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  • QUALITY MANAGEMENT OF COMPLAINTS AND RECALL OF PHARMACEUTICALS AS PER GLOBAL GMPs

    About Authors:
    Nilesh Sovasia, Prof.Sanjeev Thacker, Tarun Patel
    Seth G.L.Bihani S.D.College Of Technical Education,
    Institute Of Pharmaceutical Science & Drug Research,
    Sri Ganganagar,
    Rajasthan, India

    ABSTRACT
    Despite a company's best efforts to design, manufacture and sell safe and reliable products, the possibility still exists that dangerously defective products may reach the customers. These products may cause accidents,leading to adverse verdicts in product liability litigations.There for Quality management of Complaints and Product recalls are essential to ensure the safety of customer.

  • ADDITIVES USED IN THE FOOD PRODUCTS

    About Authors:
    Amit A. Patel , Dr.Vipin Kukkar, Sanjeev Thacker
    Seth G. L. Bihani S.D. College of Technical Education,
    Institute of Pharmaceutical Sciences and Drug Research,
    Sri Ganganagar, Rajasthan, INDIA.

    ABSTRACT:
    Food additives have been much important in food product manufacturing. Additive” became almost synonymous with “adulteration. Food additives are used in the food product toprovide nutrition,to maintain product quality and freshness, to look good. There are many type of food additives are available in the market like anti-oxidants, preservatives,Emulsifier and stabilizers,Sweetener, etc.The “E” number system, intended to assist as a short code for some of the lengthier chemical names and to indicate common European safety approval.

  • VALIDATED RP – HPLC METHOD FOR DETERMINATION OF MONTELUKAST SODIUM AND LEVOCETIRIZINE IN BULK AND ITS PHARMACEUTICAL FORMULATIONS USING UV-VIS DETECTOR

    About Authors:
    RAVISANKAR.M*1, SUBASINI.U2, ANAND THANGADHURAI.S3, KARTHIKEYAN.S4, CHANDRA SEKAR.E.5
    1.Swamy Vivekanandha College of pharmacy, dept of pharmaceutical analysis. Thiruchengode
    2.Swamy Vivekanandha College of pharmacy, dept of pharmacognosy. Thiruchengode
    3.Swamy Vivekanandha College of pharmacy, dept of pharmaceutical analysis. Thiruchengode
    4.Kausikh therapeutics and private limited.chennai
    5.Swamy Vivekanandha College of pharmacy, dept of pharmaceutical analysis. Thiruchengode

    ABSTRACT
    An isocratic reverse phase high performance liquid chromatographic method for estimation of montelukast sodium and levocetirizine in bulk dosage and in marketed formulations has been devised and validated. The chromatographic separation achieved on shodex c18-4E column (5µm, 250 mm x 4.6 mm) and  acetonitrile: methanol: ammonium acetate buffer (PH- 5.5) in the ratio of 25:55:20 v/v. The flow rate was 1.0 ml/min and the UV detection was identified at 225nm.The retention times for montelukast sodium and levocetirizine was found to be 5.15 min and 3.12 min respectively. The linearity of montelukast sodium and levocetirizine is 10 -50µg/ml with the correlation co efficient 0.99 respectively. The validation parameters such as accuracy, precision, LOD, LOQ, Robustness, ruggedness were performed as per ICH guidelines. This method can be used for routine analysis of montelukast sodium and levocetirizine in bulk and marketed dosage forms.

  • VALIDATED UV-SPECTROPHOTOMETRIC AND RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND CHLORZOXAZONE IN TABLET DOSAGE FORM

    About Authors:
    Manoj Kumar Jadia1*, U.L.Narayan2
    1 Department of Pharmaceutical Chemistry, Indira Gandhi Institute of Pharmaceautical Sciences, I.R.C. Village, Bhubaneswar, Dist:Khurda, Odhisa -751015
    2 Principal, Department of Pharmaceutical Chemistry, Indira Gandhi Institute of Pharmaceautical Sciences, I.R.C. Village,
    Bhubaneswar,
    Dist:Khurda, Odhisa -751015

    Abstract:
    Two methods are described for the simultaneous determination of Paracetamol and Chlorzoxazone in binary mixture. The first method was based on UV-spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 282.5 nm (λmax of Chlorzoxazone) and 248.0 nm (λmax of Paracetamol) in methanol; linearity was obtained in the range of 5 – 25 μg.mL-1 for both the drugs. The second method was based on HPLC separation of the two drugs in reverse phase mode using Promosil C18 column. Linearity was obtained in the concentration range of 100-500 μg.mL-1 for Paracetamol and 50-250 for  the Chlorzoxazone. Both these methods have been successively applied to pharmaceutical formulation and were validated according to ICH guidelines.

  • A COMPARATIVE RELEASE STUDY OF ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE FROM DIFFERENT VEHICLES BY USING DIFFERENT CHEMICAL ENHANCERS

    ABOUT AUTHORS:
    RANI SHALU1*, SAROHA KAMAL1, NANDA SANJU2
    1Institute of Pharmaceutical Sciences,
    Kurukshetra University, Kurukshetra 136119, Haryana, India.
    2Department of Pharmaceutical Sciences,
    MDU, Rohtak 124001,
    Haryana, India.

