OUR LADY OF FATIMA UNIVERSITY

COLLEGE OF PHARMACY
Valenzuela. Quezon City. Antipolo. Pampanga. Cabanatuan. Laguna

PHARMACEUTICAL DOSAGE FORM AND DRUG

DELIVERY SYSTEMS
PRELIM

Kristine Mae F. Pasion, RPh

Instructor- College of Pharmacy
COURSE FACILITATOR
Introduction to Drugs, Drug Dosage Forms,
and Drug Delivery Systems
Chapter I
Expected
Outcomes:
Demonstrate knowledge of the different
01 considerations in dosage forms design

Demonstrate knowledge of the physicochemical

02 properties of drug delivery systems

Demonstrate understanding of the new concepts of

03 pharmacology that influence design of drug delivery
systems

Demonstrate understanding of the factors

04 affecting DDS design
What is a drug?
• a medicine or other substance which has a
physiological effect when ingested or otherwise
introduced into the body.

• Therapeutic agent; any substance, other than

food, used in the prevention, diagnosis,
alleviation, treatment, or cure of disease.
• A substance recognized by an official
pharmacopoeia or formulary. A substance
intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of
disease. A substance (other than food)
intended to affect the structure or any
function of the body.
Drug Action/Uses

Analgesic/antipyretic/Anti-inflammatory
Anesthetics
Antihypertensive
Antineoplastic
Antipsychotic
Cardiac drugs
Diuretics
Antibacterial
Antiviral
Drugs for cough and colds
Hemostatics
GIT Drugs
Drugs for Respiratory system
Hypnotics and Sedatives
Development of The
Practice of Pharmacy
Before the Dawn of History

Ancient man learned from

instinct
Pharmacy in Ancient Babylonia

Practitioners of healing of this

era (about 2600 B.C.) were
priest, pharmacist and
physician, all in one
Pharmacy in Ancient China

An emperor (Shen nung) who

sought out and investigated the
medicinal value of several
hundred herbs .

First Pen -Tsao

Days of the Papyrus Ebers

The best known and most

important pharmaceutical
record is the "Papyrus Ebers"
(1500 B.C.), a collection of 800
prescriptions, mentioning 700
drugs.
Papyrus Ebers
Papyrus Ebers
•a continuous scroll some 60 ft. long and a
foot wide dating back the 16th century BC
•Georg Ebers discovered and translated
portions of the scroll
Hippocrates Hippocrates
Greek physician who is
credited with the introduction of
scientific pharmacy and
medicine. (pharmakon)
Known as the Father of
medicine
Theophrastus
His observations and writings
dealing with the medical
qualities and peculiarities of
herbs are unusually accurate,
even in the light of present
knowledge

Known as the father of

Botany
Dioscorides
Greek physician and botanist who
was the first to deal with botany as an
applied science of pharmacy.

He is the father of Medicinal Botany

De Materia Medica which led to the

development of pharmaceutical botany and the
study of naturally occurring medicinal plants
(pharmacognosy).
Claudius Galen
Greek pharmacist-physician who
attained roman citizenship.

He originated so many preparations of

vegetable drugs by mixing and
melting - Galenic Pharmacy

His most famous formula, cold

cream, is called Galen’s Cerate
Damian and Cosmas
Pharmacy's Patron Saints who
symbolizes the twinship of the
health professions, Pharmacy and
Medicine
Monastic Pharmacy

Remnants of the Western

knowledge of Pharmacy and
Medicine were preserved in the
monasteries
The First
Apothecary Shops

The Arabs separated the arts of

apothecary and physician,
establishing in Bagdad late in the
eighth century the first privately
owned drug stores
Separation of Pharmacy
and Medicine
Pharmacy was officially
separated from medicine for the
first time in 1240 AD, when a
decree of Emperor Frederick II
of Germany regulated the
practice of pharmacy within the
part of his kingdom
Philadelphia College of Pharmacy
Faced with two major threats;
deterioration of the practice of
pharmacy, and a discriminatory
classification by the University of
Pennsylvania medical faculty,
the pharmacists of Philadelphia
convened and signed the constitution
of the first school of pharmacy
(established in 1821)
The First Official
Pharmacopeia

The idea of a pharmacopoeia with

official status, to be followed by all
apothecaries, originated in Florence

The Nuovo Receptario, originally

written in Italian, was published and
became the legal standard for the
city-state in 1498
 First Hospital in Colonial
America

