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which of the following statements correctly differentiates creams from ointments?
a) creams are o/w emulsions and are easier to remove from skin
b) ointments have higher water content than creams
c) creams provide more occlusion than ointments
d) ointments are non-greasy and water washable
a
which factor primarily determines the suitability of a sterilization method for a specific drug product?
a) route of administration
b) physico-chemical properties of the drug
c) container shape
d) solubility in water
b
in dry heat sterilization, why are items required to be as small as possible?
a) to reduce sterilization time
b) to allow free circulation of hot air
c) to increase the oxidation rate
d) to prevent overheating of the center
b
which of the following sterilization techniques involves ‘cold sterilization’?
a) dry heat sterilization
b) ionizing radiation
c) steam sterilization
d) gas sterilization
b
a new topical formulation must be easily removable by washing. which base would be ideal?
a) absorption base
b) water soluble base
c) oleaginous base
d) water removable base
d
in hydrophilic ointment USP, the function of sodium lauryl sulfate is:
a) thickening agent
b) solvent
c) emulsifying agent
d) preservative
c
which of the following ointment bases provides maximum occlusion?
a) oleaginous base
b) water soluble base
c) absorption base
d) water removable base
a
which base is most appropriate for application to weeping or oozing skin lesions?
a) lanolin base
b) cream (water removable base)
c) water soluble base
d) oleaginous
b
the ‘fusion’ method of ointment preparation involves:
a) heating components to form an emulsion before cooling
b) filtering molten components through sterile filters
c) using ethanol as solvent to dissolve drug and base
d) mixing powders geometrically at room temperature
a
PEG ointment is classified as which type of ointment base?
a) water soluble
b) oleaginous
c) water removable
d) absorption
a
which of the following is NOT an advantage of filtration sterilization?
a) useful for thermo-labile materials
b) quick for small volumes
c) removal of viruses
d) no heat required
c
the major limitation of gas sterilization using ethylene oxide is:
a) requires high temperature
b) toxicity and flammability of the gas
c) inability to sterilize large items
d) limited penetration into porous materials
b
the LAL test detects pyrogens through which mechanism?
a) pH change induced by endotoxin
b) formation of oxidative products
c) protein denaturation by heat
d) coagulation of lysate in presence of endotoxin
d
which ointment base would be most suitable for incorporating aqueous drug solutions?
a) hydrocarbon base
b) oleaginous base
c) absorption base
d) water soluble base
c
a sterile ophthalmic solution containing a thermo-labile antibiotic should be sterilized using which method?
a) filtration sterilization
b) steam sterilization
c) gas sterilization
d) dry heat sterilization
a
which parameter is LEAST likely to affect drug absorption through the skin?
a) hydration of skin
b) area of application
c) force of application
d) color of the formulation
d
which sterilization method is most appropriate for glassware and surgical instruments that can tolerate high temperatures?
a) ionizing radiation
b) filtration
c) gas sterilization
d) steam sterilization
d
which of the following statements about pyrogens is TRUE?
a) they can be removed by autoclaving
b) they can be completely removed by filtration
c) they are thermostable and water-soluble
d) they are heat-labile bacterial proteins
c
ethylene oxide sterilization primarily kills microorganisms by:
a) denaturation of enzymes
b) disruption of cellular membranes
c) oxidation of lipids
d) alkylation of microbial proteins and nucleic acids
d
which mechanism best explains microbial destruction during dry heat sterilization?
a) dehydration followed by oxidation of cellular components
b) denaturation and coagulation of bacterial proteins
c) alkylation of microbial proteins
d) disruption of DNA and RNA by ionizing
a
which particle size category requires all material to pass through a #40 sieve, with no more than 40% passing through a #80 sieve?
a) very coarse powder
b) moderately coarse powder
c) coarse powder
d) fine powder
b
a pharmacist is preparing divided powders containing a potent corticosteroid. which technique ensures accurate dosing and uniform distribution?
a) spatulation on an ointment tile
b) trituration via geometric dilution
c) sifting to create a fluffy mixture
d) pulverization by intervention
b
which method of comminution is most suitable for rubbery substances such as camphor?
