Fortis Clinical Research Ltd.

Farīdābād, India

Fortis Clinical Research Ltd.

Farīdābād, India
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Nazish I.,Hamdard University | Samad A.,Fortis Clinical Research Ltd | Beg S.,Hamdard University | Aqil M.,Hamdard University
Recent Patents on Anti-Infective Drug Discovery | Year: 2012

Diabetes mellitus is the most common endocrine disorder, affecting 16 million individuals in the United States and 200 million worldwide. Despite the use of advanced synthetic drugs for the treatment, use of herbal remedies is gaining higher importance because of synthetic drugs have drawbacks and limitations. The herbal drugs with antidiabetic activity are extensively formulated commercially because of easy availability, affordability and less side effects as compared to the synthetic antidiabetic drugs. Antidiabetic herbal formulations (AHF) are considered to be more effective for the management of diabetes. There are around 600 herbal drug manufacturers in India of which almost all manufacturers are developing AHF in addition to others. Till date, no article is published to give detailed information of the patents on AHF. Thus, this review article undertake the attempt for providing updated information on the type of diabetes and patented AHF which will enhance the existing knowledge of the researchers. © 2012 Bentham Science Publishers.

Beg S.,Hamdard University | Samad A.,Fortis Clinical Research Ltd | Nazish I.,Hamdard University | Sultana R.,National Institute of Technology Rourkela | Akbar M.,Hamdard University
Current Drug Targets | Year: 2013

Vaccines play a vital role in the field of community medicine to combat against several diseases of human existence. Vaccines primarily trigger the acquired immune system to develop long-lasting immunity against pathogens. Conventional approaches for vaccine delivery lacks potential to target a particular antigen to develop acquired immunity by specific antibodies. Recent advancements in vaccine delivery showed that inclusion of adjuvants in vaccine formulations or delivery of them in a carrier helps in achieving desired targeting ability, reducing the immunogenicity and significant augmentation in the immune response. Colloidal carriers (liposomes, niosomes, microspheres, proteosomes, virosomes and virus like particles (VLPs), antigen cochleates, dendrimers and carbon nanotubes) have been widely explored for vaccine delivery. Further, surface engineering of these carriers with ligands, functional moieties and monoclonal antibodies tend to enhance the immune recognition potential of vaccines by differentiation of antigen specific memory T-cells. The current review, therefore, provides an updated account on the recent advancements in various colloidal delivery systems in vaccine delivery, outlining the mechanism of immune response initiated by them along with potential applications and marketed instances in an explicit manner. © 2013 Bentham Science Publishers.

Khanna A.,Ranbaxy Laboratories | Khanna A.,Indian Institute of Technology Delhi | Raj V.S.,Ranbaxy Laboratories | Tarai B.,Clinical Reference Laboratory | And 8 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2010

We screened 194 Mycobacterium tuberculosis strains isolated from tuberculosis (TB) patients in Delhi and neighboring regions in India to identify the prevalence of extensive drug resistance (XDR) in clinical isolates. Among these, 104 isolates were found to be multidrug resistant (MDR), and 6 were identified as XDR isolates, which was later confirmed by antimicrobial susceptibility testing against the respective drug screening panel. Genotyping was carried out by amplifying and sequencing the following genes: rpoB (rifampin), katG (isoniazid), gyrA (fluoroquinolones), and rrs (amikacin, kanamycin, and capreomycin). Our analyses indicated that mutations at the hot spots of these genes were positively correlated with drug resistance in clinical isolates. The key mutation observed for rpoB was in the codon for amino acid position 531 (S531L), and other mutations were seen in the hot spot, including those encoding Q510P, L511H, D516V, and H526Y mutations. We identified S315T and R463L substitutions encoded in the katG locus. An S95T substitution encoded in the gyrA locus was the most common mutation observed in fluoroquinolone- resistant isolates. In addition, we saw D94G and D94N mutations encoded in the QRDR region. The 16S rRNA (rrs) gene encoded mainly the A1401G mutation and an additional mutation, G1484T, resulting in ribosomal modifications. Taken together, the data in this report clearly establish the presence of phenotypically distinct XDR strains in India by molecular profiling and further identify specific mutational hot spots within key genes of XDR-TB strains. Copyright © 2010, American Society for Microbiology. All Rights Reserved.

