Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

829 dosage 2 > exam 3 lecture 7 > Flashcards

exam 3 lecture 7 Flashcards

1
Q

biologics

A

meds derived from living organisms
recombinant proteins, peptides, blood factors, vaccines, oliognulceotides, cell-based therapy
biotech drugs or biopharmaceuticals

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

importance of biologics

A

top 200 drug sales 2018 –> 73 were biologics
top 100 drug sales in 2003 –> 5 were biologics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

monoclonal antibodies (mAb)

A

two light chains (L)
two heavy chains (H)
linked by SS bonds
antigen binding occurs through variable domain(V) at (CDR)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

antibody drug conjugates

A

trojan horse
linker on ADC attaches to cytotoxic agent
combine target specificity of mAb with efficacy of small molecule drugs
can use mAb fragments rather than whole mAb

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

cytokines

A

IL, INF
neulasta, epogen, avonex, rebif, humatrope

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

insulins

A

a-chain and b-chain linked by ss bonds
alpha helical structure –> readily associates to form dimers, hexamers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

insulin analogs

A

lispro insulin: fast acting insulin analog, lys and pro on c-terminus are reversed
aspar insulin: fast acting insulin analog, pro on c-terminus of b-chain mutated to asp
glargin insulin: long acting, asn on a21 mutated to gly

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

peptides

A

short proteins less than 50 AAs
some secondary structure, no higher order structure
some chemical modifications
peptide vs peptide analog

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

peptidomimetic (telaprevir)

A

peptide like structure

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

vaccines

A

types: inactivated, attenuated, toxoid, conjugate, subunit
differ widely in size and structure
can be much larger than other biologics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

cell therapies –> new biologics

A

car-t cell therapies
- remove immune cells from patient’s blood,
- genetically program to fight cancer cells,
- multiplied + infused into patient,
- newly programmed car-t cells kill cancer cells

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

oligonucleotides –> new biologics

A

used to treat spinal musclar atrophy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

dosage forms for biologics

A

dosing is usually parenteral: except oral vaccines
peptides and proteins cannot be given orally
common dosage forms:
- solution for injection, pen/autoinjector, pre-filled syringe, lyphilized powder

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

solution formulation

A

simple and least expensive
convienent for patients and hospital bc they don’t need reconstitution
can be inspected prior to administration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

clinical concerns for solutions

A

efficacy, sterility, side effects (dose-limiting immune response)
pain from injection

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

formulation concerns solutions

A

all clinical concerns
stability: aggregation, chem stability, shelf-life, storage conditions
manufacturing: cost, manufacturing time

17
Q

formulation variables solutions

A

solution properties: ph, ionic strength, drug conc., volume, excipients.
container: materials
Storage conditions: refrigerator vs room, frozen

18
Q

formulation variables: pH

A

rate of sCT degradation depends on pH
pH of maximum stability is 3-4 –> not a pH for injection
additive makes stability worse

19
Q

formulation variables: concentration

A

beta lactoglobulin is a milk protein
higher concentration of it results in increased and greater aggregation
SC delivery required small volumes –> mAb concentrations risk aggregation

20
Q

formulation variables: excipients

A

stabilize proteins
promote interactions with water and stabilize native protein structure
excipients that bind to proteins can lead to denaturation
exception: protein binding to ligands can stabilize native structure

21
Q

Eythropoetin

A

erythropoetin (EPO, Epoetin) is used to treat anemia in renal disease

22
Q

anti-EPO antibodies

A

reduces drug effect and that of any naturally occur EPO

23
Q

Pure red cell aplasia (PRCA)

A

results in sudden onset anemia, death
increasesd PRCA has been associated with change in container closure (stopper)

24
Q

what if solution formulation does not work

A

store at fridge temperature
freeze
freeze-dry or spray-dry to create dried powder for reconstitution
re-engineer protein molecule
abandon drug candidate

25
Q

practical considerations

A

store at reccommended temp
protect from light
avoid agitation
examine vial for particulates prior to admin
be aware of adverse immune response

26
Q

prefilled syringes, autoinjectors, pens

A

prefilled syringes, pens, autoinjectors are not formulations
pen is a medical device
solution inside pen is formulation
together “combination product”

27
Q

advantages prefilled, pens, auto

A

ease of use
ease of transport
discrete
increased pt compliance
reduced risk of dosage error and product contamination

28
Q

disadvantages prefilled, pens, autos

A

higher cost than vials + syringes
cannot mix two drugs
drug waste bc of priming
greater surface-volume ratio, presence of lub, induce aggregation of protein drugs

29
Q

prefilled syringe components

A

syringe barrel
leur lock
finger grip
plunger
gasket
top cap

30
Q

insulin pen components

A

cap
outer needle
inner needle
needle
protective seal
rubber seal
insulin reservoir
dose window
dosage knob
injection button

31
Q

common features pen, prefilled, autos

A

solution dosage forms within a device for admin
common features: drug solution, needle, piston/plunger, housing

32
Q

special concerns prefilled, pens, autos

A

when compared to vials:
higher surface-to-volume ratio
lower total volume
syringe lubes + oils

33
Q

aggregation in syringe

A

proteins are surfactants that can unfold when exposed to surfaces or interfaces
on wall of syringe there is lubricant, which can cause proteins to unfold and dimerize then aggregate

34
Q

advantages lyphilized powders

A

reduced rates of chem + physical degradation
improved drug stability + longer shelf-life
refrigerated storage not usually needed
can use lyophilized formulations in prefilled, pens, autos

35
Q

disadvantages lyophilized powders

A

must be reconstituted prior inj
less convenient than solutions
more expensive and time consuming

36
Q

lyophilized powders

A

freeze drying
removes water by sublimation
occurs @ low temp + low pressure
gentler than other methods of moving water
same for foods

37
Q

lyophilization can cause instability

A

freeze-concentration can promote aggregation
disulfide bond scrambling can be accelerated by freezing and drying
protein structure can be perturbed by lyophilization
- excipients to inhibit this: lyoprotectants + cryoprotectants
aggregated and/or degraded protein can be observed on reconstitution

38
Q

clinical considerations

A

biologics are usually marketed in lyophilized form because they are unstable in solution
use caution: reconsitution, storing + handling, when administering ; visually inspect for particulates

829 dosage 2 (17 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions