Scale-up of Adhesive Transdermal Drug Delivery Systems

Pharmaceutical Research -     

Microaggregate counts in frozen-preserved erythrocytes: effects of washing in three blood processors and filtration

Since microaggregates have been implicated in posttransfusion pulmonary insufficiency, their elimination has become an active concern in blood transfusion. Various types of filters, as well as frozen-preserved erythrocytes, have been used to provide blood relatively low in microaggregates. We have counted particles in frozen-stored blood before deglycerolization, after washing in each of three cell processing systems, and after filtration through a 40-micrometer filter. Washing frozen erythrocytes reduced the total particle counts by an average of 89%. Slight differences were found among the three blood processors with respect to particle removal. Passing washed blood through a 40-micrometer filter did not result in significant further reduction in particle counts. Hence, the use of such filters in a frozen-preserved blood system is not warranted.     

Scaleup of Oral Extended-Release Dosage Forms

Pharmaceutical Research -     

Longitudinal study of cardiovascular disease in U.S. Navy pilots

This longitudinal study examined the consequences of cardiovascular disease (CVD) in 145 U.S. Navy pilots who suffered a CVD incident during the 1972-79 time period. Results showed that one pilot died, one suffered a second acute myocardial infarction, and 32 pilots were hospitalized and/or retired with a physical disability because of CVD. The majority of subsequent CVD incidents occurred during a 12-month period after the initial CVD event; 35% had discontinued flying prior to the initial CVD incident. Percentages of pilots who either remained on active duty or were separated for nonmedical reasons ranged from 64.3% for pilots in the chronic ischemic heart disease sample to 97.6% for the symptomatic heart disease group. Thus, the majority of pilots were returned to duty either after the initial CVD incident or subsequent to the rehospitalization or physical evaluation board. In general, these findings reflected the high level of physical and mental well-being of the U.S. Navy pilot population.     

Pharmaceutical Solids: A Strategic Approach to Regulatory Considerations

Purpose. This review describes a conceptual approach to the characterization of pharmaceutical solids. Methods. Four flow charts are presented: (1) polymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous forms. Results. These flow charts (decision trees) are suggested as tools to develop information on pharmaceutical solids for both scientific and regulatory purposes. Conclusions. It is hoped that this review will lead to a more direct approach to the characterization of pharmaceutical solids and ultimately to faster approval of regulatory documents containing information on pharmaceutical solids.     

Profiling overweight patients in the U.S. Navy: health conditions and costs

The U.S.A. has the distinction of being the "fattest" nation in the world, with an estimated 34 million obese citizens. Of grave concern is the reported finding that obesity contributes to 20% of the annual mortality rate, primarily for such conditions as diabetes mellitus, digestive diseases, coronary heart disease, and cerebrovascular disease. In 1982, the Navy initiated the "Health and Physical Readiness Program" in order to establish body fat percentages and physical conditioning standards and to provide Navy personnel with weight reduction and other health promotion programs. Participation in such programs is expected to help overweight personnel solve their weight problems and reduce the risks of obesity-related conditions. The purpose of this study was (1) to identify the health conditions recorded in a sample of U.S. Navy enlisted men who had been diagnosed as obese during one or more of their admissions to a Naval hospital from 1974 through 1984, (2) to determine whether these disorders correspond with those reported in the scientific literature, and (3) to examine the obesity-related costs in terms of numbers of days hospitalized and career outcome. The patient population consisted of 518 U.S. Navy enlisted men who were given a primary diagnosis of obesity and 1,092 who received a secondary or additional diagnosis of obesity on at least one of their inpatient medical records between 1974 and 1984. A 10% sample of Navy male patients, all of whom had not been diagnosed as obese, was selected as a comparison group (n = 30,829). All diagnoses (ICD-9) for each hospitalization were included in the data compilations; however, each unique diagnosis was only counted once.(ABSTRACT TRUNCATED AT 250 WORDS)     

Age-specific morbidity among Navy pilots

This study compares the morbidity (hospitalization) rates by age of male Navy aviators (n = 22,417) with rates for three male control populations: nonpilot aircrew officers (n = 9,483), unrestricted line officers (n = 55,593), and staff officers (n = 46,565). Aircrew members and pilots have the highest hospitalization rates of the four officer groups for both total admissions and for most of the 16 major diagnostic categories. Younger pilots have the highest rates for the disorders of tooth development and eruption and accidental injuries (primarily sports-related) while one of the highest rates for older pilots is observed for circulatory diseases. Compared to civilian samples, the four officer populations are considerably healthier. To further protect the health of Navy personnel, a health risk profile should be developed, implemented, and used as the initial step in reducing and eliminating health risk factors.     

Health profile of U.S. Navy pilots of electronically modified aircraft

This study compared hospitalization rates of pilots who primarily flew electronically modified aircraft (n = 1,063) with an age-matched group of pilots who flew other types of aircraft (n = 2,126). Of the two groups, control pilots at ages 21-26 had a significantly higher mortality rate for aviation-related injuries and a higher hospitalization rate for the diagnostic category of accidents, poisonings, and violence. Their hospitalization rates also were significantly higher than pilots of electronically modified aircraft for mental disorders at ages 27-32 and supplementary classifications at ages 39-44. Significant age-specific increases in rates were observed for cardiovascular disease and alcoholism in the control group whereas no significant increases were noted for pilots of electronic models. Pilots in the latter group had low rates for conditions postulated as related to radiation exposure. Such results indicated that pilots of electronically modified aircraft were not at increased risk for illness or injury because of the aircraft models they primarily flew.