Stability and repeatability of a continuous twin screw granulation and drying system.

The aim of this study was to investigate the process transfer of a commercially available product from the current batch fluid bed granulation and drying production method to an innovative continuously operating "from powder to tablet" production line using twin screw granulation as an intermediate granulation step. By monitoring process outcomes (torque, water temperature at the granulator jacket inlet, differential pressure over the dryer filters, and temperature mill screen) and granule and tablet quality in function of process time, the stability and repeatability during long production runs were determined. Three consecutive 5h "from powder to tablet" production runs were performed using the ConsiGma™-25 system (GEA Pharma Systems, Collette™, Wommelgem, Belgium). A premix of two active ingredients, powdered cellulose, maize starch, pregelatinized starch, and sodium starch glycolate was granulated with distilled water. After drying and milling (1000 µm and 800 rpm), granules were in-line blended with magnesium stearate and directly compressed using a Modul™ P tablet press (tablet weight: 430 mg, main compression force: 12 kN). Granule (loss on drying, particle size distribution, friability, flow) and tablet (weight uniformity, hardness, thickness, friability, content uniformity, disintegration time, and dissolution) quality was evaluated in function of process time. For each of the logged process outcomes, a stabilization period was needed to reach steady-state conditions. Slightly deviating particle size distribution and friability results for milled granules were observed during start-up due to initial layering of the mill screen. However, no deviating tablet quality was detected in function of process time. For multiple hours, granule and tablet quality was constant in function of process time. Furthermore, process data trends were highly repeatable. Consequently, the ConsiGma™-25 system can be considered as a stable and repeatable system for the continuous production of tablets via wet granulation.

Fatal outcome in atrial migration of the Tempofilter.

PURPOSE: To report the risk of fatal atrial migration with the Tempofilter. METHODS: Among temporary filters, the high safety profile Tempofilter has been marketed as offering protection for up to 6 weeks. We implanted about 60 Tempofilters to prevent pulmonary embolism. The main indications were temporary thromboembolic risk, recurrent pulmonary embolism, and contraindication to or failure of anticoagulant therapy. Follow-up was performed regularly by plain abdominal film and Doppler ultrasound. Filters were removed about 4 weeks after placement. RESULTS: We encountered three cases (5%) of atrial migration and one case of 5-cm cephalad displacement of the filter. Of the three patients with atrial migration, two died within 3 days of implantation, one from a massive pulmonary embolism and the other with cardiac tamponade. One patient did not show any serious complications. CONCLUSIONS: The Tempofilter may actively migrate cranially and become dangerous in the case of migration within the heart.

Prosthetic graft infection: diagnostic and therapeutic role of interventional radiology.

PURPOSE: Aortic graft infection is a rare complication of aortic surgery associated with high mortality and morbidity rates. The aim of the study was to evaluate the authors' experience with diagnostic and interventional procedures in the management of aortic graft infection. METHODS: Six patients with clinical signs suggestive of graft infection were studied. Abdominal computed tomography (CT) was performed in all patients. Diagnostic work-up was performed with perigraft puncture for fluid aspiration and contrast medium injection to confirm clinical signs or CT findings of graft infection, and to detect graft-enteric fistulas. Percutaneous drainage of the peri-prosthetic abscess was performed as attempted therapy in four patients. RESULTS: In four patients, CT examination findings were considered positive for graft infection. Culture and cytologic examination of aspirates revealed numerous white blood cells but did not show any growth. In three patients, direct contrast medium injection into the perigraft space allowed the detection of a graft-enteric fistula. In three patients, percutaneous drainage was performed as preoperative therapy, allowing improvement of the surgical outcome; in one patient the catheter was left in place as an attempt at definitive therapy, allowing a complete recovery. CONCLUSIONS: The percutaneous approach to prosthetic graft infection permits both the drainage and aspiration of the fluid in the perigraft area for laboratory studies. Percutaneous drainage can offer the possibility of definitive cure in patients for whom surgical management is considered too risky or, at least, represents a temporizing maneuver to improve the patient's general condition before surgery.

[The diagnostic accuracy and reproducibility of computed tomography with water distention and induced hypotonia in the preoperative staging of gastric tumors]. / Accuratezza e riproducibilità diagnostica della Tomografia Computerizzata con distensione idrica e ipotonia indotta nella stadiazione preoperatoria dei tumori gastrici.

Thirty-five patients with gastric cancer were preoperatively examined with CT performed in the prone position. Patient preparation consisted in filling the stomach with tap water and i.v. glucagon administration. The CT images were independently reviewed by two radiologists, who staged each tumor according to the TNM classification. The results were compared with surgical and histological findings. The overall accuracy for T staging ranged 74-77%, overstaging 17-23%; understaging was 3%. Diagnostic sensitivity, specificity and accuracy for serosal invasion were 100%, 80%, 85% and 100%, 84% e 88%, respectively, for the two radiologists. The overall accuracy for N staging was 48% and 51% for the two observers, respectively. Considering N1 and N2 as a single group, accuracy ranged 68-77%. The interobserver agreement analyzed by the "K tests" was 80%, with a K index of 60%. CT performed with the patient in the prone position, after preparation with gastric wall hypotony and distension with water, is a valid technique permitting excellent depiction of the gastric wall and providing useful preoperative information to the surgeon.