Colonial America's first

hospital was established in
Philadelphia in 1751; the
first Hospital Pharmacy
began operations there in
1752
The US Pharmacopeia
The first American
pharmacopeia was the so-called Lititz
Pharmacopeia,
published in 1778 at Lititz

The first "United States

Pharmacopoeia" (1820) was the work
of the medical profession.
It was the first book of drug standards
from a professional source to have
achieved a nation's acceptance.
 1600’s 1800’s 1877 1929 1940

Manufacturing Researches were Pasteur observed Fleming discovered Florey and Chain
companies conducted antibiotic activities Penicillin developed Penicillin
Philipus
Aureolus
Theophrastus
Bombastus von
Hohenheim
Also called Paracelsus
A Swiss physician and
chemist who introduced
chemical science from the
traditional botanical science
Karl Wilhelm
Scheele
Greatest of the Pharmacists-
Chemists
Discovered the following
organic acids: lactic, tartaric,
citric, oxalic, and also the
arsenic acid, he identified
glycerin, invented new methods
of preparing calomel and
benzoic acid.
Friedrich Serturner
He recognized and proved the
importance of a new class of
organic substances: alkaloids.
Caventou and
Pelletier
In 1820 Caventou and Pelletier
announced the methods for
separation of quinine and
isolated cinchonine from the
cinchona barks
and strychnine and brucine
from nux vomica
Pierre Robiquet

He isolated codeine
from opium

Together with Pelletier

isolated caffeine
Drug Standards

•The scientific basis for drugs and drug

products developed.
•To ensure quality
Pharmacopeias/ Formularies

• Organized sets of
monograph or books of
these standards.
Official Compendia

•The term pharmacopoeia comes

from the Greek word “pharmakon”
( drug) and “poiein” (make)
Official Compendia

•1580, the term was first used in

connection with a local book in
Italy
•1864, the first British
Pharmacopoeia
Official Compendia

• In US, the first American pharmacopoeia was a 32-

page booklet containing information on 84 internal
and 16 external drugs and preparations published in
1778
Official Compendia

•In 1817, Dr. Lyman Spalding proposed the

creation of national pharmacopoeia.
•He was called “the Father of USP”
 39

▪ January 1, 1820 - conducted the

first United States Pharmacopeia
Convention assembled in
Washington, D.C.

▪ December 15, 1820 - the first

United States Pharmacopeia
was published in English and
Latin.
 40

▪ 1888 - The first edition of National Formulary of

Unofficial Preparation was published.

▪ June 30, 1906 - President Theodore Roosevelt

signed into law the first Federal Pure Food and
Drug Act and changed the title to National
Formulary, designating both USP and NF as
establishing legal standards for medical and
pharmaceutic substances.
 41

• 1975, the United States Pharmacopeial

Convention, Inc. Purchased the National
Formulary, unifying the official compedia and
thereby provided the mechanism for single,
national compedium.

• July 01, 1980 - The first combined compedium,

representing the USP XX and NF XV became
official.
 42

• In 2002 - USP 25/NF20, the pharmacopeia will

be published annually.

• USP/NF is released every November and made official

on May of the next year.
Pharmacopoeia

•The official compendium contains

drug monographs which assured
availability of quality drugs and
pharmaceutical products.
Monograph
1. Official title
2. Synonyms
3. Chemical formula
4. Purity rubric
5. Packaging and storage
6. Reference standards
7. Labeling
8. Identification and preparation before use
9. Identification
10.Assay
• Other Pharmacopeia
▫ IP
▫ HPUS
▫ BP
▫ EP
▫ JP
Drug Regulation and Control

• June 30, 1906 - President Theodore

Roosevelt signed into law the first Federal
Pure Food and Drug Act. And he designating
both USP and NF as establishing legal
standards for medical and pharmaceutic
substances.

