amphotericin-b and Hypoalbuminemia

Guidance on dissolution testing for parenteral formulations is limited and not often related in vivo performance. Critically ill patients represent a target cohort, frequently hypoalbuminaemic, to whom certain parenteral formulations are administered. Amphotericin B (AmB) is a poorly soluble, highly protein-bound drug, available as lipid-based formulations and used in critical illness. The aim of this study was to develop media representing hypoalbuminaemic and healthy plasma, and to understand and simulate the dissolution profile of AmB in biorelevant media. Dissolution media were prepared with bovine serum albumin (BSA) in Krebs-Ringer buffer, and tested in a flow through cell apparatus and a bottle/stirrer setup. Drug activity was tested against Candida albicans. BSA concentration was positively associated with solubility, degradation rate and maximum amount dissolved and negatively associated with dissolution rate constant and antifungal activity. In the bottle/stirrer setup, a biexponential model successfully described simultaneous dissolution and degradation and increased in agitation reduced the discriminatory ability of the test. The hydrodynamics provided by the flow-through cell apparatus was not adequate to dissolve the drug. Establishing discriminating test methods with albumin present in the dissolution media, representing the target population, supports future development of biorelevant and clinically relevant tests for parenteral formulations.

Topics: Amphotericin B; Antifungal Agents; Buffers; Candida albicans; Candidiasis; Chemistry, Pharmaceutical; Drug Compounding; Humans; Hypoalbuminemia; Lipids; Proteins; Serum Albumin, Bovine; Solubility

The morbidity and death rate of visceral leishmaniasis (VL) is important. The aim of our study is to find prognosis factors of VL. Two hundred and thirty two children with VL were retrospectively studied. These children were followed in Rabta and Kairouan hospitals between 1985 and 1998. We identify 7 prognosis factors, at the hospital admission, visit delayed more than 56 days, fever during more than 21 days, normal or low temperature, haemorrhagic syndrome hemoglobin rate < 5.5 g/dl, sedimentation rate < 25 mm and hypoalbuminaemia < 30 g/l. The presence of one prognosis factors or more appears to consider amphotericin B as a first-line treatment.

Topics: Amphotericin B; Antiprotozoal Agents; Blood Sedimentation; Child; Child, Preschool; Female; Fever; Hemorrhage; Humans; Hypoalbuminemia; Infant; Leishmaniasis, Visceral; Male; Prognosis; Retrospective Studies; Risk Factors; Time Factors

A voluminous trichobezoar was discovered in an 11-year-old girl without major clinical implications. The diagnosis was made by endoscopy and surgery was performed without complications.

Topics: Amphotericin B; Anemia, Hypochromic; Anti-Bacterial Agents; Bezoars; Child; Diagnosis, Differential; Female; Gastroscopy; Humans; Hypoalbuminemia; Madagascar; Stomach; Weight Loss