-
Turkish Journal of Pharmaceutical... Jan 2024Post-marketing/surveillance studies show that most of the many vegetable oils that are sold with health-promoting claims or statements with high nutritional values and...
OBJECTIVES
Post-marketing/surveillance studies show that most of the many vegetable oils that are sold with health-promoting claims or statements with high nutritional values and are beneficial against diseases are off-limits of related monographs/criteria. Defining the oil with a fast, cheap, and efficient analytical method is needed to express fatty acids in any herbal product to authenticate, trace, specify, and classify the content.The majority of the after marketing/surveillance studies shows that most of the many vegetable oils that are sold with health-promoting claims or statements with high nutritional values and are beneficial against diseases are off-limits of related monographs/criteria. Defining the oil with fast, cheap and efficient analytical method to express fatty acids in any herbal product, to authenticate, trace, specify and classify the content is needed.
MATERIALS AND METHODS
Here, we define a new simple tool with a headspace single drop microextraction (HS-SDME) method coupled with a gas chromatography-flame ionization detector (GC-FID) for the analysis of common fatty acids (FAs) in oils. Linolenic acid, γ-linolenic acid, and linoleic acid in olive oil, thyme oil, and fish oil were determined. Derivatization was performed with 0.2 mL of 2 mol/L KOH in methanol to transfer the FAs of oils into their methyl esters (FAMEs). Then, FAMEs were extracted using a head space single drop, which is 2.0 μL of sodium dodecyl sulfate:1-butanol (1:3, ) mixture.
RESULTS
The most suitable extraction condition was that 360 μL of the FAMEs, 2.0 mL vial, 0.07 g NaCl as a salting-out effect, 45 °C extraction temperature, and 35 min extraction time. The precision of the method was below 12%, with accuracy validated by the GC-FID reference method.The most suitable extraction condition was that 360 μL of the fatty acid methyl esters (FAMEs), 2.0 mL vial, 0.07 g NaCl as a salting-out effect, 45 °C extraction temperature, and 35 min extraction time. The precision of the method was below 12% with an accuracy validated by the GC-FID reference method.
CONCLUSION
The HS-SDME can be used effectively for extracting FAs from oils for improved analysis of other FAs. The method is of direct importance and relevance for the herbal, pharmaceutical, and cosmetics industries.The HS-SDME can be used for effectively for extracting fatty acids from oils for improved analysis of other fatty acids while the method is direct importance and relevance for herbal, pharmaceutical, cosmetics industry.
PubMed: 38257845
DOI: 10.4274/tjps.galenos.2023.63494 -
Research and Practice in Thrombosis and... Mar 2024Tranexamic acid is safe and effective for the treatment of heavy vaginal bleeding during menstruation and childbirth. It improves the quality of life, facilitates...
Tranexamic acid is safe and effective for the treatment of heavy vaginal bleeding during menstruation and childbirth. It improves the quality of life, facilitates participation in school and work, and reduces the risk of death from postpartum hemorrhage. Despite its well-established benefits, individual- and structural-level barriers preclude its widespread utilization, hindering effective patient care and perpetuating health inequities in women's health. We first describe the evidence for the use of tranexamic acid in treating heavy menstrual bleeding and postpartum hemorrhage. Barriers to tranexamic acid use, including structural sexism, period poverty, misinformation in product monograph labeling, stigmatization of vaginal blood loss, and drug access, are then discussed. Finally, we summarize relevant data presented during the 2023 International Society on Thrombosis and Haemostasis Congress.
PubMed: 38623473
DOI: 10.1016/j.rpth.2024.102389 -
Journal of Family & Community Medicine 2024The preparticipation physical evaluation (PPE) monograph is a vital resource for medical providers aimed at ensuring the safety and well-being of athletes during sports...
BACKGROUND
The preparticipation physical evaluation (PPE) monograph is a vital resource for medical providers aimed at ensuring the safety and well-being of athletes during sports participation by screening for injuries and disease risk factors. However, the concept of PPE is relatively new in Saudi Arabia, where primary care physicians (PCPs) often lack the proper training for it. This study's aim was to assess PCPs' knowledge and practice of PPE and identify associated factors.
