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WorksheetsEXAM 2 CEUTICS II DR. JAM PART 2 PPX
Total questions: 137
Worksheet time: 3hrs 28mins
Which of the following statements are TRUE about why Lubricants are incorporated in the formulations? Select all that apply
Improve the flow of the granules
Reduce adhesion of powder material (granules) to the punches and dies during the compression
easy release of the compressed tablet from the mold or die.
added to the formulation to increase the bulk of a tablet to a practical and convenient size.
Substances that ameliorate the difficulties on manufacture of a compressed tablet are known as:
Lubricants
Binders
Diluents
All of them are correct
Which of the following are TRUE about Lubricants?
inadequate lubricant is evidenced by screeching sound and scratch marks on the edge of a tablet
agents that act between surfaces in relative motions to prevent friction and wear.
help granules to slip and slide to form a compact in the die wall of a tablet press.
materials that improve the flow characteristics of the granules.
Which of the following are TRUE about Glidants?
When used in right amount, glidants serve to assure smooth and uniform flow of granules.
materials that improve the flow characteristics of the granules.
act by reducing the inter-particulate friction.
agents that act between surfaces in relative motions to prevent friction and wear.
Which of the following function to prevent tablet granules from sticking to faces of punches and die wall ?
Lubricants
Anti-adherents
Glidants
Binders
The Phenomenon of picking Tablet defect means too much moisture; inadequate
anti-adherent; insufficient compressibility.
True
False
Surface materials of the tablet stick to the punch and get removed from the tablet surface.
Picking
Glidant
Lubricant
Binder
Which of following Lubricants can I use if I want it to be an excellent lubricant but poor anti-adherent or glidant?
Magnesium stearate (< 1% w/w)
Corn Starch 5 to 10%
Talc (1 to 5%)
All of them are correct
Which of the following Lubricants may retard drug dissolution If used in greater than 1% concentration?
Magnesium stearate (< 1% w/w)
Corn Starch
Talc (1 to 5%)
Stearic acid (1 to 5%)
Which of following Lubricants can I use if I want an excellent glidant and anti-adherent but is a poor lubricant?
Stearic acid (1 to 5%)
Magnesium stearate (< 1% w/w)
Corn Starch
in 5 to 10%
All of them are correct
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?
Stearic acid (1 to 5%)
Corn Starch 5 to 10%
Magnesium stearate (< 1% w/w)
Carbowax 4000
Carbowax 4000, carbowax 8000, and sodium lauryl sulfate (effective in 1 to 5% concentration).
True
False
In general lubricants, whether water soluble or insoluble, should be of thick particle size.
True
False
In general lubricants, whether water soluble or insoluble, should be of very fine particle size.
True
False
Lubricants function by forming a thin film around the granules.
True
False
Which of the following is TRUE about the Effectiveness of Lubricants?
is related to true density and specific surface
is related to bulk density and specific surface
is related to the particle size only
is related to the particle size and specific surface
Which of the following will facilitate tablet breakup following its administration?
Lubricant
Disintegrant
Binder
Glidant
Rapid disintegration is likely to result in rapid drug dissolution; though it is not an absolute guarantee.
True
False
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.
True
False
Which of the following is more critical and vital for rapid and complete drug absorption to occur?
rapid and complete dissolution
rapid disintegration alone
Which of the following is TRUE about the Disintegrating agent?
may be added prior to granulation or during the lubrication step prior to the compression or at both steps
may be added after granulation or before the lubrication step after to the compression only
The effectiveness of many disintegrants is affected by their position (inter granular or extra-granular) within the tablet.
True
False
Which of the following suggests the presence of disintegrant inside or within the granules?
Inter-granular
Intra-granular
Which of the following suggests the presence of disintegrating agent between the granules?
Inter-granular
Intra-granular
What is the mode of action of commonly used Disintegrant?
the water uptake through the pores of tablets, due capillary action, resulting in tablet expansion followed by disintegration.
prevent tablet granules from sticking to faces of punches and die wall
agents that act between surfaces in relative motions to prevent friction and wear.
materials that improve the flow characteristics of the granules.
