Comprehensive pharmacy review: Pharmaceutical Principles and Drug Dosage Forms

Question 1

1. Which substance is classified as a weak electrolyte?
   (A) glucose
   (B) urea
   (C) ephedrine
   (D) sodium chloride
   (E) sucrose

Answer 1

1. Th e answer is C [see IV.A.1.a; IV.A.3.d].
   Glucose, urea, and sucrose are nonelectrolytes. Sodium
   chloride is a strong electrolyte. Electrolytes are
   substances that form ions when dissolved in water.
   Thus, they can conduct an electric current through the
   solution. Ions are particles that bear electrical charges:
   Cations are positively charged, and anions are negatively
   charged. Strong electrolytes are completely ionized
   in water at all concentrations. Weak electrolytes
   (e.g., ephedrine) are only partially ionized at most concentrations.
   Because nonelectrolytes do not form ions
   when in solution, they are nonconductors.

Question 2

2. The pH value is calculated mathematically as the
   (A) log of the hydroxyl ion (OH) concentration.
   (B) negative log of the OH concentration.
   (C) log of the hydrogen ion (H
   ) concentration.
   (D) negative log of the H
   concentration.
   (E) ratio of H
   /OH concentration.

Answer 2

2. Th e answer is D [see IV.A.3.b].
   Th e pH is a measure of the acidity, or hydrogen ion
   concentration, of an aqueous solution. Th e pH is the
   logarithm of the reciprocal of the hydrogen ion (H
   )
   concentration expressed in moles per liter. Because the
   logarithm of a reciprocal equals the negative logarithm
   of the number, the pH is the negative logarithm of the
   H
   concentration. A pH of 7.0 indicates neutrality. As
   the pH decreases, the acidity increases. Th e pH of arterial
   blood is 7.35 to 7.45; of urine, 4.8 to 7.5; of gastric
   juice, approximately 1.4; and of cerebrospinal fl uid,
   7.35 to 7.40. Th e concept of pH was introduced by
   Sörensen in the early 1900s. Alkalinity is the negative
   logarithm of [OH] and is inversely related to acidity.

Question 3

3. Which property is classified as colligative?
   (A) solubility of a solute
   (B) osmotic pressure
   (C) hydrogen ion (H
   ) concentration
   (D) dissociation of a solute
   (E) miscibility of the liquids

Answer 3

3. Th e answer is B [see IV.A.2.d].
   Osmotic pressure is an example of a colligative property.
   Th e osmotic pressure is the magnitude of pressure
   needed to stop osmosis across a semipermeable
   membrane between a solution and a pure solvent. Th e
   colligative properties of a solution depend on the total
   number of dissociated and undissociated solute particles.
   Th ese properties are independent of the size of
   the solute. Other colligative properties of solutes are
   reduction in the vapor pressure of the solution, elevation
   of its boiling point, and depression of its freezing
   point.

Question 4

4. Th e colligative properties of a solution are related
   to the
   (A) pH of the solution.
   (B) number of ions in the solution.
   (C) total number of solute particles in the solution.
   (D) number of un-ionized molecules in the solution.
   (E) pKa of the solution.

Answer 4

4. Th e answer is C [see IV.A.1.b].
   Th e colligative properties of a solution are related to
   the total number of solute particles that it contains.
   Examples of colligative properties are the osmotic
   pressure, lowering of the vapor pressure, elevation of
   the boiling point, and depression of the freezing or
   melting point

Question 5

5. Th e pH of a buff er system can be calculated with the
   (A) Noyes–Whitney equation.
   (B) Henderson–Hasselbalch equation.
   (C) Michaelis–Menten equation.
   (D) Young equation.
   (E) Stokes equation

Answer 5

5. Th e answer is B [see IV.A.3.e].
   Th e Henderson–Hasselbalch equation for a weak acid
   and its salt is as follows:
   pH pKa
   log _ [[ascaildt]]
   where pKa is the negative log of the dissociation constant
   of a weak acid and [salt]/[acid] is the ratio of the
   molar

Question 6

6. Which mechanism is most oft en responsible for
   chemical degradation?
   (A) racemization
   (B) photolysis
   (C) hydrolysis
   (D) decarboxylation
   (E) oxidation

Answer 6

6. Th e answer is C [see V.D.1].
   Although all of the mechanisms listed can be responsible,
   the chemical degradation of medicinal compounds,
   particularly esters in liquid formulations, is
   usually caused by hydrolysis. For this reason, drugs
   that have ester functional groups are formulated in dry
   form whenever possible. Oxidation is another common
   mode of degradation and is minimized by including
   antioxidants (e.g., ascorbic acid) in drug formulations.
   Photolysis is reduced by packaging susceptible products
   in amber or opaque containers. Decarboxylation,
   which is the removal of COOH groups, aff ects compounds
   that include carboxylic acid. Racemization
   neutralizes the eff ects of an optically active compound
   by converting half of its molecules into their mirrorimage
   confi guration. As a result, the dextrorotatory
   and levorotatory forms cancel each other out. Th is type
   of degradation aff ects only drugs that are characterized
   by optical isomerism.

Question 7

7. Which equation is used to predict the stability of a
   drug product at room temperature from experiments
   at accelerated temperatures?
   (A) Stokes equation
   (B) Young equation
   (C) Arrhenius equation
   (D) Michaelis–Menten equation
   (E) Hixson–Crowell equation

Answer 7

7. Th e answer is C [see V.E.3.d].
   Testing of a drug formulation to determine its shelf life
   can be accelerated by applying the Arrhenius equation
   to data obtained at higher temperatures. Th e method
   involves determining the rate constant (k) values for
   the degradation of a drug at various elevated temperatures.
   Th e log of k is plotted against the reciprocal of
   the absolute temperature, and the k value for degradation
   at room temperature is obtained by extrapolation.

Question 8

8. Based on the relation between the degree of ionization
   and the solubility of a weak acid, the drug aspirin
   (pKa 3.49) will be most soluble at
   (A) pH 1.0.
   (B) pH 2.0.
   (C) pH 3.0.
   (D) pH 4.0.
   (E) pH 6.0.

Answer 8

8. Th e answer is E [see IV.A.3.g].
   Th e solubility of a weak acid varies as a function of pH.
   Because pH and pKa (the dissociation constant) are
   related, solubility is also related to the degree of ionization.
   Aspirin is a weak acid that is completely ionized
   at a pH that is two units greater than its pKa. Th erefore,
   it is most soluble at pH 6.0.

Question 9

9. Which solution is used as an astringent?
   (A) strong iodine solution USP
   (B) aluminum acetate topical solution USP
   (C) acetic acid NF
   (D) aromatic ammonia spirit USP
   (E) benzalkonium chloride solution NF

Answer 9

Th e answer is B [see VI.B.7].
Aluminum acetate and aluminum subacetate solutions
are astringents that are used as antiperspirants and
as wet dressings for contact dermatitis. Strong iodine
solution and benzalkonium chloride are topical antibacterial
solutions. Acetic acid is added to products as
an acidifi er. Aromatic ammonia spirit is a respiratory
stimulan

Question 10

10. Th e particle size of the dispersed solid in a suspension
    is usually greater than
    (A) 0.5 microm.
    (B) 0.4 microm.
    (C) 0.3 microm.
    (D) 0.2 microm..
    (E) 0.1 microm.

Answer 10

10. Th e answer is A [see IV.B.1.a].
    A suspension is a two-phase system that consists of a
    fi nely powdered solid dispersed in a liquid vehicle. Th e
    particle size of the suspended solid should be as small
    as possible to minimize sedimentation, but it is usually
    0.5 microm.

Question 11

11. In the extemporaneous preparation of a suspension,
    levigation is used to
    (A) reduce the zeta potential.
    (B) avoid bacterial growth.
    (C) reduce particle size.
    (D) enhance viscosity.
    (E) reduce viscosity.

Answer 11

11. Th e answer is C [see VI.E.3.a].
    Levigation is the process of blending and grinding a
    substance to separate the particles, reduce their size,
    and form a paste. Levigation is performed by adding
    a small amount of suitable levigating agent (e.g.,
    glycerin) to the solid and blending the mixture with a
    mortar and pestle.

Question 12

12. Which compound is a natural emulsifying agent?
    (A) acacia
    (B) lactose
    (C) polysorbate 20
    (D) polysorbate 80
    (E) sorbitan monopalmitate

Answer 12

12. Th e answer is A [see VI.D.3].
    Acacia, or gum arabic, is the exudate obtained from
    the stems and branches of various species of Acacia, a
    woody plant native to Africa. Acacia is a natural emulsifying
    agent that provides a stable emulsion of low
    viscosity. Emulsions are droplets of one or more immiscible
    liquids dispersed in another liquid. Emulsions are
    inherently unstable: Th e droplets tend to coalesce into
    larger and larger drops. Th e purpose of an emulsifying
    agent is to keep the droplets dispersed and prevent
    them from coalescing. Polysorbate 20, polysorbate 80,
    and sorbitan monopalmitate are also emulsifi ers, but
    are synthetic, not natural, substances.

Question 13

13. Vanishing cream is an ointment that may be
    classifi ed as
    (A) a water-soluble base.
    (B) an oleaginous base.
    (C) an absorption base.
    (D) an emulsion base.
    (E) an oleic base.

