Bioaccumulation of metals in mangroves and salt marshes collected from Tuticorin coast of Gulf of Mannar marine biosphere reserve, Southeastern India.

Three species of mangroves and six species of salt marshes were collected from various locations along the Tuticorin coast for the estimation of metals like Cu, Cd, Pb, and Zn. The bioaccumulation of metals in mangroves is in the order of Cu > Pb > Zn > Cd, and the season-wise accumulation was higher in monsoon followed by summer, post-monsoon, and pre-monsoon seasons. The accumulation of metals in mangroves showed higher in Rhizophoraapiculata followed by Avicenniamarina, and Rhizophoramucronata. The concentration of metals in salt marshes is in the order of Pb > Zn > Cu > Cd, and the species-wise accumulation showed in the order of Suaeda maritime > Ipomoea sp. > Suaeda sp. > Spinifix littoreous > Sesuvium portacastrum > Ipomoea pes-capras. BAF in salt marhes and mangroves is as Cd < Pb < Cu < Zn and Cd < Cu < Pb < Zn, respectively.

Health risk assessment and bioaccumulation of toxic metals in commercially important finfish and shellfish resources collected from Tuticorin coast of Gulf of Mannar, Southeastern India.

The present study was mainly focused on the distribution of metals (Cd, Cu, Pb, and Zn) in commercially important marine finfish and shellfish resources collected from the Tuticorin coast of the Gulf of Mannar, Southeastern India. Sixty-six species were collected in all four seasons for the analysis of metals. The order of bioaccumulation of metals in fishes is (Zn > Pb > Cu > Cd), in Crustaceans is (Zn > Pb > Cu > Cd), and in mollusks is (Pb > Zn > Cu > Cd). The human health risk assessment factors such as BCF, THQ, and HI were higher in most of the tested animals. The outcome of the present study will sound the alarm to the community about heavy metal contamination of sea foods. We conclude that continuous monitoring of the ecosystem is essential to the maintenance of the pristine ecosystem and quality of the seafood.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product.

Management of Acute Pulmonary Embolism: Consensus Statement for Indian Patients.

Pulmonary embolism (PE) is an important cause of morbidity and mortality among hospitalized patients. Although the exact epidemiology of PE is not known in India, Some of the studies show that more frequently it is missed and not managed appropriately leading to significant cardiovascular morbidity and mortality. Justification and purpose: Indian guidelines for the diagnosis and treatment of acute PE are not yet formulated. The objective of this consensus statement is to propose a diagnostic and management approach for acute PE in India. PROCESS: A working group of 15 experts in the management of acute PE (cardiologists, pulmonologist, haematologist, emergency specialist and intensivists). This consensus statement makes recommendations for diagnosis and management for PE based on literature review, including Indian data.

Quality by design development of brivanib alaninate tablets: degradant and moisture control strategy.

A quality by design approach was applied to the development of brivanib alaninate tablets. Brivanib alaninate, an ester pro-drug, undergoes hydrolysis to its parent compound, BMS-540215. The shelf-life of the tablets is determined by the rate of the hydrolysis reaction. Hydrolysis kinetics in the tablets was studied to understand its dependence on temperature and humidity. The BMS-540215 amount versus time profile was simulated using a kinetic model for the formation of BMS-540215 as function of relative humidity in the environment and a sorption-desorptiom moisture transfer model for the relative humidity inside the package. The combined model was used to study the effect of initial tablet water content on the rate of degradation and to identify a limit for initial tablet water content that results in acceptable level of the degradant at the end of shelf-life. A strategy was established for the moisture and degradant control in the tablet based on the understanding of its stability behavior and mathematical models. The control strategy includes a specification limit on the tablet water content and manufacturing process controls that achieve this limit at the time of tablet release testing.