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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.

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.

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.

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.

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.

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