Application of biopharmaceutics in pharmaceutical field.siam(pdf file)

2. PRESENTATION
ON
Application of biopharmaceutics
in Pharmaceutical field

4.  It must be transported by the body fluids.
 It must traverse the required biologic
membrane barriers.
 It must escape widespread distribution to
unwanted areas.
 It must endure metabolic attack.
 It must penetrate in adequate concentration
to the sites of action.

13.  Extensive bioavailability testing is carried out by
drug manufacturers because of an enlightened
self-interest to ensure the quality of its products
.
 It is important to the manufacturer that drug
product is appropriate to its side of action.
 Bioavailability testing is also carried out by
academic and government research institution to
study ADME.

14.  Biopharmaceutical principal can provide a
sound basis for rational drug product
selection.
 Drug product from different manufacturers
may perform differently in patient .
 Proper selection of drug product is a major
role and responsibility of the pharmacist

15.  This phase is the longest one in drug
development from 2-10 year
 used to determine
I. Pharmacokinetics data
II. Pharmacodynamics data
III. Max. tolerated dose
IV. Adverse reactions profile

16.  To understand process administration of drug , which
affects onset and intensity of biological response.
 To access plasma drug concentration response to
given dose which is now considered as more
appropriate parameter then intrinsic pharmacological
activity .
 In design and utilization of in vitro model system
 In design and development of new drug and their
appropriate dosage regimen.

17.  Drug Development
 Formulation Development
 Deciding Dosage Regimen
 Designing Rational Dose, Frequency and Duration
 Rational Drug Design
 Clinical Pharmacy
 ADME study, Bioavailability and Bioequivalence
studies
 Pharmacokinetics, Pharmacodynamics Relationship

19.  From toxicological and pharmacological points of view, it is
desirable to design a “safer” drug that undergoes no
metabolism.
Hard drugs: The concept of nonmetabolisable drugs called hard
drugs. Drugs are excreted primarily through either bile or kidney.
Eg: Bisphosphonates, enalaprilat, lisinopril
Soft drugs: It is pharmacologically active, it
undergoes a predictable and controllable
metabolism to nontoxic and inactive metabolites

20. Cont…
 The main concept is to avoid oxidative metabolism
as much as possible and to use hydrolytic enzymes
to achieve predictable and controllable drug
metabolism.
Eg: Atracurium, Remifentanil etc.
 Active metabolites: The metabolites of some drugs
are pharmacologically active being used as a
source of new drug candidates.
Eg: Acetaminophen which is an O-deethylated
metabolite of Phenacetin.