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Tumir H.,Agency for Medicinal Products and Medical Devices | Bosnir J.,Andrija Stampar Institute of Public Health | Vedrina-Dragojevic I.,University of Zagreb | Dragun Z.,Ruder Boskovic Institute | And 3 more authors.
Food Control | Year: 2010

Thirty samples of widely used vitamins and herbal preparations distributed on the Croatian market were analyzed by atomic absorption spectrometry in order to estimate contamination with Pb, Cd, As, Hg, Cr, Ni and Zn due to their potential toxicity if present above the maximum allowable levels (MAL). The following concentration ranges were obtained (in μg g-1): Pb 0.25-3.86; Cd 0.05-0.28; As 0.10-0.19; Hg 0.02-0.12; Cr 0.11-64.38; Ni 0.24-338.90; and Zn 1.00-95.3. Several analyzed formulations had metal levels above the maximum allowable limits (Pb: one honey-based product and one medicinal herb-based product; Cr: one product containing vitamins; Ni: two products containing vitamins and one product of animal origin). Moreover, the estimated cumulative daily intakes of several metals from some dietary supplements were higher than the oral permitted daily exposures set by the USP Advisory Panel on metal impurities (Pb: one medicinal herb-based product; Ni: one product containing minerals and one product of animal origin). Such formulations present a significant additional source of metals in the human diet, and therefore could be harmful for human health. © 2009 Elsevier Ltd. All rights reserved.

Hafner A.,University of Zagreb | Lovric J.,University of Zagreb | Lako G.P.,Agency for Medicinal Products and Medical Devices | Pepic I.,University of Zagreb
International Journal of Nanomedicine | Year: 2014

The application of nanotechnology in areas of drug delivery and therapy (ie, nanotherapeutics) is envisioned to have a great impact on public health. The ability of nanotherapeutics to provide targeted drug delivery, improve drug solubility, extend drug half- life, improve a drug's therapeutic index, and reduce a drug's immunogenicity has resulted in the potential to revolutionize the treatment of many diseases. In this paper, we review the liposome-, nanocrystal-virosome polymer therapeutic-, nanoemulsion-, and nanoparticle- based approaches to nanotherapeutics, which represent the most successful and commercialized categories within the field of nanomedicine. We discuss the regulatory pathway and initiatives endeavoring to ensure the safe and timely clinical translation of emerging nanotherapeutics and realization of health care benefits. Emerging trends are expected to confirm that this nano-concept can exert a macro-impact on patient benefits, treatment options, and the EU economy. © 2014 Hafner et al.

Orsolic N.,University of Zagreb | Bevanda M.,Clinical Hospital Mostar | Kujundi N.,University of Zagreb | Plazonic A.,Agency for Medicinal Products and Medical Devices | And 2 more authors.
Planta Medica | Year: 2010

The presence of peritoneal carcinomatosis arising from gastrointestinal and gynecologic tumors is associated with a poor prognosis. Animal models of peritoneal carcinomatosis are important in the evaluation of new treatment modalities. The purpose of this study was to investigate the effect of local chemoimmunotherapy and hyperthermal intraperitoneal chemotherapy (HIPEC) in an animal model of induced peritoneal carcinomatosis in the mouse. For induction of peritoneal carcinomatosis, cells from transplantable mammary carcinoma (MCa) were implanted intraperitoneally in CBA mice. Seven or 3 days before implantation of MCa cells (5×103) the mice were injected with lyophilized water extract from Caucalis platycarpos L. (CPL; 200mgkg 1) into the abdominal cavity. Immediately after implantation of MCa cells in the abdominal cavity, mice were treated two times with 2mL of saline that was heated either at 37°C or 43°C (hyperthermal treatment) and cytostatics (doxorubicin 20mgkg1, cisplatin 10mgkg1, mitomycin 5mgkg1, 5-FU 150mgkg1). We followed the survival of animals and the side effects appearing with different forms of treatment. CPL increased the life span of mice with peritoneal carcinomatosis without hyperthermal treatment (ILS%=32.55%) but showed no effect on the life span of mice with hyperthermal treatment (ILS%=1.44). Combined treatment with CPL and cytostatics (CIS, DOX, and MIT) significantly affected the development of peritoneal carcinomatosis and increased the survival of mice (ILS% 37°C=144.17, 415.46, and 124.13, ILS% 43°C=311.42, 200.74, and 138.33, respectively). However, intraperitoneal chemotherapy with 5-FU alone resulted in greater survival time of mice than the treatment with 5-FU + CPL. Results suggest the synergistic effect of hyperthermia, chemotherapy, and immunotherapy. CPL significantly increases the antitumor activity of the hyperthermic chemotherapy and the survival rate of mice with peritoneal carcinomatosis. The stimulative effect of CPL on immunomodulation may be a possible mechanism which protects mice from developing peritoneal carcinomatosis and reduces the side effects of chemotherapy, increasing the life span of mice. © Georg Thieme Verlag KG Stuttgart · New York.

Plazonic A.,Agency for Medicinal Products and Medical Devices | Males Z.,University of Zagreb | Mornar A.,University of Zagreb | Nigovic B.,University of Zagreb | Kujundzic N.,University of Zagreb
Chemistry of Natural Compounds | Year: 2011

The water extract of burr parsley (Caucalis platycarpos L.) showed remarkable antitumor activity in rats and mice. Phenolic compounds, including phenolic acids and flavonoids, are considered to be the major bioactive compounds. The aim of this work was to develop a reverse phase HPLC-DAD method for the simultaneous quantification of flavonoid aglycones and phenolic acids, and an HPLC-DAD-MS/MS method for structural characterization of phenolic compounds, obtained after hydrolysis of C. platycarpos methanolic extract. Caffeic acid was the predominant phenolic acid, and luteolin was the predominant flavonoid aglycone. The optimized and validated method for the determination of the five phenolic acids and four flavonoid aglycones ensured reliable results and could be used for the quality control of raw plant material. © 2011 Springer Science+Business Media, Inc.

Mirosevic Skvrce N.,Agency for Medicinal Products and Medical Devices
Croatian medical journal | Year: 2011

To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence. In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them. HALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drug-drug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n=4) was significantly higher (P<0.001) than among the remaining reports (580 out of 1982; n=2, respectively). Actual drug-drug interactions most frequently involved nervous system agents (34.0%), and interactions caused by antiplatelet, anticoagulant, and non-steroidal anti-inflammatory drugs were in most cases serious. In only 12 out of 94 reports, actual drug-drug interactions were recognized by the reporter. The study confirmed that the Spontaneous Reporting Database was a valuable resource for detecting actual drug-drug interactions. Also, it identified drugs leading to serious adverse drug reactions and deaths, thus indicating the areas which should be in the focus of health care education.

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