Formulation Design and Pharmaceutical Considerations for Paediatric Patients: Current Status and Future Dimensions

Present day’s conventional pediatrics doses forms are not very attractive towards the children. Due to various reasons such as larger size, bitter taste etc. pediatrics patients rejects the present conventional doses form in many cases. So, there is need for development of some attractive and effective dosage form for children. Present day’s conventional pediatrics doses forms are not very attractive towards the children. Due to various reasons such as larger size, bitter taste etc. pediatrics patients rejects the present conventional doses form in many cases. So there is need for the development of some unconventional dosage forms that proves to be attractive towards the paediatrics populations. This review provides possible advantages and disadvantages of the present conventional dosage forms available for children. Hence present review introduces to various alternatives and unconventional dosage forms viz. effervescent granules / tablets, oral disintegrating tablets and medicated candies and their advantages and disadvantages. Keywords: Effervescent granules, effervescent tab, medicated candy, Oral disintegrating tablet and pediatrics

Formulation and Evaluation of Novel Herbal Formulations Incorporated with Amla Extract for Improved Stability

The objective of the present study was to formulate effervescent and fast dispersible granules by incorporating the fruit extract of Emblica officinalis as an alternate of liquid herbal juices available in market. Amla juice was extracted manually and then subjected to preliminary phytochemical screening which indicates the presence of alkaloids, glycosides, flavonoids, carbohydrates, phenolic compounds, proteins and phytosterols. Lyophilized amla powder was used to formulate effervescent and fast dispersible granules which were further optimized on the basis of concentration of superdisintegrants and effervescent producing agents like croscarmellose sodium, sodium starch glycolate, sodium bicarbonate and citric acid. Powdered formulations were then evaluated on basis of their flow properties like angle of repose, bulk density, tapped density, carr’s index, hausner’s ratio, effervescent cessation time and disintegration time. Among all the effervescent formulations F2 was found to be optimum as it was having least disintegration time of 22 seconds and showed excellent flow properties. In case of the fast dispersible formulations the optimum strength were shown by formulations F9 having croscarmellose with least disintegration time of 52 seconds. Total phenolic content of fresh amla juice were found to be 8.94 mg GAE/100 gm and estimation of ascorbic acid and gallic acid in lyophilized amla powder and developed formulations was carried out by HPTLC. In vitro antioxidant activity of lyophilized amla powder was evaluated by DPPH radical scavenging assay. IC50 value of lyophilized amla powder was found to be 32 ± 0.25 ug/ml calculated in comparison to standard ascorbic acid possessing IC50 value of 25.80 ± 0.2 ug/ml.  Results of present study reveals that developed formulations may serve as alternate product with better quality, consistency and stability in comparison to available herbal liquid formulations. Keywords: Anti-oxidant, Dispersible granules, Effervescent granules, Emblica officinalis

Reduced appropriate implantable cardioverter-defibrillator therapy after cardiac resynchronization therapy-induced left ventricular function recovery: a meta-analysis and systematic review

Aims For patients undergoing cardiac resynchronization therapy (CRT) with implantable cardioverter-defibrillator (ICD; CRT-D), the effect of an improvement in left ventricular ejection fraction (LVEF) on appropriate ICD therapy may have significant implications regarding management at the time of ICD generator replacement. Methods and results We conducted a meta-analysis to determine the effect of LVEF recovery following CRT on the incidence of appropriate ICD therapy. A search of multiple electronic databases identified 709 reports, of which 6 retrospective cohort studies were included (n = 1740). In patients with post-CRT LVEF ≥35% (study n = 4), the pooled estimated rate of ICD therapy (5.5/100 person-years) was significantly lower than patients with post-CRT LVEF <35% [incidence rate difference (IRD): −6.5/100 person-years, 95% confidence interval (95% CI): −8.8 to −4.2, P < 0.001]. Similarly, patients with post-CRT LVEF ≥45% (study n = 4) demonstrated lower estimated rates of ICD therapy (2.3/100 person-years) compared with patients without such recovery (IRD: −5.8/100 person-years, 95% CI: −7.6 to −4.0, P < 0.001). Restricting analysis to studies discounting ICD therapies during LVEF recovery (study n = 3), patients with LVEF recovery (≥35 or ≥45%) had significantly lower rates of ICD therapy compared with patients without such recovery (P for both <0.001). Patients with primary prevention indication for ICD, regardless of LVEF recovery definition, had very low rates of ICD therapy (0.4 to 0.8/100-person years). Conclusion Recovery of LVEF post-CRT is associated with significantly reduced appropriate ICD therapy. Patients with improvement of LVEF ≥45% and those with primary prevention indication for ICD appear to be at lowest ris

and Validation of Hptlc Method for the Simultaneous Estimation of Ascorbic Acid and Gallic Acid in Amla Juice Preparation

The aim of this study was to asses a simple, selective, precise, and reproducible high performance thin-layer chromatography (HPTLC) method for the simultaneous estimation analysis of ascorbic acid (AA) and gallic acid (GA) in amla juice preparation. The aluminium-based pre-coated TLC plates (Silica gel G 60F 254) were used for the HPTLC fingerprinting analysis. The chromatograms of samples were developed in twin trough glass chamber pre-saturated with mobile phase (toluene: ethyl acetate: methanol: formic acid; 3:3:2:1, v/v/v/v) at room temperature (25 ± 2°C). The densitometric analysis was carried out in absorbance mode at 254 nm. The optimized mobile phase showed compact spots of AA and GA at 0.59 and 0.86 Rf respectively. The linear regression analysis data for the calibration plots of AA and GA showed good linearity (r2= 0.992 and 0.996 respectively) with respect to peak area in the range of 200-1400 ng/spot. The method was validated as per International Conference on Harmonization (ICH) guidelines. The limits of detection and quantification (40 and 140 ng/spot, respectively) were also established. The proposed method has shown the excellent recovery (98.97–99.89%), which supports the suitability of the method for the analysis of AA and GA in the amla juice and other preparations containing these ingredients. Keywords: Amla juice, Ascorbic acid, Gallic acid, HPTLC, ICH guidelines, Validation

