Nanomedicine Clinical Use, Regulatory and Toxicology Issues in Europe

Nano medicine is a revolutionizing field that can benefit both diagnosis and treatment and contribute to a better quality of life. Despite the expected huge benefits, the potential risks on human health are significant as well. This thesis aims to defense a perspective that in case of nascent technologies, where the data are still emerging and scientific uncertainty prevails, risk governance should sustain the process of scientific knowledge by developing guidelines, codes of conduct and public information and provide a minimum level of safety acceptable to protect human health. Although Nano medicine is at an early stage of development some cautious measures should be taken that will provide regulatory mechanisms able to respond to the challenges posed by Nano medicine, establish a minimum level of safety but will also allow the further promotion of scientific knowledge. This multidisciplinary approach can contribute in adopting regulatory choices and tools that will help manage the risks, protect human health and promote scientific knowledge.  As the technologies are designed based on a clear understanding of a particular disease, disease specific oriented focus is required for the development of novel pharmaceuticals. In addition, it will be important to establish a case-by-case approach to clinical and regulatory evaluation of each Nano pharmaceutical. High priority should be given to enhancing communication and exchange of information among academia, industry and regulatory agencies encompassing all facets of this multidisciplinary approach. Keywords: novel pharmaceuticals, Nano pharmaceuticals, toxicological issues, clinical use, Nano medicine

DESIGN AND EVALUATION OF SPHERICAL AGGLOMERATED CRYSTALS LOADED FAST DISOLVING TABLETS FOR ENHANCING THE SOLUBILITYOF MEFENAMIC ACID

The objective of the present work was to study the effect of different polymers on the solubility and dissolution rate of Mefenamic acid a poorly water soluble NSAIDs, by spherically agglomeration using methanol, water and dichloromethane as good solvent, poor solvent and bridging liquid, respectively. The quasi-emulsion solvent diffusion technique was used as a method for spherical agglomeration. Spherical agglomeration of Mefenamic acid were prepared by using Poloxomer -F338 and Gelucire 48/16 in the ratio of 1:0.5,1:0.75,1:1. The agglomerates were subjected to various physicochemical evaluations such as practical yield, drug content, solubility, flow properities, average particle size,scanning electron microscopy and dissolution studies. The optical electron microscopy studies showed that the agglomerates posseeses a good spherical shape. This study, demonstrated that the successful development of directly compressible spherical agglomerates of Mefenamic acid prepared with selected carrires enhances the in-vitro dissolution property of Mefenamic acid, whichcould provide rapid onset of action and potentially increases oral bioavailability. To study the influence of co-processed superdisintegrants on performance of Mefenamic acid Fast dissolving tablets, a set of three formulations (F7, F8, F9) were prepared using co-processed superdisintegrants (Croscarmalose sodium:Crospovidone) in three different ratios 1:1, 1:2, 1:3 respectively. The formulation prepared with co-processed superdisintegrants (Croscarmalose sodium: Crospovidone) in 1:3 ratio (F9) was offered relatively rapid release of Mefenamic acid when compared with other ratios employed in this investigation. Key words: Mefenamic acid, Poloxomer -F338, Gelucire 48/16, spherically agglomeratio

Past and present distribution, densities and movements of blue whales Balaenoptera musculus in the Southern Hemisphere and northern Indian Ocean

1. Blue whale locations in the Southern Hemisphere and northern Indian Ocean were obtained from catches (303 239), sightings (4383 records of 8058 whales), strandings (103), Discovery marks (2191) and recoveries (95), and acoustic recordings. 2. Sighting surveys included 7 480 450 km of effort plus 14 676 days with unmeasured effort. Groups usually consisted of solitary whales (65.2%) or pairs (24.6%); larger feeding aggregations of unassociated individuals were only rarely observed. Sighting rates (groups per 1000 km from many platform types) varied by four orders of magnitude and were lowest in the waters of Brazil, South Africa, the eastern tropical Pacific, Antarctica and South Georgia; higher in the Subantarctic and Peru; and highest around Indonesia, Sri Lanka, Chile, southern Australia and south of Madagascar. 3. Blue whales avoid the oligotrophic central gyres of the Indian, Pacific and Atlantic Oceans, but are more common where phytoplankton densities are high, and where there are dynamic oceanographic processes like upwelling and frontal meandering. 4. Compared with historical catches, the Antarctic ("true") subspecies is exceedingly rare and usually concentrated closer to the summer pack ice. In summer they are found throughout the Antarctic; in winter they migrate to southern Africa (although recent sightings there are rare) and to other northerly locations (based on acoustics), although some overwinter in the Antarctic. 5. Pygmy blue whales are found around the Indian Ocean and from southern Australia to New Zealand. At least four groupings are evident: northern Indian Ocean, from Madagascar to the Subantarctic, Indonesia to western and southern Australia, and from New Zealand northwards to the equator. Sighting rates are typically much higher than for Antarctic bluewhales