Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics

This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets) as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity. The variables selected were mannitol percent in Avicel (X1), swelling pressure of the superdisintegrant (X2), and the surface area of Aerosil as a glidant (X3). Risperidone-excipient compatibilities were investigated using FTIR and the spectra did not display any interaction. Fifteen formulations were prepared and evaluated for pre- and post-compression characteristics. The prepared OD-mini-tablet batches were also assessed for disintegration in simulated salivary fluid (SSF, pH 6.2) and in reconstituted skimmed milk. The optimized formula fulfilled the requirements for crushing strength of 5 kN with minimal friability, disintegration times of 8.4 and 53.7 s in SSF and skimmed milk, respectively. This study therefore proposes risperidone OD-mini-tablet formula having robust mechanical properties, uniform and precise dosing of medication with short disintegration time suitable for pediatric use

Development and optimization of fluoxetine orally disintegrating tablets using Box-Behnken design

Purpose: To develop and optimise some variables that influence fluoxetine orally disintegrating tablets (ODTs) formulation.Methods: Fluoxetine ODTs tablets were prepared using direct compression method. Three-factor, 3- level Box-Behnken design was used to optimize and develop fluoxetine ODT formulation. The design suggested 15 formulations of different lubricant concentration (X1), lubricant mixing time (X2), and compression force (X3) and then their effect was monitored on tablet weight (Y1), thickness (Y2), hardness (Y3), % friability (Y4), and disintegration time (Y5).Results: All powder blends showed acceptable flow properties, ranging from good to excellent. The disintegration time (Y5) was affected directly by lubricant concentration (X1). Lubricant mixing time (X2) had a direct effect on tablet thickness (Y2) and hardness (Y3), while compression force (X3) had a direct impact on tablet hardness (Y3), % friability (Y4) and disintegration time (Y5). Accordingly, Box-Behnken design suggested an optimized formula of 0.86 mg (X1), 15.3 min (X2), and 10.6 KN (X3). Finally, the prediction error percentage responses of Y1, Y2, Y3, Y4, and Y5 were 0.31, 0.52, 2.13, 3.92 and 3.75 %, respectively. Formula 4 and 8 achieved 90 % of drug release within the first 5 min of dissolution test.Conclusion: Fluoxetine ODT formulation has been developed and optimized successfully using Box- Behnken design and has also been manufactured efficiently using direct compression technique.Keywords: Box-Behnken experimental design, Orally disintegrating tablets, Direct compression, Antidepressant, Magnesium stearate, Mixing tim

The Liquisolid technique: an overview

A novel "Powder Solution Technology" involves absorption and adsorption efficiency which makes use of liquid medications, drug suspensions admixed with suitable carriers, coating materials and formulated into free flowing, dry looking, non adherent and compressible powder forms. Based upon a new mathematical model expression, improved flow characteristics and hardness of the formulation has been achieved by changing the proportion of Avicel ® PH 200 and Aerosil ® PH 200 from 50:1 ratio to 5:1 and in which the drug is dispersed in an almost molecularly state. Due to their significantly improved wetting properties a greater drug surface area is exposed to the dissolution media, resulting in an increased dissolution rate and bio availability. By using the Liquisolid technique, sustained drug delivery systems were developed for the water soluble drugs in which hydrophobic non-volatile solvents are used as vehicles.A nova "Tecnologia da Solução Sólida" envolve eficiência de absorção e de adsorção, faz uso de medicações líquidas, suspensões de fármacos e misturas com transportadores adequados, materiais de cobertura e é formulada em formas sólidas em fluxo livre, secas, não aderentes e compressíveis. Com base em novo modelo matemático, características aprimoradas de fluxo e dureza da formulação foram alcançadas modificando-se a proporção de Avicel ® PH 200 e Aerosil ® PH 200 de 50:1 para 5:1, na qual o fármaco é disperso quase que no estado molecular. Devido às propriedades de umidificação significativamente aprimoradas e à área do fármaco exposta ao meio de dissolução, que resulta na velocidade de dissolução, a biodisponibilidade foi aumentada. Utilizando a técnica Liquisólido, desenvolveram-se sistemas de liberação controlada de fármacos solúveis em água, nos quais solventes hidrofóbicos não voláteis foram usados como veículos

'What gets measured gets managed': revisiting the indicators for maternal and newborn health programmes.