PrimojelR or Explotab are examples of which of the following?
Lubricants
Disintegrants
Binders
Anti-adherents
We can say Low substituted carboxymethyl starch is used in about 1 to 8% (optimum is 4%) concentration as a Disintegrant.
True
False
Which of the following are considered Pre-gelatinized starch (Disintegrants)? Select all that apply
Alginates
Cross-linked PVP
Microcrystalline cellulose (Avicel)
Veegum HV
Which of the following statements are TRUE about Colorants? Select all that apply
incorporated into tablet for aesthetic and/or marketing value
incorporated into tablet for identifying different products
incorporated into tablet for identifying different strengths of the same product (examples, Warfarin, levothyroxine, and digoxin)
incorporated into tablet to minimize the possible mix-up during manufacturing
Any of the water soluble dyes, mixture of the dyes and their corresponding lakes may be used as colorants for tablets.
True
False
Aluminum hydroxide is an insoluble form of the dye.
True
False
Dyes are water soluble while lakes, which are formed by the adsorption of water-soluble dye on a hydrous oxide.
True
False
Dyes and lakes are photosensitive, and their photosensitivity is affected by the drug, excipient and the method of manufacture.
True
False
Which of the following statements are TRUE about Dyes? Select all that apply
aluminum hydroxide is an insoluble form of the dye.
aluminum hydroxide is a soluble form of the dye.
Dyes are water soluble while lakes, which are formed by the adsorption of water-soluble dye on a hydrous oxide
Dyes and lakes are photosensitive, and their photosensitivity is affected by the drug, excipient and the method of manufacture
Pastel shades generally show least amount of mottling (an uneven distribution of color yielding darker spots of the color on a tablet).
True
False
Yellow and green color (midrange of visible spectrum) will show less mottling compared to blue and red.
True
False
The problems of mottling becomes more pronounced when the concentration increases.
True
False
The problems of mottling becomes more pronounced when the concentration decreases.
True
False
Which of the following parameters are related to the Mottling Phenomenon? Select all that apply
concentration of the dye
type of coloring agent
slow vs. rapid drying of granules
None of them are relevant
The Migration of the coloring agent from inside of a granule to the surface of a granule is during the drying process.
True
False
Drying granules slowly at low temperature and with continuous stirring can reduce migration of the color to the surface and reduce mottling.
True
False
Drying granules slowly at High temperature and with continuous stirring can reduce migration of the color to the surface and reduce mottling.
True
False
Which of the following are the commonly employed colorants? Select all that apply
FD&C green # 3
FD & C # 40
,
FD&C # 5 and # 6
FD&C blue # 1 and # 2
Coloring agents are used in very small concentrations (0.05 to 0.1%)
True
False
Coloring agents are used in very large concentrations (5 to 10%).
True
False
Coloring agents are generally mixed with which of the following binding agent solutions? Select all that apply
acacia
Celullose
tragacanth
gelatin
It is much easier to incorporate coloring agent as a solution than as a powder.
True
False
It is much easier to incorporate coloring agent as a powder than as a solution.
True
False
Lakes, on the other hand, are blended with dry excipients because of their insoluble nature.
True
False
When we talk about Tablet Capping (defect) problem, we are talking about which of the following? Select all that apply
High powder porosity
poor compressibility
inadequate binding agent
compressional force
Which of the following methods are used to prepare tablets? Select all that apply
Wet granulation
Dry granulation
Direct compression
Wet granulation only
Which of the following are considered the powder properties? Select all that apply
hydrophobicity
compressibility
size and size distribution
true and bulk densities
flow
The choice of method of Tablet Preparation depends upon the following factors: Select all that apply
Available equipment
The powder properties
qDose of a drug (small or large dose)
Practical and regulatory concerns
In Wet Granulation, Powdered drug is mixed with which of the following? Select all that apply
binding agent (solution)
colorant
diluents
disintegrant
In Wet Granulation, Wet powder mixture is passed through a sieve of what sizes? Select all that apply
# mesh 20
# mesh 40
# mesh 100
# mesh 80
Which of the following statements are TRUE about Wet Granulation? Select all that apply
Wet powder mixture is passed through a sieve (# mesh 80 or 100) and granules are prepared
Powdered drug is mixed with diluents, disintegrant, colorant, and binding agent (solution).
