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  • A REVIEW ON CREATION AND HANDLING OF DATA IN ACCORDANCE WITH CGMP REQUIREMENTS IN PHARMACEUTICALS

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    ABOUT AUHTORS
    Suleman S. khoja * 1, Sohil S khoja 1,Parthkumar H chauhan 2,Farhad S Khoja 3 ,Shamim S Khoja3.
    1) Resource person in Pharmaceutical Quality Assurance, Audit and Compliance, Vapi -396191.
    2) Resource person in Quality Assurance, Navsari
    3) Registered Pharmacist ,Gujarat State Pharmacy council, Vapi -396191
    *premukhoja@gmail.com

    ABSTRACT:
    Data integrity is fundamental in a pharmaceutical quality system which ensures the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), Arrangements shall be in place within an organisation with respect to people, systems and facilities that shall be  designed, operated and where appropriate adapted to support a working environment and  organisational culture that ensures data is complete consistent and accurate in all its forms, i.e. paper  and electronic record .When taken collectively these arrangements fulfil the concept of data governance. Regulatory bodies expect that data shall be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to detect and prevent data integrity issues. Industry should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and best business models. In recent year Regulatory observation has increasingly observed GMP violations involving data integrity risks during CGMP inspections. This is troublesome because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, Regulatory is concern with ability to protect the public health.

  • A STUDY ON ROLE OF CLINICAL PHARMACIST IN IDENTIFICATION AND REPORTING OF DRUG INTERACTIONS IN PHYSCIATRIC WARD IN A TERITARY CARE TEACHING HOSPITAL

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    ABOUT AUHTORS
    M. Manasa Rekha*, T. Mubeena
    Department of Pharmacy Practice,
    Annamacharya college of Pharmacy,
    Rajampet, Andhra Pradesh, India.
    * manasarekharoyal@gmail.com

    ABSTRACT: 
    Clinical pharmacy is defined as that area of pharmacy concerned with the science and practice of rational medication use. The pharmacist, along with the prescriber has a duty to ensure that patients are aware of the risk of side effects and a suitable course of action should they occur. With their detailed knowledge of medicine, pharmacists have the ability to relate unexpected symptoms experienced by patients to possible drug interactions of their drug therapy. The practice in clinical pharmacy also ensures that drug interactions are minimized by avoiding drugs with potential side effects in susceptible patients. Thus, pharmacist has a major role to play in relation to prevention, detection, and reporting drug interactions.

  • COMBINATORIAL CHEMISTRY - MODERN SYNTHESIS APPROACH

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    ABOUT AUHTORS
    Sunil Shastri*, Harsh Narang.
    Seth G.L. Bihani S.D. College of Technical Education,
    Sriganganagar, Rajasthan.
    sunil11044@gmail.com

    ABSTRACT
    The Combinatorial Chemistry is a scientific method in which a very large number of chemical entities are synthesized by condensing a small number of chemical compounds together in all combinations defined by a small set of chemical reactions.

    Combinatorial technologies provided a possibility to produce new compounds in practically unlimited number. New strategies and technologies have also been developed that made possible to screen very large number of compounds and to identify useful components of mixtures containing millions of different substances. Instead of preparing and examining a single compound, families of new substances are synthesized and screened. In addition, combinatorial thinking and practice proved to be useful in areas outside the pharmaceutical research Such as search for more effective catalysts and materials research. Combinatorial chemistry became an accepted new branch within chemistry.
    The aim of this project is to provide a basic introduction to the field of combinatorial chemistry describing the development of major techniques and some applications. 

  • NANOPARTICLE - NOVEL DRUG DELIVERY SYSTEM: A REVIEW

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    ABOUT AUHTORS
    Hnawate R.M*., Deore P.
    Dr. Vedprakash Patil Pharmacy College,
    Aurangabad,
    Maharashtra, India
    ravi_hanwate@yahoo.co.in

    ABSTRACT
    For the past few years, there has been a considerable research on the basis of Novel drug delivery system, using particulate vesicle systems as such drug carriers for small and large molecules. Nanoparticles, Liposomes, Microspheres, Niosomes, Pronisomes, Ethosomes, Proliposomes have been used as drug carrier in vesicle drug delivery system. Nanotechnology refers to the creation and utilization of materials whose constituents exist at the nanoscale; and, by convention, be up to 100 nm in size.. Nanoparticles are being used for diverse purposes, from medical treatments, using in various branches of industry production such as solar and oxide fuel batteries for energy storage, to wide incorporation into diverse materials of everyday use such as cosmetics or clothes, optical devices, catalytic, bactericidal, electronic, sensor technology, biological labelling and treatment of some cancers. Various polymers have been used in the formation of Nanoparticles. Nanoparticles have been improving the therapeutic effect of drugs and minimize the side effects. Basically, Nanoparticles have been prepared by using various techniques as such dispersion of preformed polymers, polymerization of monomers and ionic gelation or co-acervation of hydrophilic polymer. Nanoparticles have been evaluated by using parameters of drug entrapment efficiency, particle shape, drug release study

