Posted by admin on Nov 1, 2012 in |
Tylophora indica is an important medicinal plant from the repository of valuable plant species of Indian subcontinent. The plant has a long reputation in curing various health ailments including asthma, bronchitis, rheumatism and other respiratory problems. Due to its vast medicinal importance, the plant is exploited on a large scale and its uncontrolled and unmonitored harvesting from the wild has categorized the plant among the endangered plant...
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Posted by admin on Nov 1, 2012 in |
Bioequivalence needs to be established on healthy human volunteers for Low Molecular Weight Heparins (LMWHs) such as Dalteparin, Enoxaparin, Tinzaparin and Fondaparinux using Pharmacodynamic marker(s) for generic approval. Anti-Xa and anti-IIa activity are used to determine the activity of LMWHs (Dalteparin, Enoxaparin and Tinzaparin) and anti-Xa activity for Fondaparinux in biological samples for the assessment of its bioavailability. These are selected based on the pharmacodynamic activities of LMWHs. LMWHs exhibit their antithrombotic activity preferentially by inhibiting clotting Factor Xa, and to a lesser extent Factor IIa. On the other hand Fondaparinux is a synthetic and specific inhibitor of Factor-Xa and hence bioequivalence needs to be established for only anti-Xa activity. The pharmacodynamic data of anti-IIa activity need to be submitted for regulatory agency as supportive data of comparable therapeutic outcome for all LMWHs except Fondaparinux. In addition to the above, pharmacokinetic data of Heptest (Heparin clotting assay) and activated Partial Thromboplastin Time (aPTT) may also serve as a supportive evidence for establishing bioequivalence of LMWH formulations as there were...
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Posted by admin on Nov 1, 2012 in |
A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting apply to both branded and generic product which include products with the wrong ingredients, without active ingredients, with insufficient active ingredients. According to WHO, 25% of medicines consumed in poor countries could be counterfeit or below standard.An estimate suggests that these drugs are a $200 billion industry worldwide. India could be an easy target for counterfeits, as the manufacturing costs is 40% cheaper here as compared to other countries. Deputy drug controller general of India says, counterfeit medicines often resemble the originals in chemical composition, but he thinks the biggest problem is in the packaging. A committee set up by the Indian Ministry of Health has approved a proposal to put 2D bar codes and scratch-off labels on medicines. The user scratches off the cover and tests what is underneath to a free phone number, to find out if a pill is real. Quick Response (QR) codes are also being tested....
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Posted by admin on Nov 1, 2012 in |
Self emulsifying is a topic of current interest for overcoming the formulation difficulties of drugs with poor aqueous solubility. SEDDS are isotropic mixture of oil, surfactant and co-surfactant with a unique ability to form fine oil-in-water (o/w) emulsions or micro emulsions upon mild agitation in the gastrointestinal tract which present the drug in a solubilized form, and the small size of formed droplet provides a large interfacial surface area for drug absorption. It is a promising strategy to improve the rate and extent of oral absorption. The SEDDS were characterized for robustness to dilution, globule size, polydispersity index and zeta...
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Posted by admin on Nov 1, 2012 in |
Traditional analytical approaches including HPLC (High-Performance Liquid Chromatograph), GC (Gas Chromatograph), UV (Ultraviolet) detection, etc., have become insufficient to effectively handle the growing number of challenges in analyses of species- specificity and sensitivity. Modern analytical technique referred to as hyphenated techniques, originate from the traditional use of molecule or element specific detection in electrophoresis or chromatography. Currently the most common techniques for trace element speciation include a combination of separation technique coupled with a detection technique that is more sensitive. Earlier such hyphenated techniques were the coupling of separation of a special sample preparation off-line and later adding a detection technique. Presently, the hyphenated technique is developed from the coupling of a separation technique (Chromatography) and an on-line spectroscopic detection technology. Hyphenated techniques combine chromatographic and spectral methods to exploit the advantages of both. Chromatography produces pure or nearly pure fractions of chemical components in a mixture. Spectroscopy produces selective information for identification using standards or library spectra. These hyphenated techniques offer shorter analysis time, higher degree of automation,...
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