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Clinical research courses

  • miRNAs A NOVEL TARGET FOR ANTICANCER THERAPY

    ABOUT AUTHORS:
    Ketan M. Parmar*, Ritesh N. Sharma
    S.K.Patel College of Pharmaceutical Education & research,
    Department of Pharmaceutical chemistry, GANPAT UNIVERSITY.
    *brave_student_90@yahoo.com

    ABSTRACT
    With the development of technologies to look at the expression levels of hundreds of miRNAs at a time and the clear role of miRNAs in cancers, groups began looking at miRNAs profiles of different cancers,especially the circulating miRNAs. We intended to make sure whether circulating miRNAs could be a promising biomarker of human cancers. Method: We comprehensively searched the Cochrane Library, Medline and EMbase from 1966 to Nov 2009 for the following terms: (“miRNA” or “microRNA”) and (“tumor” or “carcinoma”) and (“plasma” or “serum” or “circulating”). Detailed information was extracted from studies that met the inclusion criteria: blood-based miRNAs in human cancers and studies published in the English literature. Results: The current review show that different researches use different measurement methods which might impact the results;Cancers treatment might have an effect on circulating miRNAs; some miRNAs are multi-faceted RNA; small sample size might produce selection bias. Furthermore, because of the lack of randomized controlled trials and the heterogeneous nature of the available data, no attempt was made to perform quantitativemeta-analyses.
    In this review, based on those researches, circulating miRNAs are promising and difficulties for their future application for diagnosing human cancers.

  • RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUM AND DESLORATADINE IN COMBINED DOSAGE FORM

    ABOUT AUTHORS:
    Rima M. Bankar*, Dipti B. Patel
    Department of Pharmaceutical Analysis,
    Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University,
    Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
    *rima.banker@yahoo.com

    ABSTRACT
    A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for  simultaneous determination of Montelukast Sodium and Desloratadine. The method showed adequate separation for Montelukast Sodium and Desloratadine  and best resolution was achieved with ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size) using Acetonitrile-Methanol-Water (15:80:5, v/v) as a mobile phase at a flow rate of 1.0 ml/min and wavelength of 283 nm. The calibration curves were linear over the concentration ranges of 5-50 μg/ml for Montelukast Sodium and Desloratadine. The limit of detection (LOD) and limit of quantification (LOQ) for Montelukast Sodium were 0.33 and 1.01 μg/ml while for Desloratadine were 0.10 and 0.31 μg/ml, respectively. All the analytes were separated in less than 6.0 min. The proposed method could be applied for routinelaboratory analysis of Montelukast Sodium and Desloratadine in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.

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  • SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM BY RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD IN SYNTHETIC MIXTURE

    ABOUT AUTHORS:
    Rinku B Patel*1, Paresh U Patel2, Bharat G Patel3, Anil C Patel2
    1Department of Pharmaceutical Analysis, Centre For Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
    2Department of Quality Assurance, Centre For Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
    3Aspee college of Home Science and Nutrition, S.D.Agricultural University, S.K.Nagar-385506, Banaskantha, Gujarat, India.

    *rinkupatel5890@gmail.com

    ABSTRACT
    Simple, accurate, precise, and sensitive ratio spectra derivative spectrophotometric method for simultaneous estimation of Eperisone hydrochloride (EPE) and Diclofenac sodium(DIC) in synthetic mixture have been developed and validated. The ratio derivative spectroscopic method involves measurement of first derivative amplitude of ratio spectra at 247 nm for EPE and 218.4 nm for DIC as two wavelengths for estimation. Beer's law is obeyed in the concentration range of 2-18 μg/ml for both EPE and DIC. LOD values for EPE and DIC are found to be 0.0634 μg/ml and 0.5386 μg/ml, respectively. LOQ values for EPE and DIC are found to be 0.1921 μg/ml and 1.6321 μg/ml, respectively. The method was validated statistically and recovery studies were carried out. It was found to be accurate, precise and reproducible. The method was applied to the assay of the drugs in synthetic mixture, which were found in the range of 98.0% to 102.0% of the labeled value for both Eperisone hydrochloride and Diclofenac sodium. Hence, the method herein described can be successfully applied in quality control of synthetic mixture.

