scholarly journals A Systematic Review of the Stability of Extemporaneous Pediatric Oral Formulations

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Anteneh Belayneh ◽  
Zenaw Tessema

Background. Extemporaneous compounding is a pharmacy practice to produce suitable pharmaceutical preparations when there are no commercially available, licensed, and age-specific dosage forms. Compared to the use of authorized drugs, these preparations have significant risks. Stability issues are one of the major concerns during the preparation of extemporaneous formulations. Aim. The aim of this work was to study the stability of pediatric extemporaneous formulations of commercially available conventional solid dosage forms by reviewing systematically the currently available stability studies. Method. Articles were searched in the databases of the Web of Science, PubMed, Scopus, EMBASE, Cochrane Library, and Google Scholar. From all the searched articles, a total of 28 experimental studies reporting the stability of oral pediatric extemporaneous formulations were included based on the inclusion criteria. Oral extemporaneous formulations from commercially available dosage forms and pure drugs were considered. According to the United States and British Pharmacopeia (USP and BP), most extemporaneous formulations are accepted as chemically stable if they maintain ≥90% of the original drug amount, physically stable if there is no apparent change in physical property, and microbiologically stable if there is no growth of microorganisms in prepared formulations. Finding. In this study, most extemporaneous pediatric oral formulations were chemically, physically, and microbiologically stable and retained more than 90% of the initial content. Very few studies did not include either a physical stability test or a microbiological stability test. Conclusion. According to this systematic review, the chemical and physical instabilities as well as microbial growth on pediatric oral extemporaneous formulations are very rare in published experimental studies. Most studies show that extemporaneous preparations are stable at the ICH recommended storage conditions and duration. Generally, extemporaneously prepared oral formulations will be the promising option for child medications.

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 401-401
Author(s):  
Yue-Heng Yin ◽  
Liu Yat Justina

Abstract Obesity has been shown to intensify the decline of physical function and lead to frailty. Nutrition is an important method in managing obesity and frailty, while seldom reviews have ever explored the effects of nutritional education interventions. We conducted a systematic review (PROSPERO: CRD42019142403) to explore the effectiveness of nutritional education interventions in managing body composition and physio-psychosocial parameters related to frailty. Randomized controlled trials and quasi-experimental studies were searched in CINAHL, Cochrane Library, EMBASE, MEDLINE, PsycINFO, PubMed and Scopus from 2001 to 2019. Hand search for the reference lists of included papers was conducted as well. We assessed the quality of included studies by Cochrane risk of bias tool. Meta-analyses and narrative synthesis were used to analyse the data. Two studies with low risk of bias were screened from 180 articles, which involved 177 older people with an average age of 69.69±4.08 years old. The results showed that nutritional education was significantly effective in reducing body weight and fat mass than exercises, and it was beneficial to enhancing physical function and psychosocial well-being. But the effects of nutritional education in increasing muscle strength were not better than exercises. The combined effects of nutritional education and exercises were superior than either exercises or nutritional education interventions solely in preventing the loss of lean mass and bone marrow density, and in improving physical function. Due to limited numbers of relevant studies, the strong evidence of effectiveness of nutritional education interventions on reversing frailty is still lacking.


2021 ◽  
pp. 112070002110126
Author(s):  
Raman Mundi ◽  
Harman Chaudhry ◽  
Seper Ekhtiari ◽  
Prabjit Ajrawat ◽  
Daniel M Tushinski ◽  
...  

Introduction: In the United States, over 1,000,000 total joint arthroplasty (TJA) surgeries are performed annually and has been forecasted that this number will exceed 4,000,000 by the year 2030. Many different types of dressing exist for use in TJA surgery, and it is unclear if any of the newer, hydrofibre dressings are superior to traditional dressings at reducing rates of infections or improving wound healing. Thus, the aim of this systematic review and meta-analysis was to assess the impact of hydrofiber dressings on reducing complications. Methods: A systematic review and meta-analysis was performed using the online databases MEDLINE and the Cochrane Library. Randomized controlled trials (RCTs) comparing hydrofibre dressings to a standard dressing were included. Summary measures are reported as odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs). Our primary outcome was prosthetic joint infection (PJI). Secondary outcomes included blisters, dressing changes and wound irritation. Results: 5 RCTs were included. Hydrofibre dressing had no observable effect on PJI or wound irritation (OR 0.53; 95% CI, 0.14–1.98; p = 0.35). Hydrofibre dressings reduced the rate of blisters (OR 0.36; 95% CI, 0.14–0.90; p = 0.03) and number of dressing changes (MD -1.89; 95% CI, -2.68 to -1.11). Conclusions: In conclusion, evidence suggests hydrofibre dressings have no observable effect on PJI and wound irritation. Evidence for reduction in blisters and number of dressings is modest given wide CIs and biased trial methodologies. Use of hydrofibre dressings should be considered inconclusive for mitigating major complications in light of current best evidence.


