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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
201

Effects of prepolymer structure on photopolymer network formation and thermomechanical properties

Scholte, Jon Paul 01 May 2017 (has links)
Photopolymerization is a growing field within the realms of polymer and material science. With diverse applications, ranging from coatings and adhesives to newer technologies such as 3D printing photopolymerization continues to increase its prevalence and influence. This research examines fundamental structure property relationships between large prepolymer structures within a formulation and the resulting impact on thermo-mechanical properties in photocurable resins. Most prepolymer molecules utilize a “one pot” synthesis with little to no control over the placement of photoreactive moieties such as epoxies and (meth) acrylates. We have utilized novel prepolymer molecules synthesized using controlled radical polymerization to allow direct control over the placement of reactive groups. The ability to control the location of reactive groups in prepolymer molecules can also lead to the formation of multiple domains within the resulting photocured thermoset. This separation is achieved by concentrating the reactive groups at specific locations in the prepolymer backbone, e.g. at the end or near the center of the prepolymer molecule. The nonreactive groups may form one domain within the thermoset network while the reactive portion of the prepolymer forms a second phase with reactive diluent molecules. Additionally, various architectures allow greater control over polymer network formation and crosslink density. Through these manipulations of macromolecular architecture, we have been able to manipulate various thermo-mechanical properties. Using various architectured prepolymer, we have been able to generate materials with multiple glass transitions while also increasing the rate of reaction and total conversion as compared to randomly functionalized control formulations.
202

Lossless statistical data service over Asynchronous Transfer Mode.

Van Luinen, Steven M. January 1999 (has links)
Asynchronous Transfer Mode (ATM) can provide deterministic channels as required for real time signals, as well as statistical multiplexing. For this reason, ATM has been chosen as the underlying technology for providing a Broadband Integrated Services Digital Network (B-ISDN). Two main classes of services are expected to be supported over a B-ISDN. These classes are real-time services and data services. Data services include computer communications (Local Area Network (LAN) interconnections) and general non-real time traffic, such as file transfer and small transactions.The provision of data services over ATM are better served with statistical multiplexing, provided that the service is loss-free. For multiplexing to be loss-free and still statistical, while the maximum service rate is fixed, the multiplexer tributaries must be controlled in flow, to assure no overflow of the multiplexing buffer. Provision of a service over ATM is accomplished by an ATM layer. Transfer Capability (ATC).This thesis investigates and reports on the operating characteristics of an ATM layer Transfer Capability proposed to the International Telecommunications Union (ITU), and called Controlled Cell Transfer (CCT). CCT uses credit window based flow control on links and a quota based control in switches, and will give loss free statistical multiplexing for data. Other ITU defined ATCs are examined in regard to data service provision and compared with CCT. It is found that only CCT can provide a fast and at the same time efficient data service.The thesis also examines the impact that support of the CCT capability would have on an ATM switch, through determination of required functionality, and mapping of the required functions into a switch design. Finally, an architecture and implementation of an ATM switch is described that would support the CCT as well as the Deterministic Bit Rate (DBR) ++ / transfer capability, and would provide efficient data and real-time services.
203

The efficacy of a pedometer based intervention in increasing physical activity in cardiac patients in the community