Wet powder mixture is passed through a sieve (# mesh 20 or 40) and granules are prepared
Granules are dried, mixed with lubricant, and compressed into tablets
Each granule contains drug, binding agent, diluent, Coloring agent, and other excipient.
True
False
Which of the following are TRUE about Advantages of Wet Granulation ? Select all that apply
Provides good cohesiveness and compressibility to the powder mixture due to addition of liquid binder
Uniform drug distribution in granules makes it a ideal method for low dose drugs
Minimum segregation of the powders in the mixture
Cost is the greatest (HIGH)
Which of the following are TRUE about Limitations of Wet Granulation ? Select all that apply
Heat sensitive drugs may be difficult to formulate
Cost is the greatest (HIGH)
Moisture sensitive drugs may require use of non-aqueous binder solution
Migration of water-soluble dyes may cause unequal distribution of color
In Direct Compression, the powder blend of active ingredient and excipients is compressed into a tablet.
True
False
Which of the following are TRUE about the steps in Direct Compression? Select all that apply
Compressing the mixture into tablets.
Availability of specialized excipients has made this method readily available in recent times.
Milling (reducing the particle size) of a drug and excipients to approximately same size.
Mixing of a drug and other excipients.
If I'm looking for an economical and suitable method for heat and moisture sensitive drugs, Direct Compression is an option.
True
False
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.
True
False
Which of the following tests are performed by the manufactures to evaluate tablets? Select all that apply
Weight variation (USP/NF)
Drug content uniformity (USP/NF)
Drug dissolution (USP/NF Apparatus)
Tablet disintegration and Tablet Hardness
Friability (resistance to abrasion)
How many tablets are weighted individually in the Weight Variation Test?
20
40
60
100
Which of the following are TRUE statements about the Weight Variation Test? Select all that apply
Determine the mean weight and Std. Dev (mean weight (mg) ± S.D)
U.S.P and N.F. provide specifications with regards to how many test tablets may lie outside certain limits.
Forty (40) tablets are weighed individually.
Twenty (20) tablets are weighed individually.
Understand this!
Yes
NO
How many tablets are assayed individually for drug content in the Drug Content Uniformity test?
Fifty (50) tablets
Forty (40) tablets
Twenty (20) tablets
Ten (10) tablets
Which of the following are TRUE statements about the Drug Content Uniformity test? Select all that apply
is designed to establish drug homogeneity (homogenous distribution of drug) in tablets of each batch of a product.
Ten (10) tablets are assayed individually for drug content
Drug content in each tablet must be within 85 to 115 % of the labeled amount of the active ingredient (s).
None of the tablets tested must be outside the limit of 75 to 125 % range.
•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.
Which test is designed to establish drug homogeneity (homogenous distribution of drug) in tablets of each batch of a product?
Drug Content Uniformity
Weight Variation
Tablet Disintegration
Dissolution
Which of the following determines the time required for a tablet to disintegrate, when immersed in some test fluid; generally, simulated gastrointestinal fluid?
Tablet Disintegration
Drug Content Uniformity
If a tablet disintegrates quickly, it is likely (not an assurance) that drug will dissolve quickly and absorb immediately.
True
False
Understand this
Yes
No
Disintegration test is performed as a quality control test for tablets intended to be administered orally including chewable tablets.
True
False
Disintegration test is performed as a quality control test for tablets intended to be administered orally (exception is chewable tablet).
True
False
Disintegration test may be far more important for ODT type tablets.
