Formulation and Evaluation of Gliclazide Transdermal Drug Delivery Application

Abstract: A novel matrix controlled to release transdermal drug delivery system (TDDS) of GLICLAZIDE was prepared to use different ratios of poly vinyl alcohol (PVA) poly vinyl pyrrollidone (PVP) (3:1, 2:3, 4:1, 1:2, 2:1 and 1:4) by solvent casting (evaporating) method. Physicochemical parameters were characterized and dissolution studies of the formulated films were performed. In addition solubility studies at various pH, thickness test, moisture content test and flatness test were performed. In vitro permeation studies were done using modified Franz diffusion cells through animal skin utilizing in normal saline. Permeation studies were illustrated. Dimethyle sulfoxide (DMSO) was a good chemical enhancered. The prepared films were subjected to SEM, DSC and FT-IR spectral analysis. The present study resulted in optimized formulation

Failed fibreoptic intubation: 70° rigid nasendoscope and Frova introducer to the rescue

Endotracheal intubation was successfully accomplished with 70° rigid nasendoscope under video guidance in two patients in whom repeated attempts to secure airway with flexible fibreoptic bronchoscope were unsuccessful. Both patients had compromised airway (laryngeal papillomatosis and a huge thyroid swelling) and were uncooperative. Frova intubating introducer was used along with 70° rigid nasendoscope to accomplish tracheal intubation under video guidance

Transcriptomic profile of adverse neurodevelopmental outcomes after neonatal encephalopathy

A rapid and early diagnostic test to identify the encephalopathic babies at risk of adverse outcome may accelerate the development of neuroprotectants. We examined if a whole blood transcriptomic signature measured soon after birth, predicts adverse neurodevelopmental outcome eighteen months after neonatal encephalopathy. We performed next generation sequencing on whole blood ribonucleic acid obtained within six hours of birth from the first 47 encephalopathic babies recruited to the Hypothermia for Encephalopathy in Low and middle-income countries (HELIX) trial. Two infants with blood culture positive sepsis were excluded, and the data from remaining 45 were analysed. A total of 855 genes were significantly differentially expressed between the good and adverse outcome groups, of which RGS1 and SMC4 were the most significant. Biological pathway analysis adjusted for gender, trial randomisation allocation (cooling therapy versus usual care) and estimated blood leukocyte proportions revealed over-representation of genes from pathways related to melatonin and polo-like kinase in babies with adverse outcome. These preliminary data suggest that transcriptomic profiling may be a promising tool for rapid risk stratification in neonatal encephalopathy. It may provide insights into biological mechanisms and identify novel therapeutic targets for neuroprotection

Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh

Introduction Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.Methods Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.Results A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.Conclusion Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation

Additional file 4: of Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial

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