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TheScientificWorldJournal 2021Extemporaneous compounding is a pharmacy practice to produce suitable pharmaceutical preparations when there are no commercially available, licensed, and age-specific...
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. . 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.
Topics: Administration, Oral; Child; Dosage Forms; Drug Stability; Humans; Pediatrics
PubMed: 34955693
DOI: 10.1155/2021/8523091 -
Iranian Journal of Medical Sciences Sep 2023Recurrent aphthous stomatitis (RAS) is the most common ulcerative disease that affects oral mucosa. The coating agents, topical analgesics, and topical steroids are... (Review)
Review
BACKGROUND
Recurrent aphthous stomatitis (RAS) is the most common ulcerative disease that affects oral mucosa. The coating agents, topical analgesics, and topical steroids are usually used as treatment methods. has been used for RAS treatment based on its anti-inflammatory, antioxidant, and immunomodulatory properties. In this study, a systemic review on the therapeutic effect of topical licorice on RAS management was performed.
METHODS
Science Direct, Scopus, Cochrane databases, PubMed Google Scholar, and ResearchGate were searched up to September 2021 to find all English randomized clinical trials studying the effect of , or its compositions on RAS. Meta-analysis was not conducted because of data heterogeneity. Articles were reviewed qualitatively, and only those with a Jadad score ≥3 were included. Animal studies, , review papers, non-English papers, and case reports were excluded.
RESULTS
Six studies with 314 subjects were included after screening. The result showed licorice has significant effects on RAS pain reduction, ulcer size, and healing time. Its effectiveness is related to its dose-dependent anti-inflammatory and antioxidant effects through several mechanisms. It also has antibacterial effects against and as another mechanism of action in RAS treatment. In addition, licorice can elevate the epidermal growth factor (EGF) level compared to the control group, which has an essential role in oral mucosal tissue integrity.
CONCLUSION
Licorice extract has been used in different dosage forms, including paste, patch, and mouthwash with concentrations of 1% or 5%. The healing time after licorice therapy is expected to be within 4-8 days. Licorice did not show any adverse effect in the intervention groups, indicating its effectiveness and safety in RAS treatment.
Topics: Animals; Humans; Stomatitis, Aphthous; Glycyrrhiza; Anti-Inflammatory Agents
PubMed: 37786470
DOI: 10.30476/IJMS.2022.94467.2576 -
BMC Ophthalmology Jul 2023Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging evidence that nicotinic acetylcholine receptor (nAChR) agonists (e.g., varenicline and simpinicline) nasal sprays are effective for DED. Our systematic review and meta-analysis assessed the efficacy and safety of varenicline nasal spray (VNS) for DED treatment.
METHODS
The Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched. Only randomized controlled trials (RCTs) that evaluated the efficacy of VNS versus placebo were included. The efficacy endpoint was the mean change in the anesthetized Schirmer test score (STS), a measure of basal tear production, from baseline. The safety endpoints were serious adverse events (SAEs) and adverse events (AEs). The standardized mean difference (SMD) was used for continuous outcomes, while the risk ratio (RR) was used to demonstrate dichotomous variables. The certainty of the evidence was rated utilizing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The risk of bias assessment was conducted using the Revised Cochrane risk of bias tool for randomized trials.
RESULTS
Three RCTs (n = 1063) met the eligibility criteria. All RCTs had a low risk of bias. The meta-analysis found a statistically significant increase in the mean STS change from baseline on day 28. The pooled analysis found no significant difference between VNS and placebo in the frequency of SAEs and ocular AEs. However, VNS had a significant effect on developing nasal cavity-related AEs.
CONCLUSION
VNS caused a highly significant improvement regarding the efficacy endpoint but caused an increased frequency of some nasal cavity-related AEs (i.e., cough and throat irritation). However, it caused neither SAEs nor ocular AEs. Included studies had a low risk of bias.
Topics: Humans; Nasal Sprays; Varenicline; Dry Eye Syndromes
PubMed: 37452334
DOI: 10.1186/s12886-023-03069-y -
Reviews in Medical Virology May 2021A key consideration in the Covid-19 pandemic is the dominant modes of transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. The...
