with carbocysteine syrup or placebo. The beneficial effect was especially apparent in children with severe cough and/or episodes of nocturnal coughing.

ДОСВІД ЗАСТОСУВАННЯ БРОНХИПРЕТУ-СИРОПУ У ДІТЕЙ ДОШКІЛЬНОГО ВІКУ З ГОСТРИМ БРОНХІТОМ І АТОПІЧНИМ ФОНОМ

Keywords: acutebronchitis, atopicdermatitis, children, Bronchipret. Acute bronchitisis a topical issue in pediatrics and one of the most common reasons for seeking medical attention. In children with anallergic background, special requirements are made for the treatment of acute bronchitis, as treatment should notincrease the allergy of the body. Objective: to study the effectiveness and safety of the drug Bronchipret syrup in children with acute bronchitis and atopic background. Materials and methods. The study in volved 30 children 3- 7 years old with acute bronchitis with a burdensome anamnesis of allergic diseases. Allergic background was assessed by serum IgE levels in blood serum. During treatment, all children received the drug Bronchipret syrup 3 times a day for 10 days. Repeated clinical examinations of patients were performed for 3, 5, 7 and 10 days from admission to the hospital. Results. Against the background of complex treatment with the inclusion of the drug Bronchipret, the intensity of fever and intoxication syndrome were significantly lower on the 3rd day of hospital treatment and on the 5th day in the vast majority of children disappeared. Improvement in the discharge of nasal and bronchial secretions was observed on the third day of therapy. Increase in eosiophil content wasn’t observed in any child during treatment. Within 10 day softreatment, significant changes in serum Ig E didn’t occur. Thus, at the beginning of the rapy it was in the range of 38.3 ± 1.3 kU / l, after 10 days – 36.8 ± 1.1 kU / l. Conclusions. Thedrug Bronchipret syrup has shown good efficacy and safety, no allergic complications in children with acute bronchitis and allergic background and can be recommended for useinpediatric practice.

Relief of acute cough by cough syrup with mucoprotection

Two randomised, blind, controlled, multicentre studies investigated the therapeutic effect of a chemical and mechanical barrier in the upper airways produced by polysaccharide-resin-honey based cough syrup in children with acute cough associated with a common cold. The mucoprotection led to a significant alleviation of the paediatric cough compared with carbocysteine syrup or placebo. The beneficial effect was especially apparent in children with severe cough and/or episodes of nocturnal coughing.

Electrochemical determination of paracetamol in a pharmaceutical dose by adsorptive voltammetry with a carbon paste/La2O3 microcomposite.

This paper presents a new application for microcomposites based on carbon paste (CP) and La2O3 (LaOX). This simple and versatile microcomposite (LaOX/CPE) was applied toward the determination of paracetamol (PCM) through proton oxidation by square wave adsorptive voltammetry (SWAdV). The anodic peak current for PCM increased by nearly 70.0% compared with an unmodified CP, and the detection limit was 0.020 μmol L-1. The relative standard deviations (RSDs) were 1.0% (n = 7). The accuracy of the new method was evaluated with tap water spiked with known quantities of PCM, while ascorbic acid, caffeine, and acetylsalicylic acid were used for interference studies. Finally, the usefulness of the microcomposite was shown to have acceptable results when applied to detect and quantify PCM in various forms of a pharmaceutical dose, such as solid tablets, fruit-flavored powders for colds and syrups for children.

Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections

Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections

Application of unmodified boron-doped diamond electrode for determination of dopamine and paracetamol

For the first time the application of unmodified boron doped diamond electrode for dopamine (DA) and paracetamol (PA) determination in biological samples and pharmaceutical preparations with the use of differential pulse voltammetry was demonstrated in the present work. The wide linear range of calibration graphs: from 1 × 10−7 to 2 × 10−4 mol L−1 for DA and PA, and very low detection limits were achieved, equaling 1.87 × 10−8 mol L−1 for DA and 1.35 × 10−8 mol L−1 for PA. The proposed sensor was successfully applied for determination of dopamine in urine samples, paracetamol in syrups for children, and for simultaneous determination of paracetamol and dopamine in blood and serum samples.