Answer 13

13. Th e answer is D [see VI.E.2].
    Ointments are typically used as emollients to soft en
    the skin, as protective barriers, or as vehicles for
    medication. A variety of ointment bases are available.
    Vanishing cream, an emulsion type of ointment base, is
    an oil-in-water emulsion that contains a high percentage
    of water. Stearic acid is used to create a thin fi lm on
    the skin when the water evaporates.

Question 14

14. Rectal suppositories intended for adult use usually
    weigh approximately
    (A) 1 g.
    (B) 2 g.
    (C) 3 g.
    (D) 4 g.
    (E) 5 g

Answer 14

14. Th e answer is B [see VI.F.2.a].
    By convention, a rectal suppository for an adult weighs
    approximately 2 g. Suppositories for infants and children
    are smaller. Vaginal suppositories typically weigh
    approximately 5 g. Rectal suppositories are usually
    shaped like an elongated bullet (cylindrical and tapered
    at one end). Vaginal suppositories are usually ovoid.

Question 15

15. In the fusion method of making cocoa butter
    suppositories, which substance is most likely to be
    used to lubricate the mold?
    (A) mineral oil
    (B) propylene glycol
    (C) cetyl alcohol
    (D) stearic acid
    (E) magnesium silicate

Answer 15

15Th e answer is A [see VI.F.4.c].
In the fusion method of making suppositories, molds
made of aluminum, brass, or nickel–copper alloys are
used. Finely powdered drug mixed with melted cocoa
butter is poured into a mold that is lubricated very
lightly with mineral oil.

Question 16

16. A very fi ne powdered chemical is defi ned as one that
    (A) completely passes through a #80 sieve.
    (B) completely passes through a #120 sieve.
    (C) completely passes through a #20 sieve.
    (D) passes through a #60 sieve and not more than
    40% through a #100 sieve.
    (E) passes through a #40 sieve and not more than
    60% through a #60 sieve.

Answer 16

16. Th e answer is B [see VI.G; Table 2-8].
    Th e USP defi nes a very fi ne chemical powder as one
    that completely passes through a standard #120 sieve,
    which has 125-m openings. Th e USP classifi cation
    for powdered vegetable and animal drugs diff ers from
    that for powdered chemicals. To be classifi ed as very
    fi ne, powdered vegetable and animal drugs must pass
    completely through a #80 sieve, which has 180-m
    openings.

Question 17

17. Which technique is typically used to mill camphor?
    (A) trituration
    (B) levigation
    (C) pulverization by intervention
    (D) geometric dilution
    (E) attrition

Answer 17

17 Th e answer is C [see VI.G.1.c.(3.(b)].
Pulverization by intervention is the milling technique
that is used for drug substances that are gummy and
tend to reagglomerate or resist grinding (e.g., camphor,
iodine). In this sense, intervention is the addition of
a small amount of material that aids milling and can
be removed easily aft er pulverization is complete. For
example, camphor can be reduced readily if a small
amount of volatile solvent (e.g., alcohol) i

Question 18

18. The dispensing pharmacist usually blends potent
    powders with a large amount of diluent by
    (A) spatulation.
    (B) sift ing.
    (C) trituration.
    (D) geometric dilution.
    (E) levigation.

Answer 18

18. Th e answer is D [see VI.G.2.c].
    Th e pharmacist uses geometric dilution to mix potent
    substances with a large amount of diluent. Th e potent
    drug and an equal amount of diluent are fi rst mixed
    in a mortar by trituration. A volume of diluent equal
    to the mixture in the mortar is added, and the mix is
    again triturated. Th e procedure is repeated, and each
    time, diluent equal in volume to the mixture then in the
    mortar is added, until all of the diluent is incorporated.

Question 19

19. Which type of paper best protects a divided
    hygroscopic powder?
    (A) waxed paper
    (B) glassine
    (C) white bond
    (D) blue bond
    (E) vegetable parchment

Answer 19

19. Th e answer is A [see VI.G.3.b.(4)].
    Hygroscopic and volatile drugs are best protected by
    waxed paper, which is waterproof. Th e packet may be
    double-wrapped with a bond paper to improve the
    appearance of the completed powder.

Question 20

20. Which capsule size has the smallest capacity?
    (A) 5
    (B) 4
    (C) 1
    (D) 0
    (E) 000

Answer 20

20. Th e answer is A [see VI.H.2.c.(1)].
    Hard capsules are numbered from 000 (largest) to 5
    (smallest). Th eir approximate capacity ranges from 600
    to 30 mg; however, the capacity of the capsule depends
    on the density of the contents.

Question 21

21. Th e shells of soft gelatin capsules may be made elastic
    or plastic-like by the addition of
    (A) sorbitol.
    (B) povidone.
    (C) polyethylene glycol (PEG).
    (D) lactose.
    (E) hydroxypropyl methylcellulose.

