• 29 March 2013

    COMPARATIVE STUDY OF DRUG PRODUCT RECALL REGULATIONS IN USA, UK AND AUSTRALIA AND DRAFT GUIDELINES FOR INDIA

    About Authors: 
    Bane Singh Rajput*
    Research Scholar of Lachoo Memorial College of Science & Technology
    Pharmacy Wing, Jodhpur (Raj.)
    *bnsingh29@gmail.com

    Abstract
    Drug product recall is an action taken to withdraw or remove a batch or an entire production run of a drug product from distribution or use and return them to the manufacturer. It is usually done due to the discovery of deficiencies in quality, efficacy or safety in the marketed drug products. Defective drug products related to quality includes adulterated or spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the law and also those products for which product licenses are suspended/ cancelled. In USA, guidelines for drug product recall are described under 21 CFR Parts 7, 107 and 1270.  In Australia, guidelines for drug product recall are described under section 65F of the Trade Practices Act 1974. Sections 2(2), 4, 5 and 7 of the European Communities Act 1972 and Directive 2001/95/EC on general product safety are followed in UK for drug product recall. In India, references for drug product recalls, complaint and adverse reactions are mentioned in Para 27, 28 of Schedule M and conditions of license for defective product recall in Rule 74(j) and Rule 78(i) of the Drugs and Cosmetics Act, 1940 and Rules there under. But no effective and uniform recall procedure and guidelines are formulated yet in India. This paper presents a comparative study of drug product recall guidelines in USA, UK and Australia. Based on this comparative study suggestions are provided to develop regulatory guidelines for drug product recall in India.

  • 28 March 2013
    A REVIEW ON MÖSSBAUER SPECTROSCOPY

    About Authors
    Deepak Kumar Shukla*, Nazia Shahid, Vikas Kumar Alaria
    Rajasthan Pharmacy College, Bhankrota, Jaipur (Raj.)
    *deepakshukla.pharma@gmail.com

    Abstract
    Over the past several years spectroscopy has become the preeminent technique for determining the structure of organic compounds. The study of recoilless nuclear resonant absorption or fluorescence is more commonly known as Mossbauer spectroscopy. From its first origins in 1957, it has grown rapidly to become one of the most important research methods in solid-state physics and chemistry. Mossbauer spectroscopy uses the nuclear properties to get information regarding the environment surrounding the nucleus. This technique is now valid application in diverse fields, such as solid state physics, metallurgy, chemistry and biochemistry. For example, it is possible to use this method for estimating the iron or tin content in ores, alloys and wasters in a non-destructive manner to concentration down to 0.03 percent in a short time of  the order of 10 minutes. The technique can also detect the relative percentage of  different charged states of the same atom, for example fe2+ and Fe3+ present in the material. This is somewhat difficult to get from any other technique.

    [adsense:336x280:8701650588]

  • 28 March 2013
    ASPECT OF NEUROSCIENCE AND NEUROCHEMISTRY

    ABOUT AUTHORS
    Chaitanya Prasad Meher*2 , M.V.Kumar1, V.Sravanthi1 , K.Ramya1, K.Satyanarayana1
    1Maheshwara College  of Pharmacy, Chitkul, Isnapur,
    Patancheru, Hyderabad-502307  (A.P)
    2Assistant professor, Department of pharmaceutical chemistry,
    Maheshwara College of Pharmacy, Hyderabad-502307  (Andhra Pradesh)
    *chaitanyameher84@gmail.com

    ABSTRACT
    Neuroscience is a broad, multidisciplinary field concerned with the nervous system, its components, and functional activities, including behavior and consciousness. It relates to nerve cells function and development,  how do they communicate, how do brains work, and how have they evolved,  Nature of consciousness, and the neural basis for behaviors and for human brain dysfunction. These are among the many questions being answered by contemporary neuroscience. The present review article is concern on the aspect that usually reated to the neurochemistry.

  • 28 March 2013
    DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF TOLPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM IN SYNTHETIC MIXTURE

    ABOUT AUTHORS
    Satish A. Patel, Kaushik P Hariyani*
    Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research,

  • 26 March 2013
    PRESENT SCENARIO OF PROSTAGLANDINS

    ABOUT AUTHOR:
    Mayure Vijay Kumar*, G.J.Finny, C.P.Meher
    Department of pharmacology,
    Maheshwara College Of Pharmacy, Chitkul(v), Isnapur “X” Road,, Patancheru, Hyderabad-A.P-502307
    *mayurevijaykumar@gmail.com

  • 26 March 2013
    DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CHLORZOXAZONE AND DICLOFENAC SODIUM IN COMBINATION

    ABOUT AUTHORS:
    Satish A. Patel, Kalpesh M. Prajapati*
    Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research,
    Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.

