Journal of Pediatric Pharmacology and Therapeutics最新文献_第7页

Evaluation of the Safety and Efficacy of Enoxaparin Once-Daily Versus Twice-Daily Dosing for Prophylaxis in Pediatric Patients. 评估依诺肝素每日一次与每日两次用药对儿科患者预防的安全性和有效性。

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-04-01 Epub Date: 2024-04-08 DOI: 10.5863/1551-6776-29.2.130

Danielle Morgan, Jinjoo Kang, Chana Levine, Suchitra Acharya

{"title":"Evaluation of the Safety and Efficacy of Enoxaparin Once-Daily Versus Twice-Daily Dosing for Prophylaxis in Pediatric Patients.","authors":"Danielle Morgan, Jinjoo Kang, Chana Levine, Suchitra Acharya","doi":"10.5863/1551-6776-29.2.130","DOIUrl":"https://doi.org/10.5863/1551-6776-29.2.130","url":null,"abstract":"Objectives: Enoxaparin for the prevention of venous thromboembolism (VTE) in pediatric patients is -typically dosed twice a day. The use of once-daily dosing like that used in adult patients is limited because of a lack of safety and efficacy data. The aim of this study was to evaluate the safety and efficacy of -once-daily versus twice-daily dosing of enoxaparin for pediatric VTE prophylaxis based on incidence of thrombotic and bleeding events.Methods: This was a 3-year retrospective chart review of enoxaparin received for VTE prophylaxis at -Cohen Children's Medical Center, New Hyde Park, NY. Exclusion criteria were age 18 years or older, and renal dysfunction.Results: A total of 177 enoxaparin courses (81 in the once-daily and 96 in the twice-daily group) were included. The median dose in the once-daily group was 0.68 mg/kg/dose with dose capping at 40 mg/dose in 70% of patients. One patient in the once-daily group had a VTE, whereas no patients in the twice-daily group experienced a VTE. One major bleeding event occurred in the once-daily group (p = 0.46); however, minor bleeding events were comparable between the 2 groups (p = 0.69).Conclusions: Once-daily enoxaparin prophylaxis appears to be safe and effective based on minimal -differences in incidence of thrombotic and bleeding events when compared to twice-daily dosing. Based on this study, it may be reasonable to consider once-daily enoxaparin dosing for prophylaxis, especially in older children. A larger multicenter cohort study evaluating once-daily dosing for prophylaxis is warranted to validate the safety and efficacy specifically for risk-based dosing strategies.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11001208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Beta-Lactam Allergy De-labeling in a Pediatric Hospital. 一家儿科医院的β-内酰胺过敏去标签治疗

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-04-01 Epub Date: 2024-04-08 DOI: 10.5863/1551-6776-29.2.169

Shawn Meehl, Christina Salathe, Chelsea Cooley, Alejandro Jordan-Villegas, Federico R Laham, Akshita Madala, Mallory Cowart

{"title":"Beta-Lactam Allergy De-labeling in a Pediatric Hospital.","authors":"Shawn Meehl, Christina Salathe, Chelsea Cooley, Alejandro Jordan-Villegas, Federico R Laham, Akshita Madala, Mallory Cowart","doi":"10.5863/1551-6776-29.2.169","DOIUrl":"https://doi.org/10.5863/1551-6776-29.2.169","url":null,"abstract":"Objective: To assess the ability to de-label pediatric patients of their beta-lactam allergy by using a newly implemented institutional protocol and to identify potential barriers to the de-labeling process.Methods: All patients with reported allergies to prespecified beta-lactam antibiotics were eligible for a -beta-lactam allergy interview. Following the interview, patients were grouped into 4 risk categories-no risk, low risk, moderate risk, and high risk-and assessed for intervention eligibility. Potential interventions included de-labeling based on the interview alone or proceeding to an oral amoxicillin challenge with or without penicillin allergy skin testing.Results: Of the 62 patients eligible for beta-lactam allergy interviews, 40% (n = 25) were de-labeled. Among de-labeled patients, 60% (n = 15) were de-labeled on the basis of the interview alone. Additionally, no failures were documented in patients who underwent an oral amoxicillin challenge or penicillin skin testing. Barriers to performing oral amoxicillin challenges or penicillin skin testing included concomitant systemic steroid or antihistamine use, refusal of intervention, and insufficient resources to perform penicillin skin testing.Conclusions: There was a high frequency of patients de-labeled of their beta-lactam allergies in this study. Increased education to patients, parents, and providers on the de-labeling process, as well as increased personnel available to coordinate and perform de-labeling interventions, may result in more beta-lactam allergy de-labeling.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11001211/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140856132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Rare Pediatric Case of Allopurinol-Induced Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Successfully Treated With Intravenous Immunoglobulins. 用静脉注射免疫球蛋白成功治疗别嘌呤醇诱发的伴有嗜酸性粒细胞增多和全身症状的药物反应（DRESS）的罕见儿科病例。