a) trituration
b) levigation
c) pulverization by intervention
d) cyrogenic milling
c
angle of repose primarily provides information about which powder property?
a) solubility
b) flow properties
c) dissolution rate
d) chemical stability
b
which blending method if most suitable for potent drug substances?
a) trituration
b) sifting
c) spatulation
d) tumbling
d
which of the following best explains why granules exhibit better flow properties than powders?
a) spherical shape
b) larger surface area
c) lower surface area
d) larger particle size
a
in effervescent granules, what is the ideal ratio of citric acid to tartaric acid?
a) 1:1
b) 1:2
c) 2:1
d) 1:3
b
which granulation method uses internal binder (water of crystallization from citric acid)?
a) wet granulation
b) dry/fusion method
c) spray drying
d) fluid bed granulation
b
which capsule excipient enhances wettability and dissolution of hydrophobic drugs?
a) sodium starch glycolate
b) magnesium stearate
c) sodium dodecyl sulfate
d) talc
c
for divided powders, what is the primary reason they are avoided for potent drugs during spatulation?
a) difficult to taste-mask
b) risk of loss and incaccurate dosing
c) excessive caking
d) high humidity sensitivity
b
what is the primary advantage of sealing hard gelatin capsules?
a) improves taste
b) prevents dissolution
c) prevents capsule separation during handling
d) increases disintegration time
c
which capsule shell ingredient protects contents from light?
a) titanium dioxide
b) magnesium stearate
c) lactose
d) sorbital
a
what occurs if hard gelatin capsule moisture drops too low?
a) capsules become sticky
b) capsules become brittle
c) capsules expand
d) color fades
b
which excipient improves powder flow into capsule bodies?
a) lactose
b) colloidal silicon dioxide
c) sodium lauryl sulfate
d) croscarmellose sodium
b
which vehicle is acceptable in soft gelatin capsule?
a) water (10% content)
b) polyethylene glycol
c) sodium bicarbonate solution
d) saturated NaCl solution
b
why must aldehydes be excluded from soft gelatin capsule formulations?
a) cause phase separation
b) increase viscosity
c) cause gelatin cross-linking
d) decrease drug solubility
c
USP requirement for capsule dissolution?
a) 95% in 60 minutes
b) 80% in 30 minutes
c) 85% in 45 minutes
d) 75% in 20 minutes
c
which capsule size has the largest capacity?
a) size 0
b) size 5
c) size 000
d) size 2
c
which lubricant is commonly used in capsule formulations?
a) sodium bicarbonate
b) magnesium stearate
c) PEG 400
d) talc
b
why are effervescent granules preferred over powders for taste-masking?
a) better flow
b) less moisture required
c) controlled CO2 generation
d) more stable in air
c
which of the following is NOT an advantage of tablet dosage forms?
a) easy to swallow for all patients
b) chemical and physical stability
c) low price compared to capsules
d) accurate dosing
a
which tablet type is intended to dissolve slowly in the mouth?
a) chewable tablet
b) RDTs
c) buccal tablet
d) sublingual tablet
c
which type of tablet dissolves or disintegrates in the mouth within one minute or less?
a) effervescent tablet
b) buccal tablet
c) chewable tablet
d) instantly disintegrating tablet
d
which of the following statements about diluents is TRUE?
a) they are used in concentrations below 1%
b) they improve tablet flow
c) they provide bulk and improve compressibility
d) they are used to lubricate the die walls during compression
c
what is the maximum weight loss allowed in the friability test for tablets?
a) less than 2%
b) less than 5%
c) less than 1%
d) less than 0.5%
c
which tablet type is designed to release the drug in the intestine and not in the stomach?
a) enteric coated tablet
b) sugar coated tablet
c) compressed tablet
d) film (non-functional) coated tablet
a
which binder is a natural substance used as a 10-15% paste?
a) methylcellulose
b) hydroxypropyl cellulose
c) starch
d) polyvinyl pyrrolidone
c
which of the following dosage form will generate fastest effervescence?
a) capsules
b) tablets
c) powders
d) granules
c
the most common lubricant used in tablet formulation is:
a) polyvinyl pyrrolidone
b) talc
c) colloidal silica
d) magnesium stearate
d
which of the following excipients functions as a disintegrant?
a) polyvinyl pyrrolidone
b) sodium starch glycolate
c) magnesium stearate
d) microcrystalline cellulose
b
which excipient is used to promote the flow of granules and powders?
a) polyvinyl pyrrolidone
b) magnesium stearate
c) talc
d) sorbitol
c
which of the following compendial tests ensures tablet robustness?
a) thickness test
b) content uniformity test
c) friability test
d) weight variation test
c
what is the primary role (s) of starch in the following formulation?
