Chapter 1: INTRODUCTION TO DRUGS AND PHARMACY

DRUG:

Dosage vehicle or transport of the active ingredient to its receptors.

1.

Pharmacy the art and science of preparing from natural and synthetic sources,
suitable materials for distribution and use in the treatment and prevention of
diseases.

2.

Willow bark aspirin, senna (senokot)

Gk. Word PHARMAKON meaning Charm (closely associated with evil
spirits)

Articles recognized in the official United States Pharmacopeia (USP), official

Homeopathic Pharmacopeia of the United States, or official National
Formulary (NF), or any supplement to any of them.
Articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals.
Articles (other than food) intended to affect the structure or any function of
the body of man or animals.
Articles intended for use as a component of any articles specified in clauses
(1), (2), and (3), but not include device or their components, parts or
accessories.

3.
4.

Pharmacy Outline
Identification and Selection
Pharmacological Action
Preservation
Analysis
Standardization of Drugs and Medicines
HERITAGE OF PHARMACY
1.
2.

3.

4.

First Apothecary
Early Drugs
a) Sumerian Clay Tablets
b) Ebers Papyrus
Introduction of Scientific Viewpoint
a) Hippocrates
b) Galenic
c) Claudius
d) Paracelsus
Early Research
a) Swede Karl Wilhem Scheele
b) Friedrich Serturner
c) Joseph Caventou & Joseph Pelletier
d) Pierre Robiquet

CHEMISTRY OF DRUGS
Drug: an agent intended for use in the diagnosis, mitigation, treatment, sure or
prevention of disease.

Classification of Drugs by:

1.
2.

Pharmacologic activity
Based on Safety and Social Acceptability
a. OTC drugs
b. Permitted non-medical drugs
c. Prescription drugs
d. Controlled substances (stored in closed cabinets with padlock; only
pharmacist has access to it)
i. Schedule 1 no medical use; high potential of drug abuse
ii. Schedule 2 some medical use; high potential of drug abuse
iii. Schedule 3 prescription drugs; medically important; still have drug
abuse potential (e.g. barbiturates, valium)
3. Based on how they are derived
a. Natural products have other natural ingredients
b. Chemically derived synthesized, modified natural products (created to
reduce side effects of natural products)
c. Synthetic man-made; laboratory model; lock-and-key
MAIN GOAL OF DRUG RESEARCH
-

To find drugs that are specific in their action and have minimal side effect.
Standards used to have uniform specification of production
Standards:
1. USP-NF
st
Lititz Pharmacopeia 1 American Pharmacopeia
Lyman Spalding father of United States Pharmacopeia

INTIAL PART OF THE MONOGRAPH CONSISTS OF:

1) Official title (generic or nonproprietary name) of the drug
2) Graphic or Structural formula
3) Empirical formula
4) Molecular weight
5) Established chemical names
6) Drugs Chemical Abstracts Service (CAS) registry number
7) Chemical purity
8) Cautionary statements that reflects the toxic nature of the
agent
9) Packaging and storage recommendations
10) Chemical and physical tests
11) Prescribed method of assay
Homeopathic Pharmacopeia Internalis
Used by pharmacist and homeopathists and as well as by law enforcement
agencies to ensure quality of homeopathic drug.
By Samual Hahnemann
Like cure like
Minimum dose
Pharmacopeia Internalis (PI or IP)
1.
2.
3.

European Pharmacopeia
Mexican Pharmacopeia
Philippine Pharmacopeia (recognize in the country)
a. USP
b. UK P
c. JP
d. Phils P

(ISO) International Organization for Standardization (ISOP 9000; ISO 9004)

Pharmacist Contemporary Ro,e
1.
2.
3.

Pharmaceutical Care
Institutional Setting
Community Setting

PHARMACIST
Drug actions

Pharmaco Therapeutics
Formulation Dosage Form Design
Available Pharmaceutical Products
Drug Information Sources
Community Setting
1.
2.
3.
4.
5.
6.
7.
8.
9.

