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1
Introduction

Drugs, whether obtained from plant, animal or mineral sources or synthesized

chemically, are rarely administered in their pure chemical form. Often, they are
combined with a number of inert substances (excipients/adjuvants) and transformed into
a convenient dosage form that can be administered by a suitable route. Earlier, it was
believed that the therapeutic response to a drug is an attribute of its intrinsic
pharmacological activity. But today, it is very much understood that the dose-response
relationship obtained after drug administration by different routes—for example, oral and
parenteral, are not the same. Variations are also observed when the same drug is
administered as different dosage forms or similar dosage forms produced by different
manufacturers, which in turn depend upon the physicochemical properties of the drug, the
excipients present in the dosage form, the method of formulation and the manner of
administration. A new and separate discipline called biopharmaceutics has therefore
been developed to account for all such factors that influence the therapeutic effectiveness
of a drug.
Biopharmaceutics is defined as the study of factors influencing the rate and amount
of drug that reaches the systemic circulation and the use of this information to optimise
the therapeutic efficacy of the drug products. The process of movement of drug from its
site of administration to the systemic circulation is called as absorption. The
concentration of drug in plasma and hence the onset of action, and the intensity and
duration of response depend upon the bioavailability of drug from its dosage form.
Bioavailability is defined as the rate and extent (amount) of drug absorption. Any
alteration in the drug’s bioavailability is reflected in its pharmacological effects. Other
processes that play a role in the therapeutic activity of a drug are distribution and
elimination. Together, they are known as drug disposition. The movement of drug
between one compartment and the other (generally blood and the extravascular tissues)
is referred to as drug distribution. Since the site of action is usually located in the
extravascular tissues, the onset, intensity and sometimes duration of action depend upon
the distribution behaviour of the drug. The magnitude (intensity) and the duration of
action depend largely upon the effective concentration and the time period for which this
concentration is maintained at the site of action which in turn depend upon the
elimination processes. Elimination is defined as the process that tends to remove the
drug from the body and terminate its action. Elimination occurs by two processes—
biotransformation (metabolism), which usually inactivates the drug, and excretion
which is responsible for the exit of drug/metabolites from the body.
In order to administer drugs optimally, knowledge is needed not only of the
mechanisms of drug absorption, distribution, metabolism and excretion (ADME) but also
of the rate (kinetics) at which they occur i.e. pharmacokinetics. Pharmacokinetics is
defined as the study of time course of drug ADME and their relationship with its
therapeutic and toxic effects of the drug. Simply speaking, pharmacokinetics is the
kinetics of ADME or KADME. The use of pharmacokinetic principles in optimising the
drug dosage to suit individual patient needs and achieving maximum therapeutic utility is
called as clinical pharmacokinetics. Figure 1.1 is a schematic representation of
processes comprising the pharmacokinetics of a drug.

Fig. 1.1. Schematic illustration of pharmacokinetic processes

Drug administration and therapy can now be conveniently divided into four phases or
processes:
1. The Pharmaceutical Phase: It is concerned with –
(a) Physicochemical properties of the drug, and
(b) Design and manufacture of an effective drug product for administration by
a suitable route.
2. The Pharmacokinetic Phase: It is concerned with the ADME of drugs as elicited
by the plasma drug concentration-time profile and its relationship with the dose,
dosage form and frequency and route of administration. In short, it is the sum of all
the processes inflicted by the body on the drug.
3. The Pharmacodynamic Phase: It is concerned with the biochemical and
physiologic effects of the drug and its mechanism of action. It is characterized by
the concentration of drug at the site of action and its relation to the magnitude of
effects observed. Thus, in comparison –
Pharmacokinetics is a study of what the body does to the drug, whereas
Pharmacodynamics is a study of what the drug does to the body.
Pharmacokinetics relates changes in concentration of drug within the body with
time after its administration, whereas
Pharmacodynamics relates response to concentration of drug in the body.
4. The Therapeutic Phase: It is concerned with the translation of pharmacological
effect into clinical benefit.
A schematic representation of the various processes involved in the therapy with a
drug is given in Fig. 1.2.
 Fig. 1.2. Schematic representation of the processes involved in drug therapeutics

To achieve optimal therapy with a drug, the drug product must be designed to
deliver the active principle at an optimal rate and amount, depending upon the patient’s
needs. Knowledge of the factors affecting the bioavailability of drug helps in designing
such an optimum formulation and saves many drugs that may be discarded as useless.
On the other hand, rational use of the drug or the therapeutic objective can only be
achieved through a better understanding of pharmacokinetics (in addition to
pharmacodynamics of the drug), which helps in designing a proper dosage regimen (the
manner in which the drug should be taken). This obviates the use of the empirical
approach where a considerable experimentation is needed to arrive at the balance
between the desired therapeutic and the undesired toxic effects in order to define an
appropriate dosage regimen.

