Chapter 1: INTRODUCTION TO DRUGS AND PHARMACY DRUG:

Dosage vehicle or transport of the active ingredient to its receptors.
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.
Willow bark aspirin, senna (senokot)
Gk. Word PHARMAKON meaning Charm (closely associated with evil
spirits)
Pharmacy Outline
1. 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.
2. Articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals.
3. Articles (other than food) intended to affect the structure or any function of
the body of man or animals.
4. 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.

Identification and Selection Classification of Drugs by:

Pharmacological Action
1. Pharmacologic activity
Preservation
2. Based on Safety and Social Acceptability
Analysis
a. OTC drugs
Standardization of Drugs and Medicines
b. Permitted non-medical drugs
HERITAGE OF PHARMACY c. Prescription drugs
d. Controlled substances (stored in closed cabinets with padlock; only
1. First Apothecary pharmacist has access to it)
2. Early Drugs i. Schedule 1 no medical use; high potential of drug abuse
a) Sumerian Clay Tablets ii. Schedule 2 some medical use; high potential of drug abuse
b) Ebers Papyrus iii. Schedule 3 prescription drugs; medically important; still have drug
3. Introduction of Scientific Viewpoint abuse potential (e.g. barbiturates, valium)
a) Hippocrates 3. Based on how they are derived
b) Galenic a. Natural products have other natural ingredients
c) Claudius b. Chemically derived synthesized, modified natural products (created to
d) Paracelsus reduce side effects of natural products)
4. Early Research c. Synthetic man-made; laboratory model; lock-and-key
a) Swede Karl Wilhem Scheele
b) Friedrich Serturner MAIN GOAL OF DRUG RESEARCH
c) Joseph Caventou & Joseph Pelletier
- To find drugs that are specific in their action and have minimal side effect.
d) Pierre Robiquet
- Standards used to have uniform specification of production
CHEMISTRY OF DRUGS - Standards:
1. USP-NF
st
Drug: an agent intended for use in the diagnosis, mitigation, treatment, sure or Lititz Pharmacopeia 1 American Pharmacopeia
prevention of disease. Lyman Spalding father of United States Pharmacopeia
 INTIAL PART OF THE MONOGRAPH CONSISTS OF: Pharmaco Therapeutics
1) Official title (generic or nonproprietary name) of the drug Formulation Dosage Form Design
2) Graphic or Structural formula Available Pharmaceutical Products
Drug Information Sources
3) Empirical formula
4) Molecular weight Community Setting
5) Established chemical names
6) Drugs Chemical Abstracts Service (CAS) registry number 1. Dispensing
2. Compounding
7) Chemical purity
3. Selling
8) Cautionary statements that reflects the toxic nature of the
4. Storage and Handling
agent 5. Advising of Patients
9) Packaging and storage recommendations 6. Selecting products for inventory
10) Chemical and physical tests 7. Identifying fast-moving products
11) Prescribed method of assay 8. Administers
9. Supervise the Pharmacy (managerial function), entrepreneurial function
Homeopathic Pharmacopeia Internalis
- Used by pharmacist and homeopathists and as well as by law enforcement Institutional Setting
agencies to ensure quality of homeopathic drug.
1. Manage any distribution and control systems
- By Samual Hahnemann
2. Provide a variety of clinical services (DUR), drug evaluation, TDM,
- Like cure like intravenous admixture programs, pharmacokinetics, counseling services,
- Minimum dose investigational drug supplies, poison control, and drug information.

Pharmacopeia Internalis (PI or IP) Pharmaceutical Care

1. European Pharmacopeia - It is a patient-centered, outcome-oriented pharmacy practice the requires

2. Mexican Pharmacopeia the pharmacist to work in connection with the patient and the patients
3. Philippine Pharmacopeia (recognize in the country) other health care providers to promote health, initiate and modify
medication use to assure that drug therapy regimens are safe and
a. USP
effective.
b. UK P
c. JP
d. Phils P

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

Pharmacist Contemporary Ro,e

1. Pharmaceutical Care
2. Institutional Setting
3. Community Setting

PHARMACIST
Drug actions
Chapter 2: NEW DRUG DEVELOPMENT AND APPROVAL PROCESS Monoclonal Antibody Production
- Manipulation of protein within the cells of higher animals
Drug Design
- Exploits abilities of cells to produce a specific Ab and stimulate and
New Drug Discovery unending steam of Ab production.
- Expected to combat Lupus, Juvenile onset, diabetes and Myasthenia gravis
1) Target molecule discovered
- Used to produce pregnancy test
2) Preclinical Stages (animal, biosystems, preformulation)
3) Clinical Trials (Human volunteers)
Human Gene Therapy
4) NDA (FDA investigation) approved for market release
- Now medical intervention based on the modification of genetic materials
5) Post-marketing surveillance (good for a million consumers) of living cells.
- Treatment of disease by study of genes
- Ex vivo or In vivo
Sources of New Drugs - Transfer of new genetic material to the cells of a patient with a genetics
disease.
1. Synthetic discovered in laboratory
- Potentials to be treatment of sickle cell anemia, malignant melanoma,
2. Natural sources animals or plants cyctis fibrosis, familial hypercholesterolerolemia, colorectal Ca and AIDS.
Plants: keserpine: Rauwolfia serpentine
Animals: vaccines from rubella from duck embryo Goal Drug
- Product desired effects
Genetic Engineering - Minimal dosage and frequency
- Manipulation of the double helix DNA - Exhibit little or no side effects
- Eliminated efficianty
1. Recombinant DNA
- Low coast
2. Monoclonal Antibody Production
- Involved in manipulation and production of proteins
Methods of Drug Discovery
1. Screening larger number of substances or compounds
Recombinant DNA Technique 2. Molecular modification working at previous compounds and modify it to
- Produce any protein create an improved compound (modification or change of formulation =
Gene splicing combining of higher animal genes to lower animal new drug)
gene 3. Mechanism-based drug design modifies compound to interfere with
Plasmid circular DNA carrier of bacteria mechanisms of the disease
sticky ends of DNA of human are fused with bacterial DNA and then
expected to create bacteria producing proteins
Lead Compound
- Genetic material transplantation (from humans to bacteria)
Splicing - First compound discovered
Biological products - Prototype
- Has fundamental desired biologic or pharmacologic activity
- May not possess desired features:
 Potency
Absorbability
Drug Dosage
Low toxicity
Solubility - Variety of patient factors (such as: age, pharmacogenetics, pathologic, &
genders)
- Characteristic of the drug substances
Prodrug - The dosage form
- HS route of administration
- 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. 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
2. IND application
3. Clinical Studies or clinical trials
PHASE 1 20-100 people
PHASE 2 100-500 people
PHASE 3 500-1000; 1000-3000 peopke
4. Phase 4 post-marketing surveillance