Reprocessing of Microcrystalline Cellulose Spheres with Low Drug Concentrations

Spherical dosage forms have been reported to be an efficient and effective method for delivering drugs into the body and controlling their dissolution rate. Substantial work has been conducted in these laboratories illustrating the advantages of microcrystalline cellulose-based spheres for these purposes. Through various methodologies, but most routinely the extrusion and marumerization technique, it has been determined by Funck, et al. that not more than 50% drug can be incorporated into a sphere formulation without the addition of other binders.

Because of the nature of the extrusion and marumerization manufacturing process, the type of drug being processed and the resultant particle size requirements of the spheres, the percent of spheres falling outside the desired particle size can range from between 3% and 20%. For this reason and the possibility of operator errors, our objective was to determine the parameters which needed monitoring when reprocessing was necessary.     

A case study in SQA audits

Software quality assurance (SQA) audits are becoming a standard practice in corporations seeking to enter contractual relations with other organizations, or just evaluating their own state of readiness. This paper describes one approach to conducting SQA audits. Excerpts from reports of actual audits conducted on several organizations engaged in software development are used to show how an audit is conducted and what can be achieved through the auditing process. The paper is not meant to be a definitive answer or guide to doing SQA audits. Rather, it serves as an annotated case study of how SQA audits can be conducted with an emphasis on data gathering and reporting.Dr Paul W. Oman is an associate professor of computer science at the University of Idaho, and an independent software consultant who specializes in software analysis. He is the director of the Software Engineering Test Lab within the UI College of Engineering, where he conducts research in software development methods, CASE tools, and software maintainability issues. Oman has published over 50 articles and reports on software tools, software development, and computer science education. He has a PhD in computer science and is a member of the IEEE, IEEE Computer Society, and ACM.     

The Effects of Fatty Acids and Their Derivatives on the Intestinal Absorption of insulin in Rat

Insulin solution (25 U/ml/kg, pH 8.0) was administered with 50 mM of various C8-Cl8 fatty acid and derivative absorption enhancers to the duodenum, colon and rectum of fasted normal rats under sodium pentobarbital anesthesia. Solutions were administered directly into ligated or sealed intestinal segments. Blood was sampled periodically from the jugular vein and blood glucose levels determined. The maximum decrease in blood glucose level and area under the depression curve were used to estimate bioavailability. Enhancing effects rectally were further investigated in streptozotocin-induced diabetic rats in both the fasted and non-fasted states. Blood glucose levels and serum insulin concentrations were determined.     

Numerical and experimental studies of high-velocity impact fragmentation

Developments are reported in both numerical and experimental capabilities for characterizing the debris spray produced in penetration events. We have performed a series of high-velocity experiments specifically designed to examine the fragmentation of the projectile during impact. High-strength, well-characterized steel spheres (6.35 mm diameter) were launched with a two-stage light-gas gun to velocities in the range of 3 to 5 km/s. Normal impact with PMMA plates, thicknesses of 0.6 to 11 mm, applied impulsive loads of various amplitudes and durations to the steel sphere. The extent of fragmentation, loss in momentum, and divergence of the debris are shown to correspond to the impact conditions. Multiple flash radiography was used to monitor material motion and fragmentation of the steel sphere during the impact event. Dynamic fragmentation theories, based on energy-balance principles, were used to evaluate local material deformation and fracture state information from CTH, a three-dimensional Eulerian solid dynamics shock wave propagation code. The local fragment characterization of the material defines a weighted fragment size distribution, and the sum of these distributions provides a composite particle size distribution for the steel sphere. The calculated axial and radial velocity changes agree well with experimental data, and the calculated fragment sizes for a specific experiment are in qualitative agreement with the radiographic data.     

Alcoholism: independent predictor of survival in patients with head and neck cancer

BACKGROUND: Despite recognition of the high prevalence of alcoholism among patients with head and neck cancer, the prognostic importance of alcoholism has not been evaluated adequately. Previous investigators have speculated that alcoholic patients may have a poorer prognosis than nonalcoholic patients because of more advanced stage of cancer, the immunosuppressive effects of alcohol, and an increased rate of death due to other alcohol-related diseases. PURPOSE: The goal of this population-based study was to identify the features of alcoholism that are associated with survival for patients with head and neck cancer and to develop an alcoholic severity staging system from a composite of the independent features of alcoholism. METHODS: This prospective study included 649 patients who were diagnosed with cancer of the oral cavity, oropharynx, hypopharynx, or larynx during the period from September 1, 1983, through February 28, 1987, in a three-county area of western Washington state that participates in the Surveillance, Epidemiology, and End Results Program of the U.S. National Cancer Institute. Details on lifetime alcohol consumption, treatment for alcoholism, abstinence from alcohol prior to the diagnosis of cancer, and alcohol-related health problems were ascertained through in-person interviews near the time of diagnosis. Patients were classified as either nonalcoholics or alcoholics according to their responses to questions from the Michigan Alcoholism Screening Test. The measures of alcohol consumption and abuse that were found to be independently associated with 5-year survival by logistic regression analysis were combined using conjunctive consolidation to create a final composite variable, called an alcoholic severity stage. Cox proportional hazards regression analysis was done to estimate the relative risk (R) of death within 5 years due to specific causes of death for each of the alcoholic severity stages. RESULTS: Alcoholism (RR = 2.06; 95% confidence interval [CI] = 1.43-2.98) and a history of alcohol-related systemic health problems (i.e., liver disease, pancreatitis, delirium tremens, or seizures) (RR = 2.76; 95% CI = 1.69-4.49) were associated with an increased risk of death, whereas abstinence (i.e., the consumption of fewer than one drink per week at 1 year prior to the diagnosis of cancer) (RR = 0.62; 95% CI = 0.39-0.97) was associated with a decreased risk of death. These associations were independent of age, site of cancer, anatomical stage, histopathologic grade, smoking, and type of antineoplastic treatment. Patients in the two worst alcoholic severity stages had an increased risk of dying not only of head and neck cancer but also of cardiovascular disease, pulmonary disease, and other alcohol-related causes. CONCLUSIONS: Alcohol abuse, measured by alcohol consumption, functional impairment, a history of alcohol-related health problems, or abstinence, can provide important prognostic information for patients with head and neck cancer. Our results suggest that sobriety among alcoholic patients can lead to prolonged survival.     

Ultrasonography, CT and MRI of retropharyngeal ganglioneuroma: a very rare neoplasm in adults

Ganglioneuroma, a rare benign tumour, very occasionally presents in adult life. We report a case with the additional unusual feature of a retropharyngeal location.     

Cost-benefit analysis of power system reliability: two utility casestudies

There is an emerging recognition that utility investments and other decisions that affect electric service reliability should be explicitly evaluated on the basis of their cost and benefit implications. A cost-benefit approach that quantifies the reliability benefits of alternatives in terms of the reduction in costs resulting from unserved energy enables the evaluation of generation and transmission capacity additions on a consistent, economic basis. This approach has been applied to two utility case studies. In a case study for Pacific Gas and Electric Company, it was used to evaluate three options for maintaining reliability in a major load center-two involving local generation, and the third, a new 230 kV transmission connection. In a case study for Duke Power Company, the approach was used to evaluate alternative designs for proposed additions to a transmission station. This paper describes the methodology and presents the two utility studies