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EXAM 2 CEUTICS II DR. JAM PART 2 PPX

Total questions: 137

Worksheet time: 3hrs 28mins

Name
Class
Date
1.

Which of the following statements are TRUE about why Lubricants are incorporated in the formulations? Select all that apply

a)

Improve the flow of the granules

b)

Reduce adhesion of powder material (granules) to the punches and dies during the compression

c)

easy release of the compressed tablet from the mold or die.

d)

added to the formulation to increase the bulk of a tablet to a practical and convenient size.

2.

Substances that ameliorate the difficulties on manufacture of a compressed tablet are known as:

a)

Lubricants

b)

Binders

c)

Diluents

d)

All of them are correct

3.

Which of the following are TRUE about Lubricants?

a)

inadequate lubricant is evidenced by screeching sound and scratch marks on the edge of a tablet

b)

agents that act between surfaces in relative motions to prevent friction and wear.

c)

help granules to slip and slide to form a compact in the die wall of a tablet press.

d)

materials that improve the flow characteristics of the granules.

4.

Which of the following are TRUE about Glidants?

a)

When used in right amount, glidants serve to assure smooth and uniform flow of granules.

b)

materials that improve the flow characteristics of the granules.

c)

act by reducing   the inter-particulate friction.

d)

agents that act between surfaces in relative motions to prevent friction and wear.

5.

Which of the following function to prevent tablet granules from sticking to faces of punches and die wall ?

a)

Lubricants

b)

Anti-adherents

c)

Glidants

d)

Binders

6.

The Phenomenon of picking Tablet defect means too much moisture; inadequate

anti-adherent; insufficient compressibility.

a)

True

b)

False

7.

Surface materials of the tablet stick to the punch and get removed from the tablet surface.

a)

Picking

b)

Glidant

c)

Lubricant

d)

Binder

8.

Which of following Lubricants can I use if I want it to be an excellent lubricant but poor anti-adherent or glidant?

a)

Magnesium stearate (< 1% w/w)

b)

Corn Starch 5 to 10%

c)

Talc (1 to 5%)

d)

All of them are correct

9.

Which of the following Lubricants may retard drug dissolution If used in greater than 1% concentration?

a)

Magnesium stearate (< 1% w/w)

b)

Corn Starch

c)

Talc (1 to 5%)

d)

Stearic acid (1 to 5%)

10.

Which of following Lubricants can I use if I want an excellent glidant and anti-adherent but is a poor lubricant? 

a)

Stearic acid (1 to 5%)

b)

Magnesium stearate (< 1% w/w)

c)

Corn Starch

  in 5 to 10%

d)

All of them are correct

11.

Which of following Lubricants can I use if I want a good lubricant property; however, it is a poor anti-adherent and lacks glidant property?

a)

Stearic acid (1 to 5%)

b)

Corn Starch 5 to 10%

c)

Magnesium stearate (< 1% w/w)

d)

Carbowax 4000

12.

Carbowax 4000, carbowax 8000, and sodium lauryl sulfate (effective in 1 to 5% concentration).

a)

True

b)

False

13.

In general lubricants, whether water soluble or insoluble, should be of thick particle size.

a)

True

b)

False

14.

In general lubricants, whether water soluble or insoluble, should be of very fine particle size.

a)

True

b)

False

15.

Lubricants function by forming a thin film around the granules.

a)

True

b)

False

16.

Which of the following is TRUE about the Effectiveness of Lubricants?

a)

is related to true density and specific surface

b)

is related to bulk density and specific surface

c)

is related to the particle size only

d)

is related to the particle size and specific surface

17.

Which of the following will facilitate tablet breakup following its administration?

a)

Lubricant

b)

Disintegrant

c)

Binder

d)

Glidant

18.

Rapid disintegration is likely to result in rapid drug dissolution; though it is not an absolute guarantee.

a)

True

b)

False

19.

In the Tablet disintegration process, Aqueous fluid will enter tablet through the capillary structure; swelling of disintegrating agent will build the pressure inside the tablet.

a)

True

b)

False

20.

Which of the following is more critical and vital for rapid and complete drug absorption to occur?

a)

rapid and complete dissolution

b)

rapid disintegration alone

21.