MATERIALS AND METHODS
A self-administrated web-based questionnaire was distributed to PCPs in the Eastern Province of Saudi Arabia. The questionnaire covered the various aspects of PPE knowledge (including general principles, components, contraindications of sports participation, concerning history and physical findings, electrocardiography interpretations, and ethical considerations) as well as PPE practice. Initial treatment of data included descriptive statistics.; Chi-square tes or Fisher's exact test as, as appropriate, were used to determine association of knowledge and practices with various independent variables.
RESULTS
Of the 240 contacted PCPs, 192 responded yielding a response rate of 80%; 50.5% had no prior PPE training. About 43% of the PCPs had not encountered PPE during their examination, but the remainder performed monthly PPE. Notably, 82.8% demonstrated a poor level of knowledge regarding PPE and only 43% had a satisfactory level of practice.
CONCLUSION
This study revealed that a significant proportion of PCPs displayed poor knowledge of PPE and <½ of our sample showed satisfactory practice levels. Recommendations to establish the local guidelines regarding PPE for PCPs to follow should be emphasized and PPE training integrated into both undergraduate and postgraduate family medicine curricula. These measures are crucial for the enhancement of the safety of athletes in Saudi Arabia.
PubMed: 38406221
DOI: 10.4103/jfcm.jfcm_154_23 -
BMC Medical Research Methodology Feb 2024People with dementia are routinely included as research participants in trials and other quantitative studies in which they are invited to respond to standardised...
BACKGROUND
People with dementia are routinely included as research participants in trials and other quantitative studies in which they are invited to respond to standardised measures. This paper reviews the reporting of standardised data collection from people with dementia in reports published in the National Institute for Health and Care Research (NIHR) Journals Library. The aim was to understand how the administration of standardised, self-report measures with people with dementia is reported in NIHR monographs and what could be learnt from this about the feasibility and acceptability of data collection approaches for future studies.
METHODS
This was a systematic review with narrative synthesis. Broad search terms (Dementia OR Alzheimer*) were used to search the NIHR Journals Library website in December 2021. All studies that used (or intended to use) standardised measures to collect research data directly from people with dementia were eligible for inclusion. Information was extracted (where reported) on the process of data collection, dementia severity, levels of missing data and the experiences and reflections of those involved.
RESULTS
Searches returned 42 records, from which 17 reports were assessed as eligible for inclusion, containing 22 studies. Response rates from participants with dementia in these studies varied considerably and appeared to be related to dementia severity and place of residence. Little information was reported on the process of data collection or the reasons for missing data, and most studies did not report the experiences of participants or those administering the measures. However, there was an indication from two studies that standardised data collection could provoke emotional distress in some participants with dementia.
CONCLUSIONS
Through this review we identified both variation in levels of missing data and gaps in reporting which make it difficult to ascertain the reasons for this variation. We also identified potential risks to the well-being of participants with dementia which may be associated with the content of standardised measures and the context of data collection. Open reporting of and reflection upon data collection processes and the experiences of people involved is essential to ensure both the success of future data collection and the wellbeing of study participants.
TRIAL REGISTRATION
Registered with Research on Research https://ror-hub.org/study/2905/ .
Topics: Humans; Data Collection; Narration; Dementia
PubMed: 38365600
DOI: 10.1186/s12874-024-02148-y -
Pharmaceuticals (Basel, Switzerland) Apr 2024In the present work, an efficient isocratic HPLC method was developed for the precise and accurate estimation of vitamin D in tablet form. The chromatographic conditions...
In the present work, an efficient isocratic HPLC method was developed for the precise and accurate estimation of vitamin D in tablet form. The chromatographic conditions comprised an L3 silica column (5 µm in particle size, 4.6 mm × 250 mm) with a mobile phase n-hexane/ethyl acetate (85:15 /) with a flow rate of 2.0 mL/min and a detection wavelength of 292 nm. The new methodology was validated for accuracy, precision, specificity, robustness, and quantification limits according to an official monograph of USP/BP and ICH guidelines. The peak areas of the six replicates of the homogeneous sample were recorded. The mean value obtained was 67,301, and the relative standard deviation (RSD) was 0.1741. The linearity and range were in the acceptable bounds, i.e., 0.999, which was calculated using regression line analysis. The results show that the method is truly acceptable as the RSD, as the flow rate was 0.81%, while for the mobile phase composition, it was 0.72%, which lies in the acceptable range. The limit of detection (LOD) and the limit of quantification (LOQ) values were 0.0539 µg/mL and 0.1633 µg/mL, respectively. The % RSD of the intra and inter-day precision of the method was deemed acceptable according to the international commission for harmonization guidelines. The developed method has potential to be used for the detection and quantification of vitamin D during routine analysis for tablets in dosage form.