Development of a microcomposite with single-walled carbon nanotubes and Nd2O3 for determination of paracetamol in pharmaceutical dosage by adsorptive voltammetry

This study presents for the first time a new composite of carbon paste (CP), single-walled carbon nanotubes (SWCNTs) and Nd2O3 (NdOX). This versatile composite (NdOX-SWCNT/CPE) was applied to the oxidation of paracetamol (PCM). The newly formed surface was characterized by scanning electron microscopy (SEM), electrochemical impedance spectroscopy (EIS) and cyclic voltammetry (CV). The results showed greater conductivity and a higher surface area for the composite than those of the carbon paste alone. Moreover, the anodic peak currents for PCM increased from 1.6 to 3.6 µA with CPE and NdOX-SWCNT/CPE, indicating an increase of nearly 51.0% for the anodic peak current. On the other hand, the anodic peak potentials shifted from 0.67 to 0.57 V. The detection limits were 0.05 µmol/L with NdOX-SWCNT/CPE and 0.50 µmol/L with SWCNT/CPE. The relative standard deviations (RSDs) were 1.5% (n = 7). The accuracy and interference of the methods were evaluated with a urine chemistry control spiked with known quantities of PCM, uric acid, dopamine, ascorbic acid, caffeine, acetylsalicylic acid, tartrazine, sunset yellow, allure red, rutin, morin and metal ions. Finally, the novelty and usefulness of the composite were evaluated to quantify PCM in pharmaceutical dosage forms such as tablets, powders and syrups for children.

Experience of the use of combined phytopreparations in the treatment of respiratory tract diseases

The article showed the problem of integrated management of children different age groups with upper respiratory tract viral infection. It reflected modern approach of using multicomponent herbal medicine for cough therapy in children in the practice of pediatrician. We evaluated necessity of the prescription and effect of the herbal drug in syrup type Gamma in case of acute respiratory diseases in 50 children, from the age of 2 up to 15 years of life, that were treated at infectious-diagnostic department of Vinnytsya regional children’s hospital and had cough symptom. Analysis of the results of the use of herbal multicomponent Gamma syrup in children with cough was provided. The duration of the cough period, qualitative changes in the cough symptom, such as frequency and expectoration of sputum were analyzed. In every case we estimated time of cough originating, changes of its characteristics from the dry to productive, decreasing of the intensity and time of the clinical recovering. The effectiveness of Gamma syrup was evaluated by comparing the main group of patients and the control group. In 92% of patients in the main group on day 7 cough completely stopped, comparing to the control group –cough stopped in 52%. This is the evidence of positive effect on cough, sputum discharge, it`s viscosity and common improvement of drainage function respiratory tract. Using of herbal multicomponent Gamma syrup shows high clinical effectiveness as mucolytic, broncholytic, expectorant and anti-inflammatory drug in children with cough in complex treatment of upper respiratory tract viral infection.

Phenolic acid content and antiadherence activity in the urine of patients treated with cranberry syrup (Vaccinium macrocarpon) vs. trimethoprim for recurrent urinary tract infection

The effectiveness of cranberry in the treatment of urinary tract infection (UTI) has been associated with its polyphenol content, particularly proanthocyanidins (PACs) and the inhibition of adherence of Escherichia coli to the uroepithelium. This paper describes a controlled, double blind, clinical trial of children aged over one month with recurrent urinary tract infection. The study aims were to evaluate the safety and efficacy of cranberry syrup in children and to investigate the relationship between the excretion of phenolic acids in urine with the antiadherent activity of cranberry syrup.In the study population, cranberry syrup was found to be similar to trimethoprim, with a rate of UTI (reinfection) of 26% (95% CI 12–41). The administration of cranberry syrup was associated with high levels of hydroxycinnamic and hydroxybenzoic acids in urine; in both cases these molecules present activity in the biofilm inhibition or reduction of surface hydrophobicity of E. coli (Clinical Trials Registry ISRCTN16968287).

Efficacy and safety of potassium clavulanate/amoxicillin (CLAVAMOX) dry syrup in children with otitis media

To evaluate the efficacy and safety of CLAVAMOX dry syrup (potassium clavulanate/amoxicillin) in children with otitis media, we conducted a postmarketing surveillance from February to September 2006. The analysis was made on the basis of 470 survey sheets collected from 127 medical institutions, of which we investigated 455 cases for safety, and 433 cases for efficacy. The efficacy was 95.2% in the 433 subjects eligible for the efficacy analysis. The clinical improvement rates for major symptoms (otalgia, otorrhea, flare reaction of drum membrane and fever) were 95% or more. The efficacies for the three major offending bacteria of otitis media (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis) were between 94.6% and 100%. The efficacies for penicillin-resistant Streptococcus pneumoniae (PRSP) and penicillin intermediate resistant Streptococcus pneumoniae (PISP) were 95% or more. Adverse drug reactions (ADRs) were reported in 106 (23.3%) of the 455 subjects eligible for safety analysis. The major ADRs were diarrhea, of which incident was 22.6% (103 of 455). These ADRs were observed at a higher rate in younger age patients. Most of the diarrhea cases were non-serious, reversible on discontinuation or continuation of the drug. No clinically important serious diarrhea cases such as pseudomembranous colitis or dehydration were observed. Our surveillance results demonstrated that CLAVAMOX dry syrup had excellent efficacy and clinically manageable safety in children with otitis media. These findings indicated that this medicine was clinically-useful in children with otitis media.