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  • Development and Validation of RP-HPLC Method for Simultaneous Estimation of Ibuprofen and Chlorzoxazone in Synthetic Mixture

    ABOUT AUTHORS
    Anil C. Patel*, Dr Paresh U. Patel , Rinku B. Patel
    Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research,
    Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
    *anilpatel002@gmail.com

    ABSTRACT
    A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for  simultaneous determination of Ibuprofen and Chlorzoxazone. The method showed adequate separation for Ibuprofen and Chlorzoxazone and best resolution was achieved with ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size) using Acetonitrile-Phosphate buffer pH 3.5 - Methenol (20:20:60, v/v; pH adjusted to 3.5 with O-phosphoric acid and TEA(Tetra ethyl amine) as a mobile phase at a flow rate of 0.7 ml/min and wavelength of 221 nm. The calibration curves were linear over the concentration ranges of 2-30 μg/ml for Ibuprofen and Chlorzoxazone. The limit of detection (LOD) and limit of quantification (LOQ) for Ibuprofen were 0.96 and 2.92 μg/ml while for Chlorzoxazone were 0.69 and 2.09 μg/ml, respectively. All the analytes were separated in less than 6.0 min. The proposed method could be applied for routinelaboratory analysis of Ibuprofen and Chlorzoxazone in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.

  • SPECTROPHOTOMETRIC ESTIMATION OF TOLPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM IN SYNTHETIC MIXTURE BY DUAL WAVELENGTH METHOD

    ABOUT AUTHORS:
    Hiral H. Patel*, Paresh U. Patel,
    Department of Pharmaceutical Analysis, Center for Health and Science Studies,
    Ganpat University, Ganpat Vidyanagar – 384012,
    Mehsana, Gujarat, India.
    *patel.hiral2210@gmail.com

    ABSTRACT
    This method describes simple, sensitive, rapid, accurate, precise and economical derivative spectroscopic methodfor the simultaneous determination of tolperisone hydrochloride (TOL) and diclofenac sodium (DIC) in bulk and synthetic mixture. In this study, dual wavelength spectroscopic method was used for simultaneous determination of tolperisone hydrochloride and diclofenac sodium using the absorbance difference at two wavelengths. The absorbance differences of 257 nm and 306.20 nm were selected for the estimation of TOL and the absorbance differences of 243.40 nm and 265.40 nm were selected for estimation of DIC. The method was found to be linear (r2>0.999) in the range of 2- 18 μg/ml for tolperisone hydrochloride. The linear correlation was obtained (r2>0.997) in the range of 2- 18 μg/ml for diclofenac sodium. The limit of determination was 0.66 and 0.27 μg/ml for tolperisone hydrochloride and diclofenac sodium respectively. The limit of quantification was 2.00 and 0.83 μg/ml. The method was successfully applied for simultaneous determination of tolperisone hydrochloride and diclofenac sodium in binary mixture.

  • AICTE SPONSORED Two Weeks Faculty Development Programme on “Recent Advances in Parentral Drug Delivery Systems & Technology” @ Ganpat University

  • RECENT ADVANCE IN PULSATILE DRUG DELIVERY SYSTEM

    About Authors:
    Dhirendra C. Patel1*, Ritesh B. Patel1, Gargi B. Patel2
    1Department of Pharmaceutics and Pharmaceutical Technology;
    S.K. Patel College of Pharmaceutical Education and Research;
    Ganpat University, Kherva, Mehsana, Gujarat, India.
    2Pharma Management & Regulatory Affairs,
    K.B. Institute of Pharmaceutical Education & Research, Gandhinagar, Gujarat, India.
    *dhiren.pharmacy@gmail.com

    Abstract:
    Oral controlled drug delivery systems represent the most popular form of controlled drug delivery systems for the obvious advantages of oral route of drug administration. However, there are certain conditions for which such a release pattern is not suitable like cardiovascular diseases, Diabetes mellitus, Asthma, Arthritis, Peptic ulcer etc. In such cases pulsatile drug delivery system is used in which release drug on programmed pattern i.e. at appropriate time & at appropriate site of action. Pulsatile Drug Delivery systems are basically time controlled drug delivery systems in which the system controls the lag time independent of environmental factors like pH, enzymes, gastro-intestinal motility, etc. The principle rationale for the use of pulsatile release is for the drugs where a constant drug release, i.e., a zero-order release is not desired. In chronopharmacotherapy drug administration is synchronized with biological rhythms to produce maximal therapeutic effect & minimum harm for the patient. Technically, pulsatile drug delivery systems administered via the oral route could be divided into two distinct types, the time controlled delivery systems and the site-specific delivery systems, thus providing special and temporal delivery. In recent pharmaceutical applications involving pulsatile delivery; multiparticulate dosage forms (e.g. pellets) are gaining much favor over single-unit dosage forms. Various pulsatile technologies have been developed on the basis of methodologies, these includes ACCU-BREAK™, AQUALON,  CODAS®, PRODAS®, SODAS®, MINITABS®, DIFFUCAPS®, OROS® etc. Designing of proper pulsatile drug delivery will enhance the patient compliance, optimum drug delivery to the target side & minimizing the undesired effects.

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