With Answers || ||
The most suitable dosage form in the clinical Phases 1
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and 2 of drug product development is - CORRECT
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ANSWER(S)✔✔Capsule
The largest and smallest sizes of hard-shell capsule
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respectively available for compounding for human use || || || || || || ||
are sizes - CORRECT ANSWER(S)✔✔000-largest
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5-smallest
An appropriate formulation of hard-shell capsules must
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contain which of the following basic ingredients? (3) -
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CORRECT ANSWER(S)✔✔Propylene glycol || ||
gelatin
titanium dioxide ||
The presence of which of the following chemical
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components distinguishes soft gelatin capsule shells || || || || || ||
,from hard shell capsules? - CORRECT
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ANSWER(S)✔✔Plasticizers
Some important factors to be considered when selecting
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a capsule size are: (2) - CORRECT
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ANSWER(S)✔✔Density of powder || ||
Dose size ||
In capsule and other solid unit dosage forms evaluation,
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the test which indicates the potential for drug absorption
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in vivo (i.e. bioavailability) is - CORRECT
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ANSWER(S)✔✔dissolution rate ||
A pharmacist received a prescription directing to
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dispense capsules. The active ingredient/drug was a
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water miscible, non-volatile liquid. Which of the
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following types of capsule shells should s/he use to
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compound the prescription? - CORRECT || || || || ||
ANSWER(S)✔✔Soft gelatin capsule shell || || ||
Extemporaneously prepared capsules are sealed by - || || || || || || ||
CORRECT ANSWER(S)✔✔Lightly coating the inner || || || || ||
surface of the cap with a warm gelatin solution
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,For the content uniformity test for capsules, what is/are
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applicable? - CORRECT ANSWER(S)✔✔Concentration of || || || || ||
active ingredient should be within 85-115% of the label
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claim
Why should highly soluble chloride salts not be
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dispensed in hard gelatin capsules? - CORRECT || || || || || || ||
ANSWER(S)✔✔Rapid release may cause gastric irritation || || || || ||
and harm patient
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Which piece of the hard-shell capsule is filled with
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powder? - CORRECT ANSWER(S)✔✔The body || || || ||
The procedure used to load powder on an ointment slab
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into capsule shell during hand-filling operation is known
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as: - CORRECT ANSWER(S)✔✔Punching
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According to the USP Chapter <795> guideline in || || || || || || || ||
assigning expiration dates to extemporaneously || || || || ||
compounded capsules containing stable powders.....(3) - || || || || || ||
CORRECT ANSWER(S)✔✔Six months if prepared with || || || || || ||
USP/NF grade ingredients || ||
25% of remaining expiration dating if prepared from
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commercial products ||
, Any date if evidence is available to support such dating
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Which of the following types of drugs may be better
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presented in capsule rather than tablet dosage form? (3)
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- CORRECT ANSWER(S)✔✔Drugs of objectionable odor
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or taste ||
Drugs that are sensitive to oxygen and/or moisture
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Drugs of poor inherent compressibility
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When the content of drug substance in a capsule dosage
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unit is less than 25 mg or less than 25 % of capsule
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weight, the USP recommendation for uniformity
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assessment is - CORRECT ANSWER(S)✔✔Content || || || || ||
uniformity test ||
Which of the following physical properties of a drug
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substance determines the capsule shell's fill weight|| || || || || || ||
capacity? - CORRECT ANSWER(S)✔✔Tapped bulk || || || || ||
density of the powder || || ||
In the extemporaneous preparation of a dosage form,
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levigation is used to - CORRECT ANSWER(S)✔✔Reduce || || || || || || ||
particle size ||