2020 ◽  
Vol 75 (4) ◽  
pp. 457-466
Author(s):  
Matteo Amoroso ◽  
Peter Apelgren ◽  
Anna Elander ◽  
Karin Säljö ◽  
Lars Kölby

BACKGROUND: Acute normovolemic hemodilution (ANH) has been proposed as a microsurgical technique to improve blood flow in free flaps. OBJECTIVE: Here, we present the first systematic review of clinical and experimental studies on the effect of ANH. METHODS: We performed a systematic literature search of PubMed, Medline, the Cochrane Library, Google Scholar, and ClinicalTrials.gov using search strategies and a review process in agreement with the PRISMA statement and the Cochrane Handbook for systematic reviews of interventions. PICO criteria were defined before bibliometric processing of the retrieved articles, which were analyzed with the SYRCLE RoB tool for risk of bias and the GRADE scale for level of evidence. RESULTS: We retrieved 74 articles from the literature search, and after processing according to PICO criteria, only four articles remained, all of which were experimental. The rating for risk of bias was uncertain according to SYRCLE RoB results, and the level of evidence was low according to GRADE evaluation. CONCLUSIONS: There is no clinical evidence for the effect of ANH on microcirculation in free flaps, and experimental studies provide weak evidence supporting the use of hemodilution in reconstructive microsurgery.


2022 ◽  
Vol 10 (1) ◽  
Author(s):  
Fatima Safi ◽  
Anna M. Aniserowicz ◽  
Heather Colquhoun ◽  
Jill Stier ◽  
Behdin Nowrouzi-Kia

Abstract Background Eating disorders (ED) can reduce quality of life by limiting participation and performance in social and occupational roles, including paid or unpaid work. The association between ED pathologies and work participation and performance must be well understood to strengthen vocational rehabilitation programmes and prevent occupational disruptions in the ED population. The aims of this study are: (1) to examine the degree of association between ED pathologies and work participation and performance in 15-year-olds and older; (2) to highlight the specific ED symptoms that are most correlated with changes in work performance and participation; (3) to compile the most common metrics and assessments used to measure work participation and performance with ED. Methods Medline, Embase, CINAHL, Web of Science, PsycINFO, and Cochrane Library will be searched for observational and experimental studies that meet the following criteria: (1) a clinical sample of typical or atypical ED; (2) paid or unpaid employment or training; (3) an association between ED pathologies and work participation or performance. Unpublished data will also be examined. Title and abstract, and full-text screening will be conducted in duplicate. Risk of bias and quality of evidence assessments will be completed. A random-effect meta-analysis will be performed. Discussion This synthesis can clarify knowledge and gaps around the impact of ED on work functioning, thereby allowing better evaluation, improvements and development of current workplace assessments, interventions, and policies. Trial registration The registration number for this systematic review on PROSPERO is CRD42021255055.


Author(s):  
Aloisio Cunha de Carvalho ◽  
Leoni Villano Bonamin

Background: Several reviews about phytotherapy and homeopathy have been published in the last years, including Viscum album (VA.L). VA is a parasite plant whose extract has anti-cancer proprieties and is used alone or in combination with conventional chemotherapy. Methods: We performed a systematic review about the in vivo and in vitro models described in the literature, including veterinary clinical trials. The literature was consulted from Pubmed database. Results: There are several kinds of pharmaceutical preparations about VA and their active principles used in experimental studies, lectin being frequently studied (alone or as an extract compound). More than 50% of available literature about VA is related to the lectin effects. On the other hand, the effects of viscotoxins are less studied. Among the in vivo experimental studies about VA and its compounds, the B16 murine melanoma is the most used model, followed by Ehrlich, Walker and Dalton tumors. The results point to the apoptotic effects, metastasis control and tumor regression. Some veterinary clinical studies about the use of VA in the treatment of sarcoid, fibrosarcoma and neuroblastoma are quoted in literature too, with interesting results. Considering the in vitro models, our review revealed that NALM6 leukemia cells, B16 melanoma and NC1-H460 lung carcinoma were the most studied tumor models, apoptosis signals being the most important findings. Only one study verified immunoglobulin and interleukin production. All consulted papers were related to phytotherapy preparations only. Conclusions: Although the literature about the anti-cancer activity of VA extract and its lectins is enough, there is a marked lack of information about viscotoxin activities and about the effects of homeopathic preparations of this plant on animal tumors and on in vitro cultivated tumor cells.


