Microbiological quality of non-sterile pharmaceutical products.

In microbiological terms, pharmaceutical products can be divided into two groups: sterile and non-sterile. Non-sterile drugs must satisfy the appropriate microbiological purity criteria which are included in pharmacopoeial monographs. Pharmacopoeial studies are prepared specifically with a view to ensuring that the medicinal product is therapeutically effective and safe for the patient. The analysis comprised the results of microbiological purity tests performed before the products are marketed. Total of 1285 samples of non-sterile drugs manufactured by different pharmaceutical plants in Polish were taken into study. The microbiological quality of drugs was assessed in accordance with the criteria included in the European Pharmacopoeia (EP). An analysis of test results demonstrated that the percentage of non-compliant samples was 1.87%. The groups of drugs, which the most often did not satisfy EPs' requirements, were drugs containing raw materials of natural origin (5.7%). The samples of studied drugs that did not meet the criteria contained in EP, exceed the maximum allowable microbiological count limits and contained microbes whose presence is prohibited. The most common non-compliance was the excessive levels of the maximum acceptable fungal count (n = 12) and the excessive the maximum acceptable aerobic microbial count (n = 10).

Beclin-1 and its role as a target for anticancer therapy.

The Nomenclature Committee on Cell Death (NCCD, 2009) defines different types of cell death on the basis of morphological, enzymological, immunological and functional criteria. Four basic types of cell death are distinguished from the biochemical point of view: necrosis, apoptosis, autophagy and cornification. Autophagy (macroautophagy) is a highly conserved process by which defective organelles, non-functional proteins and lipids become sequestered within structures called autophagosomes, which fuse with lysosomes, and the engulfed components are then degraded by lysosomal enzymes. The role of autophagy is not only the elimination of components, it also serves as a dynamic recycling system that produces new materials and energy for cellular renovation and homeostasis. Beclin-1 is a protein that plays a central role in autophagy; it interacts with multiple cofactors (Atg14L, UVRAG, Bif-1, Rubicon, Ambra1, HMGB1, IP3R, PINK and survivin) to promote the formation of the Beclin-1-Vps34-Vps15 complex which triggers the autophagy protein cascade. Beclin-1 dysfunction may lead to immune disorders, liver and neurodegenerative diseases as well as cancer. A positive and negative correlation between the expression pattern and/or activity of Beclin-1 and carcinogenesis has been demonstrated. Here we describe recent advances in understanding the molecular dynamics and regulation of autophagy and we discuss Beclin-1's contribution to anticancer therapy.