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  • FORMULATION AND EVALUATION OF ATOMOXETINE HYDROCHLORIDE SUSTAINED RELEASE TABLETS

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    ABOUT AUHTORS
    Seema Farheen1*, Shaik Zubair1 , Alwala Arpini1, Govindapuram Kalpana  Goud2,  Saidulu Soppari3, Mangulal Kethavath4
    1Department  of pharmaceutics,
    Vijaya College Of Pharmacy, Ranga Reddy, Telangana, India.
    2Department  of pharmaceutical Analysis and Quality Assurance,
    SLC’S College Of Pharmacy, Nalgonda, Telangana, India.
    3Department  of pharmacology,
    SLC’S College Of Pharmacy, Nalgonda, Telangana, India.
    4Department  of pharmaceutics,
    SLC’S College Of Pharmacy, Nalgonda, Telangana, India
    *seemafarheen75@gmail.com

    ABSTRACT
    Atomoxetine hydrochloride (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Tablets of Atomoxetine Hydrochloride were formulated as sustained release tablet employing tamarind seed polysaccharide, guar gum, PVP, Mg. stearate, MCC  the sustained release tablets was investigated. Sustained release matrix tablets contain Atomoxetine Hydrochloride were developed using different drug polymer concentration of tamarind seed polysaccharide, guar gum,. Tablets were prepared by directly using MCC. Formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The resulting formulation produced robust tablets with optimum hardness, thickness consistent weight uniformity and low friability. All tablets but one exhibited gradual and near completion sustained release for Atomoxetine Hydrochloride, and 98.6% and 97.5 released at the end of 12 hrs. The results of dissolution studies indicated that formulation F8, the most successful of the study. An increase in release kinetics of the drug was observed on decreasing polymer concentration

  • A REVIEW ON QUALITY AGREEMENT REQUIREMENT IN PHARMACEUTICALS BY REGULATORY AUTHORITY IN COMPLIANCE TO CGMP GUIDELINES

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    ABOUT AUHTORS
    Suleman S khoja*1,Sohil S khoja1, Farhad S Khoja2,Shamim S Khoja2, Narmin A Pirani2
    1 Resource person in Pharmaceutical Quality Assurance and Facility Audit,
    Vapi, Gujarat, India.
    2 Registered Pharmacist, Gujarat State Pharmacy Council, Gujarat, India
    *premukhoja@gmail.com

    ABSTRACT
    A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP. Quality agreements may be reviewed during inspections. A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP. The quality agreement should explain how the contractor will report manufacturing deviations to the owner, as well as how deviations will be investigated, documented, and resolved in compliance with CGMP. Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with CGMP. The most critical pieces are quality and change control, as described in the following sections. Manufacturing Activities Change Control Associated With Manufacturing Activities

  • HETEROATOM (NITROGEN) BASED SYNTHETIC TEMPLATES AS ANTICANCER AGENTS

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    ABOUT AUHTORS
    Deepak Chowrasia*, Nisha Sharma
    University Institute of Pharmacy, Chhatrapati Shahu Ji Maharaj University, Kanpur (U.P.)-208024, India
    *debpratim008@gmail.com

    ABSTRACT
    Cancer remains a global concern not only for clinicians, but also for chemist owing to its alarming incidence rate. Conventional cancer chemotherapeutics are inadequate requiring newer molecule for its cure and management. Heterocyclic chemistry emerges as a distinct branch of organic chemistry responsible for yielding uncountable pharmacologically active substances among nitrogen containing ring systems are thoroughly investigated owing to their unique characteristic. The present study to explore feasibility of nitrogen containing synthetic molecules as novel anticancer agents.

