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Inhaled rifampicin powder formulations and their in vivo studies for clinical application in tuberculosis treatment
No full textBackground
Tuberculosis (TB), a global health problem caused by Mycobacterium tuberculosis, mainly affects the lungs and spreads to other organs. Rifampicin is a potent anti-TB drug, but its oral delivery results in low drug concentrations in the caseating lung lesions, affecting its bactericidal activity that may lead to treatment failure, relapse and emergence of bacterial resistance. To increase the drug concentration in the lung lesions and the systemic circulation, high-dose rifampicin has been tested clinically via the oral route. However, high oral doses of rifampicin are associated with increased risk of systemic toxicity. Pulmonary delivery is a promising alternative to achieve high drug concentration in the lungs as well as the systemic circulation using lower doses compared to the oral route.
Purpose
The work described in this thesis was aimed at development of high-dose rifampicin powder formulations for inhaled anti-TB therapy, their in vitro characterization, and in vivo assessment of safety and pharmacokinetics after intra-tracheal administration in a rat model. We hypothesized that intra-tracheal administration of high-dose powder formulations of rifampicin would be safe to rat lungs and the liver, and result in higher systemic bioavailability compared to the oral administration at same dose.
Methods
High-dose powder formulations of rifampicin for inhalation were prepared using spray drying and crystallization methods. X-ray powder diffraction (XRD) was used to determine the crystallinity of the powders. A next generation impactor (NGI) was used to study the in vitro aerosolization behaviour. In vitro dissolution test was performed using a custom-made apparatus.
The in vivo safety and pharmacokinetics of high-dose intra-tracheal rifampicin was studied in Sprague Dawley rats. High-dose rifampicin was administered by either intra-tracheal powder insufflation (25 and 50 mg/kg) or oral gavage (50 mg/kg). Following single and repeated administration of rifampicin, safety to rat lung and liver was evaluated by histopathology. Serum alanine transaminase (ALT) and aspartate aminotransferase (AST) assays were performed to study the hepatic effects. For pharmacokinetic evaluation, rifampicin quantification in plasma was carried out by liquid chromatography mass spectrometry (LC-MS/MS) at predetermined time points after drug administration on day 0 and day 6.
Results
Spray drying yielded amorphous powder formulation of rifampicin (RIF A) while crystalline pentahydrate (RIF C1 and RIF C2) and dihydrate (RIF C3) powder formulations were obtained by crystallization. All formulations had a mean particle size smaller than 3.8 μm and a fine particle fraction higher than 58.0%. RIF A and RIF C3 were selected for in vivo studies due to their rapid in vitro dissolution compared to RIF C1 and RIF C2. Intra-tracheal administration of rifampicin resulted in significantly lower serum ALT activity and similar AST activity compared to oral administration, suggesting reduced drug burden on the liver after pulmonary administration. Repeated intra-tracheal administration of rifampicin was well tolerated by rats, and the lung and hepatic architecture was normal upon histopathological evaluation. Rifampicin bioavailability after intra-tracheal RIF A (AUC0-∞ = 193.1 ± 37.9 μg.h/mL) was significantly higher compared to that from its oral administration (AUC0-∞ = 87.4 ± 64.7 μg.h/mL) at same dose. Increasing the intra-tracheal dose resulted in a more than dose proportional bioavailability suggesting nonlinear pharmacokinetics of inhaled rifampicin.
Conclusions
The amorphous and the crystalline dihydrate rifampicin formulations are suitable for inhaled high-dose delivery of rifampicin in TB treatment. A high concentration of rifampicin in the lungs and the systemic circulation at a relatively low administered dose can be achieved by pulmonary administration of rifampicin, either alone or in addition to the standard oral dose. By achieving high bioavailability of rifampicin, this approach has the potential to achieve improved bactericidal activity, minimize the development of drug resistance and reduce the duration of TB treatment
Tangible Artefacts Unearth Contemporary Legalities: Aboriginal Artefacts and the Randwick Light Rail Project
No full textThere is insufficient legal protection for tangible but non-charismatic Aboriginal artefacts in New South Wales, Australia. The State laws are insufficient because they provide State actors with the power to protect those artefacts and to decide whether artefacts are significant for Aboriginal peoples according to Aboriginal traditions. This article compares the laws that governed the excavation of Aboriginal artefacts in a colonial archaeological excavation in New South Wales. Doing so unearths how State law operates to privilege colonial heritage. This is unsurprising because law is an intangible cultural artefact that is the result of the historical and political sedimentation of power. The article then orients State cultural heritage protection within international cultural heritage law to reveal the political controversies for cultural heritage protection that animate struggles between Aboriginal peoples and States. Using a human rights regime may seem a promising means for providing Aboriginal peoples with the ability to protect their artefacts. But like international cultural heritage law, human rights depend upon layers of State control, making it unlikely that human rights will help Aboriginal peoples protect their artefacts. Despite this, the human rights regime remains a useful analytic tool for unearthing the sedimentation of power in legal artefacts.Peer Reviewe
Toitū te Mātauranga Māori: The Protection of Mātauranga Māori in the Publishing Industry
Get PDFTahau-Hodges, P. (2020). Toitū te Mātauranga Māori: The Protection of Mātauranga Māori in the Publishing Industry. (A thesis presented in partial fulfilment of the requirements for the degree of Master of Indigenous Studies at the University of Otago, Dunedin, Aotearoa, New Zealand).