Butler, Lyra, Public Health & Community Medicine, Faculty of Medicine, UNSW January 2009 (has links)
Rationale Within Australia, cardiac rehabilitation attendance is poor, with typically thirty percent of eligible patients attending programs. The majority of cardiac patients are not receiving the support or detailed information required to increase physical activity participation after hospitalisation. Further, many cardiac patients are not exercising independently, regardless of their attendance at cardiac rehabilitation. As physical activity is important in the prevention and treatment of heart disease, there could be substantial benefits to the individual and cost savings for the health system if cardiac patients were more active. Physical activity interventions based on social cognitive theory have demonstrated success in improving physical activity among people with chronic diseases. However, there is little research conducted with cardiac patients, in particular, with those who do not attend cardiac rehabilitation. This research addresses this gap in public health practice by providing an intervention to cardiac patients, irrespective of their attendance at cardiac rehabilitation, thereby addressing a population that is often overlooked and hard to reach. Research aims ?? To determine the uptake rate of cardiac rehabilitation in the north Illawarra and Shoalhaven areas of New South Wales and identify the characteristics of cardiac rehabilitation attendees and non attendees. ?? To evaluate the efficacy of a pedometer based physical activity intervention in cardiac patients referred to cardiac rehabilitation. Methodology This thesis consisted of three related studies: a cross sectional analysis of the characteristics of cardiac rehabilitation referrals (n = 944) over a 10 month period; and two randomised controlled trials conducted simultaneously. The Cardiac Rehabilitation Trial participants (n = 110) were patients who had attended cardiac rehabilitation; Community Trial participants (n = 215) were those who did not attend cardiac rehabilitation. The six week intervention evaluated in the trials included self monitoring of daily physical activity using a pedometer and step calendar, and two behavioural counselling and goal setting sessions delivered via telephone. Additional support for intervention group participants was provided through two brief telephone calls made after the six week intervention period. Self reported physical activity levels were collected at baseline, six weeks and six months. The questionnaire also collected information about psychosocial factors affecting physical activity participation. The exercise capacity of the participants in the Cardiac Rehabilitation Trial was objectively measured at baseline, six weeks and six months using a gas exchange analysis system. Results The cardiac rehabilitation uptake rate was 28.8 per cent of referred patients. Cardiac rehabilitation attendees were significantly younger and more likely to have had a coronary artery bypass graft surgery (CABGS) or percutaneous coronary intervention (PCI) procedure than non attendees. Study groups in both trials were not significantly different at baseline. In the Cardiac Rehabilitation Trial, improvements in total weekly physical activity sessions (p=0.002), walking time (p=0.013) and walking sessions (p<0.001) in the intervention group were significantly greater than the change in the control group at the end of the six week intervention. At six months, improvements in the intervention group remained significantly greater than the control group in total physical activity time (p=0.044), total physical activity sessions (p=0.016) and walking sessions (p=0.035) after adjusting for baseline differences. These self reported behavioural changes were corroborated by improvements in cardiorespiratory fitness at six months in the intervention group (p=0.010). Improvements in the intervention group in behavioural (p=0.039) and cognitive (p=0.024) self management strategy use were significantly greater than the controls at six weeks after adjusting for baseline differences. The improvement in cognitive strategy use (p=0.001) remained significantly greater in the intervention group compared to controls at six months after adjusting for baseline differences. Self efficacy, outcome expectancies and psychological distress were not significantly different between groups at six weeks or six months after adjusting for baseline differences. In the Community Trial, improvements in total weekly physical activity time (p=0.027), total physical activity sessions (p=0.003), walking time (p=0.013) and walking sessions (p=0.002) in the intervention group were significantly greater than the control group at six weeks after adjusting for baseline differences. At six months, improvements in total physical activity time (p=0.015), total physical activity sessions (p=0.019), walking time (p=0.002) and walking sessions (p=0.026) in the intervention group remained significantly greater than the control group after adjusting for baseline differences. Improvements in outcome expectancies (p=0.038) and cognitive self management strategy use (p=0.028) in the intervention group were significantly greater than the change in the control group at six weeks, after adjusting for baseline differences. However, these differences did not remain significant at six months. Conclusion This research showed that participation in a six week pedometer based intervention significantly increased the physical activity level and psychosocial status of people with heart disease. These findings suggest the pedometer based intervention could be offered as an effective and accessible option for those who do not attend cardiac rehabilitation to increase their physical activity levels. This intervention could also be promoted as an important adjunct to existing cardiac rehabilitation programs to promote adherence to physical activity after cardiac rehabilitation attendance. These studies provide community based evidence of an effective physical activity intervention for those eligible for cardiac rehabilitation, including those who do not attend. This provides a public health approach to cardiac rehabilitation programs and has the potential to improve health outcomes in this population.
204

An evaluation of the effectiveness of the Lidcombe program of early stuttering intervention