Acetaminophen 200 mg
Starch 300 mg
Magnesium stearate 5 mg
Talc 5 mg
Colloidal silicon dioxide 4 mg
a) diluent
b) dilluent, disintegrating agent and glidant
c) disintegrating agent
d) diluent and disintegrating agent
d
which of the following is TRUE for controlled-release tablets?
a) they release the drug in a delayed fashion
b) they release te drug immediately after administration
c) they release the drug at a predictable rate
d) they are designed to reduce the dosing frequency by 2-fold
c
which of the following is not characteristic of sugar-coated tablets?
a) provide a barrier to unpleasant taste
b) increase tablet weight by up to 50%
c) dissolve rapidly in water
d) suitable for diabetic patients
d
a weakly basic drug is being developed for chronic migraine treatment. this weakly basic drug has the following properties.
a) MW = 501 g/mol
b) pKa = 5.5
c) partition coefficient = 8.5
d) solubility in water = 1 mg/mL
e) stability of crystalline form at 25°C = 5 years
f) stability of amorphous form at 25°C = 3 months
h) drug is heat-sensitive
which of the following is the most suitable dosage form, if instant relief from migraine is desired?
a) granules
b) suppositories
c) soft-gelatin capsules
d) compressed tablets
e) hard gelatin capsules
e
a weakly basic drug is being developed for chronic migraine treatment. this weakly basic drug has the following properties.
a) MW = 501 g/mol
b) pKa = 5.5
c) partition coefficient = 8.5
d) solubility in water = 1 mg/mL
e) stability of crystalline form at 25°C = 5 years
f) stability of amorphous form at 25°C = 3 months
h) drug is heat-sensitive
if the drug is formulated as a suppository, which base would most likely provide the quickest drug release?
a) cocoa butter
b) polyethylene glycol (PEG) base
c) glycerinated gelatin base
d) hydrogenated vegetable oil
b
a weakly basic drug is being developed for chronic migraine treatment. this weakly basic drug has the following properties.
a) MW = 501 g/mol
b) pKa = 5.5
c) partition coefficient = 8.5
d) solubility in water = 1 mg/mL
e) stability of crystalline form at 25°C = 5 years
f) stability of amorphous form at 25°C = 3 months
h) drug is heat-sensitive
if the drug is incorporated into an enteric-coated tablet, what is the main rationale behind such coating?
a) to enhance absorption in the stomach
b) to protect the drug from stomach acid degradation
c) to prevent gastric irritation caused by excipients
d) to increase disintegration rate
b
a weakly basic drug is being developed for chronic migraine treatment. this weakly basic drug has the following properties.
a) MW = 501 g/mol
b) pKa = 5.5
c) partition coefficient = 8.5
d) solubility in water = 1 mg/mL
e) stability of crystalline form at 25°C = 5 years
f) stability of amorphous form at 25°C = 3 months
h) drug is heat-sensitive
if the drug is to be filled into hard gelatin capsules, what potential issue must be addressed?
a) risk of capsule shell brittleness
b) capsule crosslinking due to oxidation
c) poor dissolution from powder fill
d) drug recrystallization in aqueous suspension
a
a weakly basic drug is being developed for chronic migraine treatment. this weakly basic drug has the following properties.
a) MW = 501 g/mol
b) pKa = 5.5
c) partition coefficient = 8.5
d) solubility in water = 1 mg/mL
e) stability of crystalline form at 25°C = 5 years
f) stability of amorphous form at 25°C = 3 months
h) drug is heat-sensitive
which method would be ideal, if an absorption base is used to prepare an ointment dosage form?
a) molding
b) compression
c) fusion
d) incorporation