Answer 21

21. Th e answer is A [see VI.H.3.a–b].
    Th e shells of soft gelatin capsules are plasticized by
    the addition of a polyhydric alcohol (polyol), such as
    glycerin or sorbitol. An antifungal preservative can
    also be added. Both hard and soft gelatin capsules can
    be fi lled with a powder or another dry substance. Soft
    gelatin capsules are also useful dosage forms for fl uids
    or semisolids.

Question 22

22. Th e United States Pharmacopeia (USP) content
    uniformity test for tablets is used to ensure which
    quality?
    (A) bioequivalency
    (B) dissolution
    (C) potency
    (D) purity
    (E) toxicity

Answer 22

22. Th e answer is C [see VI.H.4.a].
    A content uniformity test is a test of potency. To ensure
    that each tablet or capsule contains the intended
    amount of drug substance, the USP provides two tests:
    weight variation and content uniformity. Th e content
    uniformity test can be used for any dosage unit but is
    required for coated tablets, for tablets in which the active
    ingredient makes up 50% of the tablet, for suspensions
    in single-unit containers or in soft capsules,
    and for many solids that contain added substances. Th e
    weight variation test can be used for liquid-fi lled soft
    capsules, for any dosage form unit that contains at least
    50 mg of a single drug if the drug makes up at least
    50% of the bulk, for solids that do not contain added
    substances, and for freeze-dried solutions

Question 23

23. All of the following statements about chemical
    degradation are true except
    (A) as temperature increases, degradation decreases.
    (B) most drugs degrade by a fi rst-order process.
    (C) chemical degradation may produce a toxic
    product.
    (D) chemical degradation may result in a loss of
    active ingredients.
    (E) chemical degradation may aff ect the therapeutic
    activity of a drug.

Answer 23

23. Th e answer is A [see V.A and V.B].
    Th e reaction velocity, or degradation rate, of a pharmaceutical
    product is aff ected by several factors, including
    temperature, solvents, and light. Th e degradation rate
    increases two to three times with each 10°C increase in
    temperature. Th e eff ect of temperature on reaction rate
    is given by the Arrhenius equation:
    k AeEa/RT
    where k is the reaction rate constant, A is the frequency
    factor, Ea is the energy of activation, R is the gas constant,
    and T is the absolute temperature.

Question 24

24. All of the following statements concerning zero-order
    degradation are true except
    (A) its rate is independent of the concentration.
    (B) a plot of concentration versus time yields a
    straight line on rectilinear paper.
    (C) its half-life is a changing parameter.
    (D) its concentration remains unchanged with respect
    to time.
    (E) the slope of a plot of concentration versus time
    yields a rate constant.

Answer 24

24. Th e answer is D [see V.B.2.a].
    In zero-order degradation, the concentration of a drug
    decreases over time. However, the change of concentration
    with respect to time is unchanged. In the equation
    ddCt k
    the fact that dC/dt is negative signifi es that the concentration
    is decreasing. However, the velocity of the
    concentration change is constant.

Question 25

25. All of the following statements about fi rst-order
    degradation are true except
    (A) its rate is dependent on the concentration.
    (B) its half-life is a changing parameter.
    (C) a plot of the logarithm of concentration versus
    time yields a straight line.
    (D) its t90% is independent of the concentration.
    (E) a plot of the logarithm of concentration versus
    time allows the rate constant to be determined

Answer 25

25. Th e answer is B [see V.B.2.b.(2)].
    Th e half-life (t½) is the time required for the concentration
    of a drug to decrease by one-half. For a fi rst-order
    degradation:
    t½ 0.6k9 3
    Because both k and 0.693 are constants, t½ is a constant.

Question 26

26. A satisfactory suppository base must meet all of the
    following criteria except
    (A) it should have a narrow melting range.
    (B) it should be nonirritating and nonsensitizing.
    (C) it should dissolve or disintegrate rapidly in the
    body cavity.
    (D) it should melt 30°C.
    (E) it should be inert.

Answer 26

26. Th e answer is D [see VI.F.3].
    A satisfactory suppository base should remain fi rm
    at room temperature. Preferably, it should not melt
    30°C to avoid premature soft ening during storage
    and insertion. It should also be inert, nonsensitizing,
    nonirritating, and compatible with a variety of drugs.
    Moreover, it should melt just below body temperature
    and should dissolve or disintegrate rapidly in the fl uid
    of the body cavity into which it is inserted.