Which of the following is TRUE about the Disintegrating agent?

a)

may be added prior to granulation or during the lubrication step prior to the compression or at both steps

b)

may be added after granulation or before the lubrication step after to the compression only

22.

The effectiveness of many disintegrants is affected by their position (inter granular or extra-granular) within the tablet.

a)

True

b)

False

23.

Which of the following suggests the presence of disintegrant inside or within the granules?

a)

Inter-granular

b)

Intra-granular

24.

Which of the following suggests the presence of disintegrating agent between the granules?

a)

Inter-granular

b)

Intra-granular

25.

What is the mode of action of commonly used Disintegrant?

a)

the water uptake through the pores of tablets, due capillary action, resulting in tablet expansion followed by disintegration.

b)

prevent tablet granules from sticking to faces of punches and die wall 

c)

agents that act between surfaces in relative motions to prevent friction and wear.

d)

materials that improve the flow characteristics of the granules.

26.

PrimojelR or Explotab are examples of which of the following?

a)

Lubricants

b)

Disintegrants

c)

Binders

d)

Anti-adherents

27.

We can say Low substituted carboxymethyl starch is used in about 1 to 8% (optimum is 4%) concentration as a Disintegrant.

a)

True

b)

False

28.

Which of the following are considered Pre-gelatinized starch (Disintegrants)? Select all that apply

a)

Alginates

b)

Cross-linked PVP

c)

Microcrystalline cellulose (Avicel)

d)

Veegum HV

29.

Which of the following statements are TRUE about Colorants? Select all that apply

a)

incorporated into tablet for aesthetic and/or marketing value

b)

incorporated into tablet for identifying different products

c)

incorporated into tablet for identifying different strengths of the same product (examples, Warfarin, levothyroxine, and digoxin)

d)

incorporated into tablet to minimize the possible mix-up during manufacturing

30.

Any of the water soluble dyes, mixture of the dyes and their corresponding lakes may be used as colorants for tablets.

a)

True

b)

False

31.

Aluminum hydroxide is an insoluble form of the dye.

a)

True

b)

False

32.

Dyes are water soluble while lakes, which are formed by the adsorption of water-soluble dye on a hydrous oxide.

a)

True

b)

False

33.

Dyes and lakes are photosensitive, and their photosensitivity is affected by the drug, excipient and the method of manufacture.

a)

True

b)

False

34.

Which of the following statements are TRUE about Dyes? Select all that apply

a)

aluminum hydroxide is an insoluble form of the dye.

b)

aluminum hydroxide is a soluble form of the dye.

c)

Dyes are water soluble while lakes, which are formed by the adsorption of water-soluble dye on a hydrous oxide

d)

Dyes and lakes are photosensitive, and their photosensitivity is affected by the drug, excipient and the method of manufacture

35.

Pastel shades generally show least amount of mottling (an uneven distribution of color yielding darker spots of the color on a tablet).

a)

True

b)

False

36.

Yellow and green color (midrange of visible spectrum) will show less mottling compared to blue and red.

a)

True

b)

False

37.

The problems of mottling becomes more pronounced when the concentration increases.

a)

True

b)

False

38.

The problems of mottling becomes more pronounced when the concentration decreases.

a)

True

b)

False

39.

Which of the following parameters are related to the Mottling Phenomenon? Select all that apply

a)

concentration of the dye

b)

type of coloring agent

c)

slow vs. rapid drying of granules

d)

None of them are relevant

40.

The Migration of the coloring agent from inside of a granule to the surface of a granule is during the drying process.

a)

True

b)

False

41.

Drying granules slowly at low temperature and with continuous stirring can reduce migration of the color to the surface and reduce mottling.

a)

True

b)

False

42.

Drying granules slowly at High temperature and with continuous stirring can reduce migration of the color to the surface and reduce mottling.

a)

True

b)

False

43.

Which of the following are the commonly employed colorants? Select all that apply

a)

FD&C green # 3

b)

FD & C # 40

  ,

 

 

c)

FD&C # 5 and # 6

d)

FD&C blue # 1 and # 2

44.

Coloring agents are used in very small concentrations (0.05 to 0.1%)

a)

True

b)

False

45.

Coloring agents are used in very large concentrations (5 to 10%).

a)

True

b)

False

46.

Coloring agents are generally mixed with which of the following binding agent solutions? Select all that apply

a)

acacia

b)

Celullose

c)

tragacanth

d)

gelatin

47.

