Mini-tablets (MTs) with losartan potassium were developed to treat the rare disease Epidermolysis Bullosa. The focus was placed on transfer and scale-up of a direct compressible formulation from the compaction simulator STYL\'One Evo (CS) to the rotary tablet press Korsch XM 12 (RP). Transfer of tabletability and compactibility profiles from CS to RP did not show good agreement, e.g. at a tableting pressure of 125 MPa mean tensile strengths (TS) of 4 MPa on CS and 1-1.5 MPa on RP were reached. These results highlight the impact of the feed frame on final product qualities depending on process and material factors. In the scale-up studies the critical quality attributes (CQAs) mass variation, content uniformity, TS and disintegration time were investigated. After an appropriate run-up time, most CQAs reached a plateau, after reaching a balance between influx, efflux and distribution of lubricant in the feed frame. TS values of 1-2 MPa, disintegration times of max. 50 s, mass variation of 0.9-2.2 % (CV) and acceptance values below 15.0 were reached depending on chosen process parameters.

UNASSIGNED: Acute cerebral infarction is a rare complication resulting from an unruptured cerebral aneurysm (UCA). There is presently no consensus on the optimal strategy for the management of UCAs with cerebral infarctions.
UNASSIGNED: A 53-year-old man presented with transient dysarthria and left hemiparesis. Magnetic resonance imaging (MRI) demonstrated the presence of a 7 mm UCA originating from the middle cerebral artery bifurcation, and diffusion-weighted imaging showed no evidence of cerebral infarction. One month later, his transient left hemiparesis recurred, and the patient was admitted to our hospital. Computed tomography angiography showed enlargement of the aneurysm. His left hemiparesis worsened 3 days later. MRI showed cerebral infarction in the area of perforating arteries and further enlargement of the aneurysm with surrounding parenchymal edema. Therefore, the rupture risk was considered to be rarely high and dome clipping was performed immediately. Postoperatively, his neurological status improved without any recurrent brain ischemia.
UNASSIGNED: We report a rare case of a rapidly enlarging aneurysm that presented with cerebral infarction. This is the first report describing aneurysmal sac enlargement that can lead to perforating artery obstruction and brain ischemia. The case illustrates the importance of performing close follow-up examinations to confirm findings that suggest a high rupture risk.

OBJECTIVE: The aim of this article is to compare the gravitational powder blend loading method to the tablet press and manual loading in terms of their influence on tablets\' critical quality attributes (CQA).
CONCLUSIONS: The results of the study can be of practical relevance to the pharmaceutical industry in the area of direct compression of low-dose formulations, which could be prone to content uniformity (CU) issues.
METHODS: In the preliminary study, particle size distribution (PSD) and surface energy of raw materials were determined using laser diffraction method and inverse gas chromatography, respectively. For trials purpose, a formulation containing two pharmaceutical ingredients (APIs) was used. Tablet samples were collected during the compression progress to analyze their CQAs, namely assay and CU.
RESULTS: Results obtained during trials indicate that tested direct compression powder blend is sensitive to applied powder handling method. Mild increase in both APIs content was observed during manual scooping. Gravitational approach (based on discharge into the drum) resulted in a decrease in CU, which is connected to a more pronounced assay increase at the end of tableting than in the case of manual loading.
CONCLUSIONS: The correct design of blend transfer over single unit processes is an important issue and should be investigated during the development phase since it may influence the final product CQAs. The manual scooping method, although simplistic, can be a temporary solution to improve the results of API\'s content and uniformity when compared to industrial gravitational transfer.