objective 2: resources for problematic excipients

Question 1

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

Answer 1

1. experimental data
2. extensive experience with the ingredient

Question 1

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

Answer 1

1. saccharin (sodium, calcium)
2. benzosulfimide

Question 2

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

Answer 2

sunset yellow

Question 3

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

Answer 3

tartrazine

Question 4

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

Answer 4

brilliant blue

Question 5

which antioxidant has been reported to induce bronchospasm and anaphylaxis?

Answer 5

sodium metabisulphite

Question 6

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?

Answer 6

the handbook of pharmaceutical excipients

Question 7

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

Answer 7

inactive ingredients database

Question 8

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

Answer 8

1. hives
2. runny nose
3. shortness of breath

Question 9

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

Answer 9

tartrazine

Question 10

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?

Answer 10

phenylketonuria

Question 11

which antioxidant has been reported to induce bronchospasm and anaphylaxis?

Answer 11

sodium metabisulphite

Question 12

what antimicrobial excipients do not cause contact dermatitis?

Answer 12

1. Chlorobutanol
2. thimerosal

Question 13

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

Answer 13

fast green

Question 14

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

Answer 14

lanolin

Question 15

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

Answer 15

polysorbate

Question 16

what excipient has a known reaction with cyclosporine?

Answer 16

cremophor

Question 17

what excipient is fatally toxic to dogs?

Answer 17

xylitol

Question 18

what excipient has an increased incidence in dental cavities?

Answer 18

sucrose

Question 19

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

Answer 19

chitosan

Question 20

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

Answer 20

starch

Question 21

what excipient can cause ototoxicity and hypoglycemia?

Answer 21

propylene glycol

Question 22

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

Answer 22

polyethylene glycol

Question 23

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

Answer 23

alcohol

Question 24

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

Answer 24

saccharin

Question 25

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

Answer 25

benzyl alcohol

Question 26

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

Answer 26

lactose

Question 27

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

Answer 27

false

Question 28

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?

Answer 28

1. route 2. dosage form 3. inactive ingredient

Question 29

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?

Answer 29

safety

Question 30

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?

Answer 30

incompatibilities

Question 31

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?

Answer 31

applications in pharmaceutical formulation or technology

Question 32

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?

Answer 32

functional category

Question 33

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?

Answer 33

handling precautions

Question 34

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?

Answer 34

regulatory status

Question 35

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?

Answer 35

specific references

Question 36

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?

Answer 36

general references

Question 37

what 2 colorants have a side effect of urticaria?

Answer 37

1. indigo carmine 2. sunset yellow

Question 38

what is the common name for E132?

Answer 38

indigo carmine