True
False
The quicker and more complete the drug dissolution, the faster and more complete is likely to be the drug absorption.
True
False
Which of the following is a process by which a solid drug dissolves in the surrounding fluid?
Absorption
Dissolution
Bioavailability
Compression
The quicker and more complete the drug dissolution, the faster and more complete is likely to be the drug absorption.
True
False
Which of the following are considered the USP dissolution apparatus methods? Select all that apply
A, Bounding method
B, Paddle method
A, Basket method
B, Pounder method
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.
True
False
Which test is performed by measuring the force required to fracture a tablet (measurement of the crushing strength of a tablet)?
Friability Test (Resistance to abrasion)
Tablet Hardness Test
Which test measures the weight loss in tablets upon subjecting certain number of tablets to agitation under standard conditions for a specified time?
Friability Test (Resistance to abrasion)
Tablet Hardness Test
Which of the following statements are TRUE about the Friability Test (Resistance to abrasion)? Select all that apply
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)
This test measures the weight loss in tablets upon subjecting certain number of tablets to agitation under standard conditions for a specified time.
certain number of tablets are de-dusted and weighed (W0).
tablets are subjected to well defined agitation in a close container of fixed geometry for a specific time and reweighed (W).
test is performed by measuring the force required to fracture a tablet.
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).
True
False
Resistance to the abrasion (B) is usually expressed as % loss in weight of (10) tablets.
True
False
Which value is is frequently quoted as the upper limit for the acceptability of a product for the resistance to the abrasion (B)?
2.0 to 2.8 %
1.0 to 1.8 %
0.8 to 1.0%
0.8 to 1.8 %
Which of these variables represent the index of abrasion to resistance?
B
W
W0
D
Which of these variables represent the initial weight of ten tablets?
W0
W
Which of these variables represent the final weight of ten tablets?
W
W0
Which of the following statements are TRUE about Keppra (Levetiracetam)? Select all that apply
It is the S-enantiomer of etiracetam
administered orally and by intravenous solution
anticonvulsant medication used for the treatment of epilepsy
sometimes used to treat neuropathic pain
Available in 250, 500, 750, and
1000 mg tablets and solution
Which of the following are the Physical Chemical
Properties of levetiracetam? Select all that apply
Heat of vaporization (δHv)
Melting point and pKa (Dissociation constant)
Solubility (water and other solvents)
Color and other characteristics
Molecular weight (grams) and True density (g/cc)
Levetiracetam is available in 250, 500, 750, and 1000 mg tablets and solution.
True
False
Which of the following are the inactive ingredients of Levetiracetam? Select all that apply
Sucrose
Corn starch
Colloidal silicon dioxide
Hydroxy propyl methyl cellulose (HPMC)
Which of the following are the inactive ingredients of Levetiracetam? Select all that apply
Magnesium stearate
Povidone
talc
Polyethylene glycol 4000
Cellulose ether
Which of the following are the inactive ingredients of Levetiracetam? Select all that apply
Mannitol
titanium dioxide
coloring agent
Cellulose ether
Which of the following are the inactive ingredients of Levetiracetam? Select all that apply
Colloidal silicon dioxide, Povidone, talc, titanium dioxide, and coloring agent.
Corn starch
Hydroxy propyl methyl cellulose (HPMC)
Magnesium stearate
Polyethylene glycol 4000
Which of the following has very good absorbing agent, poor lubricant and excellent anti-adherent property?
Talc
Corn starch
Which of the following Levetiracetam tablets have FD & C Blue # 2 and yellow iron oxide?
250 mg tablets
500 mg tablets
750 mg tablets
1000 mg tablets
Which of the following Levetiracetam tablets have FD & C Blue # 2, FD & C yellow # 6, and red iron oxide?
250 mg tablets
500 mg tablets
1000 mg tablets
750 mg tablets
The effectiveness of lubricants is related to particle size and specific surface.
True
False
Which of the following Levetiracetam tablets have FD & C Blue # 2 only?