2019 ◽  
Vol 5 ◽  
pp. 205520761983988 ◽  
Author(s):  
Sarah Ann Buckingham ◽  
Andrew James Williams ◽  
Karyn Morrissey ◽  
Lisa Price ◽  
John Harrison

Objective This systematic review aimed to assess the effectiveness, feasibility and acceptability of mobile health (mHealth) technology (including wearable activity monitors and smartphone applications) for promoting physical activity (PA) and reducing sedentary behaviour (SB) in workplace settings. Methods Systematic searches were conducted in seven electronic databases (MEDLINE, SPORTDiscus, Scopus, EMBASE, PsycINFO, Web of Science and the Cochrane library). Studies were included if mHealth was a major intervention component, PA/SB was a primary outcome, and participants were recruited and/or the intervention was delivered in the workplace. Study quality was assessed using the Effective Public Health Practice Project (EPHPP) tool. Interventions were coded for behaviour change techniques (BCTs) using the Coventry, Aberdeen and London – Refined (CALO-RE) taxonomy. Results Twenty-five experimental and quasi-experimental studies were included. Studies were highly heterogeneous and only one was rated as ‘strong’ methodological quality. Common BCTs included self-monitoring, feedback, goal-setting and social comparison. A total of 14/25 (56%) studies reported a significant increase in PA, and 4/10 (40%) reported a significant reduction in sedentary time; 11/16 (69%) studies reported a significant impact on secondary outcomes including reductions in weight, systolic blood pressure and total cholesterol. While overall acceptability was high, a large decline in technology use and engagement was observed over time. Conclusions While methodological quality was generally weak, there is reasonable evidence for mHealth in a workplace context as a feasible, acceptable and effective tool to promote PA. The impact in the longer term and on SB is less clear. Higher quality, mixed methods studies are needed to explore the reasons for decline in engagement with time and the longer-term potential of mHealth in workplace interventions. Protocol registration: The review protocol was registered with PROSPERO: CRD42017058856


2020 ◽  
Vol 8 ◽  
Author(s):  
Fan Yan ◽  
Huayong Zhang ◽  
Ruihua Xiong ◽  
Xingfeng Cheng ◽  
Yang Chen ◽  
...  

Background: In the latest 2017 American Heart Association guidelines for Kawasaki disease (KD), there are no recommendations regarding the early administration of intravenous immunoglobulin (IVIG). Therefore, the purpose of this systematic review and meta-analysis was to investigate the effects of early IVIG therapy on KD.Methods: We searched databases including the PubMed, Medline, the Cochrane Library, and the Clinicaltrials.gov website until July 2019.Results: Fourteen studies involving a total of 70,396 patients were included. Early treatment with IVIG can lead to an increased risk of IVIG unresponsiveness [OR 2.24; 95% CI (1.76, 2.84); P = 0.000]. In contrast to the studies performed in Japan [OR 1.27; 95% CI (0.98, 1.64); P = 0.074] that found no significant difference in coronary artery lesions (CAL) development, studies conducted in China [OR 0.73; 95% CI (0.66, 0.80); P = 0.000] and the United States [OR 0.50; 95% CI (0.38, 0.66); P = 0.000] showed a reduced risk in the occurrence of CAL with early IVIG treatment.Conclusions: At present, the evidence does not support the treatment with IVIG in the early stage of the onset of KD. But, early IVIG treatment could be a protective factor against the development of CAL, which needs to be further clarified.


2021 ◽  
Vol 7 ◽  
Author(s):  
Daniela Coclite ◽  
Antonello Napoletano ◽  
Silvia Gianola ◽  
Andrea del Monaco ◽  
Daniela D'Angelo ◽  
...  

