dosage form Sas 1-10

drug

drug

an agent intended for the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or other animals

drug delivery system (DDS)

involves a holistic approach to a formulation that is optimized for the drug's relevant biopharmaceutic

new drugs

may be derived from plant or animal sources, as by products of microbial growth

current good manufacturing practice (cGMP)

to ensure the minimum standards are met for drug product

sumerian clay tablet

is the world's oldest written prescription

hippocrates

greek physician who rationalized medicine, systematized medical knowledge and put the practice of medicine on high ethical plane

dioscorides

-de materia medica -pharmacognosy or natural product chemistry

claudius galen

galenic pharmacy is the preparations of vegetable drugs by mixing or melting the individual ingredients

auerolus theophrastus bombastus von hohenheim

he called himself paracelsus

Swede Karl Wilhelm Scheele

he discovered lactic acid, citric acid, oxalic acid, tartaric acid, arsenic acid and oxygen

Friedrich Serturner

He isolated morphine from opium.

Joseph Caventou and Joseph Pelletier

isolated quinine and cinchonine from cinchona and strychnine and brucine from nux vomica

joseph pelletier and pierre robiquet

isolated caffeine

peirre robiquet

isolated codeine from opium

United State Pharmacopeia (USP)

its objective is to select from among substances which poses medicinal power, those, the utility of which is most fully established and best understood

National Formulary (NF)

comprises the monograph on pharmaceutical agents of drugs

International Organization for Standardization (ISO)

bodies constitute to develop and promote uniform or harmonized international standards

schedule 1

drugs with no accepted medical use

schedule 1

lysergic acid

schedule 1

mescaline

schedule 1

peyote

schedule 1

methaqualone

schedule 1

marijuana

schedule 2

drugs with accepted medical uses and a high potential for abuse

schedule 2

morphine

schedule 2

cocaine

schedule 2

methamphetamine

schedule 2

amobarbital

schedule 3

drug with accepted medical used and a potential for abuse less

schedule 3

codeine

schedule 3

hydrocodone

schedule 4

drugs with accepted medical uses and low potential for abuse

schedule 4

diphenoxin

schedule 4

diazepam

schedule 4

oxazepam

schedule 5

drugs with accepted medical uses and low potential for abuse relative

schedule 5

dihydrocodeine

schedule 5

diphenoxylate

category a

animal and human studies to date have failed to show a risk to the fetus

category b

animal studies have shown no risk to the fetus, but clinical studies on women are inadequate or incomplete

category c

animal studies have shown a risk to fetus, and clinical studies on women are inadequate

category d

there is clinical evidence of risk to the human fetus

category x

there is clinical evidence that the use of drug has a high risk potential to the developing fetus

preformulation studies

are initiated to define the physical and chemical properties of the agent

formulation studies

follow to develop the initial features of the proposed pharmaceutical product or dosage forms

phase 4

-continued clinical investigations -may contribute to the understanding of the drug's mechanisms or scope of action

pre-clinical stage

-animal studies -safety and toxicity

phase 1

-healthy volunteers -initial safety and tolerability -determines safe dosage range

phase 2

-patient with targeted diseases -determine efficacy of drug

phase 3

several 100 to 1000 patients -monitor side effects -collect information that will allow the drug or treatment to be used safely

phase 4

-patient population sample -post-marketing surveillance -optimising drug use

new drug

Anything that is not recognized as being safe and effective in the conditions recommended for its use among experts who are qualified by scientific training and experience.

lead drug

A prototype and has fundamental desired biological or pharmacologic activity yet may not possess desired features of potency, absorbability, solubility and low toxicity.

goal drug

produces desired effect, minimal dosage and frequency, optimal onset and duration of activity, no side effects, X

prodrug

An inactive drug dosage form that is converted to an active metabolite by various biochemical reactions once it is inside the body.