Jones, Mark A January 2005 (has links)
Philosophy(PhD) / This thesis presents a randomised controlled trial of the Lidcombe Program of Early Stuttering Intervention. The Lidcombe Program was developed for the treatment of stuttering in preschool-age children. The effectiveness of the Lidcombe Program was compared to a control group in a parallel group randomised controlled trial with blinded outcome assessment. A number of supplementary studies were conducted in support of the trial; two literature reviews, two retrospective file audits and a statistical simulation study. A review of randomised studies of treatments for stuttering showed that there have been 27 such studies published in English language journals. Of these only one was devoted to a treatment for early stuttering and that was the Lidcombe Program. The randomised study showed that 3 months of this treatment was associated with a lower level of stuttering compared to a control group who received no treatment. However, with a sample size of 23, this study lacked power and the children did not receive a full course of treatment. Despite these limitations, this study provided evidence that a medium to large effect size could be anticipated in an adequately powered and properly conducted randomised controlled trial. The second review was of sample size and power in stuttering research studies that had been published in two speech pathology journals; the Journal of Speech, Language and Hearing Research (Vol 39, No. 1 to Vol 40, No, 4) and the Journal of Fluency Disorders (Vol 21, No. 1 to Vol 22, No, 3). Results suggested that the majority (73%) of the 26 studies reviewed were insufficiently powered to detect even large effects. However it was acknowledged that it is very difficult to recruit even moderate sample sizes of people who stutter. It was concluded that one way to help improve this situation is collaboration of multiple research centres or, in the case of a randomised controlled trial, inclusion of multiple recruitment sites in one study. This strategy was adopted in the randomised controlled trial reported in this thesis. Two retrospective file audit studies of children treated with the Lidcombe Program were conducted in Australia and Britain. One purpose of these file audits was to obtain information relevant to the design and conduct of the randomised controlled trial. Data from the case reports on more than 300 children from the two sites were included in a meta-analysis. Results showed that a median of 11 weekly clinic sessions were required for children to attain the criteria for low levels of stuttering for completion of Stage 1 of the Lidcombe Program. Approximately 90% of children had achieved those criteria within 6 months of beginning treatment and almost all children had achieved them within 1 year. In addition two variables were found to be associated with longer treatment duration: more severe pre-treatment stuttering and shorter times from onset of stuttering to the start of treatment. The latter was apparent in the meta-analysis but not for the individual cohorts. As a result of these findings, pre-treatment stuttering severity was stratified along with other relevant variables in the randomised controlled trial and follow up for participants was a minimum of 9 months. A simulation study was conducted prior to analysis of data from the primary outcome measure of the randomised controlled trial: percentage of syllables stuttered (%SS). The distribution of %SS scores is positively skewed. Nonetheless, simulation showed t-test to be an appropriate analysis for this primary outcome measure. There were two treatment sites for the randomised controlled trial: the University of Canterbury (Christchurch, New Zealand) and the Stuttering Treatment and Research Trust (Auckland, New Zealand). A total of 54 preschool-age children were recruited: 29 to the Lidcombe Program and 25 to the control group. Half the proposed sample size was achieved due to slower than anticipated recruitment. This occurred because, as the trial progressed, treatment with the Lidcombe Program became common knowledge among parents in New Zealand and they became increasingly reluctant to agree to have their child randomised to the trial. Analysis with t-test showed a highly statistically significant difference (p = 0.003) at 9-months post-randomisation. The mean percentage of syllables stuttered (%SS) at 9-months post-randomisation was 1.5 (SD = 1.4) for the Lidcombe Program group compared to 3.9 (SD = 3.5) for the control group, resulting in a treatment effect of 2.3 %SS (95% confidence interval: 0.8-3.9). This treatment effect was more than double the minimum clinically worthwhile difference specified in the trial protocol. These results show that the Lidcombe Program is significantly more effective than natural recovery for reducing stuttering levels in preschool children. The Lidcombe Program is the first early stuttering treatment to be shown to be more effective than natural recovery in a randomised controlled trial.
205