Background: Evidence is needed on the effectiveness of wearing face masks in the community to prevent SARS-CoV-2 transmission.Methods: Systematic review and meta-analysis to investigate the efficacy and effectiveness of face mask use in a community setting and to predict the effectiveness of wearing a mask. We searched MEDLINE, EMBASE, SCISEARCH, The Cochrane Library, and pre-prints from inception to 22 April 2020 without restriction by language. We rated the certainty of evidence according to Cochrane and GRADE approach.Findings: Our search identified 35 studies, including three randomized controlled trials (RCTs) (4,017 patients), 10 comparative studies (18,984 patients), 13 predictive models, nine laboratory experimental studies. For reducing infection rates, the estimates of cluster-RCTs were in favor of wearing face masks vs. no mask, but not at statistically significant levels (adjusted OR 0.90, 95% CI 0.78–1.05). Similar findings were reported in observational studies. Mathematical models indicated an important decrease in mortality when the population mask coverage is near-universal, regardless of mask efficacy. In the best-case scenario, when the mask efficacy is at 95%, the R0 can fall to 0.99 from an initial value of 16.90. Levels of mask filtration efficiency were heterogeneous, depending on the materials used (surgical mask: 45–97%). One laboratory study suggested a viral load reduction of 0.25 (95% CI 0.09–0.67) in favor of mask vs. no mask.Interpretation: The findings of this systematic review and meta-analysis support the use of face masks in a community setting. Robust randomized trials on face mask effectiveness are needed to inform evidence-based policies.PROSPERO registration: CRD42020184963.


Author(s):  
Susi Ari Kristina ◽  
Chairun Wiedyaningsih ◽  
Niken Nur Widyakusuma ◽  
Hardika Aditama

<p><strong>Objective: </strong>To identify the frequency and scope of extemporaneous compounding practice reported in community and hospital pharmacies.</p><p><strong>Method</strong><strong>s</strong><strong>:</strong><strong> </strong>A systematic literature review was undertaken to identify the prevalence of extemporaneous compounding practice in community and hospital pharmacies, including the reasons of providing compounding services.</p><p><strong>Results: </strong>Nine studies were identified and evaluated in which extemporaneous products prepared by pharmacist could be identified. Most of the studies record that prevalence of extemporaneous compounding practice is very low (less than 5%). Prescribing of compounded medicines occurs more frequently in paediatrics and for special patients’ need. The major types of extemporaneous compounding products were dermatological dosage forms and followed by oral solutions and oral suspensions. Reasons for providing compounding practice were to make a customised products that not available commercially and to provide full pharmaceutical care to patients. Issues about the stability of compounded products, accuracy in dose strength and lack of standardised protocol in extemporaneous compounding need to be addressed.</p><p><strong>Conclusion: </strong>Extemporaneous compounding practice are an essential part of pharmacist’ competency. These unique skills need to be preserved and regulations that cover rationalised compounding practice is necessary.</p>


2014 ◽  
Vol 35 (10) ◽  
pp. 1209-1228 ◽  
Author(s):  
Brittin Wagner ◽  
Gregory A. Filice ◽  
Dimitri Drekonja ◽  
Nancy Greer ◽  
Roderick MacDonald ◽  
...  

ObjectiveEvaluate the evidence for effects of inpatient antimicrobial stewardship programs (ASPs) on patient, prescribing, and microbial outcomes.DesignSystematic review.MethodsSearch of MEDLINE (2000 through November 2013), Cochrane Library, and reference lists of relevant studies. We included English language studies with patient populations relevant to the United States (ie, infectious conditions and prescriptions required for antimicrobials) that evaluated ASP interventions and reported outcomes of interest. Study characteristics and outcomes data were extracted and reviewed by investigators and trained research personnel.ResultsFew intervention types (eg, audit and feedback, guideline implementation, and decision support) substantially impacted patient outcomes, including mortality, length of stay, readmission, or incidence of Clostridium difficile infection. However, most interventions were not powered adequately to demonstrate impacts on patient outcomes. Most interventions were associated with improved prescribing patterns as measured by decreased antimicrobial use or increased appropriate use. Where reported, ASPs were generally associated with improvements in microbial outcomes, including institutional resistance patterns or resistance in the study population. Few data were provided on harms, sustainability, or key intervention components. Studies were typically of short duration, low in methodological quality, and varied in study design, populations enrolled, hospital setting, ASP intent, intervention composition and implementation, comparison group, and outcomes assessed.ConclusionsNumerous studies suggest that ASPs can improve prescribing and microbial outcomes. Strength of evidence was low, and most studies were not designed adequately to detect improvements in mortality or other patient outcomes, but obvious adverse effects on patient outcomes were not reported.


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