PubMed: 38675464
DOI: 10.3390/ph17040505 -
Plants (Basel, Switzerland) Dec 2023Climate change is one of the most prominent factors influencing the spatial distribution of plants in China, including gymnosperms. Climatic factors influence gymnosperm...
Distribution Patterns of Gymnosperm Species along Elevations on the Qinghai-Tibet Plateau: Effects of Climatic Seasonality, Energy-Water, and Physical Tolerance Variables.
Climate change is one of the most prominent factors influencing the spatial distribution of plants in China, including gymnosperms. Climatic factors influence gymnosperm distribution along elevational gradients on the Qinghai-Xizang (Tibet) Plateau (QTP), and understanding how species adapt to these factors is important for identifying the impacts of global climate change. For the first time, we examined the county-level distribution of gymnosperm species on QTP using data from field surveys, published works, monographs, and internet sources. We used simulated distribution data of gymnosperms (N = 79) along the elevational gradients to investigate the overall impact of environmental variables in explaining the richness pattern of gymnosperms. Eighteen environmental variables were classified into three key variable sets (climatic seasonality, energy-water, and physical tolerance). We employed principal component analysis and generalized linear models to assess the impact of climatic variables on the gymnosperm's richness pattern. Gymnosperm species are unevenly distributed across the plateau and decline gradually from the southeast to the northwest. The altitudinal gradients have a unimodal relationship with the richness of gymnosperms, with the maximum species richness at an elevation of 3200 m. The joint effects of physical tolerance and energy-water predictors have explained the highest diversity of gymnosperms at mid-elevation. Because the richness peak correlates significantly with the wettest month's precipitation and moisture index, this confirms the significance of moisture on gymnosperm distributions due to increased precipitation during the wet season. Furthermore, our results provide evidence that climatic seasonality factors are involved in the decline of gymnosperm richness at high elevations. A total of 37% of gymnosperm species on QTP are listed as vulnerable, nearly threatened, or endangered, with elevations ranging from 600 m to 5300 m. As a result, we conclude that gymnosperms are at high risk of extinction because of the current climate fluctuations caused by global climate change. Our research offers fundamental data for the study and protection of gymnosperm species along the steepest elevation gradients.
PubMed: 38068701
DOI: 10.3390/plants12234066 -
SAGE Open Medicine 2024Impact of drug wastage is a legitimate and persistent concern. Financial impact of drug waste is borne by the hospital network, patients, and healthcare systems....
BACKGROUND
Impact of drug wastage is a legitimate and persistent concern. Financial impact of drug waste is borne by the hospital network, patients, and healthcare systems. Measures to reduce drug wastage may have a positive impact throughout healthcare systems.
OBJECTIVE
This study investigated the stability and sterility of single-dose vials when repeatedly accessed with a closed system transfer device. By evaluating the sterility and stability, these results may be used to validate the extension of vial usage and lead to potential drug wastage reduction.
METHODS
Sterility testing was performed in accordance with US Pharmacopeia 71. A closed system transfer device was incorporated into simulated compounding tasks, utilizing growth media. Simulated compounding tasks were performed in the clinical environment, followed by incubation to stimulate growth. Stability testing was performed in accordance with US Pharmacopeia monographs at multiple timepoints post access. Test samples were comparatively tested via high-performance liquid chromatography to freshly opened vials at each timepoint.
RESULTS
No growth was observed in test samples. Control vials displayed growth, where appropriate. The drugs retained stability, when compared to freshly opened vials at 0, 24, 48, and 72 h, post access.