An open labeled study to evaluate safety and efficacy of Unicough syrup in children with acute bronchitis.

Acute bronchitis is inflammation of the main air passage to the lungs generally follows a viral respiratory infection. Children generally suffer from acute bronchitis at any stage. Fumes, dusts, decreased immunity, indigestion, viral infections are some causes due to which air passage get inflamed and irritated. Acute bronchitis is a clinical syndrome produced by inflammation of the trachea, bronchi, and bronchioles. In children, acute bronchitis usually occurs in association with viral respiratory tract infection. Acute bronchitis is rarely a primary bacterial infection in otherwise healthy children. In modern therapies using excessive expectorant, antihistaminics, and cough suppressants causes certain side effects and has no roll in rejuvenating the respiratory system. Unicough is a herbal remedy with the herbs which acts as a mucolytic and mild expectorant by its smoothening effect which helps in easy evacuation of cough and rejuvenate the respiratory passages. Current open labeled study on forty four children of acute bronchitis showed significant improvement after first and second week of the treatment in all associated symptoms which proves that Unicough syrup is a safe and effective remedy for acute bronchitis. 3 . Antibiotics are commonly prescribed, this type of therapy remains controversial, particularly since only half of all exacerbations are bacterial in origin, the rest being viral or chemical. Thus some believe that antibiotic therapy of acute exacerbation of bronchitis is an abuse of antibiotics, and can contribute to antimicrobial resistance 4 . The natural approach to treating bronchitis avoids creating new disease problems. It involves two goals: stimulating the normal processes that expel mucus, and stimulating the immune system to deal with viral infection. Expectorant herbs increase the fluidity and volume of phlegm, and stimulate cough. They are not cough suppressants, since cough suppression traps phlegm in the bronchi and lungs 5 . Unicough is a herbal remedy with Khaira Chhal (Acacia catechu),Vasakapatra (Adhatoda vasika), Vach (Acorus calamus), Elaichi (Elettaria cardamomum), Nagkeshar (Mesua ferrea), Talispatra (Abies webbina), Tulsi (Ocimum scantum), Dalchini (Cinnamomum zeylanicum), Sounth (Zingiber officinale), Pippali (Piper longum), Kababchini (Piper cubeba), Mulethi (Glycyrrhiza glabra), Somlata (Ephedra gerardiana), Dhatura panchang (Datura metel), Ajowan sat (Thymol), Pudina sat (Menthol). All these ingredients act as a smoothening, expectorant, bronchodilator and also improve the metabolism. This was an open labeled, non comparative study in the patients of acute bronchitis for the period of 15 days.