Laser plasma interaction for application to fusion energy

Evans, Peter J., University of Western Sydney, College of Science, Technology and Environment, School of Science, Food and Horticulture January 2002 (has links)
This thesis presents an investigation into inertial confinement fusion through mathematical models and computer simulations. Salient features affecting fusion are identified, in both energy absorption and fusion gains. Mathematical tools are applied to a directed investigation into plasma structure. Parameters such as these involved in electromagnetic energy absorption are identified first, and the next step is to model the immediate response of the plasma to this energy input, with a view to how this may be advantageous to initiating fusion. Models are developed that best suit plasma behaviour. The parameters are presented graphically against time and distance into a small plasma fuel pellet. It is noted how field density and ions form undulations through the plasma. Types of plasma fuels are discussed with regards to their key parameters. Computations are performed using the laser driven inertial energy option based on volume ignition with the natural adiabatic self-similarity compression and expansion hydrodynamics. The relative merits of each fuel are discussed against the parameters of density, volume and energy input versus fusion gains. / Master of Science (Hons)
206

The Recruitment of Children to Randomised Controlled Trials

Caldwell, Patrina Ha Yuen January 2003 (has links)
Abstract Background The randomised-controlled trial (RCT) provides the best evidence for evaluating treatment effects and is accepted as a gold standard for clinical and regulatory decision making (1;2). One of the major challenges to the conduct of RCTs is the recruitment of adequate numbers of participants. Inadequate numbers reduce the power of a study to detect statistically significant treatment effects, and may cause delays, increased costs and failure to complete trials. The need for clinical trials in children has been increasingly recognised by the scientific community, resulting in increased demands for the inclusion of children in trials. For several reasons, recruiting children to trials is more challenging than recruiting adults, as consent issues are more difficult because parents make decisions about trial participation on behalf of their child. Despite general professional and community support for paediatric clinical trials, parents and paediatricians express reluctance when their own child or patient is asked to participate. Although researchers working with children commonly experience difficulty with recruiting children to RCTs, little is known about this very important subject. The method by which potential participants are approached for trial participation, the influence of their health care provider and the attitude of potential participants (or their parents, in the case of children), are critical to the understanding of the decision making process for trial participation. This thesis is one of the first major attempts to explore the issues surrounding the recruitment of children to RCTs, and is divided into four studies which address these issues. Methods Recruitment strategies used to encourage participation in randomised controlled trials (systematic review) Eligible experimental and observational studies comparing methods of recruiting participants for RCTs were identified after a comprehensive search of Medline, Embase, the Cochrane Library and reference lists. Independent data extractions were completed by two reviewers who assessed the studies for eligibility and methodological quality. Outcome measures were consent rates, proportion enrolled by each method and cost of recruitment per participant. Summary estimators of effects were calculated using a random effects model and expressed as relative risk with 95% confidence intervals. Heterogeneity was analysed using the Q statistic. Paediatricians� attitudes to children�s participation in randomised controlled trials (focus group research) Qualitative analysis of focus group discussions involving 16 paediatricians and 5 trainees from a paediatric teaching hospital in Sydney was undertaken. Doctors varied in occupation, experience, research activity, age, gender, ethnicity and parenthood experience. A professional facilitator conducted the semi-structured group discussions. Recruitment ceased when informational redundancy was reached, after 4 focus groups involving 21 participants. The transcribed audiotapes were analysed by theme linkage using the constant comparative method. Australian paediatricians� and adult physicians� attitudes to randomised controlled trials (survey) A 44-item questionnaire was sent to 250 paediatricians and 250 adult physicians randomly selected from the membership list of the Royal Australasian College of Physicians. Questions assessing doctors� treatment philosophies and attitudes to trials were compared with demographic and practice variables. Parents� attitudes to children�s participation in randomised controlled trials (focus group research) Qualitative analysis of focus group discussions involving 33 parents from 5 different settings (representing parents of children with a life threatening, chronic or acute illness, with experience in trials and of healthy children) was undertaken. Parents varied in age, gender, ethnicity, level of education, research experience and their child�s health status. The transcribed discussions were analysed by theme linkage using the constant comparative method. Results Recruitment strategies used to encourage participation in randomised controlled trials (systematic review) Fifty