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-04-01 Epub Date: 2024-04-08 DOI: 10.5863/1551-6776-29.2.195

Gioacchino Andrea Rotulo, Claudia Campanello, Marcella Battaglini, Marta Bassi, Carlotta Pastorino, Andrea Angeletti, Giacomo Brisca, Sara Signa, Roberta Caorsi, Gian Marco Ghiggeri

{"title":"A Rare Pediatric Case of Allopurinol-Induced Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Successfully Treated With Intravenous Immunoglobulins.","authors":"Gioacchino Andrea Rotulo, Claudia Campanello, Marcella Battaglini, Marta Bassi, Carlotta Pastorino, Andrea Angeletti, Giacomo Brisca, Sara Signa, Roberta Caorsi, Gian Marco Ghiggeri","doi":"10.5863/1551-6776-29.2.195","DOIUrl":"https://doi.org/10.5863/1551-6776-29.2.195","url":null,"abstract":"Allopurinol-induced drug reaction syndrome with eosinophilia and systemic symptoms (A-DRESS) is a well-described condition in adults, whereas it is uncommon among children. We describe a case of A-DRESS in a 16-year-old male with steroid-dependent nephrotic syndrome. He presented a life-threatening clinical course with persisting fever, skin rash, eosinophilia, lymphadenopathy, distributive shock, and herpesvirus 6 detection. The withdrawal of allopurinol and a combination of intravenous immunoglobulins (IVIGs) and systemic corticosteroids led to the patient's recovery without sequelae. Drug reaction with eosinophilia and systemic symptoms (DRESS) in pediatrics is rare and can present in a severe form. Early diagnosis and timely treatment are critical for prognostic purposes. This report suggests the potentially crucial role of IVIG in the treatment of patients with A-DRESS.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11001218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140871400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Tadalafil in Neonates and Infants With Pulmonary Hypertension Secondary to Bronchopulmonary Dysplasia. 他达拉非在继发于支气管肺发育不良的肺动脉高压新生儿和婴儿中的应用。

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-04-01 Epub Date: 2024-04-08 DOI: 10.5863/1551-6776-29.2.140

Amy Kiskaddon, Tanaka Dang, Daniel Mauriello

{"title":"Tadalafil in Neonates and Infants With Pulmonary Hypertension Secondary to Bronchopulmonary Dysplasia.","authors":"Amy Kiskaddon, Tanaka Dang, Daniel Mauriello","doi":"10.5863/1551-6776-29.2.140","DOIUrl":"https://doi.org/10.5863/1551-6776-29.2.140","url":null,"abstract":"Objectives: The primary outcome of this study was to describe the dosing regimen of tadalafil in neonates and infants diagnosed with pulmonary hypertension (PH) secondary to bronchopulmonary dysplasia (BPD). Secondary outcomes included tolerability, efficacy, adverse events, discontinuation of therapy, and changes in echocardiography.Methods: This was a single-center, retrospective review of neonates and infants <1 year of age at initiation of tadalafil for PH secondary to BPD from January 2010 to November 2021. Data collected from the electronic medical record included patient demographics, tadalafil dosing, oxygen support, mechanical ventilation, concomitant PH medications, adverse events, and echocardiography information.Results: Forty-two patients-4 neonates and 38 infants-met the inclusion criteria. The postnatal and post-menstrual age (median, IQR) at diagnosis were 121 (35.5-153.5) days and 42.6 (40.6-47.6) weeks, respectively. The initial and highest tadalafil doses (median, range) were 1 (0.25-2) and 1 (0.5-2) mg/kg/day. Only 1 patient experienced pulmonary overcirculation and required tadalafil to be discontinued. Over half (57.1%) of the patients in this study discontinued tadalafil therapy owing to improvements in pulmonary artery pressures.Conclusions: Tadalafil 1 mg/kg/day was the most commonly used dose regimen in neonates and infants. Tadalafil at this dose of 1 mg/kg/day appears well tolerated in neonates and infants with PH secondary to BPD and correlates with improvements in pulmonary artery pressures. Further studies evaluating tadalafil in comparison to other phosphodiesterase-5 inhibitors in neonates with PH secondary to BPD are warranted.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11001203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effect of Dexmedetomidine on Incidence of Hypertension Following Repair of Coarctation of the Aorta. 右美托咪定对主动脉共济失调修复术后高血压发生率的影响

