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Dosage Forms II > Biologics Exam 3 > Flashcards

Biologics Exam 3 Flashcards

1
Q

Biologic drugs

A

medicinal agents that are derived from living systems

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2
Q

Why are biologics administered parenterally?

A

B/C biologics are degraded in the GI tract

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3
Q

Common forms of biologic dosage forms?

A

-solution for injection
-pen or autoinjector
-pre-filled syringe
-lyophilized powder for reconstitution

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4
Q

Examples of biologics solutions for injection

A

(Raging Snobs Located Expensive Xylophonic Napkins Anxiously)
Rituximab
Synagis
Lucents
Epogen
Xgeva
NovoLog
Avastin

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5
Q

Why solution formulation?

A

-simple and less expensive
-convenient for patients
-doesn’t require reconstitution
-can be inspected before administration

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6
Q

CLINICAL concerns for biologics

A

efficacy
sterility (since it’s given parenterally)
side effects
pain on injection

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7
Q

Dose limiting immune response

A

body will recognize recombinant drug proteins and creates antibodies against it (causing pain and anaphylaxis)

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8
Q

FORMULATION CONCERNS for biologics in solution

A

-stability
-solution viscosity and ease of injection
-manufacturability

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9
Q

Stability concerns

A

aggregation, chemical stability (deamination, oxidation), shelf life, storage condition

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10
Q

Solution viscosity concerns

A

mAbs can be viscous and hard to push

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11
Q

Manufacturability concerns

A

cost and manufacturing time

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12
Q

FORMULATION VARIABLES for biologics in solution

A

-pH (rate of degradation and additives can influence stability)
-ionic strength, tonicity
-drug concentration (aggregation increases with drug conc)
-volume
-excipients (promotes interactions with water and stabilizes)
-container, closure
-storage condition

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13
Q

Ways proteins aggregate

A

-chemical reaction
-colloidal interactions
-partial unfolding (most common)

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14
Q

Aggregation by chemical reaction

A

when covalent bonds link aggregates

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15
Q

Aggregation by colloidal interactions

A

bumping together and stick

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16
Q

Aggregation by partial unfolding

A

hydrophobic regions are exposed, stick together (deathtrap for the stability of drugs)

17
Q

Protein funnel

A

want proteins to stick in their native states, we do not want amorphous aggregates or amyloid fibrils

18
Q

Epoetin and PRCA

A

EPO is used to treat anemia in renal disease, bodies forms anti-EPO antibodies resulting in PRCA (causes anemia and death)

19
Q

What to do when solution formulation doesn’t work?

A

-store in refrigerated temp
-freeze
-freeze dry
-re engineer the protein molecule
-abandon drug candidate

20
Q

Recommendations for biologics

A

-store at recommended temp
-protect from light
-avoid agitation
-examine vial for particulates
-be aware for adverse immune responses

21
Q

What is considered the medical device?

A

pen and autoinjectors

22
Q

What is considered the formulation?

A

the solution inside of the pen

23
Q

What are prefilled syringes, pens and autoinjectors called?

A

a combination product

24
Q

Advantages of prefilled syringes, pens and autoinjectors

A

-Ease of use, convenience
-Easier to transport
-Discrete
-Increased patient compliance
-Reduced risk of having a dosage error
-Reduced risk of product contamination

25
Q

Disadvantages of prefilled syringes, pens and autoinjectors

A

-Higher cost than vial and syringe
-Cannot mix two drugs
-There is drug waste due to priming
-Greater surface-to-volume ratio which can increase aggregation risk

26
Q

Special concerns for prefilled syringes, pens and autoinjectors

A

-Higher surface-to-volume ratio
-Lower total volume
-Syringe lubricants, oils
(which can change interaction of proteins with solid surface, hydrophobic syringe lubricants can promote greater unfolding)

27
Q

Examples of lyophilized powders for reconstitution

A

(majority are mAbs)
Remicade
Nulojix
Orencia
Herceptin
Benlysta

28
Q

Advantages of lyophilized powders for reconstitution

A

-Reduced rates of chemical and physical degradation
-Improved drug stability and longer shelf life
-No need to be refrigerated
-Can use lyophilized formulations

29
Q

Disadvantages of lyophilized powders for reconstitution

A

-Must be reconstitution prior to injection (less convenient)
-More expensive and time-consuming to manufacture

30
Q

Lyophilized powders

A

“freeze drying” which is removing water by sublimation

Dosage Forms II (8 decks)

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