papers were included (out of 8602 titles and abstracts searched) which described 8 RCTs, 2 quasi RCTs, 13 prospective cohort studies, 30 retrospective cohort studies and 2 before-after studies. These studies assessed how over 4 million people were approached for RCT participation using 87 different recruitment strategies, with 103,406 people enrolling in RCTs. Health care provider (HCP) referrals had the highest participant consent rates at the time of exposure to trial information (HCP referral versus target mailing: relative risk (RR) 1.84 (95% confidence interval (95%CI) 1.08, 3.13)). They also had the highest consent rates when potential participants respond to the recruitment material by further enquiry about the trial (HCP referral versus community presentation: RR 1.37 (1.06; 1.78); HCP referral versus worksite approach: RR 25.20 (20.19, 31.45); HCP referral versus general community approach: RR 2.53 (0.46, 14.05); HCP referral versus mailing: RR 3.29 (1.26, 8.60); HCP referral versus media: RR 2.66 (1.31, 5.41)). However, by the time potential participants attend eligibility assessment for trial participation, no difference in consent rates could be distinguished by method of recruitment. Higher proportions of study participants were recruited by methods that exposed larger numbers of potential candidates to trial information (despite their lower consent rates). The stated recruitment cost ranged from US$0 to $1108 per participant, with mailing being the most cost-effective method and community methods (such as community presentations, pamphlets and posters displayed at community sites) the least effective. Paediatricians� attitudes to children�s participation in randomised controlled trials (focus group research) From the focus group discussions, paediatricians thought parents balanced perceived gains and risks when deciding about trial participation. They also believed the child�s condition and parents� health beliefs and personal attributes influenced parents� decisions. Other factors thought to be important by paediatricians were the doctors� beliefs and their relationship with the investigators. Paediatricians perceived gains for trial participation including professional benefits for themselves, improved patient care, convenience for the families and themselves and scientific advancement. Perceived risks included inconvenience, inadequate resources and potential harms to the patient and the doctor-patient relationship. Paediatricians with previous research experience were most knowledgeable about RCTs and perceived greatest gains from trial participation. Paediatricians� personal treatment preferences hindered trial support. Australian paediatricians� and adult physicians� attitudes to randomised controlled trials (survey) Response rate from the paediatricians� and adult physicians� survey was 60% (300/500). Australian paediatricians and adult physicians are very similar in their treatment philosophies, and are clinician-oriented rather than research-oriented in their attitudes, with primary allegiance to their patients and preference for selecting treatment rather than referring for trial participation in the face of treatment uncertainty. Professional activities are clinically focused, with limited time assigned for research. Australian doctors perceive little reward for trial participation and claim that the opinions of referring doctors regarding RCTs does not influence them. Predictors of favourable attitudes to trial participation from the survey were time allocation for research, a history of referring patients to trials in the past and younger age (all p values less than 0.0001). Parents� attitudes to children�s participation in randomised controlled trials (focus group research) When parents were interviewed, they acknowledged balancing risks and benefits when deciding about trial participation for their child. Perceived benefits include the offer of hope, better care of their child, the opportunity to access new treatments, healthcare professionals and health information, meeting others in similar circumstances and helping others. Perceived risks include potential side effects, being randomised to ineffective treatments and the inconvenience of participation. The decision for trial participation is also influenced by parental factors (parents� knowledge, beliefs and emotional response), child factors (the child�s health status and preference about participation), trial factors (the use of placebos and the uncertainties of research) and doctor factors (doctor�s recommendations and communication of trial information). Conclusions There are many challenges to the successful conduct of RCTs. Ways of addressing these include: using effective methods of recruiting potential study participants (such as mailing of recruitment material to potential participants) and abandoning ineffective strategies (such as community methods): fostering greater willingness for trial participation by addressing parents� and paediatricians� concerns including enhancing communication between researchers, paediatricians and parents, and improving the gains-hazard balance (by increasing incentives while decreasing inconveniences); and reforming in the health care system to raise the priority placed on clinical research by restructuring clinical research in a clinically predominant workplace and with a clinically predominant workforce. The findings from this study have implications for researchers planning RCTs for children in the future. Careful consideration of the above will enhance RCTs participation for children improving efficiency, lowering costs and ultimately improving the future health care of children.
207