Empirical Nomenclature

A representation of an organic compound when it is first synthesized from natural source

systematic chemical name

A name given after a knowledge of the relative location of atoms

Nonproprietary name

generic name

proprietary name

brand name

patent

a government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using, or selling an invention.

black box warning

The most serious warning required by the FDA on drug labels; such warnings appear in a box surrounded by a black border at the beginning of the label information.

usual dosage range

Indicates that drug may be prescribed safely within the the framework of usual medical practice

dosage regimen

Scheduled recommended dosage

median effective dose

desired intensity of effect in 50%

median toxic dose

defined toxic effect in 50%

therapeutic index

the ratio between the toxic and its median effective dose

API

any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment

batch

A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture

lot

A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number

component

Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product

pharmacogenetics

study of inherited genetic difference in drug metabolic pathways

pharmacogenomics

study of the role of the genome in drug response

pharmacometabolomic

quantification and analysis of metabolites produced in the body

chronopharmacology

study of how the effects of drugs vary with biological timing and endogenous

Pharmaceutics

is the study with the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms.

Biopharmaceutics

aside from designing the drugs based on pharmaceutics one of the crucial parts of consideration between the physical, chemical, and biologic sciences.

2 of the general considerations in dosage form design

1. Nature of illness, the manner in which it is treated, local or systemic

2. Age of the intended patient

Appearance and palatability

there is some psychologic basis to drug therapy, and the odor, taste and color of a pharmaceutical preparation can a play a part.

-appropriate drug has its most beneficial effect when it is accepted.

flavoring pharmaceuticals

-applies primarily to liquids for oral administration. -can degrade as a result of exposure to light, temperature, contaminants and other product. -may be derived from natural sources or prepared artificially.

Sweetening Pharmaceuticals

-have been used in foods and pharmaceuticals -approved by the FDA with parenthesis and number of times

Sweetener

1. Acesulfame potassium (200x)

2. Aspartame (180 to 200x)

3. Sucralose (600 x)

4. Saccharin (300x)

remember the numbers!

Coloring Pharmaceuticals

-used in pharmaceutical preparations for aesthetics. -distinction should be made between agents that have inherent color and those that are employed as colorants.

(if u make a medicine and resulted with color, u don't need to add an artificial one)

Certain agents (inherent color)

SULPHUR - yellow

RIBOFLAVIN - yellow

CURPRIC SULPHATE - blue

FERROUS SULPHATE - bluish green

CYANOCOBALAMIN - red

MERCURIC IODIDE - vivid red

orange

yellow no.6 (100%) or yellow no.5 (95%) , red no. 40 (5%)

Cherry

red no. 4 (100%) or red no. 40 (99%), blue no. 1 (1%)

strawberry

red no. 40 (100%) , or red no. 40 (95%), red no. 3 (5%)

Lemon

yellow no. 5 (100%)

Lime

yellow no.5 (95%), blue no. 1 (5%)

grape

red no. 40 (80) , blue no.1 (20)

raspberry

red no. 3 (75%), yellow no.6 (25%), blue no.1 (5%)

butterscotch

yellow no.5 (74%) , red no. 40 (24%), blue no.1 (2%)

chocolate

red no. 40 (52%) , yellow no.5 (40%) , blue no.1 (8%)

caramel

yellow no. 5 (64%), red no. 3 (21%) , yellow no. 6 (9%), blue no.1 (6%)

cinnamon

yellow no.5 (60%) , red no. 40 (35%) , blue no. 1 (5%)

FD&C color additives

which may be used in foods, drugs, and cosmetics

D&C color additives

some of which are approved for use in drugs, some in cosmetics and some in medical devices.

external D&C color additives

the use of which is restricted to external parts of the body, not including the lips or anybody surface covered by mucous membrane

Preservative

-prevents the growth -soluble enough -penetrating the microorganism and destroying its integrity. -does not affect the safety or comfort of the patient -nonirritating, non-sensitizing and nontoxic -has adequate stability -completely compatible -does not adversely affect

Mode of Action (MOA)

• modification of cell membrane permeability and leakage of cell constituents (partial lysis) -lysis and cytoplasmic leakage -irreversible coagulation of cytoplasmic constituents (e.g., protein precipitation) -inhibition of cellular metabolism, such as by interfering with enzyme systems or inhibition of cell wall synthesis -oxidation of cellular constituents -hydrolysis

metabolism

is the major process by which foreign substances, including drugs, are eliminated from the body.