250 mg tablets
500 mg tablets
750 mg tablets
1000 mg tablets
Are added to the formulation to increase the bulk of a tablet to a practical and convenient size.
Diluents or Fillers
Binders or Binding agents
Diluents are very important for which of the following drugs? Select all that apply
Digoxin
Levothyroxine
Metformin
CaptoprilR 12.5 mg
Which of the following are the commonly used Diluents? Select all that apply
lactose
spray dried lactose
microcrystalline cellulose
mannitol
dry starch, and powdered sugar
Which of the following Diluents are commonly used in chewable tablets? Select all that apply
mannitol
sucrose
lactose
sorbitol
Diluents are essential to produce a tablet of a reasonable size.
True
False
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.
Binders or Binding agents
Diluents or Fillers
Effective as a binding agent only in the paste form; one of best general binding agents.
Dry acacia or acacia mucilage
Starch paste
Dry tragacanth or tragacanth mucilage
Warm gelatin solution
Alcoholic solution is desirable when therapeutic agent is susceptible to hydrolysis. Select all that apply
PVP
Starch paste
Warm gelatin solution
Dry acacia or acacia mucilage
Dry tragacanth or tragacanth mucilage
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
Warm gelatin solution
Dry acacia or acacia mucilage
Dry tragacanth or tragacanth mucilage
Starch paste
PVP
Ethyl cellulose is a Cellulose Derivative Binder. Which of the following is true?
Soluble in Water
Insoluble in water
Which of the following excipients must have hard gelatin capsules? Select all that apply
Lubricants/glidants
Disintegrant
Anti-adherents
Anti-oxidants
Diluents or fillers
Which of the following excipients must have Tablets? Select all that apply
Diluents or fillers
Binding agents
Disintegrant and Anti-oxidants
Coating and Preservatives
Anti-adherents and Lubricants
Which of the following excipients must have Powders?
Diluents or fillers
Binding agents
Disintegrant
Coating
Which of the following DOES NOT require Preservatives?
Oral solutions
oral suspensions
unit dose
ophthalmic
Know this
Yes
No
Which of the following are the commonly used anti-oxidant? Select all that apply
Gallic acid and propyl gallate
Ascorbic acid
Sulfites
L-tocopherols (vitamin E)
BHT (butylated hydroxy toluene) and BHA (butylated hydroxy anisole
Which of the following are the commonly used preservatives in oral
products (Liquid & solid dosage forms)? Select all that apply
Benzoic acid
Sodium benzoate
Sorbic acid
Methyl paraben and Propyl paraben
Bronidol
Know this
Yes
No
Which of the following HAS NO UNITS? Select all that apply
Crystal nature
Hygroscopicity
Wettability (Contact angle)
Flowability (Angle of repose)
Porosity
Surface area/gram (mm2/g).
Specific Surface
Density
Which of the following will have an impact on tablet weight, content uniformity, disintegration, & dissolution? Select all that apply
Specific surface
Particle size &
size distribution
Density (true, bulk, and tap)
and porosity
Flowability
Lubricants, anti-adherent, and glidants are generally mixed with dry granules prior to the process of compression of granules into the tablet.
True
False
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.
True
False
Which of the following are examples of Lubricants? Select all that apply
Stearic acid
calcium and magnesium stearate
PEG
surfactants
Which of the following are examples of Glidants? Select all that apply
starch powder
other silica derivatives
talc powder
colloidal silica
They are intended to reduce the adhesion between surface of punches and powder granules .
Glidants
Anti-adherents
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.
Glidants
Anti-adherents
Indigotine (Indigo shade)
FD&C blue #2
FD&C blue #1
Erythrosine (Pink shade)
FD&C red #3
FD&C blue #2
Allura red (Red shade)
FD&C red #40
FD&C red #3
Tartrazine (Yellow shade)
FD&C yellow #5
FD&C red #40
Sunset yellow (Orange shade)
FD&C yellow #5
FD&C yellow #6
Yes
No
know this
Yes
No
Know this
Yes
No
