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Pharmacy 408 pharmaceutical lectures > Paeds > Flashcards

Paeds Flashcards

1
Q

What is the paediatric population important? (5 points)

A
  • one size does not fit all
  • kids cannot be treated as little adults
  • they require dosing calculations (body surface area, weight)
  • cannot extrapolate adult doses to children
  • they have variable PK and PD profile of drug depending on developmental stage of the child
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2
Q

What are the main considerations in paediatric drug delivery? (7 points)

A
  • accurate, flexible dosing schedule
  • age range
  • acceptability
  • compliance
  • stability
  • ease of compounding & administration
  • CR, desirable PK
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3
Q

What must be considered for a drug to be acceptable by a child? (4 points)

A
  • pain
  • taste/palatability
  • frequency
  • acceptable dose uniformity
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4
Q

What must be considered to achieve compliance?

A

-compliance and convenience of patient and caregiver

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5
Q

What must be considered in stability? (2 points)

A
  • physical, chemical and microbial stability

- effect of excipients

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6
Q

What must be considered in ease of compounding & admin? (2 points)

A
  • safe excipients

- safe and easy administration

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7
Q

Why is CR and desirable PK important?

A

-to achieve sufficient bioavailability

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8
Q

What is the clinical evidence in children like? (4 points)

A

generally lacking due to

  • heteregenous population (physiology)
  • small segment market (~15%)
  • difficulties in controlled clinical studies, (ethical issues)
  • formulation challenges
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9
Q

What are the preferred dosage form for infants 1 month - 2 years old?

A

liquids in small volumes e.g. syrups, solutions

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10
Q

What is the preferred dosage form for children 2-5 years old?

A

-liquids and effervescent tablets

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11
Q

What is the preferred dosage form for children 6-11 years old?

A

-solids including chewable tabs, orally disintegrating tabs

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12
Q

What is the preferred dosage form for adolescents 12-18 years old?

A

-solids like tablets and capsules

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13
Q

What is the age generally considered for a child to safely swallow a solid oral dosage form?

A

6 years old

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14
Q

What are the formulation development factors that should be considered? (3 points)

A
  • efficacy and ease of use
  • patient safety
  • access of patient to medicines
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15
Q

What criteria must a product meet to achieve efficacy and acceptability? (3 points)

A
  • dosage (flexibility)
  • easy preparation/administration
  • compliance (minimal impact on lifestyle)
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16
Q

What criteria must a product meet to achieve patient safety? (3 points)

A
  • adequate bioavailability
  • minimal, tolerable excipients
  • stability during shelf life and in use
  • minimal risk of dosing error
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17
Q

What criteria must a product meet to achieve adequate patient access? (3 points)

A
  • robust manufacturing process with commercial viability
  • Affordable (acceptable cost to patient, and payers
  • easily transported and stored, low environmental impact
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18
Q

Why should the oral delivery route be considered? (5 points)

A
  • swallowing abilities vary greatly across ages
  • solids vs liquids have diff properties
  • frequency of administration can be a challenge
  • taste masking can be difficult
  • novel delivery systems have potential
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19
Q

What is “Rubifen”? (4 points)

A
  • Methylphenidate
  • used for tx of ADHD
  • immediate release often requires morning & midday dose difficult when at school
  • CR formulation requires OD dosing
20
Q

What are some approaches to taste masking? (5 points)

A
  • Numbing/blocking taste buds
  • Obscuration of taste
  • Modification of API
  • Creating molecular barrier around API
  • Applying physical barrier on API
21
Q

How can taste be obcured? (3 points)

A
  • increasing viscosity
  • adding sweetners/flavourants
  • mixing with food
22
Q

How can the API be modified? (2 points)

A
  • changing the solubility (salt, pH)

- pro drug

23
Q

How can a molecular barrier be created around the API?

A

-complexation using ion exchange resins or cyclodextrins

24
Q

How can a physical barrier be applied around the API?

A

-using polymeric and lipidic coatings

25
Q

What are the limitations with the oral route? (4 points)

A
  • solid dosage forms often available but may be inappropriate
  • Px may have difficult doses (1/3 of a tablet)
  • swallowing difficulties
  • liquid dosage forms may be unavailable
26
Q

What happens if liquid dosage forms are unavailable?

A
  • requires extemporaneous compounding
  • liquid for inj, disp tab, formulating suspensions
  • need to consider stability, accuracy and taste
27
Q

What is extemporaneous compounding?

A

-manipulation of drugs & chemical ingredients with use of traditional compounding techniques to produce medications suitable for patients when no commercial forms are appropriate

28
Q

What are the advantages and disadvantages of oral liquid dosage forms in paediatrics?