  • 25 March 2013
    SURFACTANTS AND ITS APPLICATION IN PHARMACEUTICALS: AN OVERVIEW

    About Author:
    Dhananjay S Jadhav*
    M.Tech (Pharmaceutical Technology), Division of Pharmaceutical Technology,
    Institute of Chemical Technology, North Maharashtra University, Jalgaon -425001.
    Maharashtra, India
    * dhananjaysjadhav@hotmail.com

    Abstract
    Recently, surfactants have become one of the most important chemical products. They have become a subject of research, and their production and their use are on the increase. This wide range of properties, uses for surfactants in pharmaceutical products and systems is to try and introduce and explain in the subject of this article. Wetting of Solids, Solubilization, Emulsification, Dispersion of solid in solution, Micellization & Detergency all these are properties of surfactant. Surfactants are classified according to their polar head group, the charged head referred as Ionic surfactants and uncharged surfactants are generally referred to as nonionic surfactant. Because of their unique functional properties, surfactants find a wide range of uses in pharmaceutical preparations. These include, depending on the type of product, improving the solubility or stability of a drug in a liquid preparation, stabilizing and modifying the texture of a semisolid preparation, or altering the flow properties of a granulate, thus aiding in the processing of the final tablet dosage form. In addition to their use as excipients to improve the physical and chemical characteristics of the formulation, surfactants may be included to improve the efficacy or bioperformance of the product. The properties of surfactants are such that they can alter the thermodynamic activity, solubility, diffusion, disintegration, and dissolution rate of a drug. Each of these parameters influences the rate and extent of drug absorption. Furthermore, surfactants can exert direct effects on biological membranes thus altering drug transport across the membrane. The overall effect of inclusion of a surfactant in a pharmaceutical formulation is complex and may be beyond those initially intended. Surfactants may reduce the effectiveness of antimicrobials or preservatives included in a formulation.

  • 24 March 2013
    DESIGN, DEVELOPMENT AND FUTURE APPLICATION OF MICROSPHERES

    About Authors:
    Divya Rawat, U.K.Singh, Faizi Muzaffar
    Kharvel Subharti College of Pharmacy,
    swami Vivekanand subharti university, Subhartipuram,
    N.H-58, Meerut By Pass Road, Meerut, Uttar Pardesh-250001, India
    *drawat05@gmail.com

    Abstract
    Microspheres constitute an important part of novel drug delivery system by virtue of their small size and efficient carrier capacity. Microspheres are characteristically free flowing powders consisting of proteins or synthetic polymers having a particle size ranging from 1-1000 μm. The range of Techniques for the preparation of microspheres offers a Variety of opportunities to control aspects of drug administration and enhance the therapeutic efficacy of a given drug. There are various approaches in delivering a therapeutic substance to the target site in a sustained controlled release fashion. One such approach is using microspheres as carriers for drugs also known as micro particles. It is the reliable means to deliver the drug to the target site with specificity, if modified, and to maintain the desired concentration at the site of interest. Microspheres received much attention not only for prolonged release, but also for targeting of anticancer drugs. The purpose of the review is to compile various types of microspheres, different methods to preparation, its applications and also various parameters to evaluate their efficiency.

  • 24 March 2013
    A REVIEW ON PHARMACEUTICAL ANALYSIS OF MASS SPECTROSCOPY

    ABOUT AUTHORS:
    G.Venkateswarlu*, M.Muthukumaran, B.krishnamoorthy, Ameren nishat
    Montessori Siva Sivani Institute of Science & Technology College of Pharmacy-Mylavaram,
    Vijayawada, Andhra pradesh-521230
    *venkateswarlu460@gmail.com

    ABSTRACT
    The goal of this review is to provide a guide for understanding current MS technology. Mass spectrometry (MS) has progressed to become a powerful analytical tool for both quantitative and qualitative applications. Proteomics research, in particular, increasingly depends on MS technologies. Basically, any information gathered from a mass spectrometer comes from the analysis of gas-phase ions. There are three main components of a mass spectrometer: an ionization source, a mass analyzer and a detector the name ‘mass spectrometry’ is a misnomer of sorts. The mass is not what is measured; instead, mass spectrometry determines the mass-to-charge (m/z) ratio or a property related to m/z .A mass spectrum is a plot of ion abundance versus m/z, although in many cases the x-axis is labelled ‘mass’ rather than m/z. The spectrum is presented in terms of Daltons (Da) per unit charge The ability of mass spectrometry analyzing proteins and other biological extracts is due to the advances gained through the development of soft ionization techniques such as electrospray ionization (ESI) and matrix-assisted laser desorption ionization (MALDI) that can transform biomolecules into ions. Regardless of the ionization source, the sensitivity of a mass spectrometer is related to the mass analyzer where ion separation occurs.  

  • 22 March 2013
    DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR ASSAY OF AZITHROMYCIN IN POWDER FOR ORAL SUSPENSION

    About Author:
    Swapna.G*
    Department of pharmaceutical Pharmaceutical & Quality Assurance,
    Nirmala College of Pharmacy, Mangalagiri, Atmakuru, Guntur -522 203.
    *swapna.goday.gs@gmail.com

    Abstract
    A  simple,  precise  and  accurate  reversed phase liquid chromatographic method has been  developed  for  the  assay  of  azithromycin  in  powder  for oral suspension. The chromatographic separation was achieved on a Asahipak ODP 40 E(250 mm × 4.6 mm, 5 μm)  analytical  column.  A  mixture  of  methanol–ammonium dihydrogen phosphate (0.05M)  (30:70, v/v)  (pH 9.0)  was  used  as  the  mobile  phase,  at   a  flow  rate  of 1.5 mLmin-1  and  detector  wavelength  at  210 nm. The retention time of  azithromycin was  found to be at  8.0 min. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, robustness and stability indicating assay. The linear  dynamic range is from   382–1208 μgmL-1 for  azithromycin. The percentage recovery  obtained  for  azithromycin is 101.0%.  The developed method can be used for pharmaceutical dosage form and  in process testing.

Subscribe to Articles