Impact of lubrication on key properties of orodispersible minitablets in comparison to conventionally sized orodispersible tablets.

Orodispersible minitablets (ODMTs) offer several benefits like easy swallowability, dose flexibility and simple manufacturing through direct compression. In this study, the effect of lubrication on five different co-processed excipients (Ludiflash®, Parteck® ODT, Prosolv® ODT G2, galenIQ™ 721 and SuperTab® 50 ODT) has been studied for orodispersible tablets (ODTs) with 11.28 and 2 mm in diameter. External lubrication was compared with internal lubrication using 0.5 %, 1 % or 2 % magnesium stearate or 1 %, 2 % or 4 % sodium stearyl fumarate. Mechanical strength and disintegration time of the ODTs were evaluated beside the lubrication efficiency. Especially mannitol-based co-processed excipients show strong dependency of the lubricant concentration whereas both ODTs and ODMTs and minitablets with isomalt showed comparable properties for both lubricants and their concentrations. Sodium stearyl fumarate is considered as the preferred lubricant for ODMTs as it showed a higher lubrication efficiency and less negative impact on disintegration time. External lubrication exhibited higher tensile strength for plastic materials, but increased the disintegration time, particularly for ODMTs due to the high specific surface where the lubricant is applied. In general, this study has demonstrated that minitablets require higher lubricant concentrations than conventionally sized tablets.

Secondhand smoke exposure and endothelial stress in children and adolescents.

OBJECTIVE: Links between secondhand smoke exposure and cardiovascular disease in adults are well established. Little is known about the impact of this exposure on cardiovascular status during childhood. The purpose of this study was to investigate relationships between secondhand smoke exposure in children and adolescents and cardiovascular disease risk--systemic inflammation, endothelial stress, and endothelial repair. METHODS: A total of 145 subjects, aged 9 to 18 years, were studied. Tobacco smoke exposure was determined by hair nicotine level. Cardiovascular risk was assessed by markers of systemic inflammation (C-reactive protein [CRP] and adiponectin); by soluble intercellular adhesion molecule 1 (s-ICAM1), which measures endothelial activation after surface vascular injury; and by endothelial repair. This was measured by prevalence of endothelial progenitor cells (EPCs), which are bone marrow-derived cells that home preferentially to sites of vascular damage. RESULTS: Hair nicotine was directly correlated with s-ICAM1 (r = 0.4090, P < .0001) and negatively correlated with EPC prevalence (r = -0.2002, P = .0195). There was no relationship between hair nicotine and CRP, and a trend toward a weak relationship with adiponectin. Hair nicotine and body mass index were independent variables in a multivariate model predicting s-ICAM1; hair nicotine was the only significant variable in a model predicting EPC prevalence. CONCLUSIONS: Secondhand smoke exposure during childhood and adolescence is detrimental to vascular health because s-ICAM1 is a marker for endothelial activation and stress after vascular surface injury, and EPCs contribute to vascular repair. The fact that body mass index is also a factor in the model predicting s-ICAM1 is concerning, in that 2 risk factors may both contribute to endothelial stress.

Secondhand smoke exposure and hair nicotine in children: age-dependent differences.

INTRODUCTION: A significant proportion of children in the United States remain exposed to secondhand smoke (SHS). We are reporting on relationships observed between parental report of their child's SHS exposure in two groups of children (ages 2-5 years and 9-14 years) with a biological marker of long-term SHS exposure, hair nicotine. METHODS: Participants were healthy children recruited via convenience sampling for two age groups: 2-5 years and 9-14 years. The presence and amount of SHS exposure were assessed by both questionnaire and hair sampling for nicotine determination. RESULTS: A total of 115 participants were recruited (54 toddlers and 61 youth). The groups were similar in terms of demographics and reported SHS exposure. Hair nicotine levels were significantly different by age group, with toddlers having higher levels than youth. The most important independent determinants of hair nicotine were toddler age group, receiving Medicaid for health insurance, and number of smokers the subject was exposed to in 24 hr. CONCLUSIONS: Our findings suggest that young children who are insured by Medicaid have higher levels of hair nicotine, a biomarker of SHS exposure, when compared with an older age group. Further efforts to protect this vulnerable population and mitigate their lifetime risks of SHS exposure-related morbidities are warranted.