The knowledge and concepts of biopharmaceutics and pharmacokinetics thus

have an integral role in the design and development of new drugs and their dosage forms
and improvement of therapeutic efficacy of existing drugs.
2
Absorption of Drugs
A drug injected intravascularly (intravenously and/or intra-arterially) directly
enters the systemic circulation and exerts its pharmacological effects.
However, majority of drugs are administered extravascularly, generally orally.
If intended to act systemically, such drugs can exert their pharmacological
actions only when they come into blood circulation from their site of
application, and for this, absorption is an important prerequisite step.
Drug absorption is defined as the process of movement of unchanged
drug from the site of administration to systemic circulation. Following
absorption, the effectiveness of a drug can only be assessed by its
concentration at the site of action. However, it is difficult to measure the drug
concentration at such a site. Instead, the concentration can be measured more
accurately in plasma. There always exist a correlation between the plasma
concentration of a drug and the therapeutic response and thus, absorption can
also be defined as the process of movement of unchanged drug from the site of
administration to the site of measurement i.e. plasma. This definition takes
into account the loss of drug that occurs after oral administration due to
presystemic metabolism or first-pass effect.

Fig. 2.1. Plots showing significance of rate and extent of absorption in drug
therapy.
Not only the magnitude of drug that comes into the systemic circulation but
also the rate at which it is absorbed is important. This is clear from Fig. 2.1.
A drug that is completely but slowly absorbed may fail to show therapeutic
response as the plasma concentration for desired effect is never achieved. On
the contrary, a rapidly absorbed drug attains the therapeutic level easily to
elicit pharmacological effect. Thus, both the rate and the extent of drug
absorption are important. Such an absorption pattern has several advantages:
 1. Lesser susceptibility of the drug for degradation or interaction due
to rapid absorption.
2. Higher blood levels and rapid onset of action.
3. More uniform, greater and reproducible therapeutic response.
Drugs that have to enter the systemic circulation to exert their effect can be
administered by three major routes:
1. The Enteral Route: includes peroral i.e. gastrointestinal,
sublingual/buccal and rectal routes. The GI route is the most common
for administration of majority of drugs.
2. The Parenteral Route: includes all routes of administration through
or under one or more layers of skin. While no absorption is required
when the drug is administered i.v., it is necessary for extravascular
parenteral routes like the subcutaneous and the intramuscular routes.
3. The Topical Route: includes skin, eyes or other specific membranes.
The intranasal, inhalation, intravaginal and transdermal routes may be
considered enteral or topical according to different definitions.
Table 2.1 compares the bioavailability/absorption pattern and advantages
and disadvantages of drugs administered by common routes.
TABLE 2.1.
Bioavailability/absorption of drug from common routes of drug
administration
Route Bioavailability Advantages Disadvantages
Parenteral
Intravenous Complete (100%) Drug is given for Increased chance
(IV) systemic drug immediate or for adverse
absorption. controlled effect. reaction.
May inject large Possible
fluid volumes. anaphylaxis.
Suitable for irritating Requires skill in
drugs insertion of infusion
set.
Tissue damage at
site of injection
(infiltration,
necrosis, or sterile
abscess).
Intramuscular Rapid absorption Easier to inject than Irritating drugs
injection (IM) from aqueous intravenous may be very
solutions. injection. painful.
Slow absorption Larger volumes Variable rates of
from non-aqueous may be used absorption
(oily) solutions. compared to depending upon
subcutaneous muscle group
solution. injected and blood
flow.
Subcutaneous Rapid absorption Generally, used for Rate of drug
injection (SC) from aqueous vaccines and drugs absorption depends
solution. not absorbed orally upon blood flow
Slow absorption e.g. insulin. and injection
from depot volume.
formulations.
Enteral Routes
Buccal or Rapid absorption of No presystemic Some drug may be
sublingual lipid-soluble drugs. metabolism. swallowed. Not for
(SL) most drugs or
drugs with high
doses.
Oral (PO) Absorption may Safest and easiest Some drugs are
vary. Generally route of drug unstable in GIT, or
slower absorption administration. undergo
rate compared to IV Suitable for both presystemic
bolus or IM injection. immediate-release metabolism or
and modified- show erratic
release drug absorption.
products.
Rectal (PR) Absorption may Useful when patient Absorption may be
vary from cannot swallow erratic. Suppository
suppository. medication. may migrate to
More reliable Used for local and different position.
absorption from systemic effects. Some patient
enema (solution). discomfort.
Other Routes
Transdermal Slow absorption, Transdermal Some irritation by
rate may vary. delivery system patch or drug.
Increased (patch) is easy to Permeability of
absorption with use and withdraw. skin variable with
occlusive dressings. Continuous release condition, anatomic
for a specified site, age, and
period. gender.
Used for lipid- Type of cream or
soluble drugs with ointment base
low dose and low affects drug release
MW. and absorption.
Low presystemic
metabolism.
Inhalation Rapid absorption. May be used for Particle size of
Total dose local or systemic drug determines
absorbed is effects. anatomic
variable. placement in
respiratory tract.
May stimulate
cough reflex.
Some drug may be
swallowed.

GASTROINTESTINAL ABSORPTION OF DRUGS

The oral route of drug administration is the most common for systemically
acting drugs and therefore, more emphasis will be given to gastrointestinal
(GI) absorption of drugs. Moreover, it covers all the aspects of variability
observed in drug absorption. Before proceeding to discuss absorption aspects,
a brief description of cell membrane structure and physiology is necessary.
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men and the