Best practices for selection of excipients for paediatrics - Workshop reflection

The development of age appropriate formulations for the paediatric population has become one of the key areas of focus for the pharmaceutical industry - with a subsequent influence on excipient use. Selection of excipients with appropriate safety and tolerability is a major hurdle in paediatric formulation development. Various factors influence selection of excipients, including target age group, route of administration and dosage form. Evaluation of these factors and a clear rationale and justification is expected by the regulators when it comes to selecting excipients for paediatric formulation. Scientists are encouraged to apply the principle of benefit to risk balance to assess the suitability of excipients to the specific paediatric population for whom the formulation is intended. In order to understand how scientists approach the task of establishing the risk to benefit analysis, a workshop was organised by the European Paediatric Formulation Initiative (EuPFI) to reflect on the current scenario and the different practices employed by formulation scientists in the selection of excipients for paediatric formulations. Aspects assessed by regulators were also canvassed. Finally, the participants were asked to comment on how selecting excipients for use in paediatric formulations may differ from the considerations applied in selecting excipients for formulations for other age groups. Based on the workshop discussion, some recommendations and questions to consider emerged regarding the selection of excipients in paediatric drug development. These best practice recommendations provided a good starting point for a more systematic strategy for selecting excipients for paediatric formulation development

Value addition in the processing of copper bleed solution by solvent extraction process

Copper bleed solution generated during the electrorefining of anode copper has been used for the recovery of metals as value added products viz. metal powders following partial decopperisation, solvent extraction and electrowinning. In this process, a mixed crystal containing copper and nickel sulphates is produced from the partially decopperised bleed solution by crystallization. The mixed crystal is dissolved and iron is removed by precipitation. The copper is extracted from the purified solution using LIX84 diluted in kerosene leaving nickel in the aqueous raffinate. Bench scale simulation study for the separation of copper and nickel is further confirmed by extracting copper in a mixer settler unit. The purified solution has been used for producing copper and nickel powders by electrolysis

Variational Problems with Fractional Derivatives: Euler-Lagrange Equations

We generalize the fractional variational problem by allowing the possibility that the lower bound in the fractional derivative does not coincide with the lower bound of the integral that is minimized. Also, for the standard case when these two bounds coincide, we derive a new form of Euler-Lagrange equations. We use approximations for fractional derivatives in the Lagrangian and obtain the Euler-Lagrange equations which approximate the initial Euler-Lagrange equations in a weak sense

TEMPORAL AND SPATIAL ANALYSIS OF URBAN HEAT ISLAND USING LANDSAT SATELLITE DATA: TWO INDIAN CASE STUDIES

Urban environment is examined through time series Landsat TM (Thematic Mapper) and OLI/TIRS (Operational Land Imager & Thermal Infrared Sensor) sensor images. A continuous surface of Land Surface Temperature (LST) can be extracted from Landsat thermal bands. Similarly different band combinations and ratios will give spatial pattern of land cover categories. Among these, building and vegetation indices are used to characterize the spatiotemporal pattern of elevated temperature zones in cities. This excess heat concentration creates thermal hotspots which are known as Urban Heat Islands (UHI). Parameters of land cover are then related to LST to detect the influence of urbanization on intensity and extent of heat islands, by pixel based quantitative analysis. This paper focuses on two megacities of India and their surrounding districts for identifying the critical UHI areas. The purpose of this paper is to create a database for reconstruction in old cities and planning of new smart cities. Results suggest that urban sprawl and substitution of rural areas with impervious surface plays significant role in microclimate, causing formation of new thermal hotspots. The analysis of urban thermal environment and its dynamics is to provide a scientific basis for future strategy building

Electric dipole polarizability and the neutron skin

The recent high-resolution measurement of the electric dipole (E1) polarizability (alphad) in 208Pb [Phys. Rev. Lett. 107, 062502 (2011)] provides a unique constraint on the neutron-skin thickness of this nucleus. The neutron-skin thickness (rskin) of 208Pb is a quantity of critical importance for our understanding of a variety of nuclear and astrophysical phenomena. To assess the model dependence of the correlation between alphad and rskin, we carry out systematic calculations for 208Pb, 132Sn, and 48Ca based on the nuclear density functional theory (DFT) using both non-relativistic and relativistic energy density functionals (EDFs). Our analysis indicates that whereas individual models exhibit a linear dependence between alphad and rskin, this correlation is not universal when one combines predictions from a host of different models. By averaging over these model predictions, we provide estimates with associated systematic errors for rskin and alphad for the nuclei under consideration. We conclude that precise measurements of rskin in both 48Ca and 208Pb---combined with the recent measurement of alphad---should significantly constrain the isovector sector of the nuclear energy density functional.Comment: Manuscript contains 5 pages, 2 figures, and 1 table. Submitted to Physical Review Letter

Seperation & Recovery of Copper & Nickel from Copper Bleed Stream by Solvent Extraction Route

Bleed stream from electro r(fining step of copper slnelter was processed to recover the metals as high value products such as copper and nickel powders or salts. The process consists of partial decopperisation of the bleed stream followed by crystallisation of a ,nixed salt of copper and nickel sulphate, leaching of the mixed salt, removal of iron, solvent extraction separation of copper and nickel and winning the solution to produce metal powders. With the partially decopperised bleed stream, the composite crystal was obtained by crystallisation which contained 8.4 -12.5 % Cu and 13.7-14.38 % Ni with 1-2pptn Fe as impurity. This mixed salt was leached with water and was treated for iron precipitation. The purified solution was subjected to solvent extraction using LIX 84 and CYANI X 272, A 20% LIX 84 in kerosene extracted 99.88% copper acrd 0,059% nickel (if ct p1I of 2.5 and 5% C}'ANEX 272 in kerosene extracted 98,06% copper and 0.511, nickel at a p!I of 4.85. 1,L1' 84 was usec! for metal separation in the ,fixer-seiller unit. The pure solutions of copper and nickel sulphates obtained from stripping circuit were electrolysed to produce pure copper (99.9%) and nickel (99.8) powders; alternatively pure sulphate salts could also be crystallised

Synthesis of electrolytic copper and nickel powders from the copper bleed electrolyte of a copper smelter

The adaptation of certain processes for utilization of secondary resources to produce valuable products is currently given due attention in the metal extraction. Copper bleed solution (CBS) obtained during electropurification of the impure copper anode to produce copper cathode for the purpose of controlling impurity, is one such secondary source which can be treated to produce valuable products. Copper bleed solution generated at Indian Copper Complex (ICC), Ghatsila contains 39.86 g/L Cu, 9.58 g/L Ni, 0.26 g/L Fe, 0.108 g/L Bi, 0.007 g/L As, 0.055 g/L Sb, 198.04 g/L H2S04. The recovery of copper and nickel as high value products such as metal powders from the bleed stream of the copper smelter by pretreatment-solvent extraction (SX) separation-electrowinning (EW) has been attempted to provide an alternative to the conventional process. The purity of the eletrolytic copper and nickel powders so produced was found to be 99.93% and 99.89%, respectively. The compact density of the annealed copper powder was 8.74 g/cc whereas it was 7.72 g/cc for nickel powder. The other properties of the copper and nickel powders such as flow-ability, particle size, etc. were found to be suitable for the P/M applications