Formulation Consideration

Question 1

Finished formulation of a drug designed to contain a specific amount of medication for ease and accuracy of dosage administration.

Answer 1

Dosage Forms

Question 2

Protection of drug from oxygen/moisture, gastric acid, conceal bad taste/odor, provide liquid form, extend drug action (controlled release), optimize topical/inhalation/rectal use, or deliver directly into bloodstream.

Answer 2

Needs of Dosage Forms

Question 3

Characterization of a drug molecule and application of biopharmaceutical principles to physicochemical parameters to design an optimal drug delivery system.

Answer 3

Pre formulation Studies

Question 4

State (solid/liquid), stability, volatility.

Answer 4

Physical Description

Question 5

Particle size, shape, structure.

Answer 5

Microscopic examination

Question 6

Heat absorbed when 1g liquid vaporizes (important for safety in inhalants, aerosols).

Answer 6

Heat of Vaporization

Question 7

Used to check identity & purity.

Answer 7

Melting point

Question 8

Identifies eutectic mixtures.

Answer 8

Phase Rule Diagram

Question 9

Existence of drug in more than one crystalline form.

Answer 9

Polymorphism

Question 10

Ability of drug to dissolve; depends on particle size & pH.

Answer 10

Solubility

Question 11

Time for drug to dissolve at absorption site.

Answer 11

Dissolution Rate

Question 12

Lipid-soluble drugs diffuse passively; non-lipid require alteration.

Answer 12

Membrane Permeability

Question 13

Measure of lipophilicity of a molecule.

Answer 13

Partition Coefficient

Question 14

Indicates ionization and lipophilic nature in medium.

Answer 14

Dissociation Contrast

Question 15

Drug crystals with water/solvent; need cautious handling.

Answer 15

Hydrates/Solvates

Question 16

Improve solubility of weak acids/bases.

Answer 16

Organic Salts

Question 17

Improve solubility & stability (prodrugs).

Answer 17

Organic Esters

Question 18

Capability of a formulation in its container/closure to remain within physical, chemical, microbiological, therapeutic, and toxicological specifications.

Answer 18

Drug Stability

Question 19

Time drug remains ≥90% potency.

Answer 19

Shelf Life

Question 20

Last date drug may be dispensed/used.

Answer 20

Expiration date

Question 21

Consistency in appearance, texture, etc.

Answer 21

Physical

Question 22

Resistance to degradation (hydrolysis, oxidation).

Answer 22

Chemical

Question 23

Free from contamination.

Answer 23

Microbiological

Question 24

Retains therapeutic effect.

Answer 24

Therapeutic

Question 25

No toxic by-products.

Answer 25

Toxicologic

Question 26

Normal storage conditions (25°C/60% RH, 12 months).

Answer 26

Long term studies

Question 27

Exaggerated conditions to predict expiration.

Answer 27

Accelerated Studies

Question 28

I (Temperate), II (Subtropical), III (Hot & Dry), IVA (Hot & Humid), IVB (Very Humid).

Answer 28

Climatic Zones

Question 29

Substances added to formulation aside from API (Active Pharmaceutical Ingredient).

Answer 29

Excipients

Question 30

Provides acidic medium (HCl, HNO3)

Answer 30

Acidifying Agent

Question 31

Provides alkaline medium (Na carbonate, ammonia).

Answer 31

Alkalizing agents

Question 32

Holds molecules on surface (cellulose, charcoal).

Answer 32

Adsorbent

Question 33

Expels product from container (CO2, DCTFE).

Answer 33

Aerosol Propellant

Question 34

Prevents oxidation (BHT, ascorbic acid).

Answer 34

Antioxidant

Question 35

Prevents fungal growth (parabens).

Answer 35

anti fungal agent

Question 36

Prevents microbial growth (benzalkonium chloride, phenol).

Answer 36

antimicrobial preservatives

Question 37

Resists pH change (citrates, phosphates).

Answer 37

Buffering agent

Question 38

Binds heavy metals (EDTA).

Answer 38

Chelating agent

Question 39

Adds color (FD&C dyes, ferric oxide).

Answer 39

colorant

Question 40

Filtering aid (bentonite).

Answer 40

clarifying agent

Question 41

Maintains dispersion (acacia, spans).

Answer 41

emulsifying agent

Question 42

Adds pleasant taste.

Answer 42

flavorant

Question 43

Prevents drying (glycerin, sorbitol).

Answer 43

humectant

Question 44

Reduces particle size (mineral oil).

Answer 44

levigating agent

Question 45

Vehicle for semisolids (petrolatum, PEG).

Answer 45

ointment base

Question 46

Dissolves substances (water, alcohol, oils).

Answer 46

solvent

Question 47

Increases hardness (wax, paraffin).

Answer 47

stiffening agent

Question 48

Vehicle for suppositories (cocoa butter, PEG).

Answer 48

suppository base

Question 49

Reduces interfacial tension (SLS, polysorbates).

Answer 49

surfactant

Question 50

Prevents sedimentation (CMC, acacia). Increase Viscosity

Answer 50

suspending agent

Question 51

Adds sweetness (sucrose, saccharin).

Answer 51

sweetening agent

Question 52

300× sweeter than sucrose.

Answer 52

saccharin

Question 53

200× sweeter, unsafe for PKU patients.

Answer 53

aspartame

Question 54

130× sweeter.

Answer 54

acesulfame k

Question 55

600× sweeter.

Answer 55

sucralose

Question 56

30× sweeter, banned (1969).

Answer 56

cyclamate

Question 57

Natural, 250–300× sweeter.

Answer 57

stevia

Question 58

From minerals/plants (annatto, cochineal).

Answer 58

natural colorant

Question 59

Derived from coal tar dyes (FD&C colors).

Answer 59

synthetic colorant (aniline)

Question 60

Water-soluble. (colorant)

Answer 60

dyes

Question 61

Insoluble, used in tablets. (colorant)

Answer 61

lakes

Question 62

Prevent microbial growth and extend shelf life.

Answer 62

Preservatives

Question 63

Protects from solids.

Answer 63

well-closed

Question 64

Protects from liquids/vapors.

Answer 64

tight

Question 65

Protects from photodecomposition.

Answer 65

light resistant

Question 66

Airtight.

Answer 66

hermetic

Question 67

For one dose or multiple.

Answer 67

single/multi unit

Question 68

Difficult for <5 yrs old to open.

Answer 68

child resistant

Question 69

Shows evidence of tampering.

Answer 69

tamper resistant

Question 70

Borosilicate (high resistance).

Answer 70

TYPE I GLASS

Question 71

Treated soda-lime.

Answer 71

type II glass

Question 72

Soda-lime.

Answer 72

type III glass

Question 73

General-purpose soda-lime.

Answer 73

type IV glass

Question 74

Permeability, Leaching, Sorption, Physical alteration, Light transmission.

Answer 74

plastic container issue

Question 75

2–8°C

Answer 75

cold

Question 76

–10 to –20°C

Answer 76

freezer

Question 77

8–15°C

Answer 77

cool

Question 78

Ambient

Answer 78

room temp

Question 79

15–30°C

Answer 79

controlled temp

Question 80

30–40°C

Answer 80

warm

Question 81

>40°C

Answer 81

excessive heat