Controlled Languages in Software User Documentation

Steensland, Henrik, Dervisevic, Dina January 2005 (has links)
<p>In order to facilitate comprehensibility and translation, the language used in software user documentation must be standardized. If the terminology and language rules are standardized and consistent, the time and cost of translation will be reduced. For this reason, controlled languages have been developed. Controlled languages are subsets of other languages, purposely limited by restricting the terminology and grammar that is allowed.</p><p>The purpose and goal of this thesis is to investigate how using a controlled language can improve comprehensibility and translatability of software user documentation written in English. In order to reach our goal, we have performed a case study at IFS AB. We specify a number of research questions that help satisfy some of the goals of IFS and, when generalized, fulfill the goal of this thesis.</p><p>A major result of our case study is a list of sixteen controlled language rules. Some examples of these rules are control of the maximum allowed number of words in a sentence, and control of when the author is allowed to use past participles. We have based our controlled language rules on existing controlled languages, style guides, research reports, and the opinions of technical writers at IFS.</p><p>When we applied these rules to different user documentation texts at IFS, we managed to increase the readability score for each of the texts. Also, during an assessment test of readability and translatability, the rewritten versions were chosen in 85 % of the cases by experienced technical writers at IFS.</p><p>Another result of our case study is a prototype application that shows that it is possible to develop and use a software checker for helping the authors when writing documentation according to our suggested controlled language rules.</p>
208

In vitro and in vivo testing of a gastric retention device : development and evaluation of a new colonic delivery system

Ahmed, Iman Saad 04 September 2002 (has links)
This thesis describes evaluation of a gastric retention device (GRD) developed at Oregon State University. The device was originally fabricated from Xanthan gum and Locust bean gum. A modified gastric retention device containing other additives was developed and investigated in this work. The modified device was evaluated in vitro for swelling and dissolution properties using riboflavin as a model drug. Different shapes and sizes of GRDs were tested in dogs to study the gastric retention potential of these devices. The effect of the device on food emptying from the stomach in dogs was also investigated. Endoscopic studies in dogs also showed that the device swells rapidly and considerably in gastric fluid. The bioavailability of riboflavin from three different size GRDs was determined in six fasted human volunteers and compared to an immediate release formulation. The biostudy indicated that the bioavailability of riboflavin from a large size GRD was more than triple that measured after administration of the immediate release formulation. Deconvolution was used to determine gastric residence time of the different size GRDs. A new colonic delivery system made of acetaminophen loaded beads produced by extrusion and spheronization and coated with different ratios of pectin and ethylcellulose coating solutions in a spray coating apparatus was also developed in this work. Such beads release their drug content in the colon due to susceptibility of pectin in the outer coat to enzymatic action of colonic bacteria. The new delivery system was evaluated in vitro by conducting release studies in different dissolution media to mimic transit times, pH and enzyme conditions in the gastrointestinal tract. The gastrointestinal transit behavior of drug beads was also assessed by conducting gamma-scintigraphic studies in dogs. The bioavailability and pharmacokinetic parameters of acetaminophen from several colonic delivery system formulations were determined in human volunteers and compared to the immediate release commercial product Tylenol®. A selected pectin-ethylcellulose coat formulation in the ratio 1:3 was further evaluated in six volunteers under both fed and fasting conditions and was found to be effective and to provide sustained drug release in the colon over a period of 12 hours. / Graduation date: 2003
209

Development and testing of a sustained release acetaminophen tablet for the treatment of chronic pain in osteoarthritis patients