It is much easier to incorporate coloring agent as a solution than as a powder.

a)

True

b)

False

48.

It is much easier to incorporate coloring agent as a powder than as a solution.

a)

True

b)

False

49.

Lakes, on the other hand, are blended with dry excipients because of their insoluble nature.

a)

True

b)

False

50.

When we talk about Tablet Capping (defect) problem, we are talking about which of the following? Select all that apply

a)

High powder porosity

b)

poor compressibility

c)

inadequate binding agent

d)

compressional force

51.

Which of the following methods are used to prepare tablets? Select all that apply

a)

Wet granulation

 

 

b)

Dry granulation

c)

Direct compression

d)

Wet granulation only

52.

Which of the following are considered the powder properties? Select all that apply

a)

hydrophobicity

b)

compressibility

c)

size and size distribution

d)

true and bulk densities

e)

flow

53.

The choice of method of Tablet Preparation depends upon the following factors: Select all that apply

a)

Available equipment

b)

The powder properties

c)

qDose of a drug (small or large dose)

d)

Practical and regulatory concerns

54.

In Wet Granulation, Powdered drug is mixed with which of the following? Select all that apply

a)

binding agent (solution)

b)

colorant

c)

diluents

d)

disintegrant

55.

In Wet Granulation, Wet powder mixture is passed through a sieve of what sizes? Select all that apply

a)

# mesh 20

b)

# mesh 40

c)

# mesh 100

d)

# mesh 80

56.

Which of the following statements are TRUE about Wet Granulation? Select all that apply

a)

Wet powder mixture is passed through a sieve (# mesh 80 or 100) and granules are prepared

b)

Powdered drug is mixed with diluents, disintegrant, colorant, and binding agent (solution).

c)

Wet powder mixture is passed through a sieve (# mesh 20 or 40) and granules are prepared

d)

Granules are dried, mixed with lubricant, and compressed into tablets

57.

Each granule contains drug, binding agent, diluent, Coloring agent, and other excipient.

a)

True

b)

False

58.

Which of the following are TRUE about Advantages of Wet Granulation ? Select all that apply

a)

Provides good cohesiveness and compressibility to the powder mixture due to addition of liquid binder

b)

Uniform drug distribution in granules makes it a ideal method for low dose drugs

c)

Minimum segregation of the powders in the mixture

d)

Cost is the greatest (HIGH)

59.

Which of the following are TRUE about Limitations of Wet Granulation ? Select all that apply

a)

Heat sensitive drugs may be difficult to formulate

b)

Cost is the greatest (HIGH)

c)

Moisture sensitive drugs may require use of non-aqueous binder solution

d)

Migration of water-soluble dyes may cause unequal distribution of color

60.

In Direct Compression, the powder blend of active ingredient and excipients is compressed into a tablet.

a)

True

b)

False

61.

Which of the following are TRUE about the steps in Direct Compression? Select all that apply

a)

Compressing the mixture into tablets.

b)

Availability of specialized excipients has made this method readily available in recent times.

c)

Milling (reducing the particle size) of a drug and excipients to approximately same size.

d)

Mixing of a drug and other excipients.

62.

If I'm looking for an economical and suitable method for heat and moisture sensitive drugs, Direct Compression is an option.

a)

True

b)

False

63.

Direct Compression is not ideal for low dose drugs and antacid drugs due to high dose, high bulk volume (i.e., low bulk density), poor compressibility, and poor flow present difficulty in direct compression.

a)

True

b)

False

64.

Which of the following tests are performed by the manufactures to evaluate tablets? Select all that apply

a)

Weight variation (USP/NF)

b)

Drug content uniformity (USP/NF)

c)

Drug dissolution (USP/NF Apparatus)

d)

Tablet disintegration and Tablet Hardness

e)

Friability (resistance to abrasion)

65.

How many tablets are weighted individually in the Weight Variation Test?

a)

20

b)

40

c)

60

d)

100

66.

Which of the following are TRUE statements about the Weight Variation Test? Select all that apply

a)

Determine the mean weight and Std. Dev (mean weight (mg) ± S.D)

b)

U.S.P and N.F. provide specifications with regards to how many test tablets may lie outside certain limits.

c)

Forty (40) tablets are weighed individually.

d)

Twenty (20) tablets are weighed individually.

67.

Understand this!

a)

Yes

b)

NO

68.

How many tablets are assayed individually for drug content in the Drug Content Uniformity test?

a)

Fifty (50) tablets

b)

Forty (40) tablets

c)

Twenty (20) tablets

d)

Ten (10) tablets

69.

Which of the following are TRUE statements about the Drug Content Uniformity test? Select all that apply

a)

is designed to establish drug homogeneity (homogenous distribution of drug) in tablets of each batch of a product.

b)

Ten (10) tablets are assayed individually for drug content

c)

Drug content in each tablet must be within 85 to 115 % of the labeled amount of the active ingredient (s).

d)

None of the tablets tested must be outside the limit of 75 to 125 % range.

e)

f the drug content of one (1) tablet is outside the 85 to 115% limit, additional 20 tablets are assayed individually, and all the additional samples must be within 85 to 115 % limit.

70.

Which test is designed to establish drug homogeneity (homogenous distribution of drug) in tablets of each batch of a product?

a)

Drug Content Uniformity

b)

Weight Variation

c)

Tablet Disintegration

d)

Dissolution

71.

Which of the following determines the time required for a tablet to disintegrate, when immersed in some test fluid; generally, simulated gastrointestinal fluid?

a)

Tablet Disintegration

b)

Drug Content Uniformity

72.

If a tablet disintegrates quickly, it is likely (not an assurance) that drug will dissolve quickly and absorb immediately.

a)

True

b)

False

73.

Understand this

a)

Yes

b)

No

74.

Disintegration test is performed as a quality control test for tablets intended to be administered orally including chewable tablets.

a)

True

b)

False

75.

Disintegration test is performed as a quality control test for tablets intended to be administered orally (exception is chewable tablet).

a)

True

b)

False

76.

Disintegration test may be far more important for ODT type tablets.

a)

True

b)

False

77.

The quicker and more complete the drug dissolution, the faster and more complete is likely to be the drug absorption.

a)

True

b)

False

78.

Which of the following is a process by which a solid drug dissolves in the surrounding fluid?

a)

Absorption

b)

Dissolution

c)

Bioavailability

d)

Compression

79.

The quicker and more complete the drug dissolution, the faster and more complete is likely to be the drug absorption.

a)

True

b)

False

80.

Which of the following are considered the USP dissolution apparatus methods? Select all that apply

a)

A,  Bounding method

b)

B, Paddle method

c)

A,  Basket method

d)

B, Pounder method

81.

The Tablet Hardness Test will help tablet must be sufficiently strong and resistant to abrasion to withstand handling during the manufacturing, packaging, and shipping, in addition to “physical abuse” in a pharmacy by staff and, at home, by the patient.

a)

True

b)

False

82.

Which test is performed by measuring the force required to fracture a tablet (measurement of the crushing strength of a tablet)?

a)

Friability Test (Resistance to abrasion)

b)

Tablet Hardness Test

83.

Which test measures the weight loss in tablets upon subjecting certain number of tablets to agitation under standard conditions for a specified time?

a)

Friability Test (Resistance to abrasion)

b)

Tablet Hardness Test

84.

Which of the following statements are TRUE about the Friability Test (Resistance to abrasion)? Select all that apply

a)

Place about 20 tablets of known weight

(Initial weight or W0) and rotate at a fixed

RPM for 10 minutes and re-weigh tablets (W)

b)

This test measures the weight loss in tablets upon subjecting certain number of tablets to agitation under standard conditions for a specified time.

c)

certain number of tablets are de-dusted and weighed (W0).

d)

tablets are subjected to well defined agitation in a close container of fixed geometry for a specific time and reweighed (W).

e)

test is performed by measuring the force required to fracture a tablet.

85.

In the Friability Test we must place 20 tablets of known initial weight or W0) and rotate at a fixed RPM for 10 minutes and re-weigh tablets (W).

a)

True

b)

False

86.

Resistance to the abrasion (B) is usually expressed as % loss in weight of (10) tablets.

a)

True

b)

False

87.

Which value is is frequently quoted as the upper limit for the acceptability of a product for the resistance to the abrasion (B)?

a)

2.0 to 2.8 %

b)

1.0 to 1.8 %

c)

0.8 to 1.0%

d)

0.8 to 1.8 %

88.