• prohibited misbranded and adulterated food and

drugs in commerce.
 deaths of more than 100
Drug Regulation and Control Solventin– 15
people states glycol
diethylene

• Federal Food, Drug and Cosmetics Act of

1938
• Due to sulfanilamide incident
▫ Requires filing of NDA (New drug Application)
●Assures products are safe for human use
 Drug Regulation and Control

• Kefauver – Harris Amendment

▫ Initiated by the 1960 Thalidomide tragedy
▫ Marketed as (Kevadon) an OTC for sedation

▫ Requires filing for IND prior to NDA

▫ Enacted to ensure greater degree of safety for approved drugs and
effectiveness
Drug Regulation and Control

*Thalidomide is the standard treatment for the

fever and painful skin lesions associated with
erythema nodosum leprosum (ENL), multiple
myeloma and cancer.
Drug Regulation and Control

• Durham-Humphrey Amendment of 1952

▫ Drug products were categorized into “Rx only” drugs and
OTC
▫ Rx drugs may only be refilled upon consent of the prescriber
Drug Regulation and Control

• Comprehensive Drug Abuse Prevention

and Control Act of 1970
▫ Control on drugs of abuse
▫ Led by DEA in DOJ
▫ Classified the controlled substances
●Schedule I: no accepted medical use, high potential for
abuse
Drug Schedule

●Schedule II: accepted medical use, high

potential for abuse – may lead to psycho or
physical abuse

●Schedule III: medical use, less potential for

abuse
Drug Schedule

●Schedule IV: accepted medical use, low

potential for abuse

●Schedule V: accepted medical use, low potential

for abuse
FDA Pregnancy Categories

Category A: Adequate and well-controlled

studies have failed to demonstrate a risk to the
fetus in the first trimester of pregnancy (and
there is no evidence of risk in later trimesters).
FDA Pregnancy Categories

Category B: Animal reproduction studies have

failed to demonstrate a risk to the fetus, and
there are no adequate and well-controlled
studies in pregnant women.
FDA Pregnancy Categories

Category C: Animal reproduction studies have shown

an adverse effect on the fetus and there are no
adequate and well-controlled studies in humans, but
potential benefits may warrant use of the drug in
pregnant women despite potential risks.
FDA Pregnancy Categories

Category D: There is positive evidence of

human fetal risk based on adverse reaction
data from investigational or marketing
experience or studies in humans, but potential
benefits may warrant use of the drug in
pregnant women despite potential risks.
FDA Pregnancy Categories

Category X: Studies in animals or humans

have demonstrated fetal abnormalities and/or
there is positive evidence of human fetal risk
based on adverse reaction data from
investigational or marketing experience, and
the risks involved in use of the drug in
pregnant women clearly outweigh potential
benefits.
Other Laws

• Drug Listing Act

• Drug Price Competition and Patent
Restoration Act
• Prescription Drug Marketing Act 1987
• Dietary Supplement Health and Education
Act
• FDA Modernization Act
Prescription Drug Marketing Act 1987

The act is intended to reduce the risks of

adulterated, misbranded, repackaged, or
mislabeled drugs entering the legitimate
marketplace through “secondary sources.”
FDA Modernization Act

Expands the capacity of FDA in regulating

pharmacy standards and practices
Drug Price Competition and Patent
Restoration Act
Applications for generic copies of an originally
approved new drug can be filed through an
abbreviated new-drug application (ANDA)
Drug Listing Act

Provide the FDA with the legislative authority

to compile a list of marketed drugs to assist in
the enforcement of federal laws requiring that
drugs be safe and effective and not
adulterated or misbranded
Dietary Supplement Health and Education
Act
Regulate the labeling claims made for
these products such as the
vitamins, minerals, amino acids, and
botanicals
Drug Product Recall

• Class I – cause serious adverse effects or

death
• Class II – cause temporary or medically
reversible adverse health consequences
• Class III – not likely to cause adverse health
consequences
 References
• Ansel, Howard C.,Pharmaceutical calculations,., Medical
th
Philadelphia : Wolters Kluwer Health 10 Edition
• Alfonso, Genaro, Remington : The Science & Practice
Presentation
of
Pharmacy 22nd edition, Phila. : Lippincott , 2013
• O`Neil, Maryadele J. The Merck Index 14 ed., USA:
th
1
Merck and Company, Latest Edition
• Archana, Gibaldi's drug delivery systems in
pharmaceutical care. Maryland : American Soc. of 2
Health-System Pharmacist, Latest Edition 1 2

• Aulton, Michael E., Aulton's Pharmaceutics The Design

3 3
4
and Manufacture of Medicines., Edinburg: Churchill
Livingstone Elsevier. Latest Edition 4
THANK YOU!