ABSTRACT
This dissertation focuses on the protection of mātauranga Māori in the Aotearoa New Zealand publishing industry. Mātauranga Māori is Māori knowledge in its most expansive and all-encompassing form. It is fortified with all the values, experiences, attitudes and worldviews handed down by our tīpuna (ancestors), and reflects Māori ways of being, knowing, and thinking. Publishing is a means by which Māori (the Indigenous people of Aotearoa New Zealand) and other Indigenous peoples can preserve our mātauranga (knowledge) for future generations. However, there are a plethora of issues and challenges concerning the protection of mātauranga Māori in the publishing industry.
The primary objective of this research is to explore issues and challenges concerning the protection of mātauranga Māori in the publishing sector. Many of these issues relate to a conceptual divide that exists between Pākehā understandings of property, and how Māori and other Indigenous peoples view the world, share knowledge, and express culture.
This research provides a literature review about Indigenous knowledge and mātauranga Māori, and explores understandings and definitions of these concepts. It looks at the many facets of the publishing industry as the context for this research and examines where and how mātauranga Māori features in this sector. It presents a summary of the issues and challenges identified through interviews with experienced publishing practitioners. Finally, it offers a conceptual model developed as a tool for publishing practitioners so that they can better protect mātauranga Māori in the publishing industry
Understanding the Effect of Dining and Motivational Factors on Out-Of-Home Consumer Food Waste
Get PDFApproximately 12% of total food waste is generated at the hospitality and food service level. Previous research has focused on kitchen and storeroom operations; however, 34% of food waste in the sector is uneaten food on consumers’ plates, known as “plate waste”. The effect of situational dining factors and motivational factors on plate waste was analysed in a survey of 1001 New Zealand consumers. A statistically significantly greater proportion (p < 0.05) of participants reported plate waste if the meal was more expensive, longer in duration or at dinnertime. Irrespective of age or gender, saving money was the most important motivating factor, followed by saving hungry people, saving the planet and, lastly, preventing guilt. Successful food waste reduction campaigns will frame reduction as a cost-saving measure. As awareness of the environmental and social costs of food waste builds, multifactorial campaigns appealing to economic, environmental and social motivators will be most effective
Optimising medicine information for patients in New Zealand
Get PDFBackground
Patients must receive sufficient information about their medicines to be able to take them safely, to make informed choices, and to understand the benefits of adherence. Providing written information alongside verbal communication is best-practice to ensure comprehension and aid recall. However, leaflet provision is not mandatory in New Zealand.
Automated provision of information in a digital format may support informing people about their medicines in practice. Internationally, digital tools have allowed self-reporting of chemotherapy side-effects (Patient Reported Outcomes) to provide medicines information and self-management advice. However, such systems are not yet available in New Zealand and it is not known how they would be received.
Aim
To investigate how patients are provided with information about their medicines in New Zealand practice and explore potential solutions to optimise quality and provision.
Methods
This study was conducted in four stages:
1. A description of patients’ views on what content should be included in medicine information leaflets and how they should be designed to improve usability and usefulness.
2. Surveys to examine a) pharmacists’ and general practitioners’ (GPs’) medication counselling practices, b) their opinions and use of written information, and c) patients’ opinions and experiences of receiving written medicine information.
3. Feasibility study to determine the viability of producing a medicines information tool (automatic leaflet-tailoring and prompting system) for GPs and pharmacists: a survey of vendors of prescribing and dispensing software in New Zealand.