Question 27

27. Cocoa butter (theobroma oil) exhibits all of the
    following properties except
    (A) it melts at temperatures between 33°C and 35°C.
    (B) it is a mixture of glycerides.
    (C) it is a polymorph.
    (D) it is useful in formulati

Answer 27

27. Th e answer is E [see VI.F.3.c.(1)].
    Cocoa butter is a fat that is obtained from the seed of
    Th eobroma cacao. Chemically, it is a mixture of stearin,
    palmitin, and other glycerides that are insoluble
    in water and freely soluble in ether and chloroform.
    Depending on the fusion temperature, cocoa butter
    can crystallize into any one of four crystal forms.
    Cocoa butter is a good base for rectal suppositories,
    although it is less than ideal for vaginal or urethral
    suppositories.

Question 28

28. United States Pharmacopeia (USP) tests to ensure the
    quality of drug products in tablet form include all of
    the following except
    (A) disintegration.
    (B) dissolution.
    (C) hardness and friability.
    (D) content uniformity.
    (E) weight variation.

Answer 28

28. Th e answer is C [see VI.I.5].
    To satisfy the USP standards, tablets are required to
    pass one of two tests. A weight variation test is used if
    the active ingredient makes up the bulk of the tablet.
    A content uniformity test is used if the tablet is coated
    or if the active ingredient makes up 50% of the
    bulk of the tablet. Many tablets for oral administration
    are required to meet a disintegration test. Disintegration
    times are specifi ed in the individual monographs.
    A dissolution test may be required instead if the active
    component of the tablet has limited water solubility.
    Hardness and friability would aff ect the disintegration
    and dissolution rates, but hardness and friability tests
    are in-house quality control tests, not offi cial USP tests.

Question 29

29. Forms of water that are suitable for use in parenteral
    preparations include
    I. purifi ed water USP.
    II. water for injection USP.
    III. sterile water for injection USP.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 29

29. Th e answer is D (II, III) [see VI.A.1].
    Water for injection USP is water that has been purifi
    ed by distillation or by reverse osmosis. Th is water is
    used to prepare parenteral solutions that are subject
    to fi nal sterilization. For parenteral solutions that are
    prepared aseptically and not subsequently sterilized,
    sterile water for injection USP is used. Sterile water for
    injection USP is water for injection USP that has been
    sterilized and suitably packaged. Th is water meets the
    USP requirements for sterility. Bacteriostatic water for
    injection USP is sterile water for injection USP that
    contains one or more antimicrobial agents. It can be
    used in parenteral solutions if the antimicrobial additives
    are compatible with the other ingredients in the
    solution, but it cannot be used in newborns. Purifi ed
    water USP is not used in parenteral preparations

Question 30

30. The particles in an ideal suspension should satisfy
    which of the following criteria?
    I. Their size should be uniform.
    II. They should be stationary or move randomly.
    III. They should remain discrete

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 30

30. Th e answer is E (I, II, III) [see IV.B.2].
    An ideal suspension would have particles of uniform
    size, minimal sedimentation, and no interaction between
    particles. Although these ideal criteria are rarely
    met, they can be approximated by keeping the particle
    size as small as possible, the densities of the solid and
    the dispersion medium as similar as possible, and the
    dispersion medium as viscous as possible.

Question 31

31. The sedimentation of particles in a suspension can be
    minimized by
    I. adding sodium benzoate.
    II. increasing the viscosity of the suspension.
    III. reducing the particle size of the active
    ingredient.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 31

31. The answer is D (II, III) [see IV.B.2].
    As Stokes’s law indicates, the sedimentation rate of a
    suspension is slowed by reducing its density, reducing
    the size of the suspended particles, or increasing its
    viscosity by incorporating a thickening agent. Sodium
    benzoate is an antifungal agent and would not reduce
    the sedimentation rate of a suspension

Question 32

32. Ingredients that may be used as suspending agents
    include
    I. methylcellulose.
    II. acacia.
    III. talc.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 32

32. Th e answer is C (I, II) [see VI.C.3].
    Acacia and methylcellulose are common suspending
    agents. Acacia is a natural product, and methylcellulose
    is a synthetic polymer. By increasing the viscosity
    of the liquid, these agents enable particles to remain
    suspended for a longer period.

Question 33

33. Mechanisms that are thought to provide stable
    emulsifi cations include the
    I. formation of interfacial fi lm.
    II. lowering of interfacial tension.
    III. presence of charge on the ions.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 33

33. Th e answer is E (I, II, III) [see VI.D.3].
    Emulsifying agents provide a mechanical barrier to
    coalescence. Th ey also reduce the natural tendency of
    the droplets in the internal phase (oil or water) of the
    emulsion to coalesce. Th ree mechanisms appear to be
    involved. Some emulsifi ers promote stability by form-
    ing strong, pliable interfacial fi lms around the droplets.
    Emulsifying agents also reduce interfacial tension.
    Finally, ions (from the emulsifi er) in the interfacial
    fi lm can lead to charge repulsion that causes droplets
    to repel one another, thereby preventing coalescence.

