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    Determination of Counterfeit Drugs

    Uploaded by

    Ali Rizvi
    NIR MPA

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    © All Rights Reserved
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    Determination of Counterfeit Drugs

    Uploaded by

    Ali Rizvi
    101 views2 pages
    NIR MPA

    Original Title

    4_nektaria_servi_en

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    © © All Rights Reserved

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    NIR MPA

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    101 views2 pages

    Determination of Counterfeit Drugs

    Uploaded by

    Ali Rizvi
    NIR MPA

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    AF # 221E

    Determination of Counterfeit Drugs


    Counterfeit drugs are a
    substantial and growing
    problem, both in the
    developed and in the
    developing world.

    The legal definition of “counterfeit drug” varies by


    country, but one useful definition of that is that of the
    World Health Organization, which “defines a counterfeit
    pharmaceutical product as a product that is deliberately
    and fraudulently mislabeled with respect to identity
    and/or source.”

    Counterfeit drugs represent a two-fold danger to the


    public. On the one hand, counterfeits that do not contain
    the proper active ingredient in the proper quantity result
    in the patient’s condition going untreated. On the other
    hand, counterfeits may contain toxic materials that result
    in the patient being poisoned. In both cases, the patient
    has been the victim of fraud, and the confidence that the
    public places in the health-care system is undermined.

    Determining whether a suspect product is genuine or


    counterfeit is often done with wet-chemical procedures,
    such as thin-layer chromatography. Accurate and
    reliable performance of these techniques requires skilled
    personnel and the appropriate laboratory facilities. Figure 1. FT-IR diffuse reflectance spectra (6200-5300
    Furthermore, these methods often cannot be performed cm-1) of Zantac 75 (R) (top trace), and two generic
    as rapidly as would be desired. ranitidine formulations (middle and bottom trace).

    Determination counterfeit FT-NIR Tablet analysis OPUS/LAB is a user MPA spectrometer with
    drugs using MPA friendly software package complete accessory

    FT-NIR www.brukeroptics.com
    An Example
    Zantac 75® is a non-prescription, brand-name
    pharmaceutical, used for treatment of excess stomach
    acid. The active ingredient is ranitidine hydrochloride,
    which is also available in generic formulations. The
    differences between the formulations make it possible
    to distinguish the brand-name drug from the generic
    counterparts using near-infrared spectroscopy.

    Experimental
    Samples of Zantac 75® and two generic ranitidine
    formulations were tested. Spectra were obtained using
    a Bruker MPA equipped with an integrating sphere for
    sampling in diffuse reflectance. Since diffuse
    reflectance is a surface-sensitive technique, and Figure 2. Factor analysis graph demonstrating the
    because some of the samples had printing on one side ability of the Opus software to distinguish between the
    of the tablet, spectra were obtained of both sides of all name-brand pharmaceutical and the generic product.
    -1
    of the tablets tested. Spectra were taken at 8 cm
    resolution, 32 scans per spectrum.

    Spectra of the three samples are shown in Figure 1.


    Substantial differences can be observed between the
    Zantac (upper trace) and the two generic formulations
    (middle and bottom traces). These can be used with a
    conformity test to provide a yes/no identification of the
    suspect product.

    Automation and User Interface


    The user interface to the spectroscopic system can be
    simplified with the use of OpusLab, providing a system
    usable by non-technical personnel that provides
    unambiguous results.

    Conclusion
    Verification of the identity of a pharmaceutical product
    has been demonstrated using a Bruker Optics FT-NIR
    spectrometer. The speed and precision of this
    analytical system can aid health authorities in their fight
    to protect the public from the increasing trade in
    counterfeit pharmaceuticals.

    For more information contact us:

    Bruker Optics Inc Bruker Optik GmbH Bruker Optics Asia Pacific Ltd.
    + 1 978 439-9899 + 49 7243 504-600 + 852 2796-6100
    www.brukeroptics.com www.brukeroptics.de [email protected]

    FT-NIR [email protected] [email protected]

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