Pediatric Drug Delivery and Dosage Forms

Question 1

Challenges in drug delivery for pediatric patients

Answer 1

May require manipulation of a dosage form tailored to ability to swallow
May require dosage forms available tailored to a smaller dose
May require alterations in stability if dosage form requires alteration
May NOT be palatable for PO administration
~56% of children ages 6-11 can’t swallow a tablet

Question 2

Solid dosage forms

Answer 2

Tablets, capsules

Question 3

Manipulating tablets

Answer 3

Make sure it’s feasible and see whether or not it alters medication delivery when you split or crush it

Question 4

Manipulating capsules

Answer 4

Must determine the formulation of the capsule and its contents

Question 5

Liquid dosage forms

Answer 5

Solutions/suspensions

Question 6

Pros of liquid dosage forms

Answer 6

Dose flexibility, easy to swallow

Question 7

Cons of liquid dosage forms

Answer 7

lack of controlled release mechanisms, volume required for dose, accuracy in measuring devices

Question 8

Challenge of liquid dosage forms

Answer 8

not all are commercially available, single concentration vs. extemporaneous compounded: various available concentrations → at risk for medication errors

Question 9

Pro of chewable tablets

Answer 9

Minimizes need for additional liquid

Question 10

Con of chewable tablets

Answer 10

relies on ability to chew, can’t utilize with ER meds, may not mask taste, may be difficult to control dosage

Question 11

Pro of mini tablets

Answer 11

eases need for swallowing tablets

Question 12

Con of mini tablets

Answer 12

limited dosage flexibility, maximum mg/tablet –> may need large # of tabs to make the dose

Question 13

Pro of ODTs

Answer 13

allows for quick dissolving without need for additional liquid

Question 14

Con of ODTs

Answer 14

Can’t easily split (limits dose flexibility), challenge with masking taste

Question 15

Pro of ODFs

Answer 15

offer dose flexibility (strip-cutting mechanism)

Question 16

Con of ODFs

Answer 16

Hard to mask taste, higher cost to pack and make

Question 17

Pro of powder packets

Answer 17

eliminates need for crushing tablets, ready to use manufactured packets

Question 18

Con of powder packets

Answer 18

may require significant volume to mix, not easily titratable

Question 19

Pro of sprinkle capsules/granules

Answer 19

ease in administration with food

Question 20

Con of sprinkle capsules/granules

Answer 20

limited dose flexibility

Question 21

Primary source of noncompliance

Answer 21

Palatability

Question 22

How to get past noncompliance from palatability

Answer 22

Preferences of the individual patient taken into consideration
Manipulation can change the taste
FlavoRx
Mix with food/drinks: chocolate syrup, peanut butter, applesauce

Question 23

Considerations when administering meds through a feeding tube

Answer 23

What is the site of absorption?
Can the medication contact plastic?
Will the medication clog the tube based on formulation?

Question 24

Most common parenteral adminsitration

Answer 24

IV

Question 25

IV administration allows for what?

Answer 25

Immediate entry into the bloodstream

Question 26

IM/SQ administration considerations

Answer 26

muscle mass/fat mass is a factor, but can utilize in emergency or for single medication administration such as vaccines, limitations to volume allowed based on age

Question 27

Considerations for parenteral formulation use in general

Answer 27

Volume IV access Compatibility with other meds

Question 28

Other formulation challenges: inhalation

Answer 28

devices commonly designed for adults; use of nebulizers can be cumbersome/require patient education

Question 29

Other formulation challenges: nasal

Answer 29

commonly designed for adults, difficult to administer based on age

Question 30

Other formulation challenges: rectal

Answer 30

limited dosage forms, neonates/infants size restrictions and increased stool count

Question 31

Other formulation challenges: topical

Answer 31

consider BSA ratio, potential for systemic absorption

Question 32

Other formulation challenges: transdermal

Answer 32

limited dosage forms available for pediatrics, ability to cut/cover, age limitations

Question 33

Benzoyl alcohol risks in peds

Answer 33

Neurotoxicity and metabolic acidosis (esp. in neonates)

Question 34

Ethanol risk in peds

Answer 34

Neurotoxicity

Question 35

Polysorbate 20, 80 risks in peds

Answer 35

Liver and kidney failure; thrombocytopenia, ascites, pulmonary deterioration in neonates

Question 36

Propylene glycol risks in peds

Answer 36

Seizures, hyperosmolarity, metabolic acidosis, neurotoxicity

Question 37

Sorbitol risk in peds

Answer 37

Osmotic diarrhea

Question 38

Extemporaneous preparations:

Answer 38

Powder papers Injectable medications administered enterally Compounding PO suspensions with products like bulk powders, tablets, powder-filled capsules

Question 39

Beyond Use Dating

Answer 39

USP <795> for extemporaneous preparations that don't have available, published literature related to stability