Question 34

34. Nonionic surface-active agents used as synthetic
    emulsifi ers include
    I. tragacanth.
    II. sodium lauryl sulfate.
    III. sorbitan esters (Spans).

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 34

34. Th e answer is B (III) [see VI.D.3].
    All of the substances listed are emulsifying agents,
    but only sorbitan esters are nonionic synthetic agents.
    Tragacanth, like acacia, is a natural emulsifying agent.
    Sodium lauryl sulfate is an anionic surfactant. Sorbitan
    esters (known colloquially as Spans because of their trade
    names) are hydrophobic and form water-in-oil emul-
    sions. Th e polysorbates (known colloquially as Tweens)
    are also nonionic, synthetic sorbitan derivatives. How-
    ever, they are hydrophilic and therefore form oil-in-water
    emulsions. Sodium lauryl sulfate, as alkali soap, is also
    hydrophilic and thus forms oil-in-water emulsions

Question 35

35. Advantages of systemic drug administration by rectal
    suppositories include
    I. avoidance of fi rst-pass eff ects.
    II. suitability when the oral route is not feasible.
    III. predictable drug release and absorption.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 35

35. The answer is C (I, II) [see VI.F.1–2].
    Rectal suppositories are useful for delivering systemic
    medication under certain circumstances. Absorption of
    a drug from a rectal suppository involves release of the
    drug from the suppository vehicle, diff usion through
    the rectal mucosa, and transport to the circulation
    through the rectal veins. Th e rectal veins bypass the
    liver, so this route avoids rapid hepatic degradation of
    certain drugs (fi rst-pass eff ect). Th e rectal route is also
    useful when a drug cannot be given orally (e.g., because
    of vomiting). However, the extent of drug release and
    absorption is variable. It depends on the properties of
    the drug, the suppository base, and the environment in
    the rectum

Question 36

36. True statements about the milling of powders include
    I. a fi ne particle size is essential if the lubricant is
    to function properly.
    II. an increased surface area may enhance the
    dissolution rate.
    III. milling may cause degradation of thermolabile
    drugs.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 36

36. Th e answer is E (I, II, III) [see VI.G.1.c].
    Milling is the process of mechanically reducing the
    particle size of solids before they are formulated into a
    fi nal product. To work eff ectively, a lubricant must coat
    the surface of the granulation or powder. Hence, fi ne
    particle size is essential. Decreasing the particle size
    increases the surface area and can enhance the dissolu-
    tion rate. Th ermolabile drugs may undergo degrada-
    tion because of the buildup of heat during milling.

Question 37

37. Substances used to insulate powder components that
    liquefy when mixed include
    I. talc.
    II. kaolin.
    III. light magnesium oxide.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 37

37. The answer is D (II, III) [see VI.G.2.a.(2)].
    Some solid substances (e.g., aspirin, phenylsalicylate,
    phenacetin, thymol, camphor) liquefy or form eutectic
    mixtures when in close, prolonged contact with one
    another. Th ese substances are best insulated by the
    addition of light magnesium oxide or magnesium
    carbonate. Other inert diluents that can be used are
    kaolin, starch, and bentonite.

Question 38

38. A ceramic mortar may be preferable to a glass
    mortarwhen
    I. a volatile oil is added to a powder mixture.
    II. colored substances (dyes) are mixed into a
    powder.
    III. comminution is desired in addition to mixing.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 38

38. Th e answer is B (III) [see VI.G.2.b].
    When powders are mixed, if comminution is especially
    important, a porcelain or ceramic mortar that has a
    rough inner surface is preferred over the smooth work-
    ing surface of a glass mortar. Because a glass mortar
    cleans more easily aft er use, it is preferred for chemi-
    cals that may stain a porcelain or ceramic mortar as
    well as for simple mixing of substances that do not
    require comminution.

Question 39

39. Divided powders may be dispensed in
    I. individual-dose packets.
    II. a bulk container.
    III. a perforated, sift er-type container.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 39

39. Th e answer is A (I) [see VI.G.3.a–b].
    Powders for oral use can be dispensed by the pharma-
    cist in bulk form or divided into premeasured doses
    (divided powders). Divided powders are traditionally
    dispensed in folded paper packets (chartulae) made
    of parchment, bond paper, glassine, or waxed paper.
    However, individual doses can be packaged in metal
    foil or small plastic bags if the powder needs greater
    protection from humidity or evaporation.

Question 40

40. True statements about the function of excipients used
    in tablet formulations include
    I. binders promote granulation during the wet
    granulation process.
    II. glidants help promote the fl ow of the tablet
    granulation during manufacture.
    III. lubricants help the patient swallow the tablets.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 40

40. Th e answer is C (I, II) [see VI.I.2.b].
    Tablets for oral ingestion usually contain excipients
    that are added to the formulation for their special
    functions. Binders and adhesives are added to promote
    granulation or compaction. Diluents are fi llers that are
    added to make up the required tablet bulk. Th ey can
    also aid in the manufacturing process. Disintegrants
    aid in tablet disintegration in gastrointestinal fl uids.
    Lubricants, antiadherents, and glidants aid in reduc-
    ing friction or adhesion between particles or between
    tablet and die. For example, lubricants are used in the
    manufacture of tablets to reduce friction when the tab-
    let is ejected from the die cavity. Lubricants are usually
    hydrophobic substances that can aff ect the dissolution
    rate of the active ingredient.

Question 41

41. Which manufacturing variables would be likely
    to aff ect the dissolution of a prednisone tablet in
    thebody?
    I. the amount and type of binder added
    II. the amount and type of disintegrant added
    III. the force of compression used during tableting

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 41

41. Th e answer is E (I, II, III) [see VI.2.b.(3)].
    Disintegrants are added to tablet formulations to facili-
    tate disintegration in gastrointestinal fl uids. Disintegra-
    tion of the tablet in the body is critical to its dissolution
    and subsequent absorption and bioavailability. Th e
    binder and the compression force used during tablet
    manufacturing aff ect the hardness of the tablet as well as
    tablet disintegration and drug dissolution.

Question 42

42. Agents that may be used to coat enteric-coated tablets
    include
    I. hydroxypropyl methylcellulose.
    II. carboxymethylcellulose.
    III. cellulose acetate phthalate.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II, and III are correct

Answer 42

42. Th e answer is B (III) [see VI.I.3.a.(4)].
    An enteric-coated tablet has a coating that remains
    intact in the stomach, but dissolves in the intestines
    to yield the tablet ingredients there. Enteric coatings
    include various fats, fatty acids, waxes, and shellacs.
    Cellulose acetate phthalate remains intact in the
    stomach because it dissolves only when the pH
43. Other enteric-coating materials include povidone
    (polyvinylpyrrolidone), polyvinyl acetate phthalate,
    and hydroxypropyl methylcellulose phthalate.

Question 43

Directions for questions 43–46: Each of the following
tablet-processing problems can be the result of one of
the following reasons. The processing problems may
be used more than once or not at all. Choose the best
answer, A–E.

43. Picking

A excessive moisture in the granulation
B entrapment of air
C tablet friability
D degraded drug
E tablet hardness

Answer 43

It occurs when particles from the formulation adhere to the punch cup, resulting in defective tablets. Picking is a specific type of sticking that refers to particles getting stuck in or around the logo/characters embossed on the punch face.

A excessive moisture in the granulation

Question 44

44. Mottling

A excessive moisture in the granulation
B entrapment of air
C tablet friability
D degraded drug
E tablet hardness

Answer 44

Mottling is the term used to describe an unequal distribution of color on a tablet, with light or dark spots standing out on an otherwise uniform surface. This type of tablet defect occurs in tablet formulation with a dry coloring agent

D degraded drug

Question 45

45. Capping

A excessive moisture in the granulation
B entrapment of air
C tablet friability
D degraded drug
E tablet hardness

Answer 45

Capping can be either formulation- or process-driven. In the formulation, there can be issues with interparticle bonding, too little moisture, or too many fines in the segregation.

B entrapment of air

Question 46

46. Sticking

A excessive moisture in the granulation
B entrapment of air
C tablet friability
D degraded drug
E tablet hardness

Answer 46

Sticking is one of the most common problems tablet manufacturers encounter. Sticking describes the buildup of granules on the punch-tip face, which can be caused by several factors, including the formulation’s physicochemical properties and the surface characteristics of the punch face.

46. The answer is A [see VI.I.4].
    Sticking is adhesion of tablet material to a die wall.
    It may be caused by excessive moisture or by the use
    of ingredients that have low melting temperatures.
    Mottling is uneven color distribution. It is most oft en
    caused by poor mixing of the tablet granulation but
    may also occur when a degraded drug produces a col-
    ored metabolite. Capping is separation of the top or
    bottom crown of a tablet from the main body. Capping
    implies that compressed powder is not cohesive.
    Reasons for capping include excessive force of com-
    pression, use of insuffi cient binder, worn tablet tooling
    equipment, and entrapment of air during processing.
    Picking is adherence of tablet surface material to a
    punch. It can be caused by a granulation that is too
    damp, by a scratched punch, by static charges on the
    powder, and particularly by the use of a punch tip that
    is engraved or embossed.

