PHAR 432 Final Exam - #L8

5 dosage form components?

API, excipients, packaging, admin device, package insert

Why solid dosage form?

Ease of…

processing, handling, admin, pt preference

Which of the following dosage forms is RARELY compounded?
A. Powders
B. Granules
C. Aerosols
D. Capsules

c

Which dosage form is MOSTLY manufactured in the industry?
A. Tablets
B. Powders
C. Capsules
D. Granules

a

What type of capsules are most commonly used?
A. Soft gelatin capsules
B. Hard shell capsules
C. Liquid-filled capsules
D. Starch-based capsules

b

Which dosage forms are commonly used in compounding?
A. Tablets and aerosols
B. Granules and aerosols
C. Powders and capsules
D. Softgels and sprays

c

Granules are more commonly used in compounding than in industry

f

Tablets are rarely compounded due to equipment limitations

t

Hard shell capsules can be used to deliver different dosage forms

t

Aerosols are commonly prepared in compounding pharmacies

f

Which of the following can affect the chemical stability of a drug?
A. Capsule size
B. Light exposure
C. Tablet hardness
D. Particle size

b

Which of the following is true about the physical form of a drug?
A. It only affects the drug’s taste
B. It determines the drug’s molecular weight
C. It influences solubility and dissolution rate
D. It prevents oxidation

c

What must happen before a drug in solid dosage form can be absorbed?
A. It must be sterilized
B. It must disintegrate and dissolve
C. It must be injected
D. It must undergo oxidation

b

Which of the following material properties can influence drug dissolution?
A. Porosity and particle size
B. Color and odor
C. Sweetness and bitterness
D. Container size

a

Excipients never affect the chemical stability of a drug

f

Both disintegration and dissolution are required before absorption of a solid drug

t

Particle size has no impact on drug solubility or dissolution rate

f

Physical form of a drug includes factors like solid state, solubility, and dissolution behavior

t

In the industry, how is excipient compatibility commonly tested?
A. Only by taste and appearance
B. By mixing ingredients and storing at room temperature
C. By stress testing with heat, humidity, light, and oxidants
D. By patient feedback after formulation

c

Excipient compatibility in industry

test excipients with API under stress, may add oxygen, peroxide, light, and test formulations

Excipient compatibility in compounding

test for ingredient incompatibility

Why is excipient compatibility testing important in compounding?
A. To improve tablet coating
B. To test color and flavor
C. To check for ingredient incompatibilities like acid with sodium bicarbonate
D. To determine container size

c

What is the importance/emphasis on inactive ingredients?

A. They have no effect on the formulation
B. They are always chemically stable
C. They can still interact with the API or other excipients
D. They improve drug potency

c

Industry testing uses light and peroxide to evaluate excipient compatibility.

t

In compounding, excipient compatibility is not a concern.

f

Inactive ingredients are truly inert (not active) and never affect drug behavior.

f

Excipients can interact with the API under stress conditions.

t

What is the first step in forming a solid dosage form like a tablet?
A. Coating the tablet
B. Blending API with excipients
C. Packaging the tablet
D. Compressing the final tablet

b

What is massing in the granule formation process?
A. Filtering API from excipients
B. Heating powders until they fuse
C. Adding water or binder to create a cohesive mass
D. Compressing the tablet into shape

c

What happens after a cohesive mass is formed during solid dosage manufacturing?
A. It is dissolved
B. It is packaged
C. It is compressed into a tablet or capsule
D. It is frozen

c

The powder blend is formed after the API and excipients are mixed.

t

Compression is done before granule formation

f

Water or binder is used to help form granules from the powder blend

t

In solid dosage formation, the final product is a disintegrated powder

f

What sequence of events occurs after a solid dosage form is taken?
A. Packaging → Coating → Absorption
B. Disintegration → Granules release contents → API absorption
C. Dissolution → Compression → Disintegration
D. Mixing → Absorption → Disintegration

b

What does the breaking apart of granules release into the body?
A. Only excipients
B. Only capsule shells
C. API, excipients, and powder blend
D. Only water-soluble ingredients

c

Granule breakdown is necessary for API release and absorption.

t

Disintegration occurs after absorption in the GI tract.

f

What do incompressible APIs require during tablet formulation?
A. Higher temperatures
B. Addition of water
C. Excipients to help pack the powder
D. Capsule banding

c

What property affects how powders pack into a dosage form?
A. Taste
B. Density
C. Color
D. Absorption rate

b

How do compressible APIs behave during formulation?
A. They always require binders
B. They need to be converted into granules
C. They can be directly compressed more easily
D. They must be dissolved first

c

All APIs are compressible and can be packed without excipients.

