ObjectiveThe use of once-daily dual-release HC (DR-HC) in primary adrenal insufficiency (PAI) is often associated with benefits in metabolic parameters when compared to immediate-release HC (IR-HC). In this study, we evaluated the effects on clinical, biochemical and metabolic parameters of switching from IR-HC to lower-dose DR-HC given both in once and fractionated daily doses.MethodsTwenty autoimmune-PAI subjects were included. Patients on 30 mg/day divided in three doses IR-HC regimen (group A) were switched to DR-HC 25 mg/day given in two daily doses (20 mg in the morning and 5 mg at 2.00 p.m.); patients on 25 mg/day divided in two doses IR-HC regimen (group B) were switched to DR-HC 20 mg once daily. Biochemical and metabolic parameters, BMI and quality of life (QoL) were evaluated at the baseline and six months after the switch.ResultsOur small non-randomized study with short follow up showed significant benefits in both group A and group B without any apparent side-effects. After the switch to DR-HC, a significant decrease in adrenocorticotropic hormone (ACTH), HbA1c, total cholesterol, triglycerides, LDL, cholesterol, BMI as well as a significant improvement in QoL, were observed in both groups. At 6 months, ACTH levels were lower in group A while HbA1C and total cholesterol were lower in group B.ConclusionThe DR-HC is a valid and effective therapeutic strategy to improve the metabolic control and the QoL in PAI. The reduction of ACTH levels with DR-HC regimens reflects a better biochemical control of PAI, obtained by using a lower dose and more physiological HC formulation. Both once-daily and fractionated daily doses of DR-HC showed advantages compared with IR-HC formulation.
Flexible packaging is a growing successful market and the majority of flexible package applications are for the food industry. The demand for process optimization and reduced production costs, has led to an increase in flexible packaging. However, fast production lines can result in contamination in the seal area. For flexible food packaging, contamination is considered any food particle or substance trapped in the seal area. Current quality control processes can detect contamination in the seal area, but it is not determined if seal contamination effects seal quality. Oil-based and sodium based snack foods are two common categories that can be packaged on a horizontal flow film and seal (HFFS) flow-wrap machine. The study uses vegetable oil and a salt water solution to simulate the effect of liquid contamination along the Tpoint of flexible pouches made on an HFFS. The T-point refers to where the fin seal meets the end seal and requires the seal jaw to seal through four layers of film, which is the most difficult point to seal. The study tests a combination of different sealing temperatures and dwell time to determine the optimal sealing condition for a hermetic seal. A quality hermetic seal provides an enclosed seal with no leaks due to successful polymer chain entanglement between the two sealant layers. The different test categories of the study are non-contaminated (control), salt water solution for salt based foods, and vegetable oil for oil-based foods. Given the test parameters of the study, 140⁰C sealing temperature and 0.3 seconds dwell time are considered to be the optimal sealing condition for all three test categories. For Phase 1 of the study, salt water has a lower hermeticity pass rate compared to vegetable oil and non-contaminated seals. In addition, the effect of refrigerated storage temperature and ambient storage temperature did not show to be significant for any of the test categories. However, refrigerated conditions showed a higher hermeticity pass rate, but it was not statistically different. The findings for seal strength indicated no test category had higher or lower seal strength over the 14 day test period. Overall, the study shows there is no effect of liquid contaminant on hermeticity and seal strength for flexible film with LLDPE sealant layer.v ACKNOWLEDGMENTS
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