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SanilKumar P.,Annamalai University | Dhanapal C.K.,Annamalai University | Manavalan R.,Annamalai University | Rao K.,Lotus Labs Pvt Ltd | Ravi S.,Lotus Labs Pvt Ltd
International Journal of Pharmaceutical and Clinical Research | Year: 2012

Hospitals are created for cure the disease but not for the spreading of diseases, even though this statement is true to the theoretical concept but it is not possible practically due to various risk factors. The spread of infection in the hospitals occurs due to the microorganism. Nosocomial Pneumonia add significantly to the economic burden of managing the underlying disease that has lead to hospitalization of the patient. More than 90% of reported infections are bacterial where as viral, fungal or protozoal infections are less commonly involved in hospital-acquired infections. This project deals with bacterial nosocomial pathogens only, since they are by far major causes of nosocomial Pneumonia. Objective of the present study include the identification, prevention and control of nosocomial Pneumonia in our hospitals. The ultimate aim is the reduction of nosocomial Pneumonia and their costs. Baseline study for morbidity pattern in the hospitals, finding sources of exogenous and endogenous sources of nosocomial Pneumonia. Nosocomial Pneumonia also is the infection most likely to be fatal, with mortality rates exceeding 30%, and is the most expensive to treat. Moreover, patients on mechanical ventilators develop Pneumonia morefrequently and are more likely to have a fatal outcome than those not requiring assisted respiration (Lynch et al 1997). In large part, these findings reflect the severity of the underlying disease.Most nosocomial pneumonias occur by aspiration of bacteria growing in the back of the throat (oropharynx) or stomach. Intubation and mechanical ventilation greatly increase the risk of infection. Suggest measures to minimize the nosocomial Pneumonia and suggest guidelines for efficacious management of nosocomial infections. Key Concepts: What type of medical or surgical procedures are most often associated with nosocomial pneumonia.Importance of cross-contamination (patient to patient or staff to patient) in causing nosocomial pneumonia.How to minimize the risk of developing nosocomial pneumonia.How to clean and disinfect respiratory therapy equipment.


Sanil Kumar P.,Annamalai University | Dhanapal C.K.,Annamalai University | Ravi S.,Lotus Labs Pvt Ltd | Rao K.,Lotus Labs Pvt Ltd | Manavalan R.,Annamalai University
International Journal of Pharma and Bio Sciences | Year: 2011

In recent years, the acuity of illness of hospitals has increased. Long term care facility residents have a risk of developing Nosocomial infection that is similar to acute care hospital patients. This paper reviews the prevention and control of infections in the hospitals Routine infection control practices refers to the routine use of hand washing and personal protective equipment (gloves, facial protection and gowns) to prevent exposure to blood and body fluids and control the transmission of communicable diseases.


Shekar R.,Lotus Labs Pvt. Ltd | Sinha B.N.,Birla Institute of Technology | Arindam M.,Lotus Clinical Research Academy | Degani M.S.,Institute of Chemical Technology
International Journal of ChemTech Research | Year: 2013

Evaluation of new chemical entities for their drug like properties, early in the discovery phase will help to reduce late stage attrition due to poor stability or unsuitable pharmacokinetic properties. Four newly synthesized triazole compounds viz., 3,3,5-Trimethyl-1-(5-phenyl-4H-1,2,4-triazol-3-yl)cyclohexanol (MSDRT 8), 3,3,5-Trimethyl-1-(5-(pyridin-4-yl)-4H-1,2,4-triazol-3-yl)cyclohexanol (MSDRT 10), Cyclohex-3-enyl(5- (pyridin-4-yl)-4H-1,2,4-triazol-3-yl)methanol (MSDRT 11) and Cyclohex-3-enyl(5-phenyl-4H-1,2,4-triazol-3- yl)methanol (MSDRT 12)), having in vitro antitubercular activity, were screened for chemical stability after acid and alkali hydrolysis. Metabolic stability was also studied after incubating each compound with rat liver microsomes. Based on the results of chemical and metabolic stability, MSDRT 12 was identified as a potential lead compound. A reverse phase high performance liquid chromatographic method with UV/Visible detector was developed for all four compounds and their degradation products were developed and separation were achieved on a Zorbax XDB C18 5 μm column with mobile phase containing a gradient mixture of 0.1 % formic acid and acetonitrile for MSDRT 8, MSDRT 10 and MSDRT 12 and a gradient mixture of 0.1 % formic acid and methanol for MSDRT 11. The method was validated as per International Conference of Harmonisation (ICH) guidelines.