Which of these variables represent the index of abrasion to resistance?

a)

B

b)

W

c)

W0

d)

D

89.

Which of these variables represent the initial weight of ten tablets?

a)

W0

b)

W

90.

Which of these variables represent the final weight of ten tablets?

a)

W

b)

W0

91.

Which of the following statements are TRUE about Keppra (Levetiracetam)? Select all that apply

a)

It is the S-enantiomer of etiracetam

b)

administered orally and by  intravenous solution

c)

anticonvulsant medication used for the treatment of epilepsy

d)

sometimes used to treat neuropathic pain

e)

Available in 250, 500, 750, and

1000 mg tablets and solution

92.

Which of the following are the Physical Chemical

Properties of levetiracetam? Select all that apply

a)

Heat of vaporization (δHv)

b)

Melting point and pKa (Dissociation constant)

c)

Solubility (water and other solvents)

d)

Color and other characteristics

e)

Molecular weight (grams) and True density (g/cc)

93.

Levetiracetam is available in 250, 500, 750, and 1000 mg tablets and solution.

a)

True

b)

False

94.

Which of the following are the inactive ingredients of Levetiracetam? Select all that apply

a)

Sucrose

b)

Corn starch

c)

Colloidal silicon dioxide

d)

Hydroxy propyl methyl cellulose (HPMC)

95.

Which of the following are the inactive ingredients of Levetiracetam? Select all that apply

a)

Magnesium stearate

b)

Povidone

c)

talc

d)

Polyethylene glycol 4000

e)

Cellulose ether

96.

Which of the following are the inactive ingredients of Levetiracetam? Select all that apply

a)

Mannitol

b)

titanium dioxide

c)

coloring agent

d)

Cellulose ether

97.

 

Which of the following are the inactive ingredients of Levetiracetam? Select all that apply

a)

Colloidal silicon dioxide, Povidone, talc, titanium dioxide, and coloring agent.

b)

Corn starch

c)

Hydroxy propyl methyl cellulose (HPMC)

d)

Magnesium stearate

e)

Polyethylene glycol 4000

98.

Which of the following has very good absorbing agent, poor lubricant and excellent anti-adherent property?

a)

Talc

b)

Corn starch

99.

Which of the following Levetiracetam tablets have FD & C Blue # 2 and yellow iron oxide?

a)

250 mg tablets

b)

500 mg tablets

c)

750 mg tablets

d)

1000 mg tablets

100.

Which of the following Levetiracetam tablets have FD & C Blue # 2, FD & C yellow # 6, and red iron oxide?

a)

250 mg tablets

b)

500 mg tablets

c)

1000 mg tablets

d)

750 mg tablets

101.

The effectiveness of lubricants is related to particle size and specific surface.

a)

True

b)

False

102.

Which of the following Levetiracetam tablets have FD & C Blue # 2 only?

a)

250 mg tablets

b)

500 mg tablets

c)

750 mg tablets

d)

1000 mg tablets

103.

Are added to the formulation to increase the bulk of a tablet to a practical and convenient size.

a)

Diluents or Fillers

b)

Binders or Binding agents

104.

Diluents are very important for which of the following drugs? Select all that apply

a)

Digoxin

b)

Levothyroxine

c)

Metformin

d)

CaptoprilR 12.5 mg

105.

Which of the following are the commonly used Diluents? Select all that apply

a)

lactose

b)

spray dried lactose

c)

microcrystalline cellulose

d)

mannitol

e)

dry starch, and powdered sugar

106.

Which of the following Diluents are commonly used in chewable tablets? Select all that apply

a)

mannitol

b)

sucrose

c)

lactose

d)

sorbitol

107.

Diluents are essential to produce a tablet of a reasonable size.

a)

True

b)

False

108.

This excipient is incorporated in the formulation to impart cohesive property to the powder mixture (granules). The cohesiveness ensures that tablet will remain intact after compression and until patient uses it.

a)

Binders or Binding agents

b)

Diluents or Fillers

109.

Effective as a binding agent only in the paste form; one of best general binding agents.

a)

Dry acacia or acacia mucilage

b)

Starch paste

c)

Dry tragacanth or tragacanth mucilage

d)

Warm gelatin solution

110.