f

Powder density influences whether the material stands loosely or packs tightly.

t

What is the definition of solubility in the context of drug formulation?
A. Ability of a solid to melt
B. Amount of substance that dissolves at equilibrium in a given solvent
C. Speed at which a capsule disintegrates
D. Volume of solvent required for mixing

b

Which form of a drug is usually best absorbed in the body?
A. Ionized form
B. Cocrystal form
C. Unionized form
D. Crystalline hydrate form

c

What can alter solvent conditions and affect solubility?
A. Room temperature
B. Capsule shell thickness
C. Adding substances or changing pH/salt form
D. Tablet shape

c

There is one single best crystal form that dissolves fastest in all conditions.

f

Solvent conditions can be altered by adding other substances or changing the pH

t

Dissolution speed depends on multiple conditions, so no universal rule applies

t

What best describes a crystal in solid-state API form?
A. A mixture of liquid and powder

B. A random arrangement of molecules

C. A compressed solution

D. A regular, ordered arrangement of molecules

d

What is a polymorph?
A. A solvate with water
B. A crystal that includes a second molecule
C. A different crystal form of the same API, with only API inside
D. A salt formed by combining acid and base

c

What is a hydrate?
A. A salt that crystallizes under heat
B. A crystal that includes solvent molecules
C. An amorphous mixture
D. A solvate that contains water

d

Which of the following is true about cocrystals?
A. They only contain the API
B. They are always amorphous
C. They are crystals that include a second molecule
D. They must include water

c

Which statement is correct about API solid forms?
A. They can only be one form at a time
B. They may exist as a combination of forms
C. Amorphous forms always dissolve slower than crystals
D. Solvates and salts are chemically identical

b

All crystal forms behave the same in terms of solubility and dissolution.

f

Amorphous forms have a defined, repeating structure.

f

Solvates are crystals that contain a solvent molecule in their structure

t

Which term describes a crystal form that contains only the API in a different arrangement?
A. Salt
B. Hydrate
C. Polymorph
D. Cocrystal

c

Which type of crystal includes a second, separate molecule that is not solvent or API?
A. Cocrystal
B. Solvate
C. Dihydrate
D. Amorphous

a

Which term refers to a crystal that includes a solvent molecule in its structure?
A. Hydrate
B. Polymorph
C. Solvate
D. Salt

c

What is a hydrate?
A. A crystal including an organic base
B. A crystal with a second molecule
C. A solvate where the solvent is water
D. A disordered molecular structure

c

What best defines a salt in terms of crystal forms?
A. A hydrate with two water molecules
B. A crystal with API plus a counterion (acid or base)
C. A solvate with ethanol
D. A cocrystal with a sugar

b

What does the term "dihydrate" specify?
A. A hydrate that includes two water molecules
B. A salt form used in MR tablets
C. A cocrystal with two APIs
D. A form with rapid disintegration

a

Which form has no regular molecular arrangement?
A. Amorphous
B. Cocrystal
C. Solvate
D. Polymorph

a

Which concept explains the difference in how fast each aspirin face dissolves?
A. Bulk solubility
B. Dissolution uniformity coefficient
C. Intrinsic dissolution rate (mg/cm²/min)
D. Interfacial disruption constant

c

What does the aspirin example primarily illustrate about crystal faces?
A. Each face dissolves at the same rate regardless of conditions
B. Faces can dissolve at different rates depending on orientation
C. Solubility is only affected by particle size, not face
D. Amorphous aspirin dissolves slower than crystal faces

b

Intrinsic dissolution rate refers to how fast a drug dissolves per unit surface area

t

If a solid drug is composed of Form A and Form B crystals, and Form B has a faster dissolution rate, which of the following is most likely true about the overall dissolution behavior?
A. The final dissolution rate will match Form A
B. Form A will inhibit Form B's dissolution
C. Form B will dominate and determine the overall dissolution profile
D. The mixture will dissolve at the average rate of both forms

c

Which of the following best explains why different crystal forms of the same API show different dissolution rates?
A. The API changes into a different chemical structure
B. Crystalline arrangements affect molecular packing and surface interactions
C. The slower form is always larger in size
D. Solubility of the excipients changes the outcome

b

Which form of the same API would be expected to dissolve more quickly under identical conditions?
A. One with higher internal bonding
B. One with lower intrinsic dissolution rate
C. The form with more tightly packed crystal structure
D. The form with higher intrinsic dissolution rate

d