A key consideration in the Covid-19 pandemic is the dominant modes of transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. The objective of this review was to synthesise the evidence for the potential airborne transmission of SARS-CoV-2 via aerosols. Systematic literature searches were conducted in PubMed, Embase, Europe PMC and National Health Service UK evidence up to 27 July 2020. A protocol was published and Cochrane guidance for rapid review methodology was adhered to throughout. Twenty-eight studies were identified. Seven out of eight epidemiological studies suggest aerosol transmission may occur, with enclosed environments and poor ventilation noted as possible contextual factors. Ten of the 16 air sampling studies detected SARS-CoV-2 ribonucleic acid; however, only three of these studies attempted to culture the virus with one being successful in a limited number of samples. Two of four virological studies using artificially generated aerosols indicated that SARS-CoV-2 is viable in aerosols. The results of this review indicate there is inconclusive evidence regarding the viability and infectivity of SARS-CoV-2 in aerosols. Epidemiological studies suggest possible transmission, with contextual factors noted. Viral particles have been detected in air sampling studies with some evidence of clinical infectivity, and virological studies indicate these particles may represent live virus, adding further plausibility. However, there is uncertainty as to the nature and impact of aerosol transmission of SARS-CoV-2, and its relative contribution to the Covid-19 pandemic compared with other modes of transmission.
Topics: Aerosols; COVID-19; Humans; RNA, Viral; Retrospective Studies; SARS-CoV-2; Uncertainty
PubMed: 33105071
DOI: 10.1002/rmv.2184 -
Frontiers in Pharmacology 2022The efficacy of conventional pharmacotherapy on osteoporosis was limited and accompanied with serious side effects. Epimedium might have the potential to be developed...
The efficacy of conventional pharmacotherapy on osteoporosis was limited and accompanied with serious side effects. Epimedium might have the potential to be developed as agents to treat osteoporosis. The present systematic review and meta-analysis integrating Western medicine and Eastern medicine ("WE" medicine) was to evaluate the efficacy of Epimedium on osteoporosis. Eleven electronic databases were searched to identify the randomized controlled trials (RCTs) comparing Epimedium as an adjunctive or alternative versus conventional pharmacotherapy during osteoporosis. Bone mineral density (BMD), effective rate, and Visual Analog Scale (VAS) were measured as primary outcomes. The secondary outcomes were pain relief time, bone metabolic markers, and adverse events. Research quality evaluation was conducted according to the modified Jadad scale. Review Manager 5.4 was utilized to perform analyses, and the data were pooled using a random-effect or fixed-effect model to calculate the weighted mean difference (WMD), standardized mean difference (SMD), risk ratio (RR), and 95% confidence intervals (CI). Twelve RCTs recruiting 1,017 patients were eligible. Overall, it was possible to verify that, in the Epimedium plus conventional pharmacotherapy group, BMD was significantly improved ( = 0.03), effective rate was significantly improved ( = 0.0001), and VAS was significantly decreased ( = 0.01) over those in control group. When compared to conventional pharmacotherapy, Epimedium used alone improved BMD ( = 0.009) and effective rate ( < 0.0001). VAS was lower ( < 0.00001), and the level of alkaline phosphatase (ALP) was significantly decreased ( = 0.01) in patients taking Epimedium alone compared with those given conventional pharmacotherapy. Results of subgroup analyses yielded that the recommended duration of Epimedium as an adjuvant was >3 months ( = 0.03), the recommended duration of Epimedium as an alternative was ≤3 months ( = 0.002), and Epimedium decoction brought more benefits (SMD = 2.33 [1.92, 2.75]) compared with other dosage forms. No significant publication bias was identified based on statistical tests (t = 0.81, = 0.440). Epimedium may improve BMD and effective rate and relieve pain as an adjuvant or alternative; Epimedium as an alternative might regulate bone metabolism, especially ALP, with satisfying clinical efficacy during osteoporosis. More rigorous RCTs are warranted to confirm these results.
PubMed: 35431937
DOI: 10.3389/fphar.2022.782096 -
World Journal of Clinical Cases Apr 2021The proton pump inhibitors (PPIs), used to reduce gastric acid secretion, represent one of the most widely used pharmaceutical classes in the world. Their consumption as...
BACKGROUND
The proton pump inhibitors (PPIs), used to reduce gastric acid secretion, represent one of the most widely used pharmaceutical classes in the world. Their consumption as a risk factor for the evolution of severe forms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been investigated as well as the mortality of these patients. These risks also appear to be linked to the duration and the dosage. On the other hand, several studies have emerged with regard to the protective or therapeutic effects of these drugs. More and more evidence underlines the immunomodulatory and anti-fibrotic role of PPIs. In addition, their ability to alkalize the contents of endosomes and lysosomes serves as an obstacle to the entry of the virus into the host cells.
AIM
To identify studies on the relationship between the intake of PPIs and coronavirus disease 2019 (COVID-19) in patients affected by SARS-CoV-2 infection, with the main objective of evaluating the outcomes related to severity and mortality.
