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personalized therapeutics FINAL > objective 2: resources for problematic excipients > Flashcards

objective 2: resources for problematic excipients Flashcards

1
Q

what are the 2 ways in which the safety of excipients is established?

A
  1. experimental data
  2. extensive experience with the ingredient
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1
Q

what are 2 excipients that may have a cross sensitivity with the sulfonamide antibiotics?

A
  1. saccharin (sodium, calcium)
  2. benzosulfimide
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2
Q

what is the common name for FD&C #6?

A

sunset yellow

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3
Q

what is the common name for FD&C #5?

A

tartrazine

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4
Q

what is the common name for FD&C #1,2?

A

brilliant blue

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5
Q

which antioxidant has been reported to induce bronchospasm and anaphylaxis?

A

sodium metabisulphite

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6
Q

what is the name of the searchable database maintained by the FDA that lists the name of excipients present in drug products approved for use in the US?

A

the handbook of pharmaceutical excipients

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7
Q

a searchable database where formulation components are listed alphabetically by component name and states the functional purposes of excipients in various dosage forms

A

inactive ingredients database

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8
Q

what are 3 symptoms that are consistent with aspirin exacerbated respiratory disease?

A
  1. hives
  2. runny nose
  3. shortness of breath
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9
Q

which of the following excipients may be associated with hyperkinetic activity in children?

A

tartrazine

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10
Q

what is the name of the metabolic disorder that pharmacists should look out for which merits exercising caution prior to dispensing products that contain aspartame?

A

phenylketonuria

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11
Q

which antioxidant has been reported to induce bronchospasm and anaphylaxis?

A

sodium metabisulphite

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12
Q

what antimicrobial excipients do not cause contact dermatitis?

A
  1. Chlorobutanol
  2. thimerosal
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13
Q

what is the common name for FD&C #3?

A

fast green

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14
Q

what excipient has a known hypersensitivity reaction since it is made with wool fat?

A

lanolin

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15
Q

what excipient can cause liver and kidney failure in low birthweight infants when administered IV with vitamin E?

A

polysorbate

16
Q

what excipient has a known reaction with cyclosporine?

A

cremophor

17
Q

what excipient is fatally toxic to dogs?

A

xylitol

18
Q

what excipient has an increased incidence in dental cavities?

A

sucrose

19
Q

what type of excipient is derived from the shells of certain crustaceans?

A

chitosan

20
Q

what excipient is derived from food plants and allergies and sensitivities to source foods may be triggered?

A

starch

21
Q

what excipient can cause ototoxicity and hypoglycemia?

A

propylene glycol

22
Q

what excipient can cause hyperosmolarity, metabolic acidosis and renal failure in burn patients?

A

polyethylene glycol

23
Q

the common solvent that is particularly toxic to children and is associated with causing hypoglycemia

A

alcohol

24
Q

A patient with a known hypersensitivity to sulfonamides should not be prescribed drug products containing this sweetener, owing to a well-documented cross-sensitivity

A

saccharin

25
Q

This preservative, commonly used in injectable drugs and bacteriostatic saline is associated with fatal side-effects when administered to neonates

A

benzyl alcohol

26
Q

This common tablet and capsule diluent is associated with vomiting, abdominal pain, malabsorption and protracted diarrhea in patients with an intolerance to this excipient

A

lactose

27
Q

true or false: The IID, maintained by the FDA, lists the functions of excipients used in the dosage forms for which they are reported

A

false

28
Q

what 3 types of data is reported in the IID can be used to help identify reactions/sensitivities listed in the Unit 1 Supplement: Problematic Excipients table compiled for this class?

A
  1. route
  2. dosage form
  3. inactive ingredient
29
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data concerning possible hazards and any adverse reactions that may have been reported for an excipient?

A

safety

30
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data that lists other excipients/API that react with excipient; compromise product quality?

A

incompatibilities

31
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data that lists dosage forms that use excipients in a specific role?

A

applications in pharmaceutical formulation or technology

32
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data that lists the functions of the excipient?

A

functional category

33
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data concerning possible hazards associated with handling raw excipient. recommended containment and protection methods?

A

handling precautions

34
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data regarding accepted uses in foods and licensing drug products?

A

regulatory status

35
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data regarding references from scientific literature?

A

specific references

36
Q

Monographs in the Handbook of Pharmaceutical Excipients are organized into 22 sections, each of which contains specific information about the excipient pertaining to that category. Which section includes relevant data regarding other references applicable to excipients?

A

general references

37
Q

what 2 colorants have a side effect of urticaria?

A
  1. indigo carmine
  2. sunset yellow
38
Q

what is the common name for E132?

A

indigo carmine

personalized therapeutics FINAL (8 decks)

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