Kandhwal K.,Ranbaxy Laboratories | Dey S.,Ranbaxy Laboratories | Nazarudheen S.,Ranbaxy Laboratories | Arora R.,Ranbaxy Laboratories | And 5 more authors.
Clinical Drug Investigation | Year: 2011

Background: Type 2 diabetes mellitus is associated with a 2- to 4-fold in-creased risk of coronary heart disease (CHD). Combined therapy with an antihyperglycaemic agent and an HMG-CoA reductase inhibitor (statin) is indicated for the treatment of diabetic patients at risk of CHD. Patients with type 2 diabetes are generally considered to be at equivalent cardiovascular disease risk to patients with established CHD, and should have low-density lipoprotein (LDL) cholesterol levels reduced to < 100 mg / dL or by 30 -40 %. Atorvastatin is the drug of choice for lowering LDL cholesterol levels. Met-formin is the first therapeutic option in type 2 diabetes patients who are overweight or obese because it may also prevent vascular complications and mortality. Hence, a fixed-dose combination (FDC) of atorvastatin 10 mg and metformin 500 mg extended release (ER) was developed for patients with type 2 diabetes with or without hyperlipidaemia. Objectives: This study set out to establish bioequivalence between treatment 1 (test) - atorvastatin/ metformin ER 10 mg/ 500 mg FDC , and treatment 2 (ref -erence) - atorvastat in 10 m g (Lipitor) a nd metformin 500 mg (Glucophage XR) administ er ed concurrently as indi vidual t ab lets. Methods: The study was a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study in 40 male subjects of Asian origin aged 18 -45 years. The order of receiving the test and reference treatments for each subject during both the periods of the study was determined according to an SAS-generated randomization schedule. The two treatments were separated by a washout period of 11 days. Blood samples were collected pre-dose and up to 72 hours post-dose in each period for determination of plasma atorvastatin / metformin concentrations and calculation of the respective pharmacokinetic parameters. ANOVA was performed on the lognormal-transformed pharmacokinetic parameters. A 90 % confidence interval (CI) for the ratios of the test and reference product averages (least squares means) was calculated for atorvastatin and metformin to establish bioequivalence. Results: The 90 % CIs for atorvastatin and metformin were within the bioequivalence acceptance criteria of 80 - 125%. The 90 % CIs obtained for atorvastatin for maximum plasma concentration (C max), area under the plasma concentration-time curve (AUC) from time zero to time of last mea-surable concentration (AUClast ) and AUC from time zero to infinity (AUC) were (88.11, 106.93), (91.18, 107.94) and (89.25, 106.60), respectively. The 90 % CIs observed for metformin for C max, AUC last, AUC and AUC from time zero to 24 hours (AUC 24) were (113.3, 124.0), (102.65, 117.97), (101.87, 116.82) and (102.44, 117.53), respectively. The two treatments were well tolerated by the study subjects. Conclusion: Atorvastatin / metformin ER 10 mg / 500 mg FDC has similar bioavailability to the co-administration of separate atorvastatin 10 mg and metformin 500 mg tablets. The FDC tablets show similar safety and toler-ability profiles to their individual components. Therefore, atorvastatin/metformin ER 10 mg/ 500 mg FDC tablets can be used safely in clinical settings to decrease the pill burden and increase patient compliance with therapy. © 2011 Adis Data Infor mation BV. All rights reserved.

PubMed | Sri Venkateswara University, Indira Gandhi Institute of Pharmaceutical science, LNM University, Hamdard University and Fortis Clinical Research Ltd
Type: Journal Article | Journal: Journal of chromatographic science | Year: 2016

The current studies describe the Quality by Design (QbD)-based development and validation of a LC-MS-MS method for quantification of fluoxetine in human plasma using fluoxetine-D5 as an internal standard (IS). Solid-phase extraction was employed for sample preparation, and linearity was observed for drug concentrations ranging between 2 and 30 ng/mL. Systematic optimization of the method was carried out by employing Box-Behnken design with mobile phase flow rate (X1), pH (X2) and mobile phase composition (X3) as the method variables, followed by evaluating retention time (Rt) (Y1) and peak area (Y2) as the responses. The optimization studies revealed reduction in the variability associated with the method variables for improving the method robustness. Validation studies of the developed method revealed good linearity, accuracy, precision, selectivity and sensitivity of fluoxetine in human plasma. Stability studies performed in human plasma through freeze-thaw, bench-top, short-term and long-term cycles, and autosampler stability revealed lack of any change in the percent recovery of the drug. In a nutshell, the developed method demonstrated satisfactory results for analysis of fluoxetine in human plasma with plausible utility in pharmacokinetic and bioequivalence studies.

Hasnain M.S.,Seemanta Institute of Pharmaceutical science | Rao S.,Fortis Clinical Research Ltd | Singh M.K.,Fortis Clinical Research Ltd | Vig N.,Fortis Clinical Research Ltd | And 5 more authors.
Analyst | Year: 2013

For the determination of lenalidomide using carbamazepine as an internal standard, an ultra-fast stability indicating LC-MS/MS method was developed, validated and optimized to support clinical advancement. The samples were prepared by solid-phase extraction. The calibration range was 2-1000 ng mL -1, for which a quadratic regression (1/x2) was best fitted. The method was validated and a 32 factorial was employed using Box-Behnken experimental design for the validation of robustness. These designs have three factors such as mobile phase composition (X1), flow rate (X2) and pH (X3) while peak area (Y1) and retention time (Y2) were taken as response. This showed that little changes in mobile phase and flow rate affect the response while pH has no affect. Lenalidomide and carbamazepine were stable in human plasma after five freeze thaw cycles, at room temperature for 23.7 h, bench top stability for 6.4 h. This method competes with all the regulatory requirements for selectivity, sensitivity, precision, accuracy, and stability for the determination of lenalidomide in human plasma, as well as being highly sensitive and effective for the pharmacokinetic and bioequivalence study of lenalidomide. © 2013 The Royal Society of Chemistry.

Hussain A.,Guru Nanak Dev University | Samad A.,Fortis Clinical Research Ltd | Nazish I.,Jamia Hamdard University | Ahmed F.J.,Jamia Hamdard University
Drug Development and Industrial Pharmacy | Year: 2014

Objective: The conventional liposomal amphotericin B causes many unwanted side effects like blood disorder, nephrotoxicity, dose-dependent side effects, highly variable oral absorption and formulation-related instability. The objective of the present investigation was to develop cost-effective nanoemulsion as nanocarreir for enhanced and sustained delivery of amphotericin B into the skin. Methods and characterizations: Different oil-in-water nanoemulsions were developed by varying the composition of hydrophilic (Tween® 80) surfactants and co-surfactant by the spontaneous titration method. The developed formulation were characterized, optimized, evaluated and compared for the skin permeation with commercial formulation (fungisome 0.01% w/w). Optimized formulations loaded with amphotericin B were screened using varied concentrations of surfactants and co-surfactants as decided by the ternary phase diagram. Results and discussion: The maximum % transmittance obtained were 96.9±1.0%, 95.9±3.0% and 93.7±1.2% for the optimized formulations F-I, F-III and F-VI, respectively. These optimized nanoemulsions were subjected to thermodynamic stability study to get the most stable nanoemulsions (F-I). The results of the particle size and zeta potential value were found to be 67.32±0.8 nm and -3.7±1.2mV for the final optimized nanoemulsion F-I supporting transparency and stable nanoemulsion for better skin permeation. The steady state transdermal flux for the formulations was observed between 5.89±2.06 and 18.02±4.3g/cm2/h whereas the maximum enhancement ratio were found 1.85- and 3.0-fold higher than fungisome and drug solution, respectively, for F-I. The results of the skin deposition study suggests that 231.37±3.6g/cm2 drug deposited from optimized nanoemulsion F-I and 2.11-fold higher enhancement ratio as compared to fungisome. Optimized surfactants and co-surfactant combination-mediated transport of the drug through the skin was also tried and the results were shown to have facilitated drug permeation and skin perturbation (SEM). Conclusion: The combined results suggested that amphotericin B nanoemulsion could be a better option for localized topical drug delivery and have greater potential as an effective, efficient and safe approach. © 2014 Informa Healthcare USA, Inc. All rights reserved: reproduction in whole or part not permitted.