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-04-01 Epub Date: 2024-04-08 DOI: 10.5863/1551-6776-29.2.144

Hope Mae L Abarintos, Christine A Kapuscinski, Taylor Wheaton, Sierra D Stauber, Michael F Swartz, Madeline Grossman, Sarah Masri, David J Hutchinson

{"title":"Effect of Dexmedetomidine on Incidence of Hypertension Following Repair of Coarctation of the Aorta.","authors":"Hope Mae L Abarintos, Christine A Kapuscinski, Taylor Wheaton, Sierra D Stauber, Michael F Swartz, Madeline Grossman, Sarah Masri, David J Hutchinson","doi":"10.5863/1551-6776-29.2.144","DOIUrl":"https://doi.org/10.5863/1551-6776-29.2.144","url":null,"abstract":"Objective: Recent literature suggests a potential role for dexmedetomidine in reducing the incidence and severity of hypertension following repair of coarctation of the aorta (CoA). The primary aim of this study was to assess the association between dexmedetomidine use and the incidence of hypertension following repair of CoA in pediatric patients.Methods: This was a single-center, retrospective cohort study in patients younger than 19 years who underwent surgical repair of CoA between January 1, 2016, and September 30, 2021. Patients were divided into 2 groups: dexmedetomidine initiation within the first 3 hours after surgery or no dexmedetomidine. The primary outcome was incidence of hypertension within the first 4 to 24 hours after repair. Secondary outcomes included the incidence of hypotension and bradycardia.Results: A total of 80 patients were included, 25 (31.25%) received dexmedetomidine. Median age at the time of procedure was 26 days (IQR, 13-241) in the dexmedetomidine group and 14 days (IQR, 8-53) in the no dexmedetomidine group (p = 0.014). The primary outcome of hypertension was met in 7 patients (28%) in the dexmedetomidine group and 12 patients (21.8%) in the no dexmedetomidine group, p = 0.547. The only variable found to be associated with the incidence of hypertension was age greater than 30 days at the time of procedure. More patients who received dexmedetomidine experienced bradycardia. There was no difference in the incidence of hypotension.Conclusions: There was no association between the use of dexmedetomidine and the incidence of -hypertension following repair of CoA in pediatric patients.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11001214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140874860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Ceftriaxone Pharmacokinetics and Pharmacodynamic Target Attainment for Three Pediatric Patients Receiving Continuous Kidney Replacement Therapy. 三名接受持续肾脏替代疗法的儿科患者的头孢曲松药代动力学和药效学目标达成情况。

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-04-01 Epub Date: 2024-04-08 DOI: 10.5863/1551-6776-29.2.180

H Rhodes Hambrick, Francisco Cervantes, Min Dong, Peter Tang, Trent Arbough, Alexander A Vinks, Tomoyuki Mizuno, Stuart L Goldstein, Jennifer Kaplan, Sonya Tang Girdwood

