• PharmaTutor
    22 January 2016

    QUALITY ASSURANCE OF COSMETICS

    ABOUT AUTHOR:
    Vinay Kumar Singh
    General Manager-Technical,
    Mikasa Cosmetics Limited,
    Ahmedabad, Gujarat
    vinay.s@mikasacosmetics.com

    Quality does not merely mean the goodness of a finished product. Of course, the quality of a finished product is the ultimate objective of a company;  this is also what the consumers expect from the product. However, in order to achieve the desired quality in the finished product, it is essential that the whole plan, starting from the purchase of raw materials to the stage where the ultimate product reaches the consumers, has to contribute towards building quality into the product. Even after the product has reached the consumer, the reactions have to be fed back, so that the product enjoys continuous sales. Quality embraces all spheres of activity. In any organisation, the quality function involves all departments and all groups of personnel. No Quality Assurance Department or Manager will be in position to build and control quality. To build quality, each and every personnel; right from Managing Director to Attender need to contribute.

  • 18 January 2016
    PHARMACOLOGY OF COMBINED MESALZINE AND RIFAXIMIN THERAPY TO INFLAMMATORY BOWEL DISEASE

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    ABOUT AUTHORS
    Prajapati Krishna V*, Raj Hasumati A, Jain Vinit C, Prajapati Neelam S.
    Department of Quality Assurance,
    Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, India
    *krish1112k@gmail.com

    ABSTRACT
    This review article presents the pharmacology of combined Mesalazine and Rifaximin therapy especially in inflammatory bowel disease. Mesalazine is used as in anti-inflammatory agent, Non-Steroidal. Rifaximin is used in Gastrointestinal Agents, Anti-infective agent. The use of Rifaximin in combination with Mesalazine has been proved to provide beneficial effect in inflammatory bowel disease. The mechanism of Mesalazine and Rifaximin is quite different. Mesalamine and Rifaximin are two different types of drugs offering some symptomatic relief to the IBD patients. Mesalamine treats inflammation, whereas, Rifaximin reduces bio burden.
    Patent for combination of both drugs were approved by WIPO. The main objective of this review article is to provide pharmacological information of combined therapy of Mesalazine and Rifaximin to researcher in development of combined dosage form of this.

  • 11 January 2016
    BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS: ABOUT ITS STABILITY TESTING

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    ABOUT AUTHORS
    Vivek P. Chavda1*, Dharmesh Shaliya2, Bhargav Patel3, Ashish Gabani4
    1Department of Pharmaceutics, B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India
    2Quality Assurance, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India
    3Quality Assurance, Zydus cadila pharmaceuticals Ltd., Ahmedabad, Gujarat, India
    4 Intas Biopharmaceuticals Ltd., Ahmedabad, Gujarat, India
    * vivek7chavda@gmail.com

    ABSTRACT
    The drug delivery systems have made some of the technological advances especially in the case of biopharmaceuticals. When one talks about biotechnological product stability of drug product becomes main culprit due to dynamic nature of drug molecule. This review is grafted using ICH and other regulatory guidelines to provide an overview to stability testing of such molecules.

  • 4 January 2016
    A REVIEW ON: PRESERVATIVES USED IN PHARMACEUTICALS AND IMPACTS ON HEALTH

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    ABOUT AUTHORS
    Sabir M. Shaikh*1, Rajendra C. Doijad1, Amol S. Shete1, Poournima S. Sankpal2
    1 Department of Pharmaceutics, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
    2 Department of Pharmaceutical chemistry, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
    *sabirmshaikh17@gmail.com

    ABSTRACT
    For several decades pharmacist have been aware of the need to protect their products against microbial contamination but it is only during the last one or perhaps two decades the serious thought of has been applied to the science of preservation. Preservatives are commonly used as additives in pharmaceutical products, food and cosmetics. Some of the liquid preparation are susceptible to microbial contamination because of the nature of ingredients present in it. Such preparation are protected by preservatives which avoids degradation and alteration of the product.A preservative is a natural or synthetic chemical added to various products which helps to prevent microbial decomposition. Present article deals with the study of ideal properties, classification, mechanism of action, Pharmaceutical applications and its impact on health of various preservatives used in pharmaceuticals.

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  • 29 December 2015
    RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF MEBENDAZOLE IN API AND PHARMACEUTICAL FORMULATIONS

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    ABOUT AUTHORS
    Durgesh Rameshlal Parakh1*, Jayshri K. Madagul1, Harshad Rajendra Mene2, Moreshwar P. Patil1, Sanjay J. Kshirsagar1
    1     Department of Pharmaceutics,
    MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, India.
    2 Department of Pharmaceutics,
    Government College of Pharmacy, Osmanpura, Aurangabad, Maharashtra, India.
    *aryanparakh57@gmail.com

    ABSTRACT
    A new simple and sensitive RP-HPLC method was developed and validated for quantification of Mebendazole in Active Pharmaceutical Ingredient (API) and pharmaceutical formulation.The gradient RP-HPLC method was developed on Agilent (India) C18 250 × 4.6 mm, 5 μ column using mobile phase as acetonitrile: water pH 3.0 with orthophosphoric acid (90:10 v/v) at a flow rate of 1 mL/min and detection was carried out at 234 nm using UV-Visible detector (UV 3000 M). The method was validated linearity, limit of detection, limit of quantification, precision, ruggedness, robustness, accuracy and specificity were found to be satisfactory. The method was found to be linear in the concentration range of 20-100 μ/mL with correlation coefficient of 0.999. The method was validated according to the ICH guidelines and was proved to be specific, linear, accurate, precise and economical for the analysis of Mebendazole.