4. Focus groups and interviews with former oncology/haematology patients to determine their opinions regarding the information provided about their chemotherapy, and their views of the possible use of an online digital tool to report side-effects and receive information.
Main findings
1. Both summary and comprehensive medicine information leaflets should be readily available. Leaflet content requirements were identified, including names of the medicine, dose, benefits of treatment, and potential harms of therapy. The guidance provided by the New Zealand regulatory agency about how to design written medicine information does not align with patients’ stated needs.
2. Patients may not be receiving all the information they want or need to know about their medicines during verbal communication with GPs and pharmacists.
3. GPs and pharmacists do not routinely provide written medicines information leaflets. Facilitators to encourage provision included having summary and tailored leaflets available, more time with patients, and automatic computer prompts. GPs, pharmacists, and patients believe it is important that leaflets are given with new medicines.
4. At this time, it is not feasible to build an automatic leaflet-tailoring and prompting system within prescribing and dispensing management software used in New Zealand.
5. Oncology/haematology patients consider the way they are given information about their treatment could be improved. Many thought having a digital system available to report side-effects and receive information about management would be beneficial.
Conclusion
We need to improve the way we give people information about their medicines in New Zealand. Providing verbal and written information is not mandatory at present and may sometimes result in suboptimal practice.
Patients and health professionals thought digital technology could be used to help provide medicines information. Furthermore, online digital tools utilising Patient Reported Outcomes might help patients better manage their medicines’ side-effects
Retail Potential for Upcycled Foods: Evidence from New Zealand
Get PDFFood waste is a problem that manifests throughout the food supply chain. A promising solution that can mitigate the food waste problem across various stages of the food supply chain is upcycling food ingredients that would otherwise be wasted by converting them into new upcycled food products. This research explores perception of upcycled foods from a panel of 1001 frequent shoppers at a large grocery retailer in New Zealand. Findings from this research uncover several hitherto unexamined aspects of consumers’ evaluations of upcycled foods. These include consumers’ indications about shelf placements of upcycled foods, willingness to buy upcycled foods for people or pets other than themselves, and consumers’ preferences about information pertaining to these foods. This research advances our understanding of how consumers perceive upcycled foods and provides actionable insights to practitioners in the food industr
A Systematic Review of Consumer Perceptions of Smart Packaging Technologies for Food
Get PDFSmart packaging, an emerging technology in the food packaging industry incorporates both active and intelligent technologies. Consumer demand for natural products and increasingly extended and diverse supply chains required to feed the growing global population, mean that traditional packaging is becoming less capable of meeting the functional demands placed on it. To help ensure the commercial success of proposed smart packaging technologies a thorough understanding of consumers attitudes toward them is required. Understanding the cultural, social and cognitive factors that affect acceptance will help “fine tune” smart packaging development to best meet consumer preferences and needs and ensure that communication about the technologies effectively addresses consumer concerns and educates them on the benefits. This systematic review of 28 peer reviewed journal articles summarizes the current knowledge on consumer acceptance or rejection of active and intelligent packaging, and the behavioral forces behind those attitudes. Articles containing primary data and published in the English language over the last 10 years reporting consumer responses to active and/or intelligent packaging technologies in general or to more specific technologies that achieved the functional goals of active or intelligent packaging were obtained and analyzed for themes in the qualitative data analysis software NVivo. Themes were organized into groups as to whether they identified control variables, moderating variables, barriers or motivations to purchase and the benefits of the technology. To develop a conceptual framework for understanding consumer preferences for smart packaging, the identified themes were integrated with several consumer behavior models including the theory of planned behavior and an attitude model. Consumer perceptions of smart packaging is a poorly covered research area with most research being clustered in Europe and a smaller cluster in the Americas so there were significant opportunities to build on the body of knowledge
Health and wellbeing of under-25 year olds in Hawke's Bay 2019
Get PDFIn this report the New Zealand Child and Youth Epidemiology Service (NZCYES) presents information to assist in the planning and funding of services that can collectively improve, promote and protect the health and wellbeing of children and young people aged under-25 years. This is the final of three age-based reports: indicators presented in 2017 had a focus on the first five years of life, and the 2018 report had a focus on the health and wellbeing of under-15 year olds.
Data for the indicators presented in this report were extracted in 2019 from a range of routinely collected national datasets. The report provides an analysis of the most recent data available for each indicator at the time of writing. Unadjusted rates should be interpreted in light of the differing patterns in age structure, ethnic composition, social and material deprivation in each DHB and in Aotearoa overall. Evidence for good practice is presented for each section, compiled from published scholarly literature and from publicly available guidelines, policies, and reports. Where possible, the evidence for good practice includes discussion of equity issues relevant to each indicator, to inform service planning and delivery.