The Potential Impact on Farmer Health of Enhanced Export Horticultural Trade between the U.K. and Uganda

The export of vegetables from African countries to European markets presents consumers with an ethical dilemma: should they support local, but relatively well-off farmers, or poorer farmers from distant countries? This paper considers the issue of farm worker health in the U.K. and Uganda, and considers the dilemma facing U.K. consumers if Uganda achieves their aim of exporting more vegetables to the U.K. Self-reported health scores of 1,200 farm workers in the U.K. and Uganda were measured with the internationally recognised SF-36 questionnaire and compared to an international population norm. The age-corrected health status of U.K. farm workers was significantly lower than the population norm, whereas Ugandans scored significantly higher (indicating good health) for physical health and lower for mental health. If Ugandan produce enters U.K. markets, then consumers may wish to consider both the potential benefits that enhanced trade could offer Ugandan farmers compared with its impacts on U.K. workers

A Novel Method to Capture the Onset of Dynamic Electrocardiographic Ischemic Changes and its Implications to Arrhythmia Susceptibility

Background: This study investigates the hypothesis that morphologic analysis of intracardiac electrograms provides a sensitive approach to detect acute myocardial infarction or myocardial infarction‐induced arrhythmia susceptibility. Large proportions of irreversible myocardial injury and fatal ventricular tachyarrhythmias occur in the first hour after coronary occlusion; therefore, early detection of acute myocardial infarction may improve clinical outcomes. Methods and Results: We developed a method that uses the wavelet transform to delineate electrocardiographic signals, and we have devised an index to quantify the ischemia‐induced changes in these signals. We recorded body‐surface and intracardiac electrograms at baseline and following myocardial infarction in 24 swine. Statistically significant ischemia‐induced changes after the initiation of occlusion compared with baseline were detectable within 30 seconds in intracardiac left ventricle (P<0.0016) and right ventricle–coronary sinus (P<0.0011) leads, 60 seconds in coronary sinus leads (P<0.0002), 90 seconds in right ventricle leads (P<0.0020), and 360 seconds in body‐surface electrocardiographic signals (P<0.0022). Intracardiac leads exhibited a higher probability of detecting ischemia‐induced changes than body‐surface leads (P<0.0381), and the right ventricle–coronary sinus configuration provided the highest sensitivity (96%). The 24‐hour ECG recordings showed that the ischemic index is statistically significantly increased compared with baseline in lead I, aVR, and all precordial leads (P<0.0388). Finally, we showed that the ischemic index in intracardiac electrograms is significantly increased preceding ventricular tachyarrhythmic events (P<0.0360). Conclusions: We present a novel method that is capable of detecting ischemia‐induced changes in intracardiac electrograms as early as 30 seconds following myocardial infarction or as early as 12 minutes preceding tachyarrhythmic events

Real‐World Disparities in Remote Follow‐Up of Cardiac Implantable Electronic Devices and Impact of the COVID‐19 Pandemic: A Single‐Center Experience

Background Remote monitoring (RM) of cardiac implantable electronic devices has been shown to improve cardiovascular morbidity and mortality. To date, no studies have investigated disparities in use and delivery of RM. This study was performed to investigate if racial and socioeconomic disparities are present in cardiac implantable electronic device RM. Methods and Results This was a retrospective observational cohort study at a single tertiary care center in the United States. Patients who received a newly implanted cardiac implantable electronic device or device upgrade between January 2017 and December 2020 were included. Patients were classified as RM positive (RM+) when they underwent at least ≥2 remote interrogations per year during follow‐up. Of all eligible patients, 2520 patients were included, and 34% were women. The mean follow‐up was 25 months. Mean age was 71±14 years. Pacemakers constituted 66% of implanted devices, whereas 26% were implantable cardioverter‐defibrillators, and 8% were cardiac resynchronization therapy with implantable cardioverter‐defibrillators. Most patients (83%) were of European American ancestry. During follow‐up, 66% of patients were classified as RM+. Patients who were younger, European American, college‐educated, lived in a county with higher median household income, and were active on the hospital's patient portals were more frequently RM+. In an adjusted regression model, RM+ remained associated with the use of the online patient portal (odds ratio [OR], 2.889 [95% CI, 2.387–3.497]), presence of an implantable cardioverter‐defibrillator (OR, 1.489 [95% CI, 1.207–1.835]), advanced college degree (OR, 1.244 [95% CI, 1.014–1.527]), and lastly with European American ancestry (P<0.05). During the years of the COVID‐19 pandemic, the number of RM+ patients increased, whereas the association with ancestry and ethnicity decreased. Conclusions Despite being offered to all patients at implantation, significant disparities were present in cardiovascular implantable electronic device RM in this cohort. Disparities were partly reversed during COVID‐19. Further studies are needed to examine health center‐ and patient‐specific factors to overcome these barriers, and to facilitate equal opportunities to participate in RM