RESUMEN
The distribution of biopharmaceuticals often requires either ultra-cold conditions or lyophilisation. In both cases, the drug product is frozen and, thus, exposed to similar stress conditions, which can be detrimental to its quality. However, these stresses can be inhibited or mitigated by a suitable formulation and/or an appropriate freezing design. This paper addresses how the key freezing parameters, i.e., ice nucleation temperature and cooling rate, impact the freezing behaviour of a sucrose-based formulation. The analysis included two loading configurations, vials directly resting on the shelf and nested in a rack system. The loading configuration affected the product freezing rate and the ice nucleation temperature distribution, resulting in larger ice crystals in the case of vials nested in a rack system. SEM micrographs and specific surface area measurements confirmed the different product morphology. Eventually, the different product morphology impacted the bioactivity recovery of lactate dehydrogenase.
RESUMEN
BACKGROUND: To investigate the epidemiology, visual outcome, and hospitalization costs of open globe injury in Northern Sardinia, Italy. METHODS: A population-based study involving all residents of Northern Sardinia. Hospital records were analyzed to obtain information on open globe injury. Age, gender, place of residence, occupation, cause of injury, circumstances, eye protection, visual outcome, and hospitalization costs were assessed. Statistical analysis was performed using an ordered probit estimate to calculate the predicted probability of visual outcome and a cross sectional linear regression model to evaluate some determinants of hospitalization costs. RESULTS: From 1993 to 2004, 176 residents (169 men, 7 women) were hospitalized for open globe injury. The overall annual incidence was 3.2 per 100,000. A bimodal age pattern was observed, with peaks at ages 20-24 and 50-59 years. The commonest occupation was "retired" (13.6%); 71% of injuries occurred during domestic or leisure activities. At the time of injury, 93.2% of patients were wearing no eye protection, 5.7% were wearing only ordinary spectacles, and 1.1% were wearing the correct protective equipment (safety goggles, shield). Final vision was < 3/60 in 27.3% of cases. Analyzing the predicted probability of blinding outcome, hospitalization costs were significantly influenced by greater age, retirement, residence in a rural area, and trauma occurrence during the weekend. CONCLUSIONS: Open globe injury in Northern Sardinia varied with age, gender, and residence, was associated with lack of eye protection, and often resulted in severe visual loss. People engaged in domestic or leisure activities, especially the retired, are at highest risk, suggesting the need for targeted messages. This could reduce the incidence of open globe injury and its associated costs on the community.