BACKGROUND: The health of women and children are critical for global development. The Sustainable Development Goals (SDG) agenda and the Global Strategy for Women's, Children's, and Adolescent's Health 2016-2030 aim to reduce maternal and newborn deaths, disability, and enhancement of well-being. However, information and data on measuring countries' progress are limited given the variety of methodological challenges of measuring care around the time of birth, when most maternal and neonatal deaths and morbidities occur. MAIN BODY: In 2015, the World Health Organization launched Mother and Newborn Information for Tracking Outcomes and Results (MoNITOR), a technical advisory group to WHO. MoNITOR comprises 14 independent global experts from a variety of disciplines selected in a competitive process for their technical expertise and regional representation. MoNITOR will provide technical guidance to WHO to ensure harmonized guidance, messages, and tools so that countries can collect useful data to track progress toward achieving the Sustainable Development Goals. SHORT CONCLUSION: Ultimately, MoNITOR will provide technical guidance to WHO to ensure harmonized guidance, messages, and tools so that countries can collect useful data to track progress toward achieving the Sustainable Development Goals

Treatment of hypertension in rural Cambodia: results of a 6-year programme

This study was aimed to describe the outcomes of a hypertension treatment programme in two outpatient clinics in Cambodia. We determined proportions of patients who met the optimal targets for blood pressure (BP) control and assessed the evolution of mean systolic and diastolic BP (SBP/DBP) over time. Multivariate analyses were used to identify predictors of BP decrease and risk factors for LTFU. A total of 2858 patients were enrolled between March 2002 and June 2008 of whom 69.2% were female, 30.5% were aged >/=64years and 32.6% were diabetic. The median follow-up time was 600 days. By the end of 2008, 1642 (57.4%) were alive-in-care, 8 (0.3%) had died and 1208 (42.3%) were lost to follow-up. On admission, mean SBP and DBP were 162 and 94 mm Hg, respectively. Among the patients treated, a significant SBP reduction of 26.8 mm Hg (95% CI: 28.4-25.3) was observed at 6 months. Overall, 36.5% of patients reached the BP targets at 24 months. The number of young adults, non-overweight patients and non-diabetics reaching the BP targets was more. Older age (>64 years), uncontrolled DBP (>/=90 mm Hg) on last consultation and coming late for the last consultation were associated with LTFU, whereas non-diabetic patients were 1.5 times more likely to default than diabetics (95% CI: 1.3-1.7). Although the definite magnitude of the BP decrease due to antihypertension medication over time cannot be assessed definitely without a control group, our results suggest that BP reduction can be obtained with essential hypertension treatment in a large-scale programme in a resource-limited setting

'What gets measured gets managed': revisiting the indicators for maternal and newborn health programmes

BACKGROUND: The health of women and children are critical for global development. The Sustainable Development Goals (SDG) agenda and the Global Strategy for Women’s, Children’s, and Adolescent’s Health 2016–2030 aim to reduce maternal and newborn deaths, disability, and enhancement of well-being. However, information and data on measuring countries’ progress are limited given the variety of methodological challenges of measuring care around the time of birth, when most maternal and neonatal deaths and morbidities occur. MAIN BODY: In 2015, the World Health Organization launched Mother and Newborn Information for Tracking Outcomes and Results (MoNITOR), a technical advisory group to WHO. MoNITOR comprises 14 independent global experts from a variety of disciplines selected in a competitive process for their technical expertise and regional representation. MoNITOR will provide technical guidance to WHO to ensure harmonized guidance, messages, and tools so that countries can collect useful data to track progress toward achieving the Sustainable Development Goals. SHORT CONCLUSION: Ultimately, MoNITOR will provide technical guidance to WHO to ensure harmonized guidance, messages, and tools so that countries can collect useful data to track progress toward achieving the Sustainable Development Goals

Measures matter: A scoping review of maternal and newborn indicators.

BACKGROUND: A variety of global-level monitoring initiatives have recommended indicators for tracking progress in maternal and newborn health. As a first step supporting the work of WHO's Mother and Newborn Information for Tracking Outcomes and Results (MoNITOR) Technical Advisory Group, we aimed to compile and synthesize recommended indicators in order to document the landscape of maternal and newborn measurement and monitoring. METHODS: We conducted a scoping review of indicators proposed by global multi-stakeholder groups to suggest next steps to further support maternal and newborn measurement and monitoring. Indicators pertaining to pregnancy, childbirth, and postpartum/postnatal and newborn care were extracted and included in the indicator compilation, together with key indicator metadata. We examined patterns and relationships across the compiled indicators. RESULTS: We identified 140 indicators linked to maternal and newborn health topics across the continuum of service provision. Fifty-five indicators relate to inputs and processes, 30 indicators relate to outputs, outcomes comprise 37 indicators in the database, and 18 impact indicators. A quarter of indicators proposed by global groups is either under development/discussion or is considered "aspirational", highlighting the currently evolving monitoring landscape. Although considerable efforts have been made to harmonize indicator recommendations, there are still relatively few indicators shared across key monitoring initiatives and some of those that are shared may have definitional variation. CONCLUSION: Rapid, wide-ranging work by a number of multi-stakeholder groups has resulted in a substantial number of indicators, many of which partially overlap and many are not supported with adequate documentation or guidance. The volume of indicators, coupled with the number of initiatives promoting different indicator lists, highlight the need for strengthened coordination and technical leadership to harmonize recommendations for improved measurement and monitoring of data related to maternal and newborn heath

Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes

Background: While maternal, infant and under-five child mortality rates in developing countries have declined significantly in the past two to three decades, newborn mortality rates have reduced much more slowly. While it is recognised that almost half of the newborn deaths can be prevented by scaling up evidence-based available interventions such as tetanus toxoid immunisation to mothers, clean and skilled care at delivery, newborn resuscitation, exclusive breastfeeding, clean umbilical cord care, management of infections in newborns, many require facility based and outreach services. It has also been stated that a significant proportion of these mortalities and morbidities could also be potentially addressed by developing community-based packages interventions which should also be supplemented by developing and strengthening linkages with the local health systems. Some of the recent community-based studies of interventions targeting women of reproductive age have shown variable impacts on maternal outcomes and hence it is uncertain if these strategies have consistent benefit across the continuum of maternal and newborn care.Objectives: To assess the effectiveness of community-based intervention packages in reducing maternal and neonatal morbidity and mortality, and improving neonatal outcomes.Search strategy: We searched The Cochrane Pregnancy and Childbirth Group\u27s Trials Register (January 2010), World Bank\u27s JOLIS (12 January 2010), BLDS at IDS and IDEAS database of unpublished working papers (12 January 2010), Google and Google Scholar (12 January 2010). Selection criteria: All prospective randomised and quasi-experimental trials evaluating the effectiveness of community-based intervention packages in reducing maternal and neonatal mortality and morbidities, and improving neonatal outcomes.Data collection and analysis: Two review authors independently assessed trial quality and extracted the data.Main results:The review included 18 cluster-randomised/quasi-randomised trials, covering a wide range of interventional packages, including two subsets from one trial. We incorporated data from these trials using generic inverse variance method in which logarithms of risk ratio estimates were used along with the standard error of the logarithms of risk ratio estimates. Our review did not show any reduction in maternal mortality (risk ratio (RR) 0.77, 95% confidence interval (CI) 0.59 to 1.02, random-effects (10 studies, n = 144,956), I(2) 39%, P value 0.10. However, significant reduction was observed in maternal morbidity (RR 0.75, 95% CI 0.61 to 0.92, random-effects (four studies, n = 138,290), I(2) 28%, neonatal mortality (RR 0.76, 95% CI 0.68 to 0.84, random-effects (12 studies, n = 136,425), I(2) 69%, P value \u3c 0.001), stillbirths (RR 0.84, 95% CI 0.74 to 0.97, random-effects (11studies, n = 113,821), I(2) 66%, P value 0.001) and perinatal mortality (RR 0.80, 95% CI 0.71 to 0.91, random-effects (10 studies, n = 110,291), I(2) 82%, P value \u3c 0.001) as a consequence of implementation of community-based interventional care packages. It also increased the referrals to health facility for pregnancy related complication by 40% (RR 1.40, 95% CI 1.19 to 1.65, fixed-effect (two studies, n = 22,800), I(2) 0%, P value 0.76), and improved the rates of early breastfeeding by 94% (RR 1.94, 95% CI 1.56 to 2.42, random-effects (six studies, n = 20,627), I(2) 97%, P value \u3c 0.001). We assessed our primary outcomes for publication bias, but observed no such asymmetry on the funnel plot.Authors\u27Conclusion:Our review offers encouraging evidence of the value of integrating maternal and newborn care in community settings through a range of interventions which can be packaged effectively for delivery through a range of community health workers and health promotion groups. While the importance of skilled delivery and facility-based services for maternal and newborn care cannot be denied, there is sufficient evidence to scale up community-based care through packages which can be delivered by a range of community-based workers

A cross-national study on the antecedents of work–life balance from the fit and balance perspective

Drawing on the perceived work–family fit and balance perspective, this study investigates demands and resources as antecedents of work–life balance (WLB) across four countries (New Zealand, France, Italy and Spain), so as to provide empirical cross-national evidence. Using structural equation modelling analysis on a sample of 870 full time employees, we found that work demands, hours worked and family demands were negatively related to WLB, while job autonomy and supervisor support were positively related to WLB. We also found evidence that resources (job autonomy and supervisor support) moderated the relationships between demands and work–life balance, with high resources consistently buffering any detrimental influence of demands on WLB. Furthermore, our study identified additional predictors of WLB that were unique to some national contexts. For example, in France and Italy, overtime hours worked were negatively associated with WLB, while parental status was positively associated with WLB. Overall, the implications for theory and practice are discussed.Peer ReviewedPostprint (author's final draft