    ABSTRACT
    The aim of the present study was to investigate the in-vitro release properties of Ziprasidone hydrochloride monohydrate from different topical vehicles. By the unique advantages over the traditional drug delivery, transdermal drug delivery is becoming increasingly important and has got a vital interest in pharmaceutical industries. An in vitro release experiment was designed to reveal the rate of release of ziprasidone hydrochloride monohydrate from four different topical vehicles: (i) cream; (ii) a gel; (iii) an ointment (iv) pronoisomal gel. In vitro release of ziprasidone hydrochloride monohydrate from the four bases was monitored spectrophotometrically at a wavelength of 318 nm. In vitro release study results showed that the release of drug from vehicles ranks according to the following order: gel> proniosomal gel> cream> ointment. Gel base showed considerably higher drug release than other vehicles. Five types of chemical enhancers was used in the study and among them tulsi oil was the best enhancer. As we increase the concentration of chemical enhancer the release of drug also increases. By monitoring and attempting to explain the many possible reasons for the different rates of drug release from the vehicles, it was hope that the experiment would confer essential information concerning factors affecting the release of drugs from topical formulations.

  • TECHNOLOGY TRANSFER PROCESS IN PHARMACEUTICAL INDUSTRY: AN OVERVIEW

    About Authors:
    YASWANTH ALLAMNENI*, P DAYANANDA CHARY, S CHAITANYA KUMAR, VENKATA BALAKRISHNA RAO N
    Research and Development Department,
    Natco Pharma Limited,
    Kothur, Mahaboobnagar,
    Andhra Pradesh – 509228.

    Abstract:
    The main objective of this study is to provide the clear procedure for technology transfer process in pharmaceutical industry. Technology transfer is a process to transfer information and technologies necessary to manufacture quality drug product consistently or technology transfer is the process of taking an invention from its inception in a laboratory to a commercialized product.  Investment in R&D is a necessary but not a sufficient condition for economic growth. Productivity gains only result from the natural diffusion of innovation to the marketplace (technology transfer). Responsible departments for successful technology transfer of a product in pharmaceutical industry are R&D, Production, Engineering, QC and QA.  

  • A PRIMER ON QUALITY AND SAFETY OF COSMETICS

    About Author:
    Tarun Patel, Prof. Dr. Vipin Kukkar, Amit Patel

    Seth G.L. Bihani S.D. College of Technical Education,
    Institute of Pharmaceutical Sciences and Drug Research,
    Sri Ganganagar, Rajasthan, INDIA

    ABSTRACT:
    It is a product which is used for improvement of appearance of human body by applying it externally on human body. For better results and minimizing risk of adverse reaction of cosmetic products on human body we have to check out and maintain quality of cosmetic products during its manufacturing.  And  also required some safety parameters for manufacturing of cosmetic products. In this review article we discussed briefly about quality and safety parameters during manufacturing of cosmetic products.

  • FORMULATION AND EVALUATION OF ITRACONAZOLE TRANSDERMAL PATCHES

    About Authors:
    Sreedhar Reddy C
    M.Pharm, Department of Pharmaceutics,
    Vasavi Insitute of Pharmaceutical Sciences,
    Vasavi Nagar, Peddapalli (V), Kadapa (dist),
    A.P, India

    Abstract:
    In this study, transdermal patches containing Itraconazole were prepared using different ratios of polyvinylpyrrolidone (PVP) and Hydroxy propyl methyl cellulose (HPMC) by solvent evaporation technique using 10%w/w of dibutyl phthalate incorporated as plasticizer. The drug matrix film of PVP and HPMC was casted on a polyvinylalcohol backing membrane that was previously dried at 600C for 6 hrs. All the prepared formulations were subjected to physical studies (moisture content, moisture uptake, Tensile strength, flatness and Drug content determination), in vitro release studies and in vitro skin permeation studies. The physiochemical compatibility of the drug and the polymers studied by IR spectroscopy have absence of any incompatibility. In vitro permeation studies were performed across  skin using a Franz diffusion cell. Variations in drug release profiles among the formulations studied were observed. Based on a physicochemical and in vitro skin permeation study, formulation F1 (PVP/HPMC, 5:1) and F5 (PVP/HPMC, 1:5) were chosen for further in vivo experiments. The anti inflammatory effect and a sustaining action of Itraconazole from the two transdermal patches selected were studied by inducing paw edema in rats with 1% w/v carrageenan solution. Hence, it can be reasonably concluded that Itraconazole can be formulated into the transdermal matrix type patches to sustain its release characteristics.

  • TECHNOLOGY TRANSFER AND PROCESS VALIDATION OF METFORMIN HYDROCHLORIDE IMMEDIATE RELEASE TABLET

    About Authors:
    Mr. Davender. S. Bhandari

    Department Of Pharmaceutical Science
    Kumarhatti, Solan (H.P)

    TECHNOLOGY TRANSFER
    “Technology Transfer involves transferring technique & responsibility from  development phase to regular production group .Whether transfer takes place between two sites, two companies, a company & third party manufacturer, or from R&D to a pilot plant or commercial facility.”

  • Naming of Drug Molecules and Pharmaceutical Brands

    About Authors:
    Dr. Amit Gangwal,
    Smriti College of Pharmaceutical Education,
    Indore

    Abstract
    For running any business or organization their products or services should be of utmost quality keeping other things aside. These products or services are known in commerce by their names. These names are called brand names and these are assigned by the owner or innovator or researcher or sponsor of that product or service depending on the type of produce and various parameters. Though company introduces the brand in commerce but after its (brand’s) establishment, brand becomes the identity of company. Brand names are most important attribute of a product after its quality and packing from end user’s (customer) point of view. Successful brand names never escape from the memory of consumer. Few such brand names are Bislery, Maggi, Vicks, Surf Excel, Coca-Cola, Google etc. Few reputed and well known pharmaceutical brands are Corex, Lipitor, Gleevac, Viagra etc. In present article various process to name a drug and a pharmaceutical formulations’ name (brand name) have been described. Article throws light on generic, chemical and brand names of a drug or formulations besides few case studies and guidelines.

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