{"title":"Ceftriaxone Pharmacokinetics and Pharmacodynamic Target Attainment for Three Pediatric Patients Receiving Continuous Kidney Replacement Therapy.","authors":"H Rhodes Hambrick, Francisco Cervantes, Min Dong, Peter Tang, Trent Arbough, Alexander A Vinks, Tomoyuki Mizuno, Stuart L Goldstein, Jennifer Kaplan, Sonya Tang Girdwood","doi":"10.5863/1551-6776-29.2.180","DOIUrl":"10.5863/1551-6776-29.2.180","url":null,"abstract":"Ceftriaxone is used commonly for sepsis, including in children requiring continuous kidney replacement therapy (CKRT). No reports exist of pharmacokinetic (PK) parameters for children receiving ceftriaxone on CKRT. We enrolled children admitted to our pediatric intensive care unit (PICU) who received CKRT for >24 hours and received >1 dose of ceftriaxone while on and off CKRT. We measured free ceftriaxone -concentrations from residual blood samples then used Bayesian estimation with PK modeling software to generate concentration-time profiles and determine PK parameters and the percentage of time free ceftriaxone concentrations were above 1× or 4× MIC (% fT >MIC). Three patients aged 2 to 17 years were included; all were anuric at CKRT initiation and received 50 mg/kg (max 2000 mg) ceftriaxone every 12 to 24 hours. Total ceftriaxone clearance (CL) was 0.50 to 3.67 L/hr while receiving CKRT and 0.29 to 2.71 L/hr while off, indicating CKRT provided 25% to 42% of total ceftriaxone CL. All achieved 100% fT >1× and 4× MIC using an estimated MIC (1 mg/L) for patients 1 to 2 (no culture data) and a measured MIC (0.016 mg/L) for patient 3. Therefore, CKRT contributed significantly to total ceftriaxone clearance in 3 children though the dosing strategies used in each patient attained PD targets.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11001209/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140869241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Potential Application of Large Language Models in Pharmaceutical Supply Chain Management. 大型语言模型在医药供应链管理中的潜在应用。

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-04-01 Epub Date: 2024-04-08 DOI: 10.5863/1551-6776-29.2.200

David Aguero, Scott D Nelson

引用次数: 0

Evaluation of KIDs List Compliance at a Children's Hospital Within a Large Academic Medical Center. 大型学术医疗中心内一家儿童医院的 KID 列表合规性评估。

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-01-01 Epub Date: 2024-02-07 DOI: 10.5863/1551-6776-29.1.61

Alexandra Cooper, Shannon Lyons, Lisa Thames, Timothea Scott, Ansley Gayle, Alexandra Lehman, Tara Higgins

{"title":"Evaluation of KIDs List Compliance at a Children's Hospital Within a Large Academic Medical Center.","authors":"Alexandra Cooper, Shannon Lyons, Lisa Thames, Timothea Scott, Ansley Gayle, Alexandra Lehman, Tara Higgins","doi":"10.5863/1551-6776-29.1.61","DOIUrl":"10.5863/1551-6776-29.1.61","url":null,"abstract":"Objectives: In 2020, a list of Key Potentially Inappropriate Drugs in Pediatrics, known as the \"KIDs List,\" was published. The objective of this analysis was to evaluate institutional compliance with the -recommendations in this publication and identify areas for improvement.Methods: Medications in the KIDs List were compared to the institutional formulary at a large academic medical center caring for pediatric and adult patients. Medications listed in the formulary were then -evaluated for order comments and restrictions related to their use in pediatric patients. Oral liquid products and a group of commonly used intravenous (IV) medications were reviewed for potentially inappropriate excipients through available manufacturer information. The pediatric clinical specialists were then solicited to review and make recommendations for medications that had not been addressed.Results: Of the 67 medications or classes listed in the KIDs List, 47 (70.1%) of the medications are listed in our formulary and available for use. Of these 47 medications, 4 (8.5%) included warnings related to their use in pediatric patients. Of the 270 oral liquid medications reviewed, 206 (76.3%) contained at least 1 -potentially inappropriate excipient. Of the 20 commonly used IV medications, 3 (15%) contained at least 1 potentially inappropriate excipient.Conclusions: This review found that many medications listed in the KIDs List are included in our -institution's formulary and that few have warnings for pediatric patients built into the institutional electronic health record. Further review of medications in the formulary will be conducted to determine the next steps to implementing KIDs List recommendations.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10849687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effectiveness of Alprostadil for Ductal Patency. 阿普前列地尔治疗导管通畅的效果

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-01-01 Epub Date: 2024-02-07 DOI: 10.5863/1551-6776-29.1.37