Alcoholic solution is desirable when therapeutic agent is susceptible to hydrolysis. Select all that apply

a)

PVP

b)

Starch paste

c)

Warm gelatin solution

d)

Dry acacia or acacia mucilage

e)

Dry tragacanth or tragacanth mucilage

111.

Which of the following binders are more effective when used as mucilage, compare to dry powder and require presence of a preservative? Select all that apply

a)

Warm gelatin solution

b)

Dry acacia or acacia mucilage

c)

Dry tragacanth or tragacanth mucilage

d)

Starch paste

e)

PVP

112.

Ethyl cellulose is a Cellulose Derivative Binder. Which of the following is true?

a)

Soluble in Water

b)

Insoluble in water

113.

Which of the following excipients must have hard gelatin capsules? Select all that apply

a)

Lubricants/glidants

b)

Disintegrant

c)

Anti-adherents

d)

Anti-oxidants

e)

Diluents or fillers

114.

Which of the following excipients must have Tablets? Select all that apply

a)

Diluents or fillers

b)

Binding agents

c)

Disintegrant and Anti-oxidants

d)

Coating and Preservatives

e)

Anti-adherents and Lubricants

115.

Which of the following excipients must have Powders?

a)

Diluents or fillers

b)

Binding agents

c)

Disintegrant

d)

Coating

116.

Which of the following DOES NOT require Preservatives?

a)

Oral solutions

b)

oral suspensions

c)

unit dose

d)

ophthalmic

117.

Know this

a)

Yes

b)

No

118.

Which of the following are the commonly used anti-oxidant? Select all that apply

a)

Gallic acid and propyl gallate

b)

Ascorbic acid

c)

Sulfites

d)

L-tocopherols (vitamin E)

e)

BHT (butylated hydroxy toluene) and BHA (butylated hydroxy anisole

119.

Which of the following are the commonly used preservatives in oral

products (Liquid & solid dosage forms)? Select all that apply

a)

Benzoic acid

b)

Sodium benzoate

c)

Sorbic acid

d)

Methyl paraben and Propyl paraben

e)

Bronidol

120.

Know this

a)

Yes

b)

No

121.

Which of the following HAS NO UNITS? Select all that apply

a)

Crystal nature

b)

Hygroscopicity

c)

Wettability (Contact angle)

d)

Flowability (Angle of repose)

e)

Porosity

122.

Surface area/gram (mm2/g).

a)

Specific Surface

b)

Density

123.

Which of the following will have an impact on tablet weight, content uniformity, disintegration, & dissolution? Select all that apply

a)

Specific surface

b)

Particle size &

size distribution

c)

Density (true, bulk, and tap)

and porosity

d)

Flowability

124.

Lubricants, anti-adherent, and glidants are generally mixed with dry granules prior to the process of compression of granules into the tablet.

a)

True

b)

False

125.

Lubricants, anti-adherents, and glidants which are inactive ingredients are mixed with dry granules of powder prepared by mixing active ingredient (s) with other excipients such as diluent, binding agent and coloring agent.

a)

True

b)

False

126.

Which of the following are examples of Lubricants? Select all that apply

a)

Stearic acid

b)

calcium and magnesium stearate

c)

PEG

d)

surfactants

127.

Which of the following are examples of Glidants? Select all that apply

a)

starch powder

b)

other silica derivatives

c)

talc powder

d)

colloidal silica

128.

They are intended to reduce the adhesion between surface of punches and powder granules .

a)

Glidants

b)

Anti-adherents

129.

They are intended to promote smooth and uniform flow of granules into tablet die so that each tablet will have same amount of powder mixture.

a)

Glidants

b)

Anti-adherents

130.

Indigotine (Indigo shade)

a)

FD&C blue #2

b)

FD&C blue #1

131.

Erythrosine (Pink shade)

a)

FD&C red #3

b)

FD&C blue #2

132.

Allura red (Red shade)

a)

FD&C red #40

b)

FD&C red #3

133.

Tartrazine (Yellow shade)

a)

FD&C yellow #5

b)

FD&C red #40

134.

Sunset yellow (Orange shade)

a)

FD&C yellow #5

b)

FD&C yellow #6

135.
a)

Yes

b)

No

136.

know this

a)

Yes

b)

No

137.

Know this

a)

Yes

b)

No