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Patel M.M.,Sudan University of Science and Technology | Bhuva S.D.,Veeda Clinical Research | Patel M.M.,Zydus Cadila Healthcare Ltd
Reviews in Analytical Chemistry | Year: 2015

An extensive survey of the literature published in various analytical and pharmaceutical chemistry-related journals have been conducted, and the instrumental analytical methods that were developed and used for the determination of proton pump inhibitors in bulk drugs, formulations, and biological fluids have been reviewed. This review covers the time period from 1990 to 2011 during which 80 analytical methods, including all types of spectrophotometric and chromatographic techniques were reported. High-performance liquid chromatography (HPLC) with ultra violet (UV) detection was found to be the technique of choice for many workers, and more than 50 methods were based on liquid chromatography (LC) and ultra violet (UV). A critical analysis of the reported data was carried out and the present state of the art of the analytical techniques for the determination of omeprazole, esomeprazole, pantoprazole, rabeprazole, dexrabeprazole, tenatoprazole, lansoprazole, and dexlansoprazole is discussed. © 2015 by De Gruyter.

Shafiq S.,Zydus Cadila Healthcare Ltd. | Shakeel F.,University of Benghazi | Talegaonkar S.,Jamia Hamdard University | Khar R.K.,Jamia Hamdard University | Ali M.,Jamia Hamdard University
Journal of Dispersion Science and Technology | Year: 2010

Ramipril is a very sensitive and unstable antihypertensive drug molecule. Marketed formulations of ramipril lead to decrease in its assay value due to mechanical stress, compression, manufacturing processes, excipients, storage conditions, heat, moisture, and alkaline pH. Therefore the purpose of the present study was to enhance its stability using nanoemulsion technique. In order to enhance its stability, pH degradation studies at room temperature were performed using different standard buffer solutions as an aqueous phase in the nanoemulsion formulation. Nanoemulsion formulation was prepared by aqueous phase titration method. Shelf life of nanoemulsion was determined using Arrhenius plot. The degradation of ramipril after 180 days of storage was significantly lowest in formulation of pH 5.0 as compared to other formulations. The shelf life of nanoemulsion formulation was found to be highest at refrigerator temperature (2.87 years). These results indicated that stability of ramipril can be enhanced in nanoemulsion formulation using standard buffer (pH 5.0) as an aqueous phase. © Taylor & Francis Group, LLC.

Shafiq S.,Zydus Cadila Healthcare Ltd. | Shakeel F.,University of Benghazi
Clinical Research and Regulatory Affairs | Year: 2010

The aim of the present investigations was to evaluate the capacity of a combination of Labrasol and Plurol oleique as surfactant and cosurfactant on self-nanoemulsification efficiency of ramipril nanoemulsion. Sefsol-218, Labrasol, Plurol oleique, and standard buffer solution (pH 5.0) were selected as oil phase, surfactant, cosurfactant, and aqueous phase, respectively. Nanoemulsion formulations of ramipril were developed by a spontaneous emulsification method. Pseudoternary phase diagrams were constructed to identify nanoemulsion zones of ramipril. Selected formulations were evaluated in terms of thermodynamic stability tests using centrifugation, heating-cooling cycles, and freeze-thaw stress test. Some formulations were found stable and other formulations were unstable upon thermodynamic stability tests. Thermodynamically stable formulations were taken for self-nanoemulsification efficiency test. All the selected formulations passed self-nanoemulsification test in grade E only but not in grades A and B. Because none of the formulations passed the self-nanoemulsification efficiency test in grades A and B, it was concluded that a combination of Labrasol and Plurol is not suitable as surfactant and cosurfactant, respectively, for oral or self-nanoemulsifying drug delivery system of ramipril. © 2010 Informa UK Ltd.

Ravish H.S.,Kempegowda Institute of Medical science KIMS | Vijayashankar V.,BGS Global Institute of Medical science | Madhusudana S.N.,National Institute of Mental Health and Neuro Sciences | Sudarshan M.K.,Kempegowda Institute of Medical science KIMS | And 5 more authors.
Human Vaccines and Immunotherapeutics | Year: 2014

The affordability to rabies vaccine for intramuscular administration in post exposure prophylaxis is a major constraint. Therefore, in countries, where there are financial constraints, World Health Organization recommends intradermal rabies vaccination that reduces the quantity and cost of vaccination. This study was done to evaluate the safety and immunogenicity of indigenously developed rabies vaccine (VaxiRab N) in comparison to a WHO recommended rabies vaccine (Rabipur) with demonstrated efficacy when administered by intradermal route using updated Thai Red Cross regimen. Eighty-six dog bite cases were randomly given either VaxiRab N (n = 43) or Rabipur (n = 43) as post exposure prophylaxis. The rabies virus neutralizing antibody concentrations on days 14, 28, 90, and 180 were tested by modified rapid fluorescent focus inhibition test. The geometric mean RVNA concentration of both the groups were compared using t- test and was found that, P value > 0.05 on all days, thus showing no significant difference between the 2 groups. The adverse drug events were also compared using Z-test and was found to be not statistically significant (Z = 1.476, P = 0.139). In conclusion, VaxiRab N was found to be safe and effective in post exposure prophylaxis by intradermal route and was similar to the WHO recommended rabies vaccine (Rabipur) of demonstrated efficacy. © 2014 Landes Bioscience.