Keller, Carol Ann 04 May 2000 (has links)
Acetaminophen has been safely used for analgesia for many years. Literature suggests that a plasma acetaminophen level of 5��g/ml is necessary to maintain analgesic relief in humans. Current dosing regiments are inconvenient (every 4-6 hours) and do not maintain this minimum plasma level. Simulations were conducted to examine various doses and input rates for sustained release formulations of acetaminophen. Once parameters were selected from the simulations, sample formulations were prepared and tested using standard dissolution techniques. Investigations into dose/size relationships, hydroxypropylmethylcellulose (HPMC) percentage for erosion matrix tablets, compression force, tablet shape, tablet divisibility, and granulation methods were performed for non-disintegrating hydrophilic matrix tablets. Tablets containing 5% and 7.5% HPMC were selected for pharmacokinetic study in 10 healthy human subjects. Tylenol Extra Strength and Tylenol Extended Relief tablets were administered as control formulations. Pharmacokinetic fitting of the kinetic profiles of all four formulations were performed using Win Nonlin. The formulations were best described by a 1-compartment open model with first order input and first order elimination. The 5% HPMC sustained release acetaminophen formulation was selected for Phase II clinical trials. Patients with osteoarthritis of the knee were recruited for a double blind crossover study of 5% HPMC sustained release acetaminophen formulations and immediate release acetaminophen. Patients received two tablets of study medication, four times a day for 4 weeks. After a seven day wash-out period patients were then crossed over to the other treatment. Patients were evaluated using a twelve question questionnaire and the time to walk 50 feet was measured. Thirty patients were enrolled in the study and seventeen patients completed the study. The sustained release formulations were statistically superior to the baseline treatments in reducing pain level, decreasing disability, and improving the duration of pain relief. Additional, larger scale studies are needed to confirm these findings. / Graduation date: 2000
210

1) Development and in vivo testing of a gastric retention device (GRD) in dogs : 2) product formulations and in vitro-in vivo evaluation of a) immediate release formulation of itraconazole, b) controlled-release formulation of ketoprofen in adults

Kapsi, Shivakumar G. 24 November 1998 (has links)
This thesis describes 1) development of a gastric retention device (GRD) to increase gastric retention time of certain drugs, 2) product formulations of an immediate release itraconazole and controlled-release ketoprofen. GRD was fabricated from crosslinked carbohydrate polymers. Rate and extent of hydration of the film in water and in simulated gastric fluid, compressibility of film, shape of the film, and in vivo gastric transit time in the stomach of dog were used as tools to evaluate gastric retention properties. Hydration studies were carried out at 37��C. Evaluation of the device containing radio-opaque agents, in dogs for gastric retention was carried out with the help of X-rays. The device was found to stay in the stomach of dogs for at least 10 hours. GRD containing amoxicillin trihydrate caplets were evaluated in a human. The area under the excretion rate curve was found to increase by 30% when compared to without the device. A successful development of a formulation of water insoluble itraconazole, without the use of organic solvents, was achieved with modifications from eutectic mixture techniques. Solubilization of the drug was achieved in polyethylene glycol of higher molecular weight. A series of formulations made by varying the amounts ingredients therein, were evaluated for dissolution profile in comparison with the reference, Sporanox��. Effect of molecular weights of PEG and types of PEG were evaluated for desired drug dissolution. Preliminary study from 6 subjects under the conditions of fasting and fed indicated that bioavailability from the new formulation was increased slightly when compared to the reference. This may be correlated to difference in the rate of in vitro dissolution, where the new formulation has initial faster dissolution. A controlled-release formulation of ketoprofen was also developed using a diffusion-controlled polymer, which was coated onto the drug beads. Release of drugs from such beads is controlled by the thickness of the coat. Thickness of the coat was evaluated by SEM and was correlated to the desired in vitro drug release in comparison to the reference Oruvail��. A three-way cross over study involving the new formulation and two marketed products in 12 subjects under fasting conditions indicated that there was a significant difference between the new product and marketed products, so as to be considered non-bioequivalent. Use of In Vitro-In Vivo Correlations and Convolution- Deconvolution relations predicted desired in vitro drug dissolution in a subsequent modification of the formulation. / Graduation date: 1999

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