METHODS
A literature review was performed in November 2020. The MEDLINE/PubMed, Cochrane Library, EMBASE and Google Scholar databases were searched for all relevant articles published in English on this topic. The search terms were identified by means of controlled vocabularies, such as the National Library of Medicine's MESH (Medical Subject Headings) and keywords. The MESH terms and keywords used were as follows: "COVID-19", "proton pump inhibitors", "PPIs", "SARS-CoV-2", "outcomes", "severity" and "mortality". The inclusion criteria regarding the studies considered in our analysis were: meta-analysis, case-control, hospital-based case-control, population-based case-control, retrospective studies, online survey, as well as cohort-studies, while articles not published as full reports, such as conference abstracts, case reports and editorials were excluded. We tried to summarize and pool all the data if available.
RESULTS
A total of 9 studies were found that described the use of PPIs, of which only 5 clearly reported the severity and mortality data in SARS-CoV-2 patients. Our pooled incidence analysis of severe events did not differ between patients with and without PPIs (odds ratio 1.65, 95% confidence interval: 0.62-4.35) ( = 0.314), or for mortality (odds ratio 1.77, 95% confidence interval: 0.62-5.03) ( = 0.286).
CONCLUSION
Detailed and larger case studies are needed to accurately understand the role of PPIs in this viral infection.
PubMed: 33969059
DOI: 10.12998/wjcc.v9.i12.2763 -
European Neuropsychopharmacology : the... Jun 2024Long-acting injectable antipsychotics (LAIs) are primarily used for relapse prevention, but in some settings and situations, they may also be useful for acute treatment... (Meta-Analysis)
Meta-Analysis Review
Long-acting injectable antipsychotics (LAIs) are primarily used for relapse prevention, but in some settings and situations, they may also be useful for acute treatment of schizophrenia. We conducted a systematic review and frequentist network meta-analysis of randomized-controlled trials (RCTs), focusing on adult patients in the acute phase of schizophrenia. Interventions were risperidone, paliperidone, aripiprazole, olanzapine, and placebo, administered either orally or as LAI. We synthesized data on overall symptoms, complemented by 17 other efficacy and tolerability outcomes. Confidence in the evidence was assessed with the Confidence-in-Network-Meta-Analysis-framework (CINeMA). We included 115 RCTs with 25,550 participants. All drugs were significantly more efficacious than placebo with the following standardized mean differences and their 95 % confidence intervals: olanzapine LAI -0.66 [-1.00; -0.33], risperidone LAI -0.59[-0.73;-0.46], olanzapine oral -0.55[-0.62;-0.48], aripiprazole LAI -0.54[-0.71; -0.37], risperidone oral -0.48[-0.55;-0.41], paliperidone oral -0.47[-0.58;-0.37], paliperidone LAI -0.45[-0.57;-0.33], aripiprazole oral -0.40[-0.50; -0.31]. There were no significant efficacy differences between LAIs and oral formulations. Sensitivity analyses of the primary outcome overall symptoms largely confirmed these findings. Moreover, some side effects were less frequent under LAIs than under their oral counterparts. Confidence in the evidence was moderate for most comparisons. LAIs are efficacious for acute schizophrenia and may have some benefits compared to oral formulations in terms of side effects. These findings assist clinicians with insights to weigh the risks and benefits between oral and injectable agents when treating patients in the acute phase.
Topics: Humans; Antipsychotic Agents; Administration, Oral; Schizophrenia; Delayed-Action Preparations; Network Meta-Analysis; Randomized Controlled Trials as Topic; Injections; Treatment Outcome
PubMed: 38490016
DOI: 10.1016/j.euroneuro.2024.03.003 -
Tissue Engineering and Regenerative... Oct 2023Due to its high water content and biomimetic properties simulating extracellular matrix (ECM), hydrogels have been used as preferred cell culture and delivery systems.... (Review)
Review
BACKGROUND
Due to its high water content and biomimetic properties simulating extracellular matrix (ECM), hydrogels have been used as preferred cell culture and delivery systems. Similarly, cell-loaded hydrogels can be easily injected into target areas in a minimally invasive manner, minimizing surgical trauma, adapting to irregular shaped defects, and benefiting patients. In this study, we systematically reviewed multiple studies on hydrogel-based bone defect research and briefly summarized the progress of injectable and cell-loaded hydrogels in bone defect repair.
METHODS
A systematic search was conducted in the PubMed and Web of Science databases using selected search terms.
RESULTS
Initially, 185 articles were retrieved from the databases. After full-text screening based on inclusion and exclusion criteria, 26 articles were included in this systematic review. Data collected from each study included culture model, seed cell type and origin, cell concentration, scaffold material, scaffold shape, experimental animal and site, bioactive agents, and binding method. This injectable and cell-loaded hydrogel shows certain feasibility in bone tissue engineering applications.
CONCLUSION
Injectable and cell-loaded hydrogels have been widely applied in bone tissue engineering research. The future direction of bone tissue engineering for bone defect treatment involves the use of new hydrogel materials and biochemical stimulation.