Hasnain M.S.,Seemanta Institute of Pharmaceutical science | Rao S.,Fortis Clinical Research Ltd | Singh M.K.,Fortis Clinical Research Ltd | Vig N.,Fortis Clinical Research Ltd | And 2 more authors.
Journal of Pharmacy and Bioallied Sciences | Year: 2013

Purpose: For the determination of desloratadine (DES) and 3-OH desloratadine (3-OHD) in human plasma using deutrated desloratadine (DESD5) as internal standard (IS), a novel stability indicating liquid chromatography- tandem mass spectrometric method was developed and validated to support the clinical advancement. Materials and Methods: The solid-phase extraction method used for sample preparation and calibration range was 100-11,000 pg/ml, for which a quadratic regression (1/x 2) was best fitted. The blank plasma was screened and observed free from any endogenous interference. Results: The accuracy (% nominal) at low limit of quantification LLOQ level for DES and 3-OHD was 100.4% and 99.9% whereas precision (%CV) was 4.6 and 5.1%. They (DES and 3-OHD) were stable in human plasma after five freeze-thaw cycles, at room temperature for 23.8 hour, bench top stability for 6.4 hour. Conclusion: This method fulfills all the regulatory requirements for selectivity, sensitivity, precision, accuracy, stability, goodness of fit, and ruggedness of the method for the determination of DES and 3-OHD in human plasma.

PubMed | Jamia Hamdard University, Fortis Clinical Research Ltd., Birla Institute of Technology and Central University of Costa Rica
Type: Journal Article | Journal: Drug delivery | Year: 2016

In this study, attempt has been focused to prepare a nanoemulsion (NE) gel for topical delivery of amphotericin B (AmB) for enhanced as well as sustained skin permeation, in vitro antifungal activity and in vivo toxicity assessment.A series of NE were prepared using sefsol-218 oil, Tween 80 and Transcutol-P by slow spontaneous titration method. Carbopol gel (0.5%w/w) was prepared containing 0.1%w/w AmB. Furthermore, NE gel (AmB-NE gel) was characterized for size, charge, pH, rheological behavior, drug release profile, skin permeability, hemolytic studies and ex vivo rat skin interaction with rat skin using differential scanning calorimeter. The drug permeability and skin irritation ability were examined with confocal laser scanning microscopy and Draize test, respectively. The in vitro antifungal activity was investigated against three fungal strains using the well agar diffusion method. Histopathological assessment was performed in rats to investigate their toxicological potential.The AmB-NE gel (18.090.6g/cm(2)/h) and NE (15.740.4g/cm(2)/h) demonstrated the highest skin percutaneous permeation flux rate as compared to drug solution (4.590.01g/cm(2)/h) suggesting better alternative to painful and nephrotoxic intravenous administration. Hemolytic and histopathological results revealed safe delivery of the drug. Based on combined results, NE and AmB-NE gel could be considered as an efficient, stable and safe carrier for enhanced and sustained topical delivery for AmB in local skin fungal infection.Topical delivery of AmB is suitable delivery system in NE gel carrier for skin fungal infection.

PubMed | c PCTE Institute of Pharmacy, Hamdard University, Fortis Clinical Research Ltd. and Birla Institute of Technology
Type: Journal Article | Journal: Drug delivery | Year: 2016

This investigation has focused to characterize the elastic liposome containing 5-fluorouracil (5-FU) and to enhance drug permeation across stratum corneum (SC) of the skin (rat) using various surfactants and in vivo dermal toxicity evaluation.5-FU-loaded elastic liposomes were developed, prepared and characterized for their entrapment efficiency, vesicle size, number of vesicles, morphological characteristics, surface charge and turbidity. In vitro drug release profile, in vitro skin permeation potential and in vitro hemolytic ability of the formulation have been evaluated to compare with drug solution for 24h. In vitro skin permeation potential was also compared with marketed cream. Furthermore, in vivo skin irritation potential, drug penetration into the skin using confocal laser scanning microscopy (CLSM) and in vivo toxicity studies were performed.The optimized elastic liposomes demonstrated maximum drug entrapment efficiency, optimum vesicular size and considerable elasticity. In vitro skin permeation studies showed the highest drug permeation flux like 77.076.34, 89.748.5 and 70.909.6g/cm(2)/h for EL3-S60, EL3-S80 and EL3-T80, respectively, as compared to drug solution (8.9586.9g/cm(2)/h) and liposome (36.806.4g/cm(2)/h). Drug deposition of optimized elastic liposome EL3-S80 was about three fold higher than drug solution. Skin irritation and CLSM studies suggested that optimized gel was free from skin irritation and capable to deliver 5-FU into the epidermal area for enhanced topical delivery than drug solution. The in vitro study showed minimum hemolysis in the optimized formulation. Finally, in vivo toxicity studies followed with hisptopathological assessment showed that elastic liposome was able to extract SC to improve drug permeation without changing general anatomy of the skin.

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