  • 21 December 2015
    A SHORT REVIEW ON RHEUMATOID ARTHRITIS (RA)

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    ABOUT AUTHORS
    Sabya Sampad Swain, Nadugopal Bhuyan, Chaitanya Prasad Meher
    Gayatri institute of science & technology (GIST), Gunupur, Rayagada, Orissa
    swainsabhya@gmail.com

    ABSTRACT
    Rheumatoid arthritis is most common disease in India as well as outside India. The Centers for Disease Control and prevention estimates that more than 40 million Americans have some form of arthritis or chronic joint disorder out of them 7 million Americans suffer from arthritis in its most debilitating forms. Arthritis foundation classified rheumatic diseases as inflammatory disorders affecting more & more individuals than any chronic illness. Osteoarthritis is the most common form of arthritis in the United States, affecting about 12% of Americans between the ages of 25 and 74. Rheumatoid arthritis is thought to affect well over 2 million Americans (two to three times more females more than males), whereas juvenile arthritis affects 71,000 children under 16 years of age, 61,000 of whom are females. The presented article is concern with a brief idea about rheumatoid arthritis.

  • 16 December 2015
    HAIR DRESSING

    ABOUT AUTHOR:
    Vinay Kumar Singh
    General Manager-Technical,
    Mikasa Cosmetics Limited,
    Ahmedabad, Gujarat
    vinay.s@mikasacosmetics.com

  • 10 December 2015
    DATA INTEGRITY AND WORLDWIDE REGULATORY GUIDANCE

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    ABOUT AUTHORS
    Rohit A. Patil1*, Shruti N.Patil2
    Department of Regulatory Affairs,
    Supreme Pharma Healthcare Pvt. Ltd. Mumbai, MH, India
    * rohitpharma3250@gmail.com

    ABSTRACT
    Good storage of data & record management are critical elements of pharmaceutical quality system. Data integrity refers to maintaining & assuring the accuracy & consistency of data over its entire life –cycle in compliance with its applicable regulatory requirements.
    Data integrity is mandatory for the regulated pharmaceutical industry, as processing and disposition decisions regarding product quality, safety, efficacy, purity, and compliance with the applicable regulatory requirements are made based on data that is recorded and reported. Data integrity risk should be assessed, mitigated, communicated & reviewed throughout the data life cycle. Healthcare industries should be designed Record-keeping methodologies and systems, in a way that encourages compliance and assures data quality and reliability.

  • 6 December 2015
    REVIEW STUDY ON FACTORS AFFECTING THE PRESCRIPTION PATTERN OF PHYSICIANS

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    About Authors
    Amoah-Binfoh Kenneth1*, Pradhyuman Singh Lakhawat1, Archana Chandra2
    1 SHIATS, Allahabad, UP, India
    2 Dept. of Human Resources, SHIATS, Allahabad, UP, India
    * geokin08@gmail.com

    ABSTRACT
    Prognosis the medical outcome of a corrective prediction, physicians become aware of a particular drug through promotional strategies. If all relevant information received is positive, the drug may be tried on few patients’. As a matter of fact if the outcomes of the trials are acceptable physicians will shift and may be more interested to prescribe the drugs consistent. Prescribing drugs is a standard component of most physicians’ practices. It is an important area of practice that requires appropriate knowledge, skill and professional judgment. To improve patient safety when prescribing, these qualities set out expectations for physicians who prescribe drugs. However in connection with the physician’s prescription pattern, Indian pharmaceutical industry is at a turning point. The pharmaceutical firms have to change their strategies for the challenges ahead. Quality systems, innovation, manufacturing and marketing competence are associate factors that affects physicians prescription pattern. The efficacy of drug discovery process has been reported to have suffered a major transformation. New drug discovery has to be strictly adhere to the tight intellectual property rights to ensure effective and efficient, prescriptions and protections. Further clinical and behavioral characteristics of the patient, research and the pressures from drug firms, high curing effect; habitual or non-habitual choice, behavior pattern of patients, peer influence of physicians (community of physicians) and education and advertising are reviewed factors affecting physician’s prescription pattern.

  • 3 December 2015
    DTK OF MEDICINES FROM BIO-PIRACY: ITS CONSCIENTIOUSNESS BY TKDL OF INDIA

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    ABOUT AUTHORS:
    NG Dhawan*1, Manisha Mavai2, Priyanka Bishnoi3, Raaz K Maheshwari3
    1Amity Institute of Environmental Sciences, Amity University,  Noida, UP, India
    2Department of Botany Physiology, AIIMS, Jodhpur, Rajasthan, India
    3Department of Botany & Biotechnology, University of Rajasthan, Rajasthan, India
    4Department of Chemistry, SBRM Govt PG College, Nagaur, India
    *rkmgreenchem.jaipur@gmail.com

    ABSTRACT
    The genetic resources and indigenous communities traditional knowledge of developing countries is being exploited by the Developed countries in the name of patents for inventions that are derived from genetic  resources. The exploitation of genetic resources and indigenous communities traditional knowledge by the developed countries in the name of patents on the inventions derived from those genetic resources is actually bio-piracy.  Protection of the TK of the local and indigenous communities appears to be one of the most debatable and complex issues. This paper brings out the role of domestic IPR constitution that looks to protect traditional system of medicine and associated TK in Indian sub-continent. Further, it attempts to validate the necessity of introduction of a national TKDL, which can be utilized as an evidence of the 'prior art' by the examiners of patent offices, nationally as well as internationally. Thus, it aims to address the concerns relating to the creation of TKDL in India.

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