Ph I

Front 1

Pharmaceutics

Back 1

An applied science and technology based on the Physical, Chemical, Biological, and Biotechnological Principles that are used in the Preparation, Preservation, and Utilization of drug products and pharmaceutical dosage forms.

Front 2

Pharmaceutics I

Back 2

Homogeneous Pharmaceutical Systems : Dispersed particles (X < 1 nm), e.g., true solutions, syrups, elixir, injectable solutions.

Front 3

Pharmaceutics II

Back 3

Heterogeneous Pharmaceutical systems: Dispersed particles (X > 1 nm), e.g., emulsions, suspensions, creams, ointments, powders, capsules, and tablets.

Front 4

Current Methods of Treating Disease

Back 4

Drug Medication – Chemotherapy
Surgery
Psychotherapy
Physical Therapy
Radiation

Front 5

Drugs

Back 5

A chemical agent being used in the Diagnosis, Mitigation, Treatment, Cure, or Prevention of disease in human and animals.

Front 6

Pharmacy

Back 6

Art or scientific practice of Preparing, Preserving, Compounding, and Dispensing drugs.

Front 7

Pharmaceutics smaller definition

Back 7

An applied science and technology of pharmacy based on the Physical, Chemical, Biological, and Biotechnological principles

Front 8

Biopharmaceutics

Back 8

An advanced studies in pharmaceutics describing how the formulation and biological factors affect Absorption, Distribution, Metabolism, and Elimination of drugs in the body.

Front 9

The Pharmacist's Intimate Knowledge

Back 9

Drug Action
Drug Therapy
Dosage Form Design and Utilization
Available Pharmaceutical Products
Drug Information Sources

Front 10

The pharmacist's contemporary role

Back 10

Community Pharmacy Setting
Institutional Setting: Hospitals;Extended Care Facilities;Health Maintenance Organization (HMO)
Postgraduate Residency: Clinical Pharmacy;Industrial Pharmacy; Medicinal Chemistry;Pharmacology and Toxicology; MBA, Law, Medicine, etc
Industrial Setting: Pharmaceutical R & D; Production and Quality Assurance; Marketing; Management
Government Setting: Military Pharmacy and Services; Public Health Service; FDA; NIH

Front 11

Institutional setting

Back 11

Hospitals;Extended Care Facilities;Health Maintenance Organization (HMO)

Front 12

Postgraduate residency

Back 12

Clinical Pharmacy;Industrial Pharmacy; Medicinal Chemistry;Pharmacology and Toxicology; MBA, Law, Medicine, etc

Front 13

Industrial setting

Back 13

Pharmaceutical R & D; Production and Quality Assurance; Marketing; Management

Front 14

Governmental setting

Back 14

Military Pharmacy and Services; Public Health Service; FDA; NIH

Front 15

Hippocrates

Back 15

(BC 460-377): Greek Physician and Philosopher; Introduced scientific and rationalized medicine and pharmacy

Front 16

Dioscorides

Back 16

( approx. AD 100): Greek Physician and Botanist; Developed pharmacognosy

Front 17

Claudis Galen

Back 17

(AD 130-200):Greek Pharmacist and Physician; Developed pharmaceutics - Galenic Pharmacy

Front 18

Fredrick II

Back 18

(AD 1240): German Emperor; Issued a decree separating the health sciences into Medicine and Pharmacy

Front 19

Targets Drug Delivery System

Back 19

The most ideal drug delivery systems.
Deliver a drug to the site of action.
Maintain a sufficient amount of drug at the action site for a desired time period.
After showing the therapeutic effect, excretes completely out of the body.
TDDS: Liposomes and Nanoparticles

Front 20

Drug Standards

Back 20

United States Pharmacopoeia/National Formulary (USP/NF)
USP DI
Other Pharmacopoeias/Drug Standards

Front 21

United States Pharmacopoeia/National Formulary (USP/NF)

Back 21

The USP is a nongovernmental, standards-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements.
http://www.usp.org/index.htm
Currently, USP provides standards for more than 4000 Rx and non-Rx drugs, dietary supplements, veterinary drugs, and health care products.
New USP28/NF23 available August. 2005
Example of a Monograph *Chlorambucil*

Front 22

How a Chemical Becomes A Drug

Back 22

New Drug: A drug substance that is required for proof of its safety and efficacy. (FDA Definition)
Food and Drug Administration (1938)
Drug Approval
The Mission of FDA is to protect the public health against risks associated with the production, distribution, and sale of food, food additives, human drugs, biologics, radio-chemicals, medicinal devices, animal drugs, animal feeds, and cosmetics.

