The development of direct extrusion-injection moulded zein matrices as novel oral controlled drug delivery systems

Purpose: To evaluate the potential of zein as a sole excipient for controlled release formulations prepared by hot melt extrusion. Methods: Physical mixtures of zein, water and crystalline paracetamol were hot melt extruded (HME) at 80°C and injection moulded (IM) into caplet forms. HME-IM Caplets were characterised using differential scanning calorimetry, ATR-FTIR spectroscopy, scanning electron microscopy and powder X-ray diffraction. Hydration and drug release kinetics of the caplets were investigated and fitted to a diffusion model. Results: For the formulations with lower drug loadings, the drug was found to be in the non-crystalline state, while for the ones with higher drug loadings paracetamol is mostly crystalline. Release was found to be largely independent of drug loading but strongly dependent upon device dimensions, and predominately governed by a Fickian diffusion mechanism, while the hydration kinetics shows the features of Case II diffusion. Conclusions: In this study a prototype controlled release caplet formulation using zein as the sole excipient was successfully prepared using direct HME-IM processing. The results demonstrated the unique advantage of the hot melt extruded zein formulations on the tuneability of drug release rate by alternating the device dimensions

Defining Smallness for Gestational Age in the Early Years of the Danish Medical Birth Registry

Background: Being born small for gestational age (SGA) is associated with decreased insulin sensitivity and increased blood pressure in childhood, but the association with clinical disease in early adulthood is less certain. The Danish Medical Birth Registry has registered all births in Denmark since 1973, but due to variable data quality, data is most often used only from 1981 onwards, and birth registers in other countries may have similar problems for the early years. We wanted to examine whether the data can be used for identification of children born SGA and used in future research. Methodology/Principal Findings: All persons born between 1974 and 1996 were identified in the Danish Medical Birth Registry (n = 1.704.890). Immigrants and children without data on gestational age and birth weight were excluded, and a total of 1.348.106 children were included in the analysis. The difference between the different variables used in the history of the registry were examined, and the quality of data in the birth registry from 1974-1981 was examined and compared to subsequent years. Data on birth weight and gestational age in the early years of the registry is inconsistent, and the identification of children born SGA is inaccurate, with 49 % false-positives. The biggest source of error is due to the rough and inaccurate intervals used for gestational age. By using –3 standard deviations as a cut-off for the identification of children born SGA, the number of false-positives was reduced to 9%, while the amount of false-negatives were increased. Conclusion: Choosing –3 standard deviations for identifying children born SGA is a viable, though not optimal solution fo

Additional file 1: of Process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to improve neonatal survival in the Quang Ninh province, Vietnam

Study flow of the NeoKIP trial. NMR, neonatal mortality rate. (TIFF 135 kb

Hospital admissions from birth to early adolescence and early-life risk factors: the 11-year follow-up of the 1993 Pelotas (Brazil) birth cohort study

The aim of this prospective analysis was to describe the cumulative incidence of hospital admissions in the first year of life and between 1 and 11 years of age and to explore associated factors. Hospital admissions were collected through regular monitoring in the first year of life, and through maternal report on admissions between 1 and 11 years. Analyses were stratified by sex and adjusted for confounding factors. 18.1% of children were hospitalized in the first year of life, and 30.7% between ages 1 and 11 years. Among boys, hospital admission in the first year was associated with low family income, paternal smoking during pregnancy, preterm delivery, and low birthweight. Among girls, in addition to the variables described for boys, black/mixed skin color was also a risk factor for hospital admission. For admissions between 1 and 11 years of age, low family income and gestational age ≥ 37 weeks were found to be significant risk factors.Com o objetivo de descrever a incidência cumulativa de hospitalizações no primeiro ano de vida e entre 1-11 anos de idade, e identificar fatores de risco precoces, foi realizado um estudo de coorte de nascimento de 1993 a 2004-2005. As hospitalizações foram coletadas por meio de monitoramento hospitalar até 1 ano de idade, e relato das mães sobre internações ocorridas de 1-11 anos. As análises foram estratificadas por sexo e ajustadas para fatores de confusão. Os percentuais de hospitalizações de 0-1 ano e de 1-11 anos foram 18,1% e 30,7%, respectivamente. As variáveis associadas com internações de 0-1 ano em meninos foram: baixa renda familiar, tabagismo paterno na gestação, prematuridade e baixo peso ao nascer. No sexo feminino, além dos fatores de risco descritos entre os meninos, observou-se associação com cor da pele preta/parda. Quanto às hospitalizações de 1-11 anos, no sexo masculino, encontrou-se associação com baixa renda familiar e idade gestacional ≥ 37 semanas