Shekar R.,Lotus Labs. Pvt. Ltd. | Sinha B.N.,Birla Institute of Technology | Mukhopadhya A.,Lotus Clinical Research Academy | Degani M.S.,Institute of Chemical Technology
Chromatographia | Year: 2014

Cyclohex-3-enyl(5-phenyl-4H-1,2,4-triazol-3-yl)methanol (MSDRT 12) is a novel triazole-based antitubercular compound with two chiral centres. Evaluation of the enantio-specific antitubercular activity has established that the stereoisomer 3 of MSDRT12 (Isomer 3) was the most potent isomer with a minimum inhibitory concentration of 0.78 μg/mL. The other stereoisomers show negligible or no activity. A sensitive, simple, specific, precise and accurate chiral chromatographic method for the direct analysis of the four stereoisomers of MSDRT 12 and the active Isomer 3 has been developed and validated. The method has also been validated for analysing the stereoisomeric impurities Isomer 1, Isomer 2 and Isomer 4 in the active Isomer 3. The separation of the four stereoisomers of MSDRT 12 was achieved using an immobilized polysaccharide-based column, Chiralpak ID with amylose tris(3-chlorophenylcarbamate) as the chiral selector. The separation was performed using a mixture of n-hexane, isopropyl alcohol, ethanol and diethylamine (60:35:5:0.1 v/v/v/v) at a flow rate of 1 mL/min. The method offers excellent separation of the four stereoisomers with resolution more than 1.5 and tailing factor <1.5. The standard curves were linear over the concentration range 5-500 μg/mL and 0.40-505 μg/mL for MSDRT 12 and Isomer 3, respectively. Excellent linearity in the range 0.4-5 μg/mL was obtained for Isomer 1, Isomer 2 and Isomer 4 and these stereoisomeric impurities could be accurately and precisely quantified at a level of 0.1 % of the active isomer. © 2014 Springer-Verlag.


D'Souza H.J.B.,Lotus Labs. Pvt. Ltd. | Pai B.,Lotus Labs. Pvt. Ltd. | Kumar A.,Lotus Labs. Pvt. Ltd. | Shekar R.,Lotus Labs. Pvt. Ltd. | And 2 more authors.
Biomedical Chromatography | Year: 2010

While the practice of using a smaller number of non-zero standards (typically seven to eight) has not been entertained in routine bioanalytical work, it is important to innovate and be pragmatic about minimizing the number of calibration standards to promote cost-eff ective and speedy assessment. In this exercise, two important compounds, omeprazole and clopidogrel carboxylic acid, were considered. Additionally, both analytes off ered a 1000-fold calibration curve range with eight non-zero standards to permit a systematic evaluation. Accordingly various scenarios of post-hoc analysis of the calibration data were formulated which included step-wise reduction of the number of calibration standards from a maximum of n = 8 to a minimum of n = 3. In all the scenarios evaluated in this exercise, a calibration curve was reconstructed and both quality control samples and in vivo pharmacokinetics were calculated in each instance. Based on the data generated in this exercise, a minimum of three non-zero calibration standards were adequate to predict the quality control samples with the predefined accuracy and precision estimates for both omeprazole and clopidogrel carboxylic acid. Additionally, the in vivo pharmacokinetic characterization of the chosen compounds was not hampered by the reduction of calibration standards (from n = 8 to n = 3). Hence, consideration for reducing number of calibration standards in bioanalytical work may provide a viable alternative in several situations such as formulation screening strategies, routine therapeutic drug monitoring and sparse sample analyses. Copyright © 2009 John Wiley & Sons, Ltd.


Jayalakshmi N.R.,Bangalore University | Saraswathi K.J.T.,Bangalore University | Vijaya B.,Bangalore University | Prasad D.P.H.S.S.,Lotus Labs Pvt Ltd | Suresh R.,Bangalore University
Journal of Plant Sciences | Year: 2012

Plants of Malva sylvestris L., were studied for morphological variations and anthocyanin production, malvidin and delphinidin with silver nitrate treatment. Effects of exogenous silver nitrate on anthocyanin accumulation have been examined. Foliar spray of 0.1 M silver nitrate for five consecutive days significantly increased the anthocyanin content showing distinct morphological variations with respect to plant height, plant biomass, leaf number and leaf mass. By traditional chilled acidified methanol the total anthocyanins were extracted and estimated by pH differential spectroscopic method. The anthocyanins were purified by C-18 Sep-pak column and further analyzed for different anthocyanins by Thin Layer Chromatography (TLC) and High Performance Liquid Chromatography (HPLC) methods respectively. The evidence presented in this paper indicates that the enhanced anthocyanin production is related to different levels of oxidative stress induced by silver nitrate to the plant tissues. © 2012 Academic Journals Inc.