Front 23

New Drug

Back 23

A drug substance that is required for proof of its safety and efficacy. (FDA Definition)

Front 24

The mission of FDA

Back 24

is to protect the public health against risks associated with the production, distribution, and sale of food, food additives, human drugs, biologics, radio-chemicals, medicinal devices, animal drugs, animal feeds, and cosmetics.

Front 25

New Drug Development and Approval Process

Back 25

Drug Discovery & Drug Design
Biological Characterization
Early Formulation Studies in Animals
The Investigational New Drug (IND) Application
Phase I, II, and III Clinical Studies
The New Drug Application (NDA)
Phase IV Studies & Postmarketing

Front 26

Drug Discovery & Drug Design

Back 26

Source of New Drugs
A “Goal Drug”
Methods of Drug Discovery
A “ Lead Compound”
Prodrugs
FDA’s Definition of a New Drug
Drug Nomenclature

Front 27

“Goal Drug”

Back 27

Produces the specifically desired therapeutic effect.
Can be administered by the most desired route at minimal dosage and minimal frequency.
Has optimal onset and duration.
Shows no side effects.
After showing the desired therapeutic effect, it is excreted efficiently and completely from the body.
Low cost.
Physically and chemically stable.
Pharmaceutically elegant.

Front 28

Prodrugs

Back 28

A compound that requires metabolic transformation after administration to produce the desired pharmacological effect. For examples,
Enalapril maleate --> Enalaprilat
Chloramphenicol palmitate --> Chloramphenicol

Front 29

Sources of New Drugs

Back 29

Isolation from Plants
reserpine, vinblastine, vincristine, paclitaxel
Extraction from Animals (tissues)
thyroid extract, insulin, estrogens, vaccines
Molecular Modification
Organic Synthesis
Genetic Engineering

Front 30

Genetic Engineering

Back 30

Recombinant DNA (rDNA) Technology

Monoclonal Antibody (MoAB) Technology

Human Gene Therapy

Front 31

Recombinant DNA Technology

Back 31

Genetic material (DNA) of higher species (human) may be transplanted to a lowly bacterium – Gene Splicing)
Gene-splicing induces the lower organism to make proteins, it would not otherwise have made.
rDNA technology can potentially produce almost any protein drug; e.g., Insulin, Growth hormone, Hepatitis B vaccine, Epoetin alpha, and Interferon.

Front 32

Monoclonal Antibody (MoAB) Technology

Back 32

MoABs are highly specific immunoglobulin produced against a single antigen foreign material.
MoAB production is conducted within the cells of higher animals, including the patient.
MoABs have the capacity to combat the specified target cells.
Other applications: Diagnostics, Site-directed therapies, Immunology, and Home test kits (pregnancy and ovulation prediction); Adalimumab – Rheumatoid Arthritis; Daclizumab – Prophylaxis of acute rejection in patients receiving renal transplantation.

Front 33

Human Gene Therapy

Back 33

Gene therapy is another new technology used to prevent, treat, cure, diagnosis, or mitigate human disease caused by genetic disorder.
Human body contains up to 100,000 genes that are involved in cell functioning and growing via protein synthesis.
In genetic-based diseases: Gene expression altered and Gene sequences mismatched.

Front 34

Gene Delivery Systems

Back 34

The transfer of new healthy genetic material to the cells of a patient with genetic disease.
A cloned genetic material is transferred into the cells of patients via (a) Microinjection, (b) Chemically mediated method, (c) Disabled retroviral gene delivery systems.
Applications: Adenosine deaminase deficiency (abnormal immune system); Sickle cell anemia; Malignant melanoma; Lung and colorectal cancer and AIDS

Front 35

Methods of Discovery

Back 35

Random or Non-Targeted Screening
Non-Random or Targeted Screening
Bio-Assays
Molecular Modification
Mechanism-Based Drug Design

Front 36

Prodrugs properties

Back 36

Solubility
Absorption
Biostability
Prolonged

Front 37

FDA’s Definition of a New Drug

Back 37

New Drug
New Formulation
New Manufacturing Method
New Combination of Drugs

Front 38

Drug Nomenclature

Back 38

Empirical Formula
Synthetic Chemical Name
Code Number
Nonproprietary (generic name)
United State Adopted Names Council (USAN Council)
Trade Name

Front 39

Biological Characterization

Back 39

Pharmacology
Drug Metabolism
First Pass Effect
Toxicology
Acute or Short-Term Studies
Sub-Acute or Sub-Chronic Studies
Carcinogenicity Studies

Front 40

Pharmacology

Back 40

Pharmacokinetics
Pharmacodynamics
Clinical Pharmacology

Front 41

Pharmacokinetics

Back 41

Studying quantitative change in ADME of drugs as a function of time.

Front 42

Pharmacodynamics

Back 42

Studying the biochemical and physiological effects of drugs, and their mechanisms of action as a function of time.

