Week 1 Content

Question 1

Monographs of USP-NF

Answer 1

-USP Monographs: info about drug substances, dosage forms, and compounded preps
-NF Monographs: provides excipient info
-Dietary supplement monographs

Question 2

General chapters of USP-NF

Answer 2

Provides info about tests and procedures
<795> Non-sterile prep
<797> Sterile prep
<800> HD Handling in Healthcare settings

Question 3

United States Pharmacopeia and the National Formulary (USP-NF)

Answer 3

Divided into general chapters and monographs

Question 4

United States Pharmacopeia (USP)

Answer 4

-Sets standards for medications, food ingredients, and dietary supplements including identity, strength, purity and quality
-Enforceable by the FDA and are often adopted by state boards of pharmacy
-Has no role in enforement

Question 5

Intensity

Answer 5

How strong the drug action will be; associated with concentration

Question 6

Duration

Answer 6

How long drug action will last; associated with concentrations above a certain level

Question 7

Onset

Answer 7

How quickly drug action will be seen; associated with how quickly drug appears in blood/plasma

Question 8

Biopharmaceutics

Answer 8

The study of how the properties of drugs, dosage forms, and routes of administration affect the onset, duration, and intensity of drug action

Question 9

Steps in designing a dosage form

Answer 9

1. Preformulation
2. Dosage form selection and formulation
3. Determine processes for manufacturing/ compounding

Question 10

Ionization

Answer 10

The conversion of neutral molecules to electrically charged molecules

Question 11

Solubility

Answer 11

The extent to which a drug dissolves in a given solvent at a given temperature

Question 12

Examples of physiochemical properties

Answer 12

MW, solubility, lipophilicity, dissolution rate, ionization, stability, solid-state properties

Question 13

Preformulation

Answer 13

-Involves the characterization of physiochemical properties of the drug
-Helps to determine the optimum drug candidate for further development

Question 14

Processes by which elimination occurs

Answer 14

1. Metabolism
2. Excretion of unchanged drug
   a) Urine –> Urination
   b) Bile –> Feces

Question 15

Elimination

Answer 15

The removal of drug from the body

Question 16

Drug distribution

Answer 16

Drug moves from its administration site to site of action and/or other parts of the body

Question 17

Metabolism

Answer 17

Takes a drug molecule and chemically modifies it

Question 18

First pass loss

Answer 18

The drug that is lost to metabolism and biliary elimination before reaching systemic circulation

Question 19

Systemic absorption

Answer 19

Movement into the systemic circulation

Question 20

Absorption

Answer 20

-When the dissolved drug moves across the cell membrane and enters the cell

Question 21

Permeability

Answer 21

The ability of a molecule to pass through a cell membrane

Question 22

Define dissolution

Answer 22

The transfer of molecules from solid state into solution

Question 23

Define disintegration

Answer 23

The breakdown of the dosage form into smaller particles

Question 24

ROA that have only systemic effects

Answer 24

Parenteral (IV, IM, SubQ), Transdermal

Question 25

ROA that have only local effects

Answer 25

Topical, Ophthalmic

Question 26

ROA that are both local and systemic

Answer 26

Sublingual, buccal, oral, rectal, nasal, inhalations

Question 27

Systemic administration

Answer 27

-Enters systemic circulation
-Puts patient at higher risk of adverse effects

Question 28

Local administration

Answer 28

-Affects that particular area
-Minimizes systemic side effects

Question 29

Ideal qualities of a dosage form

Answer 29

-Provides an accurate dose
-One dose in a manageable size unit
-Palatable or comfortable
-Convenient and easy to use
-Appropriate stability and compatibilty

Question 30

What makes up a dosage form?

Answer 30

Active ingredient and excipients (inactive ingredients)

Question 31

Parenteral routes

Answer 31

Administration by injection, infusion or implantation (IV, IM, SubQ)

Question 32

Enteral routes

Answer 32

Refer to ROA to a part of the ailmentary canal: Mouth –> Esophagus –> Stomach –> Intestines –> Rectum (buccal, sublingual, oral, rectal)

Question 33

Examples of excipients

Answer 33

-Fillers
-Disintegrants
-Binders
-Flow enhancers
-Preservatives
-Emulsifying agents
-Suspending agents
-Flavors
-Colors
-Antioxidants

Question 34

What are excipients?

Answer 34

Pharmacologically inactive substances formulated with the active ingredient

Question 35

What is compounding?

Answer 35

The preparation of a medication by a licensed pharmacist to meet the unique needs of a patient that would otherwise not be met by commercially available preparations

Question 36

Drug delivery systems allow for….?

Answer 36

-Enhanced safety
-Improved efficacy

Question 37

What is a drug delivery system?

Answer 37

-A type of dosage form with engineered technologies for the targeted delivery and/or controlled release of therapeutic agents
-May be a formulation of the drug or a particular device used to deliver the drug

Question 38

What is a dosage form?

Answer 38

The entity administered to a patient so they receive the correct dose of the drug
Examples: tablets, suspensions, ointments

Question 39

What is pharmaceutics?

Answer 39

-The design and manufacture of dosage forms and drug delivery systems
-Converts a drug substance into medicine