Topics: Animals; Humans; Hydrogels; Tissue Engineering; Bone and Bones; Extracellular Matrix; Cell Culture Techniques
PubMed: 37563482
DOI: 10.1007/s13770-023-00569-2 -
Seminars in Nephrology Mar 2020To characterize current evidence and current foci of perioperative clinical trials, we systematically reviewed Medline and identified perioperative trials involving 100...
To characterize current evidence and current foci of perioperative clinical trials, we systematically reviewed Medline and identified perioperative trials involving 100 or more adult patients undergoing surgery and reporting renal end points that were published in high-impact journals since 2004. We categorized the 101 trials identified based on the nature of the intervention and summarized major trial findings from the five categories most applicable to perioperative management of patients. Trials that targeted ischemia suggested that increasing perioperative renal oxygen delivery with inotropes or blood transfusion does not reliably mitigate acute kidney injury (AKI), although goal-directed therapy with hemodynamic monitors appeared beneficial in some trials. Trials that have targeted inflammation or oxidative stress, including studies of nonsteroidal anti-inflammatory drugs, steroids, N-acetylcysteine, and sodium bicarbonate, have not shown renal benefits, and high-dose perioperative statin treatment increased AKI in some patient groups in two large trials. Balanced crystalloid intravenous fluids appear safer than saline, and crystalloids appear safer than colloids. Liberal compared with restrictive fluid administration reduced AKI in a recent large trial in open abdominal surgery. Remote ischemic preconditioning, although effective in several smaller trials, failed to reduce AKI in two larger trials. The translation of promising preclinical therapies to patients undergoing surgery remains poor, and most interventions that reduced perioperative AKI compared novel surgical management techniques or existing processes of care rather than novel pharmacologic interventions.
Topics: Acute Kidney Injury; Anti-Inflammatory Agents, Non-Steroidal; Blood Transfusion; Cardiotonic Agents; Clinical Trials as Topic; Colloids; Crystalloid Solutions; Fluid Therapy; Glucocorticoids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Inflammation; Ischemia; Ischemic Preconditioning; Oxidative Stress; Perioperative Care; Postoperative Complications; Saline Solution
PubMed: 32303280
DOI: 10.1016/j.semnephrol.2020.01.008 -
Pharmaceuticals (Basel, Switzerland) Nov 2023Pain can have a serious impact on a patient's physical, mental, and social health, often causing their quality of life to decline. Various nicotine dosage forms, such as... (Review)
Review
BACKGROUND
Pain can have a serious impact on a patient's physical, mental, and social health, often causing their quality of life to decline. Various nicotine dosage forms, such as nicotine patches and nasal spray, have been developed and used as analgesics in clinical settings. However, there is controversy over the anti-nociceptive effects of nicotine among different clinical trials. The purpose of this meta-analysis is to quantify the analgesic effect of nicotine patches, nicotine nasal spray, and tobacco smoking on pain in humans.
METHODS
Relevant articles published in English prior to July 2023 were identified using the PubMed, Cochrane Library, and Embase online databases in accordance with PRISMA (2020) guidelines. Two reviewers independently screened and selected studies, extracted data, and assessed the quality of the included studies using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). RStudio was used for data synthesis, heterogeneity assessment, sensitivity analysis, publication bias assessment, trim-and-fill analyses, and generating forest plots.
RESULTS
Sixteen eligible articles, including k = 5 studies of pain tolerance ( = 210), k = 5 studies of pain threshold ( = 210), and k = 12 studies of pain scores (N = 1249), were included for meta-analysis. Meta-analytic integration for pain threshold (Hedges' g = 0.28, 95% CI = 0-0.55, Z = 1.99, = 0.05) and pain tolerance (Hedges' g = 0.32, 95% CI = 0.05-0.59, Z = 2.30, = 0.02) revealed that nicotine administered via tobacco smoke generated acute analgesic effects to thermal stimuli. Meta-analytic integration for pain scores revealed that nicotine had a weak anti-nociceptive effect on postoperative pain of -0.37 (95% CI = -0.77 to 0.03, Z = -1.80) but with no statistical significance ( = 0.07). In addition, a limited number of included studies revealed that long-term smoking produced hyperalgesia that may be characterized as small to medium in magnitude (Hedges' g = 0.37, 95% CI = 0.29-0.64, Z = 5.33, < 0.01).
CONCLUSION
These results help to clarify the mixed outcomes of trials and may ultimately inform the treatment of pain. We observed that acute nicotine administration prolonged the laboratory-induced pain threshold and tolerance time and may mildly relieve postoperative pain. In addition, long-term tobacco smoking may have a nociceptive effect on different types of chronic pain. More research is needed to determine the anti-nociceptive effects of nicotine in humans, and to understand the optimal timing, dose, and method of delivery of nicotine.
PubMed: 38139792
DOI: 10.3390/ph16121665