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Sarmah J.K.,Gauhati University | Mahanta R.,Cotton College | Bhattacharjee S.K.,Gauhati University | Mahanta R.,Gauhati Medical College | Biswas A.,Central Drugs Laboratory
International Journal of Biological Macromolecules | Year: 2011

Natural polysaccharides, due to their outstanding merits, have received more and more attention in the field of drug delivery. In the present study tamoxifen citrate, TMX (a non-steroidal antiestrogenic drug) loaded guar gum nanoparticles, GG NPs, crosslinked with glutaraldehyde were prepared for treatment of breast cancer. An oil in water (o/w) emulsion polymer cross-linking method was employed for preparation of blank and drug loaded sustained release nature biodegradable nanoparticles. Prepared nanoparticles were characterized by morphology in scanning electron microscope (SEM), size distribution in transmission electron microscope (TEM), TMX loading by high performance liquid chromatography (HPLC) and in vitro drug release characteristics. An overall sustained release of the drug from the biodegradable nanoparticles was observed in in vitro release studies. The release of TMX from GG NPs was found to be effected by guar gum and glutaraldehyde concentration. Regression coefficient (R2) analysis suggested that the predominant mechanism behind the drug release from the nanoparticles was time dependent release and diffusion. In vivo studies on female albino mice demonstrated maximum uptake of the drug by mammary tissue after 24h of administration with drug loaded guar gum nanoparticles in comparison with that with the tablet form of the drug. These findings demonstrate that controlled release of TMX from GG NPs could be a potential alternative pharmaceutical formulation in passive targeting of TMX in breast cancer treatments. © 2011 Elsevier B.V.

Chatterjee A.,Mahatma Jyotiba Phule Rohilkhand University | Chatterjee A.,Central Research Laboratory | Chatterjee S.,Central Research Laboratory | Biswas A.,Central Drugs Laboratory | And 4 more authors.
Evidence-based Complementary and Alternative Medicine | Year: 2012

The healing activity of gallic acid enriched ethanolic extract (GAE) of Phyllanthus emblica fruits (amla) against the indomethacin-induced gastric ulceration in mice was investigated. The activity was correlated with the ability of GAE to alter the cyclooxygenase- (COX-) dependent healing pathways. Histology of the stomach tissues revealed maximum ulceration on the 3rd day after indomethacin (18 mg/kg, single dose) administration that was associated with significant increase in inflammatory factors, namely, mucosal myeloperoxidase (MPO) activity and inducible nitric oxide synthase (i-NOS) expression. Proangiogenic parameters such as the levels of prostaglandin (PG) E 2, vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), von Willebrand Factor VIII, and endothelial NOS (e-NOS) were downregulated by indomethacin. Treatment with GAE (5 mg/kg/day) and omeprazole (3 mg/kg/day) for 3 days led to effective healing of the acute ulceration, while GAE could reverse the indomethacin-induced proinflammatory changes of the designated biochemical parameters. The ulcer healing activity of GAE was, however, compromised by coadministration of the nonspecific NOS inhibitor, N-nitro-L-arginine methyl ester (L-NAME), but not the i-NOS-specific inhibitor, L-N6-(1-iminoethyl) lysine hydrochloride (L-NIL). Taken together, these results suggested that the GAE treatment accelerates ulcer healing by inducing PGE 2 synthesis and augmenting e-NOS/i-NOS ratio. Copyright © 2012 Ananya Chatterjee et al.

Mukherjee A.,Central Drugs Laboratory | Bera A.,Central Drugs Laboratory
Research Journal of Pharmaceutical, Biological and Chemical Sciences | Year: 2012

All analytical techniques used for the development of drugs and pharmaceuticals and for the determination of their quality characteristics have to be validated. The purpose of this paper is to present the issues to consider when evaluating chromatographic test methods from a regulatory perspective. It has been discussed in this paper the points to note and weaknesses of chromatography so that Center for Drug Evaluation and Research (CDER) reviewers can ensure that the method's performance claims are properly evaluated, and that sufficient information is available for the field chemist to assess the method. This paper presents the discussions about the parameters for Validation of HPLC methods for Drug substance and Drug product and practical recommendations and criteria for finding correct solutions and also presents the importance of the system suitability test to ensure the performance of the HPLC system. With proper validation and tight chromatographic performance (system suitability) criteria, an improvement in the reliability of the data can be obtained.

Biswas A.,Central Drugs Laboratory | Basu A.,Central Drugs Laboratory
International Journal of Pharma and Bio Sciences | Year: 2010

A fast and reliable high performance liquid chromatography method for determination of paracetamol, chlorzaxozone and diclofenac potassium has been developed. The chromatographic method was standardised using a reverse phase C18 column with UV-VIS detector at 254 nm. Mobile phase consisted of methanol-0.01M monobasic sodium phosphate with equal volume of 0.01M ortho phosphoric acid (70:30) (p H adjusted to 2.5 ± 0.2 using 10% orthophosphoric acid) at a flow rate 1 ml/min. The method was validated and produced accurate and precise result for these drugs.

Khan A.U.,Hamdard University | Iqbal J.,Hamdard University | Khattak S.-U.-R.,Central Drugs Laboratory | Najam-Us-Saquib,Central Drugs Laboratory | Qazi M.S.,Pharmaceutical Research Center
Pakistan Journal of Scientific and Industrial Research Series A: Physical Sciences | Year: 2015

The effect of reconstitution solvents such as water, 0.5% metronidazole solution, 0.9% sodium chloride and 5% dextrose injections, have been investigated on the kinetics of degradation of cephradine neutralised with L-arginine contained in glass, polyvinylchloride (PVC) and polyethylene pthalate (PET) containers at 5, 15 and 30 °C. The analytical method described in USP-31 for the analysis of cephradine injection was employed in this study and validation in respect of specificity, linearity, accuracy and precision was observed. The degradation of the compound showed first-order kinetics and the degradation rate constants 'kobs' were found in the range of 1.84-3.07 × 10-3/h (r2 = 0.990-0.999) at 5 °C, 2.3-4.2 × 10-3/h (r2 = 0.993-0.999) at 15 °C and 7.18-9.97 × 10-3/h (r2 = 0.998-0.999) at 30 °C, respectively. Cephradine showed maximum stability in dextrose solution followed by water, sodium chloride and metronidazole injections, however, linear effect of containers on degradation rate could not be established. The extended degradation did not change the kinetics of the reaction. The abnormal toxicity/ safety test on mice for the admixtures in different containers at various temperatures showed no abnormal toxicity. © 2015, PCSIR-Scientific Information Centre. All rights reserved.

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