The removal of Cremophor® EL from paclitaxel for quantitative analysis by HPLC-UV

The most common technique for analysis of drug substances is high performance liquid chromatography (HPLC) using a variable wavelength detector (UV). Cremophor® EL (ethoxylated castor oil, CrEL) is a non-ionic emulsifier that is used to assist in the solubilization of hydrophobic drugs such as the antineoplastic agent, paclitaxel. However, the molecular weight distribution of CrEL creates difficulties in the analysis of potency and related substances of hydrophobic drugs via UV detection. Using a precipitation method, CrEL was selectively removed from the paclitaxel by pre-treating the injectable dosage form with mercuric chloride and analyzing the filtered extract by HPLC-UV. The removal of CrEL from the injectable dosage form of paclitaxel by precipitation with mercuric chloride resulted in a solution that was suitable to quantitate active and related substances by HPLC-UV. The precipitate was then characterized by nuclear magnetic resonance, infrared spectrophotometry and x-ray diffraction to elucidate its mechanism of action. The combination of these analyses provided sufficient evidence that the complex formed between CrEL and mercuric chloride is from the coordination of the mercury atom to the ether oxygens present in the CrEL

Physician Consultation, Multidisciplinary Care, and 1-Year Mortality in Medicare Recipients Hospitalized with Hip and Lower Extremity Injuries

To determine whether routine surgeon consultation with medicine specialists and multidisciplinary care conferences—potentially modifiable hospital characteristics—are associated with lower 1-year mortality in older adults with hip and lower extremity injuries.Retrospective cohort study.Oregon hospitals.Two thousand five hundred thirty-eight Medicare recipients aged 67 and older hospitalized in Oregon hospitals in 2002 with hip or lower extremity injuries.Demographic, injury, comorbidity, and survival information were gathered from Medicare records for 2000 to 2003. All Oregon hospitals with a qualifying case were surveyed using a structured telephone interview to collect information about routine surgeon consultations and multidisciplinary care conferences for older adult orthopedic patients. Multivariable generalized estimating equation models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between hospital characteristics and mortality.After adjusting for age, injury severity, comorbid conditions, trauma center status, and hospital annual volume of patients with hip fracture, the relative odds of dying in the year after injury for inpatients treated in settings with routine surgeon consultation with medical staff was 0.69 (95% CI 0.57–0.83) compared with patients not treated in such settings. Inpatient treatment in settings with routine multidisciplinary care conferences did not significantly affect the relative odds of dying in the year after injury (OR=1.06, 95% CI=0.89–1.26).Routine consultation by attending orthopedic surgeons with medicine or primary care specialists for Medicare inpatients is associated with better survival 1 year after injury.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/79088/1/j.1532-5415.2010.03087.x.pd

Obesity: should there be a law against it? Introduction to a symposium

The rapid rise in rates of overweight and obesity among adults and children in Australia and New Zealand has intensified debate about the most effective policies for obesity prevention. Law has much to contribute to this policy discussion, although its role is often misunderstood. The articles in this symposium follow on from a conference hosted in September 2006 by the Centre for Health Governance, Law & Ethics in the Faculty of Law, University of Sydney, titled: Obesity: should there be a law against it? In different ways, these articles provide a variety of perspectives on regulatory responses to obesity, including theoretical justifications for a legal approach, conceptual models that assist in making sense of law's role, as well as specific legal strategies for obesity prevention in various settings

Obesity prevention: the role of policies, laws and regulations

The commercial drivers of the obesity epidemic are so influential that obesity can be considered a robust sign of commercial success – consumers are buying more food, more cars and more energy-saving machines. It is unlikely that these powerful economic forces will change sufficiently in response to consumer desires to eat less and move more or corporate desires to be more socially responsible. When the free market creates substantial population detriments and health inequalities, government policies are needed to change the ground rules in favour of population benefits

