A chemical substance that produces pharmacological activity. *Pharmacological activity – therapeutic effect

(a)  

Agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals.

(a)  

facilitates an examination to reach a conclusion.

EXAMPLE

Iodine 101 – radiopaque drug or media contrast for diagnosis

Barium - in combination of other elements used as media contrast.

(a)  

lessen/reduce the severity of condition

(a)  

treats condition of disease

Ex. Paracetamol (analgesic) – manages the symptoms

(a)  

patients no longer have the disease

Ex. Antibiotics – kills the bacteria

(a)  

prevents illness or disease from occurring.

Ex. Vaccines, Vitamins, Doxycycline – prevent leptospirosis

(a)  

drugs that are naturally occurring biological products that are made or taken from a single-celled called organisms such as plants, animals or humans, and minerals

(a)  

(phenobarbital) created artificially to exert a specific pharmacological effect.

Ex. Paracetamol & other common meds

(a)  

same with synthetic drugs that are created in the laboratory but an imitation of a naturally occurring drugs.

Ex. Adrenaline -> epinephrine

(a)  

combination of natural and

synthetic molecule. The natural molecule is being

modified synthetically

(a)  

can be gathered through its extracts; has

active metabolites (secondary metabolites) that has

pharmacological effect.

Ex. Vinka-alkaloids, Periwinkle (kumintang) – has

substance termed as vincristine and vinblastine that

have anti-cancer activity.

(a)  

First insulin was taken from a pig then human insulin

to recombinant insulin.

EXAMPLE:

Lanolin & Parmacetti

(a)  

some bacteria

that produces substances that can kill itself.

Ex. Antibiotics, Penicillin & Streptomycin

*Antibiotics are considered semi-synthetic

(a)  

raw materials of chemicals to make a specific modification to have a pharmacological effect.

(a)  

either synthetic or semisynthetic or synthesized.

A structure is removed or added to create a pharmacological effect.

Ex. Stem cell/ stem cell treatment o Biotechnology o Genetic Engineering – Ex. Dolly (first cloned sheep)

(a)  

drugs purchased

without prescription; does not need prescription.

Ex. Paracetamol, for allergic reactions, or vitamins

(a)  

these drugs can only be purchased with prescription from a doctor or healthcare professional. Ex. Maintenance drugs, dangerous drugs, hypertensive drugs

(a)  

biochemically reactive

component of drug; causes therapeutic

pharmacological activity.

(a)  

has little or no physiologic or therapeutic effect. Purpose: to dilute the active ingredient and stabilize drug product; to provide vehicle of the active ingredient to take drug product conveniently.

Ex. Flavoring such as sugar to mask the unpleasant taste of medications. Adds size. Tablet bulk.

(a)  

Active Ingredient + Inert ingredient

(a)  

Formulation containing a specific quantity of active ingredient(s) in combination with one or more excipients

(a)  

Physical manifestation of a drug that can be used in a way

(a)  

powder, granules, capsule, tablet, beads (pellets), lozenges, implants, medical lollipop (phased out)

(a)  

solutions, syrups, elixir, tincture (Betadine), fluid extracts

(a)  

ointments, creams, gel (single phased), lotions, plasters, suppositories, magma

(a)  

suspension, emulsion,

disperse system, two phased gel (like Milk of

Magnesia)

(a)  

Device use to deliver drug

➔ Design feature of the dosage form that affects the

delivery of the drug

➔ Transporting a drug to its site(s) of action within the

body

Ex. Aerosol Canister of Inhalers (DS) AND Capsules (DS)

(a)  

WHAT ARE THE FACTORS TO BE CONSIDERED IN CHOOSING THE DELIVERY SYSTEM?

(a)  

RX

(a)  

Where all information is located to ensure the safety, quality, and effectiveness when producing drug products

- Organized sets of monographs or books that contains information to standardized drugs

(a)  

Pharmakon

(a)  

Poiein

(a)  

provides suitable tests and assay

procedures for demonstrating compliance with these

standards.

(a)  

Paracetamol IN ASIA

(a)  

First federal law in US. The law required drugs marketed interstate to comply with their claimed standards for strength, purity, and quality

(a)  

The need for additional drug standards was

tragically demonstrated in 1938 –

sulfanilamide. It killed more than 100

people because of diethylene glycol

poisoning

(a)  

This created the Food and Drug Administration (FDA) to enforce the law - Its equivalent law in the Philippines

(a)  

Amendment to the Federal Food, Drug and

Cosmetic Act. Also, this is the law that

distinguish the OTC and Prescription drugs

(a)  

A tragedy in 1960 led to the passage of the (a)   to the Federal

Food Drug and Cosmetic Act of 1938 –

thalidomide tragedy

This amendment requires that a manufacturer should ensure that the drug product is safe and effective.

Served to consolidate and codify control authority over drugs of abuse into a single state.

(a)  

The drug has a high potential for abuse. The drug has no currently accepted medical use in

treatment

(a)  

The drug has a high potential for abuse. The drug has a currently accepted medical use in

treatment

EX. COCAINE, MORPHINE

(a)  

The drug has a potential for abuse less than the drugs in schedules 1 and 2. The drug has a currently

accepted medical use in treatment

Abuse of the drug may lead to moderate

or low physical dependence or high psychological dependence.

(a)  

The drug has a low potential for abuse relative to the drugs in schedule 3. The drug has a currently

accepted medical use

Abuse of the drug may lead to limited

physical dependence or psychological dependence relative to the drugs in schedule 3.

EX. DIAZEPAM

(a)  

The drug has a low potential for abuse relative to the drugs in schedule 4. The drug has a currently

accepted medical use

(a)  

Comprehensive Drug Abuse Prevention and Control Act of 1970

The equivalent law in the Philippines is

(a)  

Adequate and well controlled studies have failed to demonstrate a risk to the fetus in the first

trimester of pregnancy

(a)  

Studies indicate no risk to animal fetus; information in humans is not available

(a)  

Adverse effects reported in animal fetus; information in humans is not available

(a)  

Possible fetal risk in humans reported; however, considering potential benefit vs risk may, in selected

cases, warrant the use of these drugs in pregnant women

(a)  

- Fetal abnormalities reported and positive evidence of fetal risk in humans is available from animal

and/or human studies; should not be used by pregnant women

EX. LOSARTAN

(a)  

Prescription drug labeling is used to call attention to one of the following situations. There could be adverse reaction. - Warning precautions; anti-depressant drugs

(a)  

Requires the manufacturing companies to

register their products to the FDA and will

be given a permanent registration number

even it closes

(a)  

Patency of the drug product to control the competition in the market.

EX. TYLENOL

(a)  

There is a reasonable probability that the use

of or exposure to a violative product will cause

serious adverse health consequences or death

(a)  

The use of or exposure to a violative product

may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.

(a)  

The use of or exposure to a violative product is not likely to cause adverse health consequences.

(a)