어린이용 시럽제의 우식유발능에 대한 생체 외 연구

어린이용 시럽제의 우식유발능에 관해 알아보기 위하여 국내에서 시판 중인 일반의약품 어린이용 시럽제 8종에 대한 생체 외 연구를 사행하였다. 어린이용 시럽제 8종을 실험군으로 10% 자당을 양성 대조군, 인공 타액을 음성 대조군으로 하였다. 실험군 및 대조군의 pH를 측정하고 시료용액 20 ml의 pH를 7로 맞추는데 필요한 2 N NaOH의 부피로 완충능을 측정하였다. Ostwald 파이햇을 시료용액 2 ml가 통과하는데 걸린 시간을 측정하여 비점조도를 계산하였다. Streptococcus mutans의 배양액을 접종 후 48시간 배양하여 pH의 변화를 측정해서 산생성능을 살펴보았다. 하루에 3번 시료용액에 유치 법랑질 시편을 20분간 넣은 후 인공타액에 보관하는 pH 순환모텔을 5일간 적용하였고 표면미세정도의 변화를 측정하여 유치 법랑질 침식능을 검사하였다. 본 연구 결과로부터 어린이용 시럽제는 자체 산도 및 완충능, 점조도, 유치 법랑질 침식능에서 모두 우식유발 가능성이 높음을 알 수 있으며 산생성능에서도 3종를 제외한 어린이용 시럽제가 양성대조군보다 높게 나타남으로써 우식 유발가능성이 높음을보여준다. An in vitro study on cariogenic potential of 8 over-the-counter syrups for children was performed. The experimental groups were 8 over-the-counter syrups. The positive control group was 10% sucrose solution, and the negative control group was artificial saliva. The pH of each group was determined. The buffering capacity was measured by the volume of 2 N NaOH adding to equalize the pH of 20 ml of experimental solution to pH 7. The consistency was measured by the time to pass Ostwald pipette for 2 ml of the experimental solution. The experimental solutions were inoculated with S. mutans and cultured in <TEX>$37^{\circ}C$</TEX> anaerobic condition for 48 hours. To estimate acid production, pH of the experimental solutions were measured before and after the culture. The primary teeth specimens were soaked in the experimental solutions for 20 minutes three times a day. Except on those hours the specimens were stored in artificial saliva. After 5 days, the microhardness changes of the specimens were measured. These results show that most of syrup-form medicines for children tend to have cariogenic potential partially in endogenous pH, buffering capacity, consistency, acid production and erosive ability of enamel. For the oral health of children, the alternative sweeteners (ex. xylitol) may be substituted for the cariogenic sweeteners of syrups. Additionally, It may be helpful that the chewable tablet replace liquid or syrup in term of dose form.

Safety of Desloratadine Syrup in Children Six Months to Younger Than 2 Years of Age: A Randomized, Double-Blinded, Placebo-Controlled Study

The aim of this double-blinded, randomized, placebo-controlled, multicenter study was to assess the general and cardiac safety of desloratadine syrup in children aged 6 months to less than 2 years....

Population Pharmacokinetics of Pranlukast Hydrate Dry Syrup in Children with Allergic Rhinitis and Bronchial Asthma

This study aimed to assess the steady-state pharmacokinetics of pranlukast, a leukotriene receptor antagonist, in children with allergic rhinitis and bronchial asthma, and to clarify factors affecting apparent clearance (CL/F). A total of 192 plasma samples were obtained from 98 children (rhinitis 64, asthma 13, complications 21), aged 3-14 years in 2 clinical trials. Plasma concentration of pranlukast was determined by liquid chromatography connected with a tandem mass spectrometer and analyzed by a population approach using NONMEM program. The plasma concentration-time course of pranlukast was described by using a one-compartment model with the first-order absorption and lag time. The robustness of the population pharmacokinetic model was evaluated by using 200 bootstrap samples. The results of population pharmacokinetic analysis showed that only age was a factor affecting the CL/F per body weight, with CL/F decreasing with increasing age. No significant variation was seen in the CL/F between rhinitis and asthma. The interindividual variability in the CL/F and the residual variability were 19.7% and 48.4%, respectively. All the parameters fell within 10% of the bootstrapped mean. In conclusion, the results show that age is the most influential factor for explaining interindividual variability in CL/F, and the difference in diseases does not affect CL/F.

Taste Comparisons for Lansoprazole Strawberry-Flavoured Delayed-Release Orally Disintegrating Tablet and Ranitidine Peppermint-Flavoured Syrup in Children

To compare the flavour and taste preferences of two acid-inhibitory therapies in children. 104 (52 male and 52 female) healthy children aged 6-11 years participated in this phase IV single-centre, taste-test study after parental consent was obtained. Children were divided into two groups based upon age: group 1 included children aged 6-8 years and group 2 included children aged 9-11 years. Within each group an equal number of male and female subjects were recruited. Within each of the four strata defined by group and sex, an equal number of subjects were randomised to taste the strawberry-flavoured lansoprazole 15mg orally disintegrating tablet or the ranitidine 75mg/5mL peppermint-flavoured syrup samples in position 1. In group 1, the lansoprazole 15mg delayed-release orally disintegrating tablet was dispersed in 5mL of water, while in group 2, children gently rolled the tablet on the tongue until dissolution, before swallowing the particles. Children given the dose of lansoprazole dispersed in water (group 1) and the ranitidine dose (groups 1 and 2) were to taste it, swish it in their mouth for up to 10 seconds, and then swallow it. Children were given ambient temperature water and unsalted crackers to cleanse the palate during a 10-minute break between tastings. After each tasting, children rated their degree of liking on a five-point facial hedonic scale (5 = like very much, 1 = dislike very much). Product preference was recorded after the tasting of both samples. Among group 1 and group 2 participants, 86.5% (45/52) and 90.4% (47/52) of children, respectively, 'liked' ('like a little' or 'like very much') the strawberry-flavoured lansoprazole orally disintegrating tablet. The proportion of children who 'liked' the peppermint-flavoured ranitidine syrup was lower than the proportion who liked lansoprazole, and the proportions were similar between the groups: 13.5% (7/52) in group 1 and 9.6% (5/52) in group 2. Children in both groups preferred the strawberry-flavoured lansoprazole delayed-release orally disintegrating tablet: 92% (95% CI 81.1, 97.8; p < 0.001) of those in group 1 and 98% (95% CI 89.7, 100.0; p < 0.001) of those in group 2. After tasting both products, >92% of children aged from 6-11 years preferred the strawberry-flavoured lansoprazole delayed-release orally disintegrating tablet, either dissolved in a small amount of water or allowed to dissolve on the tongue, over the peppermint-flavoured ranitidine syrup.