What's law got to do with it Part 2: Legal strategies for healthier nutrition and obesity prevention

This article is the second in a two-part review of law's possible role in a regulatory approach to healthier nutrition and obesity prevention in Australia. As discussed in Part 1, law can intervene in support of obesity prevention at a variety of levels: by engaging with the health care system, by targeting individual behaviours, and by seeking to influence the broader, socio-economic and environmental factors that influence patterns of behaviour across the population. Part 1 argued that the most important opportunities for law lie in seeking to enhance the effectiveness of a population health approach

Obesity prevention and personal responsibility: the case of front-of-pack food labelling in Australia

<p>Abstract</p> <p>Background</p> <p>In Australia, the food industry and public health groups are locked in serious struggle for regulatory influence over the terms of front-of-pack food labelling. Clear, unambiguous labelling of the nutritional content of pre-packaged foods and of standardized food items sold in chain restaurants is consistent with the prevailing philosophy of 'personal responsibility'. An interpretive, front-of-pack labelling scheme has the capacity to encourage healthier patterns of eating, and to be a catalyst for improvements in the nutritional quality of food products through re-formulation. On the other hand, the strength of opposition of the Australian Food and Grocery Council to 'Traffic Light Labelling', and its efforts to promote a non-interpretive, voluntary scheme, invite the interpretation that the food industry is resistant to any reforms that could destabilise current (unhealthy) purchasing patterns and the revenues they represent.</p> <p>Discussion</p> <p>This article argues that although policies that aim to educate consumers about the nutritional content of food are welcome, they are only one part of a broader basket of policies that are needed to make progress on obesity prevention and public health nutrition. However, to the extent that food labelling has the capacity to inform and empower consumers to make healthier choices - and to be a catalyst for improving the nutritional quality of commercial recipes - it has an important role to play. Furthermore, given the dietary impact of meals eaten in fast food and franchise restaurants, interpretive labelling requirements should not be restricted to pre-packaged foods.</p> <p>Summary</p> <p>Food industry resistance to an interpretive food labelling scheme is an important test for government, and a case study of how self-interest prompts industry to promote weaker, voluntary schemes that pre-empt and undermine progressive public health regulation.</p

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

BACKGROUND: Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee. METHODS: The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS. DISCUSSION: The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials. TRIAL REGISTRATION: ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014)

Dietary outcomes within the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial

Abstract Background Young adults (YA) are at high-risk for unhealthy dietary behaviors and weight gain. The Study of Novel Approaches to Weight Gain Prevention (SNAP) Trial demonstrated that two self-regulation approaches were effective in reducing weight gain over 2 years compared with control. The goal of this analysis was to examine effects of intervention on dietary outcomes and the association of diet changes with weight change. Methods Participants were 599 YA, age 18–35 years, BMI 21.0–30.0 kg/m2 (27.4 ± 4.4 years; 25.4 ± 2.6 kg/m2; 22% men; 73% non-Hispanic White), who were recruited in Providence, RI and Chapel Hill, NC and randomized to self-regulation with Small Changes (SC), self-regulation with Large Changes (LC) or Control (C). SC and LC emphasized frequent self-weighing to cue behavior changes (small daily changes vs. periodic large changes) and targeted high-risk dietary behaviors. Diet and weight were assessed at baseline, 4 months and 2 years. Results LC and SC had greater decreases in energy intake than C at 4 months but not 2 years. LC had the greatest changes in percent calories from fat at 4 months, but differences were attenuated at 2 years. No differences in diet quality were observed. Across conditions, increased total energy consumption, fast food, meals away from home, and binge drinking, and decreased dietary quality and breakfast consumption were all associated with weight gain at 2 years. Conclusions This study suggests the need to strengthen interventions to produce longer term changes in dietary intake and helps to identify specific behaviors associated with weight gain over time in young adults. Trial registration Clinicaltrials.gov # NCT01183689 , registered August 18, 2010