Dosage Form Design

Question 1

what does API stand for?

Answer 1

active pharmaceutical ingredient

Question 2

what is the most diverse subject area in the pharmaceutical sciences

Answer 2

dosage form design

Question 3

a drug must be _____ to work

Answer 3

in solution

Question 4

list the 5 effects of a drug in its solid state

Answer 4

1. crystalluria
2. gout
3. precipitation of drugs
4. inhalation
5. toxic effects of particulates

Question 5

list the 6 important factors in dosage form design

Answer 5

1. dose accuracy and uniformity
2. compliance and patient acceptance
3. stability of the active ingredient
4. improved bioavaliability
5. rate controlled drug action
6. optimal administration

Question 6

what is the principle objective of dosage form design

Answer 6

to achieve a predictable therapeutic response to a drug in a formulation which is capable of large scale manufacturing and reproducible product quality

Question 7

what are the 2 main states of active ingredients in formulation?

Answer 7

solid or insolution (crystal or molecule)

Question 8

what state is the API in for liquid-filled capsules

Answer 8

molecules or crystals in vegetable oil

Question 9

what state is the API in for suppositories

Answer 9

crystal in a waxy, water-miscible or water-immiscible base

Question 10

what state is the API in for suspensions

Answer 10

crystals in an aqueous or nonaqueous liquid

Question 11

what state is the API in for ointments

Answer 11

crystals or molecules in a semisolid oleaginous base

Question 12

what state is the API in for creams

Answer 12

crystals or molecules in water-miscible or immiscible semisolid cream

Question 13

what state is the API in for gels

Answer 13

crystals or molecule in water-miscible semisolid gel base

Question 14

what state is the API in for aerosols

Answer 14

crystals or molecules in a gas, liquid, or semisolid base

Question 15

define excipeints

Answer 15

pharmacologically inactive substances formulates alongside the drug in medication

Question 16

list the pharmaceutical properties of excipients

Answer 16

1. solubilize
2. suspend
3. thicken
4. emulsify
5. flavor
6. color
7. dilute
8. compact
9. stabilize
10. preserve
11. fillers/diluents

Question 17

list an example of a biological implication of an excipient

Answer 17

excipients can cause allergic reactions, such as Taxol must pre-dose with antihistamine or corticosteroid

Question 18

true or false: all excipients are biologically active

Answer 18

false, they are pharmacologically active

Question 19

list the physicochemical properties of the drug

Answer 19

1. particle size
2. solubility
3. crystallinity
4. salt form
5. hydration
6. ionization
7. partition coefficient
8. hydrophobicity
9. organoleptic
10. stability

Question 20

list the 4 biopharmaceutical considerations for dosage forms

Answer 20

1. route of administration
2. ADME
3. pathophysiology
4. transport across membranes

Question 21

define ADME

Answer 21

Absorption
Distribution
Metabolism
Excretion

Question 22

list the 6 therapeutic considerations of dosage forms

Answer 22

1. systemic/local
2. emergency
3. targeting/toxicity
4. onset/frequency
5. age/weight
6. manifestation

Question 23

list the 6 factors that are of concern when switching from a tablet to a liquid-filled capsule

Answer 23

1. solubility
2. stability
3. excipients
4. polarity
5. pH
6. toxicity