The two review topics included in this report were selected by DHB representatives: Alcohol use in young people by Lee Smith and Promoting mental wellbeing in schools by Judith Adams and Georgia Richardson. These two sections of the report can inform strategies to promote health and wellbeing for all young people. Intervention and treatment services, supportive environments, and healthy cultural norms around drinking are some key components to addressing hazardous alcohol consumption in Aotearoa’s youngest generations. Through school-based initiatives, services can support the mental wellbeing of children and adolescents and thus invest in their long-term flourishing.
Navigating sexual and reproductive health is important to the lives of many young people. Information on reproductive planning and pregnancy rates can provide an indication about the accessibility of services and provide an indication about the future social and economic participation of this generation of young people and the sustainability of the overall population and economy.1 These indicators are presented in the section on Reproductive health.
The section on Mental Health presents information on the prevalence of selected mental health diagnoses in young people, the mental health services utilised by young people and the hospitalisations of young people that are associated with mental health issues.
Selected indicators about substance use and smoking, alcohol and drug service utilisation, and alcohol and drug hospitalisations are presented in the Substance use section. These indicators are important for overall wellbeing, growth, and long-term health of children and young people and inextricably linked to other wellbeing measures presented in the 2019 report.
The United Nations Convention on the Rights of the Child establishes that every child is deserving of a state-level commitment towards the promotion of their social, spiritual and mental wellbeing, as well as towards their protection from all forms of violence and harm.2 The section on Safety and Security provides an overview of indicators relating to the protection of children and young people in Aotearoa, including information about assault and self-harm.
Supporting and adding value to the lives of children and young people with cancer is an important part of planning and funding decisions and is presented in the section on Cancer.
The report appendices describe the processes used in compiling information for these reports, including the methods used to develop evidence for good practice, and the statistical methods used in the data analyses. The appendices give further information about the data sources used for the indicators in the report, explanation about classification of ethnicity and social and material deprivation, and a list of the clinical codes relevant to each indicator.
In summary, the 2019 report on health and wellbeing of under-25 year olds presents data and interpretation on a set of relevant indicators extracted from national health datasets. The data used were the most recent available at the time of writing, and provide a snapshot of achievements and challenges in these areas. This report cannot address questions that require outpatient data, as these are not yet available at a national level. Developing systems that can provide a fuller picture of outpatient and primary health care data is important to inform child health service planning at national and DHB levels. The NZCYES is liaising with the Ministry of Health as they develop and roll out a patient flow system that will include primary care and outpatient data
Health and wellbeing of under-25 year olds in Canterbury and West Coast 2019
Get PDFIn this report the New Zealand Child and Youth Epidemiology Service (NZCYES) presents information to assist in the planning and funding of services that can collectively improve, promote and protect the health and wellbeing of children and young people aged under-25 years. This is the final of three age-based reports: indicators presented in 2017 had a focus on the first five years of life, and the 2018 report had a focus on the health and wellbeing of under-15 year olds.
Data for the indicators presented in this report were extracted in 2019 from a range of routinely collected national datasets. The report provides an analysis of the most recent data available for each indicator at the time of writing. Unadjusted rates should be interpreted in light of the differing patterns in age structure, ethnic composition, social and material deprivation in each DHB and in Aotearoa overall. Evidence for good practice is presented for each section, compiled from published scholarly literature and from publicly available guidelines, policies, and reports. Where possible, the evidence for good practice includes discussion of equity issues relevant to each indicator, to inform service planning and delivery.
The two review topics included in this report were selected by DHB representatives: Alcohol use in young people by Lee Smith and Promoting mental wellbeing in schools by Judith Adams and Georgia Richardson. These two sections of the report can inform strategies to promote health and wellbeing for all young people. Intervention and treatment services, supportive environments, and healthy cultural norms around drinking are some key components to addressing hazardous alcohol consumption in Aotearoa’s youngest generations. Through school-based initiatives, services can support the mental wellbeing of children and adolescents and thus invest in their long-term flourishing.
Navigating sexual and reproductive health is important to the lives of many young people. Information on reproductive planning and pregnancy rates can provide an indication about the accessibility of services and provide an indication about the future social and economic participation of this generation of young people and the sustainability of the overall population and economy.1 These indicators are presented in the section on Reproductive health.