Front 43

Clinical Pharmacology

Back 43

Studying the therapeutic effects and action of drugs as a function of time using pharmacological principles.

Front 44

Early Formulation Studies

Back 44

Preformulation Studies
Drug Solubility
Partition Coefficient
Dissolution Rate
Physical Form
Stability
Initial Product Formulation
Clinical Trial Materials (CTM)

Front 45

The Investigational New Drug (IND) Application

Back 45

Content of the IND
Pre-IND meeting
FDA review of the IND Application
FDA Drug Classification System
Clinical Protocols
Phases of a Clinical Investigation
“Treatment IND”

Front 46

FDA Review of the IND Application

Back 46

Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)

Front 47

Divisions of CDER

Back 47

Cardio-Renal Drugs
Gastrointestinal & Coagulation Drugs
Topical Drugs
Oncology & Pulmonary Drugs
Analgesic & Anti-Inflammatory Drugs
Metabolism & Endocrine Drugs
Anti-Infective Drugs
Anti-Viral Drugs
Medical Imaging, Surgical & Dental Drugs

Front 48

FDA Drug Classification System

Back 48

By Chemical Type
By Therapeutic Classification

Front 49

The New Drug Application (NDA)

Back 49

General Content of the NDA Submission
Drug Dosage
Drug Product Data in the NDA Submission
Drug Product Labeling
FDA Review Decision, “Action Letters”
Phase 4 Studies & Postmarketing Surveillabce
Annual Reports

Front 50

Drug Dosage

Back 50

Age
Body Weight
Body Surface Area
Sex
Pathologic State
Tolerance
Concomitant Drug Therapy
Time of Administration
Dosage Form & Route of Administration

Front 51

Drug Product Labeling

Back 51

Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Abuse & Dependence
Overdosage
Dosage & Administration
How Supplied

Front 52

Supplemental, Abbreviated, & Other Applications

Back 52

Supplemental New Drug Application (SNDA)
Abbreviated New Drug Application (ANDA)
Biologics License Application
Animal Drug Applications
Medical Devices

Front 53

Classification of Drugs

Back 53

Over-The-Counter Drugs
Legend Drug

Front 54

Over-The-Counter Drugs

Back 54

OTC: Drugs deemed safe enough for use by the layman in the self-treatment of simple conditions.
The over-the counter status of a drug product may be changed if more stringent control over the drug’s distribution and use is warranted later.

Front 55

Legend Drug

Back 55

(Prescription Drugs)

Front 56

Controlled Drugs

Back 56

(According to the comprehensive drug abuse prevention and control act - 1970: Five Schedules)

Front 57

Controlled Drug Substances

Back 57

Schedule I: Heroine, Marihuana, LSD (Lysergic acid diethylamide), THC (Tetrahydrocannabinois)
Schedule II: Morphine, Codeine, Cocaine, Methadone, Secobarbital
Schedule III: Paragoric, Nalorpine, Probarbital
Schedule IV: Diazepam, Clonazepam, Chloral hydrate
Schedule V: Burpenorphine

Front 58

Drug Dosages

Back 58

Usual Dose
Usual Dose Range
Usual Pediatric Dose
Single Dose
Daily Dose
Initial and Maintenance Doses, e.g., 0. 1 mg and 0.2 mg digoxin tablet: Initial dose - 4 tablets a day and then 1 tablet per day

Front 59

Factors Affecting Drug Dosage

Back 59

Drug Absorption Characteristics
Minimum Effective Concentration (MEC)
Minimum Toxic Concentration (MTC)
Therapeutic Window
Therapeutic Index (TI) = MTC/MEC
Drug Effect in a Population Sample
Median Effective Dose (ED50)
Median Toxic Dose (TD50)

Front 60

Examples of TI for Drugs

Back 60

TI less than 5: Diphenhydramine, Amytriptyline, Quinidine

TI 5 - 10: Digoxin, Diazepam, Meperidine


TI greater than 10:Acetaminophen, Meprobamate, Propoxyphene

Front 61

Factors Affecting a Proper Dose of Drugs

Back 61

Age
Body Weight - Clark’s Rule Children Dose =[ WLB x Dadult ]/150 LB
Body Surface Area = [BSAchild/BSAadult] x Dadult

BSAadult = 1.7 m2
Sex: Women more susceptible to certain drugs
Pathologic State: e.g., Tetracycline for renal impairment
Tolerance: e.g., Antihistamines, Narcotics
Concomitant Drug Therapy: Drug interaction and Alteration of ADME; 1. Beneficial Effect: Probenecid-Penicillin; 2. Detrimental Effect: Tetracycline-Antiacids
Time of Administration (Chronopharmacology) and Food
Dosage Forms and Route of Administration