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    BIOPHARMACEUTICS 1b

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    BIOPHARMACEUTICS 1b

    Uploaded by

    jonderek50
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    3 views12 pages

    BIOPHARMACEUTICS 1b

    Uploaded by

    jonderek50

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 12

    BIOPHARMACEUTICS 2

    Distribution
    Metabolism
    Excretion
    Bioavailability
    • Refers to the rate and extent at which the active moiety (drug or
    metabolite) enters circulation and thereby accesses the site of action
    • Is the rate at which the drug becomes available to the body and the
    extent to which the dose is ultimately absorbed after administration of
    a particular pharmaceutical form.
    • Is dependent upon the properties of dosage form; i.e. the design and
    manufacture of the formulation from which the drug is released
    – Poor or inappropriate formulation results in a product that releases drug too
    slow or fails to release a portion of the drug or leads to undesired variations in
    performance of individual units
     excipient -components greatly influence rate of release of drug from a
    formulation: both slow and fast rates of absorption can be desirable
    depending on specific therapeutic goals
    – The factors that influence the process of dissolution of drug in a dosage form
    especially for particulate drug affect bioavailability
    Differences in bioavailability between formulations of the same drug can have
    clinical significance
    Biopharmaceutics 2
    Bioequivalence
    • Bioequivalence indicates that the two or more drug
    products under comparison, when given to the same
    patient in the same dosage regimen, result in equivalent
    concentrations of drug in plasma and tissues
    – Bioequivalent products are expected to be therapeutically
    equivalent
    • Chemical equivalence: indicates that drug products
    contain the same active compound in the same amount
    and meet current official standards; although, the
    inactive ingredients in drug products may differ.
    Pharmaceutical Equivalence
    Pharmaceutical products with similar
    bioavailability, include active
    ingredients drug amounts dosage
    form although they may NOT have
    the same inactive ingredients
    • What is clinical equivalence?
    Key Parameters
    • Minimum Effective Concentration(MEC):
    • Onset of drug action:
    • Onset time: t0
    • Cmax = Peak concentration
    • tmax = peak time
    • Intensity of action
    • Area under curve (AUC)

    Biopharmaceutics 5
    Key Parameters ctd.
    • Duration of therapeutic action
    • Therapeutic range: sub-therapeutic, toxic levels
    • Maximum Safe Therapeutic Concentration:
    (MSC)
    • Absorption Phase
    • Elimination phase
    • Absorption process in equilibrium with
    elimination process

    Biopharmaceutics 6
    A typical blood plasma drug concentration-
    time curve (oral admin)
    https://1.bp.blogspot.com/-gb1DRJlFUKM/UmBMmZ5FLAI/AAAAAAAAAes/ktF967EFlOs/s1600/Screen+shot+2013-10- 17+at+4.45.57+PM.png

    Biopharmaceutics 7
    Blood plasma drug –time concentration curve
    following IV and 3 oral dosage forms https://www.boomer.org/c/p4/c20/Fig2012.jpg

    Biopharmaceutics 8
    PHARMACOKINETICS
    Is the study of the quantitative
    changes of absorption,
    distribution, metabolism and
    excretion of a drug with time,
    following its administration to
    man or animals.

    Biopharmaceutics 9
    Multiple dosing regimen
    http://www.thebody.com/content/art875.html

    Biopharmaceutics 10
    Drug half-life
    Is the amount of time it takes for the
    blood concentration of a drug to
    decline to one half of the an initial
    concentration value

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