STUDY OF BIOPHARMACEUTICS IS THE
STUDY OF DRUG FATE IN THE BODY
PRESENTED BY
GROUP NO-08
RUBEL HOSSAIN – ASH1803001 M
SHAHADUL ISLAM – ASH1803020 M
ISRAT JAHAN BINTA ELIAS – BKH1803046 F
SANJIDA AKTHAR – BKH1803048 F
MD ZAKARIA – ASH1803049 M
OUTLINE
1 2 3
BIOPHARMACEUTICS PHARMACOKINETICS PHARMACODYNAMICS
4 5 6
MEASUREMENT OF DRUG PHARMACOKINETIC
PLASMA CONC. CURVE MODEL
CONC.
BIOPHARMACEUTICS
Biopharmaceutics is the study of -
• The physical and chemical properties of a drug
• Its dosage form in which the drug is given,
• The route of administration on the rate and extent of systemic drug absorption.
Biopharmaceutics involves factors that influence-
The design of the drug product
Stability of the drug within the drug product
The manufacture of the drug product
The release of the drug from the drug product
The rate of dissolution/ release of the drug at the absorption site.
Delivery of drug to the site of action.
STUDY OF BIOPHARMACEUTICS
The study of biopharmaceutics is based on fundamental scientific principles and
experimental methodology, Studies in biopharmaceutics use both in vitro and in vivo
methods.
In vitro methods are procedures employing test apparatus and equipment without
involving laboratory animals or humans.
In vivo methods are more complex studies involving human subjects or laboratory
animals.
These methods must be able to assess the impact of the physical and chemical
properties of the drug, drug stability, and large-scale production of the drug and
drug product on the biologic performance of the drug.
PHARMACOKINETICS
• What the body does to a drug.
• Refers to the movement of drug into,
through, and out of the body—the time
course of its absorption , distribution,
metabolism and excretion.
ADME SCHEME
The various compartments that the model is divided into are commonly
referred to as the ADME scheme:
• Absorption – the process of a substance entering the blood circulation.
• Distribution – the dispersion or dissemination of substances
throughout the fluids and tissues of the body.
• Metabolism – the recognition by the organism that a foreign
substance is present and the irreversible transformation of parent
compounds into daughter metabolites.
• Excretion – the removal of the substances from the body. In rare
cases, some drugs irreversibly accumulate in body tissue.
PHARMACOKINETICS STUDIES
• Experimental approach:
• Development of biologic sampling techniques.
• Analytical methods for the measurement of drugs and
metabolites.
• Procedures that facilitate data collection and manipulation.
• Theoratical approach:
• Development of pharmacokinetic models that predict drug
desposition after drug administration.
PHARMACODYNAMICS
• Pharmacodynamics is defined as the response of the body to the drug.
• It refers to the relationship between drug concentration at the site of action and any resulting effects
namely, the intensity and time course of the effect and adverse effects.
• Pharmacodynamics is affected by receptor binding and sensitivity, post receptor effects, and chemical
interactions.
PLASMA LEVEL-TIME CURVE
• The plasma level–time curve is generated by obtaining the drug concentration in
plasma samples taken at various time intervals after a drug product is
administered.
• The concentration of drug in each plasma sample is plotted on rectangular
coordinate graph paper against the corresponding time at which the plasma
sample was removed.
• As the drug reaches the general (systemic) circulation, plasma drug
concentrations will rise up to a maximum.
• As the drug is being absorbed into the systemic circulation, the drug is
distributed to all the tissues in the body and is also simultaneously being
eliminated.
PLASMA LEVEL-TIME CURVE
The MEC (minimum effective concentration) reflects the minimum
concentration of drug needed at the receptors to produce the desired
pharmacologic effect.
The MTC (minimum toxic concentration) represents the drug concentration
needed to just barely produce a toxic effect.
The onset of time corresponds to the time required for the drug to reach the
MEC.
The intensity of the pharmacologic effect is proportional to the number of drug
receptors occupied, which is reflected in the observation that higher plasma drug
concentrations produce a greater pharmacologic response, up to a maximum.
The duration of drug action is the difference between the onset time and the time
for the drug to decline back to the MEC.
PLASMA LEVEL-TIME CURVE
• The time of peak plasma level ( Tmax ) is the time of
maximum drug concentration in the plasma and is a
rough marker of average rate of drug absorption.
• The peak plasma level ( Cmax ) or maximum drug
concentration is related to the dose, the rate constant for
absorption, and the elimination constant of the drug.
• The AUC is related to the amount of drug absorbed
systemically.
• A different term therapeutic index is also used. This
term refers to the ratio between the toxic and
therapeutic doses .
MEASUREMENT OF DRUG CONCENTRATION
• Drug concentration are an important element in determining individual or population
pharmacokinetics.
• Drug concentration are measured in biologic samples such as:
✔ Milk ✔ Saliva ✔ Plasma ✔ Urine ✔ Others
SAMPLING OF BIOLOGIC SPECIMEN
• Invasive methods include sampling • Noninvasive methods include sampling
Blood Urine,
Spinal fluid, Saliva,
Synovial fluid, Feces,
Tissue biopsy, or any biologic material Expired air, or any biologic material that
that requires parenteral or surgical can be obtained without parenteral or
intervention in the patient. surgical intervention.
LABELING FOR HUMAN
PRESCRIPTION OF DRUG &
BIOLOGICAL PRODUCT
Highlights
Highlights of
of Prescribing
Prescribing Information
Information (Highlights)
(Highlights)
Table
Table of
of Contents
Contents (Contents)
(Contents)
Full
Full Prescribing
Prescribing Information
Information (FPI)
(FPI)
PHARMACOKINETIC MODEL
Pharmacokinetic model is a mathematical modeling technique for predicting the
absorption, distribution, metabolism and excretion (ADME) of synthetic or natural
chemical substances in humans and other animal species.
COMPARTMENT MODEL
Depending upon whether the compartments are arranged parallel or series, compartments models
are divided into two categories.
COMPARTMENT
COMPARTMENT
MODEL
MODEL
MAMMILARY
MAMMILARY CATENARY
CATENARY MODEL
MODEL
MODEL
MODEL
MAMMILARY MODEL
• It consists of one or more peripheral
compartments connected to the central
compartment in a manner similar to connection
of satellites to a planet.
• They are joint parallel to the Central
compartment.
• The central compartment comprises of plasma
and highly perfused tissues, Such as lungs
,liver ,kidney etc. Which rapidly equilibriate
with drugs.
CATENARY MODEL
• The compartments are joined to on another in a
series like compartment of a train.
• It is rarely used because it is not observed that
anatomically or physiologically various of organs
are directly linked to the blood compartment.
CONCLUSION