CONCLUSIONS
This study confirms that closed system transfer devices do not contribute to microbial contamination of drug vials, following the repeated access, for up to 7 days and the tested drugs retained equivalent chemical stability for up to 72 h post access. This study may offer a manner by which a facility may assess single-dose vials' sterility and stability, following repeated access by a closed system transfer device.
PubMed: 38414830
DOI: 10.1177/20503121241230449 -
Environment International Mar 2024The World Health Organization is coordinating an international project aimed at systematically reviewing the evidence regarding the association between radiofrequency... (Meta-Analysis)
Meta-Analysis
Effects of radiofrequency electromagnetic field (RF-EMF) exposure on male fertility: A systematic review of experimental studies on non-human mammals and human sperm in vitro.
BACKGROUND
The World Health Organization is coordinating an international project aimed at systematically reviewing the evidence regarding the association between radiofrequency electromagnetic field (RF-EMF) exposure and adverse health effects. Reproductive health outcomes have been identified among the priority topics to be addressed.
OBJECTIVES
To evaluate the effect of RF-EMF exposure on male fertility of experimental mammals and on human sperm exposed in vitro.
METHODS
Three electronic databases (PubMed, Scopus and EMF Portal) were last searched on September 17, 2022. Two independent reviewers screened the studies, which were considered eligible if met the following criteria: 1) Peer-reviewed publications of sham controlled experimental studies, 2) Non-human male mammals exposed at any stage of development or human sperm exposed in vitro, 3) RF-EMF exposure within the frequency range of 100 kHz-300 GHz, including electromagnetic pulses (EMP), 4) one of the following indicators of reproductive system impairment:Two reviewers extracted study characteristics and outcome data. We assessed risk of bias (RoB) using the Office of Health Assessment and Translation (OHAT) guidelines. We categorized studies into 3 levels of overall RoB: low, some or high concern. We pooled study results in a random effects meta-analysis comparing average exposure to no-exposure and in a dose-response meta-analysis using all exposure doses. For experimental animal studies, we conducted subgroup analyses for species, Specific Absorption Rate (SAR) and temperature increase. We grouped studies on human sperm exposed in vitro by the fertility status of sample donors and SAR. We assessed the certainty of the evidence using the GRADE approach after excluding studies that were rated as "high concern" for RoB.
RESULTS
One-hundred and seventeen papers on animal studies and 10 papers on human sperm exposed in vitro were included in this review. Only few studies were rated as "low concern" because most studies were at RoB for exposure and/or outcome assessment. Subgrouping the experimental animal studies by species, SAR, and temperature increase partly accounted for the heterogeneity of individual studies in about one third of the meta-analyses. In no case was it possible to conduct a subgroup analysis of the few human sperm in vitro studies because there were always 1 or more groups including less than 3 studies. Among all the considered endpoints, the meta-analyses of animal studies provided evidence of adverse effects of RF-EMF exposure in all cases but the rate of infertile males and the size of the sired litters. The assessment of certainty according to the GRADE methodology assigned a moderate certainty to the reduction of pregnancy rate and to the evidence of no-effect on litter size, a low certainty to the reduction of sperm count, and a very low certainty to all the other meta-analysis results. Studies on human sperm exposed in vitro indicated a small detrimental effect of RF-EMF exposure on vitality and no-effect on DNA/chromatin alterations. According to GRADE, a very low certainty was attributed to these results. The few studies that used EMP exposure did not show effects on the outcomes. A low to very low certainty was attributed to these results.
DISCUSSION
Many of the studies examined suffered of severe limitations that led to the attribution of uncertainty to the results of the meta-analyses and did not allow to draw firm conclusions on most of the endpoints. Nevertheless, the associations between RF-EMF exposure and decrease of pregnancy rate and sperm count, to which moderate and low certainty were attributed, are not negligible, also in view of the indications that in Western countries human male fertility potential seems to be progressively declining. It was beyond the scope of our systematic review to determine the shape of the dose-response relationship or to identify a minimum effective exposure level. The subgroup and the dose-response fitting analyses did not show a consistent relationship between the exposure levels and the observed effects. Notably, most studies evaluated RF-EMF exposure levels that were higher than the levels to which human populations are typically exposed, and the limits set in international guidelines. For these reasons we cannot provide suggestions to confirm or reconsider current human exposure limits. Considering the outcomes of this systematic review and taking into account the limitations found in several of the studies, we suggest that further investigations with better characterization of exposure and dosimetry including several exposure levels and blinded outcome assessment were conducted.