Manjunath S.J.,Lotus Labs Pvt. Ltd | Kamath N.,Lotus Labs Pvt. Ltd | Shekar A.K.R.,Lotus Labs Pvt. Ltd | Srinivas N.R.,Suramus Biopharm | Kristjansson F.,Lotus Labs Pvt. Ltd
Biomedical Chromatography | Year: 2010

Sensitivity enhancement via summation of multiple MRM transition pairs is gaining popularity in tandem mass spectrometric assays. Numerous validation experiments describing the assays for two model substrates, clopidogrel and ramiprilat, were performed. The quantitation of clopidogrel was achieved by the summation of transition pairs m/z 322.2 to m/z 212.0 and m/z 322.2 to m/z 184.0, while that of ramiprilat was achieved by the summation of transition pairs m/z 389.2 to m/z 206.1 and m/z 389.2 to m/z156.1. The use of summation approach achieved sensitivities of >2 fold for both compounds as compared with the reported single MRM transition pair assays. The validation experiments addressed some important assay development issues, such as: (a) lack of impact of matrix effect; (b) unequivocal verification of the percentage contribution of each MRM transition pair towards sensitivity; (c) sensitivity enhancement factor achieved by summation approach of MRM transition pairs; and (d) accurate prediction of quality control samples using summation approach vs a single MRM transition pair. In summary, the appropriateness of using two MRM transition pairs for quantitation was demonstrated for both clopidogrel and ramiprilat. Additionally, pharmacokinetic application of the MRM transition pair assays using a summation approach was established for the two compounds. Copyright © 2009 John Wiley & Sons, Ltd.


Kandasamy M.,Biometrics | Srinivas P.,Lotus Labs Pvt. Ltd. | Subramaniam K.,Lotus Labs Pvt. Ltd. | Ravi S.,Lotus Labs Pvt. Ltd. | And 4 more authors.
European Journal of Clinical Pharmacology | Year: 2010

Background: Venlafaxine (VEN), a well accepted anti-depressant, is metabolized through the cytochrome P 450 (CYP) 2D6 isozyme to form O-desmethyvenlafaxine (ODV). Due to the involvement of CYP2D6, the formation of ODV is influenced by genetic polymorphism. We used standard tools of assessment to explore the phenotypic distribution in a retrospective manner using the pharmacokinetic (PK) data of VEN and ODV obtained from several bioavailability/bioequivalence (BA/BE) studies in healthy subjects using the reference formulation. Methods: Four single oral dose, open-label, randomized crossover BA/BE studies of VEN (doses: 37.5-150 mg) were performed in 141 healthy subjects. Plasma samples were collected over a period 72 h post VEN administration. The samples were analyzed for VEN and ODV using a validated LC/MS/MS assay with a limit of quantification 2.073 ng/mL for VEN and 3.973 ng/mL for ODV. PK parameters (Cmax, Tmax, AUC 0-t, AUC0-∞, t1/2) were computed using the noncompartmental approach. AUC metabolic ratios of VEN/ODV and ODV/VEN were computed for all subjects and were subjected to normality test procedures to tease out phenotypic distribution. Results: ODV/VEN and VEN/ODV AUC metabolic ratios were evaluated for standard normal distribution and outliers to determine phenotypic distribution. Use of the VEN/ODV AUC metabolic ratio, arranged in a rank order, resulted in a distribution that distinguished poor metabolizers (PM) and extensive metabolizers (EM). The application of the ODV/VEN AUC metabolic ratio showed a unique distribution that distinguished ultra metabolizers (UM) and extensive metabolizers. By using both metabolic ratios, 141 healthy subjects were classified as follows: PMs = 18, EMs = 118, UMs = 5. Regardless of the formulation or dose size used, the plasma concentration-time profiles for both VEN and ODV were distinct amongst the three phenotypes identified in this work. Conclusions: The use of VEN/ODV and ODV/VEN AUC metabolic ratios suggested quantitative differences. The data support the use of ODV/VEN but not VEN/ODV metabolic ratio for the identification of UM phenotypes of VEN. The derived metabolic ratios of ODV/VEN from this work were in line with other studies that used both phenotypic and genotypic correlation strategies for VEN. © 2010 Springer-Verlag.