Question 47

Directions for questions 47–49: Each of the following
processes can be described by one of the following
comminution procedures. Th e processes may be used more
than once or not at all. Choose the best answer, A–E.

47. Rubbing or grinding a substance in a mortar that has a
    rough inner surface

A trituration
B spatulation
C levigation
D pulverization by intervention
E tumbling

Answer 47

A trituration

Question 48

48. Reducing and subdividing a substance by adding an
    easily removed solvent

A trituration
B spatulation
C levigation
D pulverization by intervention
E tumbling

Answer 48

D pulverization by intervention

Question 49

49. Adding a suitable agent to form a paste and then
    rubbing or grinding the paste in a mortar

A trituration
B spatulation
C levigation
D pulverization by intervention
E tumbling

Answer 49

49. The answer is C [see VI.G.1.c; VI.G.2].
    Comminution is the process of reducing the par-
    ticle size of a powder to increase its fi neness. Several
    comminution techniques are suitable for small-scale
    use in a pharmacy. Trituration is used both to com-
    minute and to mix dry powders. If comminution is
    desired, the substance is rubbed in a mortar that has
    a rough inner surface. Pulverization by intervention
    is oft en used for substances that tend to agglomerate
    or resist grinding. A small amount of easily removed
    (e.g., volatile) solvent is added. Aft er the substance is
    pulverized, the solvent is allowed to evaporate or is
    otherwise removed. Levigation is oft en used to prepare
    pastes or ointments. Th e powder is reduced by adding
    a suitable nonsolvent (levigating agent) to form a paste
    and then either rubbing the paste in a mortar with a
    pestle or rubbing it on an ointment slab with a spatula.
    Spatulation and tumbling are techniques that are used
    to mix or blend powders, not to reduce them. Spatula-
    tion is blending small amounts of powders by stirring
    them with a spatula on a sheet of paper or a pill tile.
    Tumbling is blending large amounts of powder in a
    large rotating container

Question 50

Directions for questions 50–53: Each of the following
controlled-release dosage forms is represented by one
of the following drug products. Th e dosage forms may
be used more than once or not at all. Choose the best
answer,A–E.
A matrix formulations
B ion-exchange resin complex
C drug complexes
D osmotic system
E coated beads or granules

50. Ionamin capsules

Answer 50

B ion-exchange resin complex

Question 51

51. Thorazine Spansule capsules

A matrix formulations
B ion-exchange resin complex
C drug complexes
D osmotic system
E coated beads or granules

Answer 51

E coated beads or granules

Question 52

52. Rynatan pediatric suspension

A matrix formulations
B ion-exchange resin complex
C drug complexes
D osmotic system
E coated beads or granules

Answer 52

C drug complexes

Question 53

53. Procardia XL

A matrix formulations
B ion-exchange resin complex
C drug complexes
D osmotic system
E coated beads or granules

Answer 53

53. The answer is D [see VI.K.3.d].
    Controlled-release dosage forms are designed to re-
    lease a drug slowly for prolonged action in the body.
    A variety of pharmaceutical mechanisms are used to
    provide the controlled release. Ion-exchange resins
    may be complexed to drugs by passing a cationic drug
    solution through a column that contains the resin.
    Th e drug is complexed to the resin by replacement of
    hydrogen atoms. Release of drug from the complex
    depends on the ionic environment within the gastroin-
    testinal tract and on the properties of the resin. Coated
    beads (e.g., Th orazine Spansule capsules) or granules
    produce blood levels similar to those obtained with
    multiple dosing. Th e various coating thicknesses pro-
    duce a sustained-release eff ect.
    Matrix devices may use insoluble plastics, hydrophilic
    polymers, or fatty compounds. Th ese components are
    mixed with the drug and compressed into a tablet. Th e
    primary dose, or the portion of the drug to be released
    immediately, is placed on the tablet as a layer or coat.
    Th e remainder of the dose is released slowly from the
    matrix. Relatively insoluble tannate–amine complexes
    provide for a prolonged gastrointestinal absorption
    phase and sustained systemic concentrations of the
    weak bases. Osmotic systems employ osmotic pressure
    to control the release of the active ingredient from the
    formulation. Osmotic tablet formulations provide a
    semipermeable membrane as a coating that surrounds
    the osmotically active core. Th e coating allows water
    to diff use into the core but does not allow drug to dif-
    fuse out. As water fl ows into the tablet, the drug dis-
    solves. Th e laser-drilled hole in the coating allows the
    drug solution within the tablet to fl ow to the outside at
    a rate that is equivalent to the rate of water fl ow into the
    tablet. Th e osmotic pressure gradient and a zero-order
    drug-release rate will be maintained as long as excess
    osmotically active solute (e.g., electrolyte) remains in
    the tablet core.