Premkumar B.,JNTUH College of Engineering | Srinivasamurthy M.,Vignan Institute of Pharmaceutical Sciences | Rajagopal K.,Zydus Cadila Healthcare Ltd.
Biosciences Biotechnology Research Asia | Year: 2013

To study the clinical characteristics of rheumatoid arthritis (RA) patients attending the rheumatology unit in a private hospital The demographic characteristics, laboratory parameters, comorbidities, articular manifestations and pattern of prescriptions were studied from the case records. A total of 75 RA patients were studied. Female preponderance was observed and the ratio was found to be 3:1. The frequent laboratory measurements were found to be erythrocyte sedimentation rate (ESR), hemoglobin (Hb), and other hematological parameters. The articular manifestations were found to be knee, wrist, ankle, shoulder and elbow joints. The most common comorbidity was found to be hypertension and diabetes mellitus. The prescription pattern revealed the disease modifying antirheumatic drugs (DMARDs) as the first line drugs followed by steroids and non -steroidal anti-inflammatory drugs (NSAIDs). The first line DMARD was found to be methotrexate. The tendency of polypharmacy was more and the most combination was DMARD with a steroid and NSAID. The trend reveals aggressive therapy among rheumatologists. Frequent monitoring of adverse drug reactions like hepatic abnormalities for DMARDs and bone densitometry for oral glucocorticoids and drug interactions could further improve the quality of life of RA patients.

Nathani B.R.,P.A. College | Pandya K.S.,P.A. College | Jeni M.M.,P.A. College | Patel M.R.,Zydus Cadila Healthcare ltd
Der Pharma Chemica | Year: 2011

Some new N-[3-(2-Oxo-1, 2-dihydro-indol-3-ylidene-hydrazinocarbonyl)-benzyl]-nicotinamide (III) have been synthesised from different isatin derivatives (I) by condensing with N-(3-hydrazinocarbonylbenzyl) nicotinamide (II). Their chemical structures have been confirmed by IR, 1H NMR, Mass and by elemental analysis. Investigation of antimicrobial activity of compounds was done by the disk diffusion technique. Among the compounds tested, the compound with 5-F, 5-CH3 substitution showed the most favourable antimicrobial activity.

Maitreyi Z.,Institute of Pharmaceutical Education and Research | Amit K.,Zydus Cadila Healthcare Ltd
International Journal of Advances in Pharmaceutical Sciences | Year: 2010

The reverse phase high performance liquid chromatography (RP-HPLC) method of Atenolol and Hydrochlorothiazide is individually available in United State of Pharmacopoeia-27 (USP-27) but no reference is available for combined estimation of Atenolol and Hydrochlorothiazide in tablets formulation. The aim of our present work was to develop a precise and validated RP-HPLC method for the simultaneous determination of Atenolol and Hydrochlorothiazide in tablets formulation. The quantification was carried out by using Zorbax SB-CN (250 x 4.6 mm), 5μm column in isocratic mode with mobile phase, Water: Buffer: Methanol (50:35:15). The flow rate was 1.2 ml/min. The peak purity of Atenolol and Hydrochlorothiazide were 0.999 and 1.000 respectively. Ruggedness and robustness of method were performed and the percentage relative standard deviation (RSD) was found below 2.0%. The percentage recovery was found in the range of 98% to 102% at three different levels. Calibration curves were linear over studies ranges with correlation co-efficient found between the range of 0.99 to 1.00. Sample and standard solution stability study was performed over 21 h at room temperature and found stable. The percentage deviation was below 2.0%.

Zaveri M.,Institute of Pharmaceutical Education and Research | Khandhar A.,Zydus Cadila Healthcare Ltd
International Journal of Advances in Pharmaceutical Sciences | Year: 2010

The objective of this present work was to develop and validate analytical method for quantitative determination of Paracetamol and Etoricoxib in a tablet formulation and also the comparison of invitro data with reference dosage form. Chromatographic separations of the two drugs were analyzed on a Kromasil C18 column (25cm × 4.6mm, 5μm). The mobile phase constituted of Buffer: Acetonitirile with gradient program was delivered at the flow rate 1.0 mL/min. Detection was performed at 220 nm. Separation was completed within 20 min. Calibration curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 48 to 146 μg/mL of Paracetamol and 6 to 19 μg/mL for Etoricoxib respectively. The relative standard deviation (R.S.D) was found to be less than 2.0%. Analysis for dissolution study was also performed by Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method. Difference factor (f1) were found to be 2.85 and 3.83 and similarity factor (f2) were found to be 73.514 and 68.961 for Paracetamol and Etoricoxib respectively. © arjournals.org, All rights reserved.

PubMed | Zydus Cadila Healthcare Ltd.
Type: Journal Article | Journal: Die Pharmazie | Year: 2010

The purpose of the present investigation was to evaluate the capacity of Labrasol as surfactant for self-nanoemulsification efficiency of ramipril nanoemulsion formulation. Based on the solubility profile of ramipril, Sefsol-218, Labrasol and Carbitol were selected as oil phase, surfactant and cosurfactant, respectively. Based on the stability profile of ramipril, standard buffer solution of pH 5.0 was selected as an aqueous phase for the development of ramipril nanoemulsion formulation. Nanoemulsion formulations of ramipril were developed using an aqueous phase titration method. Pseudoternary phase diagrams were constructed to identify the nanoemulsion region. Selected formulations were subjected to different thermodynamic stability tests using centrifugation, heating cooling cycles and freeze thaw cycles. The formulations which were stable at thermodynamic stability tests were taken for self-nanoemulsification efficiency test. No creaming, cracking, coalescence or phase inversion was observed on most of the formulations upon thermodynamic stability tests. All the formulations passed self-nanoemulsification tests in grade C, D and E but not in grade A and B. Because none of the formulation passed self-nanoemulsification efficiency test in grade A and B, it was concluded that Labrasol is not suitable as surfactant for oral or self nanoemulsifying drug delivery system of ramipril.

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