Biopharmaceutics:
the study of how the physicochemical properties of drugs, dosage forms and routes of administeration affect the rate and extent of the drug absorption.
Thus, biopharmaceutics involves factors that influence the: 1) protection and stability of the drug within the product; 2) the rate of drug release from the product; 3) the rate of dissolution of the drug at the absorption site; and 4) the availability of the drug at its site of action .
nADME: is an acronym in pharmacokinetics and
pharmacology for absorption, distribution, metabolism,
and excretion,
and describes the disposition of a pharmaceutical compound within an organism.
nPharmacokinetics: The study and characterization of the
time course (kinetics) of drug absorption, distribution, metabolism and
elimination (ADME).
nAbsorption: is the process of a substance entering
the body.
nDistribution: is the dispersion of substances throughout the fluids and tissues of the body.
nMetabolism: is the irreversible transformation of parent compounds into daughter metabolites.
nExcretion: is the elimination of the substances from the body.
nDistribution: is the dispersion of substances throughout the fluids and tissues of the body.
nMetabolism: is the irreversible transformation of parent compounds into daughter metabolites.
nExcretion: is the elimination of the substances from the body.
nBioavailability: The rate and extent of drug absorption.
nBioavailable dose: The fraction of an administered dose of a
particular drug that reaches the systemic circulation intact.
nPlasma level-time curve:
nThe
plasma level-time curve is generated by measuring the drug concentration in
plasma samples taken at various time intervals after a drug product is
administered.
nThe
concentration of drug in each plasma sample is plotted against the
corresponding time at which the plasma sample was removed.
nDrug
Product Performance Parameters:
1- Minimum effective concentration (MEC): The minimum concentration of drug needed
at the receptors to produce the desired pharmacologic effect.
2- Minimum toxic concentration (MTC): The
drug concentration needed to just produce a toxic effect.
3- Onset time: The
time required for the drug to reach the MEC.
4- Duration of action: The
difference between the onset time and the time for the drug to decline back to
the MEC.
5- The time of peak plasma level:
The time of maximum drug concentration in
the plasma and is proportional to the rate of drug absorption.
6- The peak plasma level: The
maximum drug concentration, usually related to the dose and the rate constants
for absorption and elimination of the drug.
7- Area under the curve: It
is related to the amount of drug absorbed systemically.
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