[Acute treatment of pregnant women after severe trauma-a retrospective multicenter analysis]. / Akutbehandlung schwangerer Patientinnen nach schwerem Trauma ­ eine retrospektive Multicenteranalyse.

BACKGROUND: For the medical team, the management of pregnant trauma patients is a particular challenge. The aim of this study is to compile this data and to determine differences between pregnant and not pregnant trauma patients. MATERIALS AND METHODS: We carried out a retrospective data analysis from the TraumaRegister DGU® with a comparison of 102 pregnant and 3135 not pregnant women of child-bearing age (16-45 years) from 2016-2018 who were treated in a trauma center. All patients were delivered to the resuscitation room and received intensive care treatment. RESULTS: In Germany, Austria and Switzerland 3.2% of all trauma patients (102 women) were pregnant. Women with an average age of 29 years suffered most often trauma as a result of a road traffic accident. Major trauma (Injury Severity Score [ISS] ≥16 points) was seen in 24.5% of the pregnant women and 37.4% of the nonpregnant women. A computer tomography (whole body computer tomography) was carried out in 32.7% of all pregnant women but in 79.8% of the nonpregnant women. As a result of the trauma, 2.9% of the pregnant and 3.5% of the not pregnant women died. The standardised mortality rate (SMR) was 0.42 in pregnant women and 0.63 in nonpregnant women. CONCLUSION: For the first time there is data regarding incidence, trauma mechanism, prehospital and in-hospital care as well as intensive care of pregnant trauma patients in Germany, Austria and Switzerland. Further research regarding foetal outcome and trauma-related injuries in pregnant women is needed to develop an adjusted management for these patients ready to implement in trauma centres. Gynaecologists and obstetricians should be implemented in the trauma room team when needed.

Injection molding as a one-step process for the direct production of pharmaceutical dosage forms from primary powders.

The objective of the present study was to develop a one-step process for the production of tablets directly from primary powder by means of injection molding (IM), to create solid-dispersion based tablets. Fenofibrate was used as the model API, a polyvinyl caprolactame-polyvinyl acetate-polyethylene glycol graft co-polymer served as a matrix system. Formulations were injection-molded into tablets using state-of-the-art IM equipment. The resulting tablets were physico-chemically characterized and the drug release kinetics and mechanism were determined. Comparison tablets were produced, either directly from powder or from pre-processed pellets prepared via hot melt extrusion (HME). The content of the model drug in the formulations was 10% (w/w), 20% (w/w) and 30% (w/w), respectively. After 120min, both powder-based and pellet-based injection-molded tablets exhibited a drug release of 60% independent of the processing route. Content uniformity analysis demonstrated that the model drug was homogeneously distributed. Moreover, analysis of single dose uniformity also revealed geometric drug homogeneity between tablets of one shot.