India’s Marketing Regulations of Drugs

Approval of the drug product for import, manufacturing and marketing in India, its demonstration for safety and efficacy in humans is essential. The Rules 122A, 122B and 122D, 122 DA, 122DAA, 122E and Appendix I, IA and VI of Schedule Y of the Drugs & Cosmetics Act, 1945, describes the information/data required for approval of clinical trial and/or to import, manufacture, or market any new drug in the country. However, the requirements for approval of clinical trials and new drugs may vary depending on the nature of new drugs.

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Natural products as a gold mine for arthritis treatment

Arthritis, an inflammation of the joints, is usually a chronic disease that results from dysregulation of pro-inflammatory cytokines (e.g. tumour necrosis factor and interleukin-1b) and pro-inflammatory enzymes that mediate the production of prostaglandins (e.g. cyclooxygenase-2) and leukotrienes
(e.g. lipooxygenase), together with the expression of adhesion molecules and matrix metalloproteinases, and hyperproliferation of synovial fibroblasts. All of these factors are regulated by the activation of the transcription factor nuclear factor-kB. Thus, agents that suppress the expression of tumour necrosis factor-a, interleukin-1b, cyclooxygenase-2, lipooxygenase, matrix metalloproteinases or adhesion molecules, or suppress the activation of NF-kB, all have potential for the treatment of arthritis.

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STUDIES ON PHYSICOCHEMICAL EVALUATION OF LEAVES OF ABUTILON MUTICUM DC

Abutilon muticum DC. (Malvaceae) are traditional medicinal herb used for analgesic, anthelmintic, hepatoprotective, and hypoglycemic properties. The present paper deals with the physicochemical evaluation of leaf of the plants. In this study various physicochemical studies such as ash value, LOD, FOM, extractive values are reported.

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COMPARATIVE EVALUATION OF SOLUBILITY AND DISSOLUTION ENHANCEMENT OF BICALUTAMIDE SOLID BY DISPERSION TECHNIQUE

Bicalutamide is poorly water soluble Anti- Cancer drug used in prostate cancer. Due to poor solubility of drug, its bioavailability rate is limited by drug dissolution. In the present study, an attempt has been made to increase solubility and dissolution of Bicalutamide by solid dispersion technique using Solvent Evaporation and Hot Melt method with PEG- 6000 (Poly ethylene glycol), PVP K-90 (Poly vinyl pyrrolidone), and Poloxamer F-68.

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CYCLOOXYGENASE-2 – AN ALLURING TARGET FOR MEANINGFUL DRUG DESIGNING

Cyclooxygenase, an enzyme involved in the conversion of C-20 acids to prostaglandins, exists in two isoforms. COX-1 is constitutively expressed and has a gastroprotective function. COX-2, induced at the site of injury, is responsible for the expression of pro-inflammatory prostaglandins. Despite overall similarities, COX-1 and COX-2 show subtle difference in amino acid composition at the active sites. COX-2 has valine at positions 89 and 523, while COX-1 has isoleucine, resulting in larger space availability in the former.

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ESTIMATION AND VALIDATION OF RESIDUAL SOLVENT BY GC HEAD SPACE MASS CHROMATOGRAPHY OF COLCHICINE USP

The present paper deals with the estimation and validation of residual solvent by GC head space mass chromatography of the drug Colchicine USP. The various parameters were evaluated and the data were presented in the present communications which establish the estimation and validation of the drug colchicines USP.

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PREDICTION OF HUMAN INTESTINAL PERMEABILITY SINGLE-PASS INTESTINAL PERFUSION IN RAT: A QSAR/QSPR APPROACH

The aim of the study was the prediction of human intestinal permeability and fraction absorbed of oral dose using QSAR/QSPR methods. To explore physicochemical and topological properties of 15 compounds responsible for their Human intestinal permeability, a quantitative structure activity relationship, Hansch approach was applied on sixteen compounds. Various physicochemical and topological descriptors and reported Human intestinal permeability values of different 15 compounds were used as independent variables and dependent variable respectively.

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EVALUATION AND PHYTOCHEMICAL SCREENING OF SEED OIL OF NIGELLA SATIVA LINN.

Nigella sativa (Ranunculaceae) is a flowering plant, native to Southwest Asia. Seeds contain 36%–38% fixed oils, proteins, alkaloids, saponin and 0.4%–2.5% essential oil. The fixed oil is composed mainly of unsaturated fatty acids, including the unusual C20:2 arachidic and eicosadienoic acids. The seeds are used as a carminative and stimulant to ease bowel and indigestion problems and are given to treat intestinal worms and nerve defects to reduce flatulence, and induce sweating. The present paper deals with preliminary phytochemical screening of fixed oil obtained by the seeds. Also attempt was made to evaluate the oil so as to establish the standardization parameters.

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