Safety of desloratadine syrup in children

SUMMARYBackground: Allergic rhinitis (AR) and acute urticaria are common childhood maladies. Typically, the first-line treatment options for both include non-sedating antihistamines. First-generation antihistamines, such as diphenhydramine and hydroxyzine, although useful, cause sedation. Desloratadine, an oral non-sedating antihistamine, has been shown in multiple studies to be safe and effective in relieving the symptoms of AR and chronic idiopathic urticaria (CIU) in adults and adolescents.Objective and methods: The current double-blind, placebo-controlled, parallel-group, single-center studies were undertaken to determine the safety and tolerability of desloratadine syrup in children aged 2 years–11 years with AR or CIU. Over 14 days, subjects aged 2 years–5 years were randomly assigned to receive once a day either 1.25 mg of desloratadine syrup (0.5 mg/mL) or matching placebo, and subjects aged 6 years–11 years were randomly assigned to receive once a day either 2.5 mg of desloratadine syrup or matching placebo. Safety evaluations included adverse event report collection, monitoring of vital signs, clinical laboratory measurements, and standard 12-lead electrocardiogram (ECG) measurements.Results: In the study involving subjects aged 2 years–5 years (n = 111), the incidence of adverse events was 7/55 for the group treated with desloratadine and 6/56 for placebo. In the study involving subjects aged 6 years–11 years (n = 120), the incidence of adverse events was 1/60 for the group treated with desloratadine and 6/60 for placebo. No severe or serious adverse events occurred, and no clinically relevant changes were noted in median clinical laboratory test values or mean vital signs in either group. ECG results from both age groups demonstrated no significant changes ( p = NS) in mean ventricular rate or PR, QRS, or QT. No subjects had a Fridericia QTc interval > 440 ms at day 8 or day 15.Conclusion: These studies demonstrate the safety of desloratadine syrup in children aged 2 years–11 years with AR or CIU.

Population pharmacokinetics of pranlukast hydrate dry syrup in children with bronchial asthma

This is the first report about the pharmacokinetics (PK) of pranlukast in children. The aim of the present study was to assess the PK parameters of pranlukast in children and to compare them with those in adults. Six healthy adult male volunteers and 22 children with bronchial asthma at 3–14 years of age were enrolled in the study. Both 225 and 112.5 mg pranlukast hydrate dry syrup was administered orally to adults, whereas 3.5 mg/kg pranlukast hydrate dry syrup was given to children. Blood samples were obtained at approximately 20 time points per adult (n = 121) and at two or three time points per child (n = 54). Population PK analysis was performed using NONMEM (Globomax, Hanover, MD, USA). The concentration-time-course of pranlukast was described by using a one-compartment model with first-order absorption. The robustness of the final model was evaluated using 200 bootstrap samples. Apparent clearance (CL/F) was 1.81 and 1.14 L/h per kg in children and adults, respectively. According to subgrouping of children, no significant difference was observed in CL/F between infants (3–6 years of age) and schoolchildren (7–14 years of age). The interindividual variability of CL/F accounted for 48.7%. The additive and proportional residual variability was 7.33 ng/mL and 73.8%, respectively. All fixed effect parameters fell within 10% of the bootstrapped mean. Compared with adults, children showed a higher CL/F and more rapid elimination after ingestion of pranlukast hydrate dry syrup. However, no significant variation was seen in CL/F between infants and schoolchildren.