Caitlin M Gordon, Jason T Tan, Roxane R Carr

{"title":"Effectiveness of Alprostadil for Ductal Patency.","authors":"Caitlin M Gordon, Jason T Tan, Roxane R Carr","doi":"10.5863/1551-6776-29.1.37","DOIUrl":"10.5863/1551-6776-29.1.37","url":null,"abstract":"Objectives: This study aims to describe the effectiveness of low initial alprostadil dosages to maintain a patent ductus arteriosus (PDA) in infants with ductal-dependent congenital heart disease (DDCHD). Secondary objectives were to describe any adverse drug events, describe prescribing trends, describe ductus arteriosus diameter changes, and compare the safety and efficacy of very low and low initial alprostadil dosage regimens.Methods: This retrospective observational cohort study at the British Columbia's Women's and Children's Hospital neonatal intensive care unit and pediatric intensive care unit examined neonates admitted with DDCHD who received alprostadil to maintain ductal patency. Very low-dose alprostadil (less than 0.01 mcg/kg/min) versus low-dose alprostadil (equal to or greater than 0.01 mcg/kg/min) was examined. Effectiveness was defined as survival and infants not requiring a resuscitation event (cardiac arrest, cardiogenic shock, code blue, extracorporeal life support, requirement for emergent cardiac surgery, and respiratory acidosis). Adverse drug events with a Naranjo score of 3 or more were included.Results: Alprostadil was effective for 88% of patients, with no difference between the very low-dose and low-dose groups. Of the 75 patients included, 25 received very low-dose alprostadil. Adverse drug events were common (51%) with neonates in the low-dose group experiencing more apnea and pyrexia than neonates in the very low-dose group.Conclusions: Alprostadil therapy was effective in maintaining the PDA in neonates with DDCHD with low-dosage regimens. Adverse drug events were common with both dosage regimens; however, the very low dosage appeared to have less apnea and pyrexia.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10849693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Bioavailability of CHF6563, an Ethanol-Free, Sublingual Neonatal Buprenorphine Formulation: A Bridging Study Conducted in Adults. 无乙醇、舌下含服新生儿丁丙诺啡制剂 CHF6563 的生物利用度：在成人中开展的一项衔接研究。

Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2024-01-01 Epub Date: 2024-02-07 DOI: 10.5863/1551-6776-29.1.49

Walter K Kraft, Irene Barneschi, Maria Bocchi, Debora Santoro, Massimo Cella

{"title":"The Bioavailability of CHF6563, an Ethanol-Free, Sublingual Neonatal Buprenorphine Formulation: A Bridging Study Conducted in Adults.","authors":"Walter K Kraft, Irene Barneschi, Maria Bocchi, Debora Santoro, Massimo Cella","doi":"10.5863/1551-6776-29.1.49","DOIUrl":"10.5863/1551-6776-29.1.49","url":null,"abstract":"Objective: Sublingual buprenorphine has demonstrated efficacy for treatment of the neonatal opioid withdrawal syndrome (NOWS), but the current formulation used in clinical practice contains 30% ethanol. Ethanol as a pharmacologically active excipient ideally should be removed from neonatal formulations. The objective of this study was to determine the relative bioavailability of a novel ethanol-free -formulation (CHF6563) compared with the commonly used ethanolic solution in a phase I, open-label, 2-period, -single-dose, crossover study in healthy adults.Methods: Eighteen adult opioid-naïve volunteers were administered one of the formulations in a randomized crossover treatment. After a 10-day washout period, subjects received the other formulation. Serial blood samples were drawn for pharmacokinetic analysis over 48 hours.Results: The geometric mean ratio (90% CIs) of the ethanol-free buprenorphine solution AUC0-last was 0.80 (0.65-0.99) and Cmax was 0.81 (0.66-0.99) compared with reference ethanolic formulation. The -ethanol-free formulation had a greater degree of intersubject variability than the ethanol-containing -reference formulation (coefficient of variation of 59% vs 31.5%, respectively, for AUC0-last).Conclusions: In an adult population, a novel ethanol-free formulation of buprenorphine containing widely used excipients demonstrated a slight decrease in bioavailability when compared with an ethanolic solution. These results will inform those seeking to develop ethanol-free pediatric drug formulations.","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10849686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0