Dispensing
Compounding
Selling
Storage and Handling
Advising of Patients
Selecting products for inventory
Identifying fast-moving products
Administers
Supervise the Pharmacy (managerial function), entrepreneurial function

Institutional Setting
1.
2.

Manage any distribution and control systems

Provide a variety of clinical services (DUR), drug evaluation, TDM,
intravenous admixture programs, pharmacokinetics, counseling services,
investigational drug supplies, poison control, and drug information.

Pharmaceutical Care
-

It is a patient-centered, outcome-oriented pharmacy practice the requires

the pharmacist to work in connection with the patient and the patients
other health care providers to promote health, initiate and modify
medication use to assure that drug therapy regimens are safe and
effective.

Chapter 2: NEW DRUG DEVELOPMENT AND APPROVAL PROCESS

Monoclonal Antibody Production

-

Drug Design
New Drug Discovery
1) Target molecule discovered

Manipulation of protein within the cells of higher animals

Exploits abilities of cells to produce a specific Ab and stimulate and
unending steam of Ab production.
Expected to combat Lupus, Juvenile onset, diabetes and Myasthenia gravis
Used to produce pregnancy test

2) Preclinical Stages (animal, biosystems, preformulation)

3) Clinical Trials (Human volunteers)
4) NDA (FDA investigation) approved for market release

Human Gene Therapy

-

5) Post-marketing surveillance (good for a million consumers)

Sources of New Drugs

1.

Synthetic discovered in laboratory

2.

Natural sources animals or plants

Now medical intervention based on the modification of genetic materials

of living cells.
Treatment of disease by study of genes
Ex vivo or In vivo
Transfer of new genetic material to the cells of a patient with a genetics
disease.
Potentials to be treatment of sickle cell anemia, malignant melanoma,
cyctis fibrosis, familial hypercholesterolerolemia, colorectal Ca and AIDS.

Plants: keserpine: Rauwolfia serpentine

Animals: vaccines from rubella from duck embryo
Genetic Engineering
Manipulation of the double helix DNA
1.

Recombinant DNA

2.

Monoclonal Antibody Production

-

Involved in manipulation and production of proteins

Recombinant DNA Technique

- Produce any protein
Gene splicing combining of higher animal genes to lower animal
gene
Plasmid circular DNA carrier of bacteria
sticky ends of DNA of human are fused with bacterial DNA and then
expected to create bacteria producing proteins
- Genetic material transplantation (from humans to bacteria)
Splicing
Biological products

Goal Drug
-

Product desired effects

Minimal dosage and frequency
Exhibit little or no side effects
Eliminated efficianty
Low coast

Methods of Drug Discovery

1.
2.

3.

Screening larger number of substances or compounds

Molecular modification working at previous compounds and modify it to
create an improved compound (modification or change of formulation =
new drug)
Mechanism-based drug design modifies compound to interfere with
mechanisms of the disease

Lead Compound
-

First compound discovered

Prototype
Has fundamental desired biologic or pharmacologic activity
May not possess desired features:

Potency
Absorbability
Low toxicity
Solubility

Prodrug
-

Drug in inactive form

Requiring metabolic biotransformation to be a pharmacologically active
compound (Ex. Leudopa dopamine
Absorption
Solubility
biostability
Prolonged release

Drug Development Process

1.

2.
3.

4.

Preclinical Trials not tested on humans

Pharmacology
Drug metabolism
Toxicology
Goal:
1. Efficacy
2. Toxicity
3. Pharmacokinetics
In vitro (test tubes)
In vivo (living cell cultures and test animals)
Drug candidate IND application
Test for 4 areas
1. Pharmacology
a) Pharmacodynamics body to drug
b) Pharmacokinetics drug to body (ADME)
2. Drug metabolism
3. Pre-formulation initial formulation (physical and chemical
properties of a drug)
4. Toxicology
IND application
Clinical Studies or clinical trials
PHASE 1 20-100 people
PHASE 2 100-500 people
PHASE 3 500-1000; 1000-3000 peopke
Phase 4 post-marketing surveillance

Drug Dosage
-

Variety of patient factors (such as: age, pharmacogenetics, pathologic, &

genders)
Characteristic of the drug substances
The dosage form
HS route of administration