A

+liquid formulations viewed as the gold standard
+accurate dose can be administered in an easy to swallow form
+formulating suspension can improve Px compliance
-taste is a major obstacle to compliance
-choice of appropriate vehicle is important

29
Q

What is the nipple shield device? (3 points)

A
  • modified silicone nipple shield
  • has an insert containing the API
  • also has lips to hold the insert
30
Q

How does the nipple shield device work? (4 points)

A
  • uses milk as a vehicle for the administration of drugs
  • designed to accommodate drug-loaded insert delivering API into milk while breastfeeding neonates
  • lipid based vehicles provide solubilisation of highly lipophilic drugs
  • Self emulsifying DDS can be prepared as solid dosage forms for reconstitution (milk = emulsion)
31
Q

What is dose sip technology? (4 points)

A
  • consists of a straw containing spheroids
  • spheroids are neutral tasting
  • liquid permeable controller supports spheroid transport during sipping, enables final check whether dose has been delivered to Px
  • cap closes the system at the top
32
Q

How does the dose sip technology work? (4 points)

A
  • contains premeasured ready to use medicine with taste masking (coated with spheroids) and potential for SR
  • drug initially in solid form improves stability
  • drug is delivered as the Px uses the draw to drink liquid.
  • e.g. Clarosip containing clarithromycin
33
Q

What are fast dissolving drug delivery systems? (4 points)

A
  • designed to disintegrate/dissolve once in contact with saliva
  • may dissolve over a few seconds to 1 minute
  • drug may absorb from oral cavity or from GIT as dissolved drug is swallowed
  • need to consider taste masking
34
Q

What are the advantages with FDDDS? (5 points)

A

+excellent dose flexibility
+water not required
+avoids swallowing
+preferred over conventional formulations
+continuous manufacturing can be achieved

35
Q

What are the disadvantages with FDDDS? (8 points)

A
  • CR and taste masking is challenging
  • excipients of unknown safety profile may be required
  • specialised packaging required
  • retention time in mouth alters bioavailability
  • uniformity of dose challenging
  • only low doses can be incorporated
  • technology subject to intellectual copyright
  • uses solvent based manufacturing process
36
Q

What is Benznidaole? what is chagas disease? (5 points)

A
  • drug indicated for Tx of Chagas Disease
  • Chagas disease affects 8-10M ppl worldwide, kills 12K ppl annually
  • transmitted during pregnancy from infected mother to baby
  • children are at high risk of infection
  • Tx in first year of life eliminates the parasite from 90% of newborns
37
Q

What are the limitations with conventional Benznidazole formulations? (4 points)

A
  • previously only available as 100mg tablet for adults
  • dosing is 5-10mg/kg/day
  • treatment for young children requires compounding and administered BD for 60 days
  • improper dosing, increased S/Es, ineffective Tx, stopping Tx
38
Q

What are the advantages of the new formulated Bnznidazole treatment? (2 points)

A
  • new 12.5mg tab is easily dispersed

- indicated in Px up to 2 years of age

39
Q

What is EMLA? (4 points)

A
  • contains lignocaine 2.5% and prilocaine 2.5%
  • sufficient application time is required
  • used in vaccines to ease discomfort
  • although EMLA acts on local blood vessels, vaccines are still effective in promoting protective levels of antibodies
40
Q

What formulations is EMLA available in? (3 points)

A
  • cream (5x5g or 30g tubes)
  • patches (1g patch in packs of 2 or 20)
  • AstraZeneca Ltd
41
Q

What is Bioject? (4 points)

A
  • liquid medicine formed at high speed through tiny orfice held against the skin
  • designed to deliver accurate dose of medicine with minimal or no discomfort without using a needle
  • can deliver subcut, IM
  • skin and injector are swabbed with alcohol prior to injection
42
Q

How does Bioject work? (4 points)

A
  • uses high pressure CO2 to pierce the skin
  • medication dissipates over greater area compared to needle stick
  • during injection, Px will feel some pressure
  • localised redness and tenderness may follow
43
Q

What is the pulmonary delivery route? (4 points)

A
  • large bloodflow and SA
  • predominantly for local delivery, but has potential for systemic delivery
  • some dosage forms are difficult for younger Px to understand and coordinate
  • preparations for inhlation include liquids for nebulisation, MDI, DPI
44
Q

What is a metered dose inhaler? (3 points)

A
  • pulmonary pressurised delivery device
  • contains active drug, propellant and cosolvent in the container
  • when pushed, the actuator seal releases a set dose of drug through the nozzle and out via the spray orfice.
45
Q

What are the challenges of pulmonary delivery? (3 points)

A
  • need to consider implications of physiology of children
  • limited by their ability to use devices correctly (coordination problems)
  • total lung deposition is important for clinical effect (affected by formulation and delivery device controlling size distribution of aerosol)
46
Q

What is the issue with ethanol in paediatric medicines? (4 points)

A
  • WHO wants safe and effective meds for children
  • excipients are usually biologically inert, but some do have biological effects
  • ethanol is used in some liquid medicines as solvent, preservative and sometimes as an active
  • safety concerns regarding ethanol use (case reports and anecdotal evidence)
47
Q

What are examples of ethanol used in formulations? (3 points)

A
  • Elixirs: clear, sweetened hydroalcoholic liquids with alcohol content ranging from 5-40% v/v e.g. antihistaminic elixirs
  • Digoxin contains 10.1-11.4$ v/v ethanol, used in Px of all ages at small quantities with unknown effect. Unsure of chronic exposure implications
  • Oral gel for teething and mouth ulcers for general sale should have “this preparation contains alcohol” as can have 38-76% v/v ethanol

Pharmacy 408 pharmaceutical lectures (5 decks)

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