Effect of the material of primary packaging containers on providing of visual inspection of pharmaceutical products

Introduction:Today all over the world requirements to drug quality have become more and more strict and its evaluation is one of the most important tasks. Usually input quality control of medicines and other groups of goods is carried out organoleptically (mainly visually) by authorized persons of pharmaceutical establishments. Primary packaging is one of the most critical components in this process, because it strongly influences on possibility of visual control of goods and, of coarse, it should be transparent. Aim:The aim of this article was to analyze primary packaging of some drugs and possibility of their identification and quality evaluation.Materials and Methods:Objects of this study were primary packages of 65 randomly taken drugs produced by some leading manufacturers in different dosage forms. Inspection analysis of quality of the researched medicinal products was provided in 8 steps: checking of the accompanying documents, checking quantity of the goods, organoleptic control of packaging, checking of labeling, checking of barcodes, checking of completeness, visual control of a product, composing of documentation for acceptance of the goods.Results and Conclusion:All investigated drugs passed the first 6 stages of inspection analysis positively. 46 samples among 65 (or 71%) could not be visually controlled (stage 7) and their appearance was impossible to check because of non-transparency of the containers. If in terms of dosage forms 53% of studied tablet drugs, 88% of eye drops and 100% of suppositories can not be evaluated visually

Perinatal asphyxia: current status and approaches towards neuroprotective strategies, with focus on sentinel proteins

Delivery is a stressful and risky event menacing the newborn. The mother-dependent respiration has to be replaced by autonomous pulmonary breathing immediately after delivery. If delayed, it may lead to deficient oxygen supply compromising survival and development of the central nervous system. Lack of oxygen availability gives rise to depletion of NAD+ tissue stores, decrease of ATP formation, weakening of the electron transport pump and anaerobic metabolism and acidosis, leading necessarily to death if oxygenation is not promptly re-established. Re-oxygenation triggers a cascade of compensatory biochemical events to restore function, which may be accompanied by improper homeostasis and oxidative stress. Consequences may be incomplete recovery, or excess reactions that worsen the biological outcome by disturbed metabolism and/or imbalance produced by over-expression of alternative metabolic pathways. Perinatal asphyxia has been associated with severe neurological and psychiatric sequelae with delayed clinical onset. No specific treatments have yet been established. In the clinical setting, after resuscitation of an infant with birth asphyxia, the emphasis is on supportive therapy. Several interventions have been proposed to attenuate secondary neuronal injuries elicited by asphyxia, including hypothermia. Although promising, the clinical efficacy of hypothermia has not been fully demonstrated. It is evident that new approaches are warranted. The purpose of this review is to discuss the concept of sentinel proteins as targets for neuroprotection. Several sentinel proteins have been described to protect the integrity of the genome (e.g. PARP-1; XRCC1; DNA ligase IIIα; DNA polymerase β, ERCC2, DNA-dependent protein kinases). They act by eliciting metabolic cascades leading to (i) activation of cell survival and neurotrophic pathways; (ii) early and delayed programmed cell death, and (iii) promotion of cell proliferation, differentiation, neuritogenesis and synaptogenesis. It is proposed that sentinel proteins can be used as markers for characterising long-term effects of perinatal asphyxia, and as targets for novel therapeutic development and innovative strategies for neonatal care