The section on Mental Health presents information on the prevalence of selected mental health diagnoses in young people, the mental health services utilised by young people and the hospitalisations of young people that are associated with mental health issues.
Selected indicators about substance use and smoking, alcohol and drug service utilisation, and alcohol and drug hospitalisations are presented in the Substance use section. These indicators are important for overall wellbeing, growth, and long-term health of children and young people and inextricably linked to other wellbeing measures presented in the 2019 report.
The United Nations Convention on the Rights of the Child establishes that every child is deserving of a state-level commitment towards the promotion of their social, spiritual and mental wellbeing, as well as towards their protection from all forms of violence and harm.2 The section on Safety and Security provides an overview of indicators relating to the protection of children and young people in Aotearoa, including information about assault and self-harm.
Supporting and adding value to the lives of children and young people with cancer is an important part of planning and funding decisions and is presented in the section on Cancer.
The report appendices describe the processes used in compiling information for these reports, including the methods used to develop evidence for good practice, and the statistical methods used in the data analyses. The appendices give further information about the data sources used for the indicators in the report, explanation about classification of ethnicity and social and material deprivation, and a list of the clinical codes relevant to each indicator.
In summary, the 2019 report on health and wellbeing of under-25 year olds presents data and interpretation on a set of relevant indicators extracted from national health datasets. The data used were the most recent available at the time of writing, and provide a snapshot of achievements and challenges in these areas. This report cannot address questions that require outpatient data, as these are not yet available at a national level. Developing systems that can provide a fuller picture of outpatient and primary health care data is important to inform child health service planning at national and DHB levels. The NZCYES is liaising with the Ministry of Health as they develop and roll out a patient flow system that will include primary care and outpatient data
Assessing wound measurement within a high-risk foot ulcer clinic for people with diabetes - clinical and patient perspectives
Get PDFIntroduction
Around a third of people with diabetes will develop a foot ulcer requiring specialist podiatry treatment during their lifetime. The formation of a foot ulcer for people with diabetes is a consequence of chronic hyperglycaemia, which causes poor wound healing and damage to nerves and blood vessels. This study has two aims. The first was to describe wound healing trajectories from baseline (Day 0), to wound closure, for wounds that had healed within six months. Our hypothesis was that a clinical marker exists, such as a certain time point along the wound healing trajectory, which is associated with subsequent rapid healing. The second aim was to understand patient perceptions associated with wound images and how discussion about images might optimise self-care, as few studies have explored this aspect of clinical care. Images undertaken as part of routine clinical care, enables patients to visualise their foot ulcers, maybe for the first time. Both patient and podiatrist can jointly view the current foot ulcer image on a computer screen and compare this with an earlier electronic image, to gauge wound healing progression. These images thus have the potential to provide a communication medium for facilitating patient self-management discussions.
Methods
This study consisted of two parts. Part 1 included an exploratory retrospective analysis of wound healing as measured by surface area metrics, from 103 individual patients who had attended the high-risk foot ulcer clinic over the previous three years.
Part 2 focused on descriptive qualitative research of semi-structured interviews of patients attending the high-risk foot ulcer clinic, studying their perceptions of wound imaging, including clinical utility, during routine clinic appointments. Interviews were audio-recorded and transcribed, thereby allowing thematic analysis of participant responses and identification of themes.
Results and findings
Part 1 results determined wound healing trajectories for the 103 individual patient wounds, showed no identifiable time point, after which there would be no deterioration in wound healing. A greater than 50% reduction in wound surface area at four weeks has previously been described as a marker of wound healing success, however only 61.2% of healed wounds in this study met this parameter.
Analysis of 31 patient interviews for Part 2 described participants’ positive reactions to being able to visualise and discuss their wound images. This visualisation and discussion led to valuable insights and enhanced understanding of clinical aspects of wound healing. Patient engagement increased with the self-care advice around wound healing, provided by the podiatrists and other specialist clinicians. Patients also considered that these discussions positively impacted on their health literacy.
Conclusion
The study showed that sharing and discussing wound images helps advance patient education and understanding. In doing so, the patient can feel more included in their care and more likely to participate in self-care. The study also shows that real-world wound healing trajectories do not provide the podiatrist or patient with certainty around length of time needed to complete wound healing, thus it can be difficult to answer the patient’s question “when will my wound fully heal”. In conclusion, in-clinic discussions of wound images can enhance wound healing opportunities