Fluoxetine, belonging to the class of selective serotonin uptake inhibitors, has been extensively used for the treatment of depression and other psychiatry related disorders. Fluoxetine (CAS 59333-67-4) is a substrate of polymorphic cytochrome P450 2D6 isozyme (CYP2D6) leading to the formation of norfluoxetine (CAS 83891-03-06), which is not only active but long lived than the parent in the systemic circulation. Since the parent and metabolite levels are important from a therapeutic perspective, knowledge of phenotypic distribution of the population may be an important consideration.The aim of the work was to retrospectively evaluate the pharmacokinetic data of fluoxetine and norfluoxetine from several bioavailability/bioequivalence (BA/BE) studies to identify the poor metabolizer (PM) phenotypes from the unsuspected healthy subjects across varied protocol designs, dose sizes and differing formulations.The pharmacokinetic data of fluoxetine and norfluoxetine were gathered from several BA/BE studies conducted at clinical facilities located at Bangalore and Chennai, India. The BA/BE studies involved open label, two-way randomized crossover designs with two periods and two treatments (reference and test). Blood samples were collected for at least 672 h after fluoxetine dosing and the plasma was analyzed using validated tandem liquid chromatography mass spectrometric assay to determine fluoxetine and norfluoxetine levels. Standard pharmacokinetic parameters were computed using noncompartmental methods. For the purpose of this paper, retrospective evaluation of pharmnacokinetic data from only the reference formulation was considered. The AUC ratio of fluoxetine/norfluoxetine was computed. The individual fluoxetine/norfluoxetine AUC(0-infinity), ratios were plotted in increasing rank order and using outlier test (T procedure at 5% level of significance) the subjects were categorized as extensive metabolizer (EM) and PM phenotypes. The unequivocal confirmation of PM phenotypes was obtained by performing linear regression analysis of fluoxetine vs norfluoxetine AUC(0-infinity) values.Each study was evaluated for the distribution of EM and PM phenotypes of fluoxetine. There were 144 subjects evaluable from four studies, 89.6% (129 out of 144) of which could be categorised as EMs and 10.4% (15 out of 144) as PMs of fluoxetine. The pharmacokinetic parameters were quite distinct between the two phenotypes: (1) PM phenotypes showed much higher exposure (approximately 2.3-fold increase in AUC(0-infinity) and much slower elimination (almost 2-fold increase in elimination half-life) for fluoxetine as compared to EM phenotypes; (2) PM phenotypes showed approximately 0.5-fold lower exposure of norfluoxetine as compared to the EM counter parts; (3) There was no change (approximately 1.2-fold) in the elimination half life of norfluoxetine in EM and PM phenotypes.Retrospective evaluation of fluoxetine and norfluoxetine pharmacokinetic data demonstrated existence of both PM and EM phenotypes in the Indian population. Based on the overall data (n=144 subjects) there appeared to be 10.4% of PM phenotypes for fluoxetine and/or possibly for other polymorphic CYP2D6 substrates commonly used in this region.


PubMed | Lotus Labs Pvt. Ltd
Type: Journal Article | Journal: Biomedical chromatography : BMC | Year: 2010

Sensitivity enhancement via summation of multiple MRM transition pairs is gaining popularity in tandem mass spectrometric assays. Numerous validation experiments describing the assays for two model substrates, clopidogrel and ramiprilat, were performed. The quantitation of clopidogrel was achieved by the summation of transition pairs m/z 322.2 to m/z 212.0 and m/z 322.2 to m/z 184.0, while that of ramiprilat was achieved by the summation of transition pairs m/z 389.2 to m/z 206.1 and m/z 389.2 to m/z156.1. The use of summation approach achieved sensitivities of >2 fold for both compounds as compared with the reported single MRM transition pair assays. The validation experiments addressed some important assay development issues, such as: (a) lack of impact of matrix effect; (b) unequivocal verification of the percentage contribution of each MRM transition pair towards sensitivity; (c) sensitivity enhancement factor achieved by summation approach of MRM transition pairs; and (d) accurate prediction of quality control samples using summation approach vs a single MRM transition pair. In summary, the appropriateness of using two MRM transition pairs for quantitation was demonstrated for both clopidogrel and ramiprilat. Additionally, pharmacokinetic application of the MRM transition pair assays using a summation approach was established for the two compounds.

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