  • NANO-PARTICLES CONTAINING ANTICANCER DRUG

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    ABOUT AUHTORS
    Debpratim Chakraborty*, Nisha Lama Yolmo
    Department of Pharmaceutical tech,
    Jadavpur University,
    Kolkata, West Bengal, India
    *debpratim008@gmail.com

    ABSTRACT:
    Now a day in medical science and researches, cancer is one of the most life threatening disease but unfortunately still now we have no medical treatment for procurement of this disease. The pathology is not totally clear but according to medical evidence if we consider genes then we must agree that oncogene and tumor suppressor genes are mainly responsible. There are some risk factor also consider which may leads to cancer. The conventional treatments are surgery, Radio-therapy and chemo therapy but the real fact is none of the above mentioned treatment is enough for procurement of cancer and that’s why now scientist and researchers are thinking about nan-technology. NCI has identified that nano-technology have the potential to make paradigm changing impacts on the detection, treatment and prevention of cancer.  There are different strategies for cancer therapy using nano-particles like targeted and non-targeted nano-particles. Different studies show that the side effect of doxorubicine (an anticancer drug) can be minimizing by nano-technology, which also reduce the multi drug resistance. Nano-sphere and Nano-capsule of anti-steroid 4-hydroxytamoxifen RU reduce estrogen dependent tumor. Dendritic nano-technology with 5-fluro Uracil decreases the drug clearance and increase the therapeutic time. Methotrixate incorporated dendritic polymer target the folic acid receptor. Camptothecin loaded nano-particles show longer plasma retention, high and longer tumor localization. Nano-particles prepared by poly-lactic-co-glycolide increase the half life of Cisplatin. Paclitaxel, a microtubule-stabilizing agent that promotes polymerization of tubulin causing cell death by disrupting the dynamics necessary for cell division, is effective against a wide spectrum of cancers. Miscellaneous agent like Arsenic trioxide, Butyric Acid, Diethylene-triamine-Acetic acid show more prominent activity. Recent development in nanoparticle-based combination therapy have shown several unique features that are untenable in traditional chemotherapy. Drug combinations can now be optimizedand cleverly delivered in a more effective way.

  • CINNAMON: A MAGICAL DRUG

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    ABOUT AUHTOR
    Pranav Nayak B*
    Srinivas college of pharmacy,
    Mangalore, Karnataka India,
    *nayak.pranav10@gmail.com

     

    ABSTRACT:
    Cinnamon is used as a spice in our day to day life. It is aromatic. It is principally employed in cookery as a condiment and flavoring agent. It has been acquainted as one of the healthiest spices and has medicinal activity. When it is checked for chemical constituents it reveals phenolic flavonoid and carotenoid contents. They contain rich amount of polyphenols which are powerful antioxidants. It inhibits the growth of certain bacteria and fungi. It helps to reduce the blood glucose by increasing insulin in the body by the mechanism of resisting insulin depletion. It interferes with carbohydrate digesting enzyme and reduces degradation of carbohydrate as a result of which it decreases entry of glucose from intestine to blood stream. It reduces the growth of cancer cells. ‘N’ number of pharmacological investigationsconfirmed that the ability of this plant is to exhibit hepatoprotective, neuroprotective and cardioprotective action. This present article will provide you with detailed information on the most of the aspects of cinnamon.

  • TURMERIC AS MEDICINAL PLANT FOR THE TREATMENT OF ACNE VULGARIS

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    ABOUT AUHTORS
    Priyanka R. Waghmare1*, Priynka G. Kakade1 , Prashant L. Takdhat2, Ashwini M. Nagrale2, SM Thakare2, MM Parate3
    1 Dr. R. G. Bhoyar Institute of Pharmaceutical Education and Research,
    Wardha, Maharashtra, India
    2 Dr. R. G. Bhoyar Institute of Pharmacy,
    Wardha, Maharashtra, India
    3 Daga Memorial Hospital,
    Maharashtra, Nagpur, India

    *waghmarepriyancka@gmail.com

    ABSTRACT
    Herbal medicines are gaining increased popularity due to their advantages, such as better patient tolerance, long history of use, fewer side-effects and being relatively less expensive. Furthermore, they have provided good evidence for the treatment of a wide variety of difficult to cure diseases. The skin is the outermost layer of the body that is often easily damaged by environmental factors as well as stress and poor eating habits. Acne vulgaris (or simply acne) is an infectious disease and one of the most prevalent human diseases. Acne is a cutaneous pleomorphic disorder of the pilosebaceous unit involving abnormalities in sebum production and is characterized by both inflammatory and noninflammatory lesions. Common therapies that are used for the treatment of acne include topical, systemic, hormonal, herbal and combination therapy. Although here is a wide market for cosmetic products that offers to improve skin problems, nature also provides a solution to these. Although the medical and surgical treatment options are the same, it is these features that should be kept in mind when designing a treatment regimen for acne. Natural treatments for skin that give lasting results are often better than expensive commercial products and cosmetic procedures. One such natural treatment is turmeric powder for skin. Turmeric is considered safe in amounts found in foods and when taken orally and topically in medicinal quantities. Turmeric’s primary biologically active component is curcumin. Research has shown that curcumin has potent antioxidant, wound-healing, and anti-inflammatory properties, which may prove to be therapeutic against acne. This review focuses on the treatment of acne using turmeric as medicinal drug.

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