PROTOCOL REGISTRATION
Protocols for the systematic reviews of animal studies and of human sperm in vitro studies were published in Pacchierotti et al., 2021. The former was also registered in PROSPERO (CRD42021227729 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID = 227729) and the latter in Open Science Framework (OSF Registration DOI https://doi.org/10.17605/OSF.IO/7MUS3).
Topics: Animals; Humans; Male; Electromagnetic Fields; Mammals; Radio Waves; Reproduction; Semen; Infertility, Male
PubMed: 38492496
DOI: 10.1016/j.envint.2024.108509 -
The Journal of Antimicrobial... Jul 2024The quality of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets was evaluated to determine whether there is any difference in quality when... (Comparative Study)
Comparative Study
OBJECTIVES
The quality of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets was evaluated to determine whether there is any difference in quality when comparing the country of origin. This was undertaken because it has been claimed that antibiotics manufactured in Europe are of superior quality to those originating from Africa or Asia.
METHODS
Samples of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets were collected from three randomly selected wholesale pharmacies in each city, namely Arusha, Dar es Salaam and Mwanza, Tanzania. The collected samples of collected brands were subjected to quality control testing as per their respective pharmacopoeial monographs. Amoxil 250 mg capsules (Glaxo Wellcome, Mayenne, France), Rocephin (Roche, Switzerland) and Cipro-Denk 500 (Allphamed Pharbil Arzneimittel GmbH, Gottingen, Germany) were used as reference brands for the other generic brands of amoxicillin, ceftriaxone and ciprofloxacin, respectively.
RESULTS
A total of 31 brands (10 different brands of amoxicillin capsules, 9 of ceftriaxone sodium injections, and 12 of ciprofloxacin tablets) were collected from the targeted regions and subjected to quality control testing. All samples of collected brands complied with the requirements of their respective pharmacopoeial monographs.
CONCLUSIONS
There was no significant difference in quality between brands of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets manufactured in Africa and Asia against those manufactured in Europe in terms of compliance with the respective pharmacopoeial monographs.
Topics: Tanzania; Anti-Bacterial Agents; Ciprofloxacin; Quality Control; Humans; Ceftriaxone; Amoxicillin; Tablets
PubMed: 38804149
DOI: 10.1093/jac/dkae155 -
Planta Medica May 2024"Children are not small adults with respect to the treatment with medicinal products." This statement of the WHO was the basis for the initiative of the European...
"Children are not small adults with respect to the treatment with medicinal products." This statement of the WHO was the basis for the initiative of the European Commission for the establishment of a paediatric regulation in 2007 to improve the health of children by facilitating the development of medicines for children and adolescents. Seventeen years later, in the field of herbal medicinal products, results are still sobering. Therefore, the Foundation Plants for Health, Society for Medicinal Plants and Natural Products Research, and German Society for Phytotherapy organised a symposium to assess the status quo for the paediatric use of herbal medicinal products (HMPs), to analyse the causes of the current situation, and to discuss strategies for establishing the proof of safe and efficacious HMPs for children.The current situation for HMPs and their use in children is not fulfilling the requirements of legislation. HMPs in paediatrics are effective and safe, but considering the needs of children is necessary. In European countries, the use, registration, and marketing of HMPs are different, depending on the respective national regulations and specific traditions. EU herbal monographs are the best common denominator for such procedures. Emerging safety discussions must be considered. New approaches with real-world data might be a solution. The regulatory framework is to be adapted. Defining rationalised dosing for HMPs can be achieved by the extrapolation of data from adults, by using existing clinical data for children, and by using RWD. Therefore, a strong need for revising restrictions for the use of HMPs in children and rationalising defined dosage regimes is obvious.
Topics: Humans; Child; Phytotherapy; Plants, Medicinal; Adolescent; Plant Preparations
PubMed: 38527490
DOI: 10.1055/a-2294-5259