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Dosage Exams > Dosage Exam 3 > Flashcards

Dosage Exam 3 Flashcards

1
Q

What kind of curve represents a polydispersed molecular weight?

A

A broad curve

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2
Q

What kind of curve represents a monodispersed molecular weight?

A

A narrow curve

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3
Q

What does Mn stand for?

A

Number average

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4
Q

What does Mw stand for?

A

Weight average

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5
Q

How is a molecular weight distribution determined?

A

By dividing Mw/Mn

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6
Q

What number polydispersity represents a “monodispersed” weight distribution?

A

Mw/Mn is about equal to 1

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7
Q

What number polydispersity represents a “polydispersed” weight distribution?

A

Mw/Mn&raquo_space;> 1

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8
Q

What are the characteristics of a crystalline polymer?

A

-Linear
-Can pack together at T < Tm
-Sharp Tm
Good barrier to drug diffusion, durable
*Hard to dissolve
*Uniform molecular structure in straight rows

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9
Q

What are the characteristics of an amorphous polymer?

A

-More common
*Irregular structure
-Forms “glass” at T < Tg (low temperatures)
-Softens over a wide temperature range (Tg)
**Rubbery at high temperatures
*Transition temperature is where it goes from being glass to rubbery

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10
Q

What does Tg stand for?

A

Glass transition temperature

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11
Q

What is the Glass Transition temperature (Tg)?

A

The temperature range where a polymer changes from a hard, rigid (glassy) state to a more pliable, compliant (rubbery) state

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12
Q

At T«Tg what state is a polymer in?

A

The polymer is hard, stiff, and glassy

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13
Q

At T»Tg what state is a polymer in?

A

Polymers are rubbery and may flow

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14
Q

What is an example of a drug that utilizes the Tg in its release?

A

Chewable dosage forms like Nicotine gum have Tg’s close to the body temperature so that they become rubbery upon chewing and release nicotine quickly

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15
Q

What are the 3 factors that affect Tg?

A

-Polymer length (longer = higher Tg)
-Side chains (bulkier = Higher Tg)
-Crosslinking (More crosslinked = Higher Tg)

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16
Q

What are plasticizers?

A

Molecules that increase the entropy and mobility of polymer chains
**Ultimately lowers Tg

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17
Q

What is the most common example of a plasticizer?

A

Water

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18
Q

In a stress-strain curve, what does the “slope” represent?

A

Slope is a measure of modulus (stiffness)

–the greater the slope, the less likely a polymer is to bend (more likely to stay stiff)

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19
Q

In a stress-strain curve, what does the “area under the curve” represent?

A

Toughness
(energy required to break the polymer)

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20
Q

What is the difference between chemical gels and physical gels?

A

Chemical gels are crosslinked by covalent bonds

Physical gels are crosslinked by hydrogen bonds, hydrophobic interactions, or complexation

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21
Q

What are hydrogels?

A

Crosslinked networks of hydrophilic polymers
*swell rapidly when in water
*retain large volumes of water in structure

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22
Q

What are biologics?

A

Medications derived from or produced by living organisms

*these are large molecule drugs

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23
Q

What are the 6 kinds of biologics?

A

-Recombinant proteins
-Peptides
-Blood Factors
-Vaccines
-Oligonucleotides
-Cell-based therapies

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24
Q

What is the most common type of biologic drug?

A

Monoclonal antibodies

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25
Q

What are the structural features of MAbs?

A

-high beta-sheet content
-quaternary structure (two light chanins and two heavy chains linked by disulfide bonds)
-molecular weight about 150,000 daltons

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26
Q

Where does antigen binding occur on MAbs?

A

Through the variable domain (V), at the complementarity determining region (CDR)

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27
Q

What drugs are MAb derivatives?

A

-Remicade
-Humira
-Simponi
-Cimzia
-Enbrel

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28
Q

What is an antibody drug conjugate (ADC)?

A

A MAb-based drug where an antibody is linked to a cytotoxic agent

-the antibody is specific for a tumor-associated antigen with restricted expression on normal cells (target specific)

-the cytotoxic agent kills target wells when internalized and released
(efficacious killing)

-these are connected by a linker

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29
Q

What are three examples of cytokines?

A

-Interleukins
-Interferons
-Erythropoeitins

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30
Q

What are some structural features of cytokines?

A

-High alpha-helix content (4-helix bundles)
-Molecular weight is about 30,000 daltons (smaller than MAbs)

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31
Q

What are some structural features of insulins?

A

-Forms hexamers and dimers
-Small peptides or proteins
-Have BOTH A-chains and B-chains linked by SS bonds
-Molecular weight is 5800 daltons (very small)

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32
Q

What kind of insulin analog is Lispro insulin?

A

Fast acting insulin analog
-Lys and Pro on C-terminus are reversed and block dimer and hexamer formation

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33
Q

What kind of insulin analog is Insulin aspart?

A

Fast acting insulin analog
-Pro on C-terminus of B-chain is mutated to Asp

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34
Q

What kind of insulin is Insulin glargine?

A

Long-Acting insulin analog
-Microcrystals form on injection causing slow release of drug

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35
Q

What are peptides?

A

Short proteins (less than 50 amino acids)
-Some secondary structure but no higher order structure

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36
Q

What is an important note about vaccine size?

A

They can be much larger than other biologics

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37
Q

What are the first living drugs?

A

CART-cell therapy

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38
Q

What is an example of an oligonucleotide?

A

Spinraza
-used to treat spinal muscular atrophy
**nucleotide chemical structure

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39
Q

What are the 3 types of coronavirus vaccines?

A

-Protein-based
-Viral vector
-mRNA

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40
Q

What is the route typically used for biologics?

A

parenteral

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41
Q

What are the typical dosage forms for biologics?

A

-Solution for injection
-Pen or autoinjector
-Pre-filled syringe
-Lyophilized powder for reconstitution

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42
Q

What are the benefits to solution formulations for biologics?

A

-Simple
-Least expensive
-Convenient
-Do not require reconstitution
-Can be inspected visually prior to administration

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43
Q

What are the clinical concerns for biologics in solution?

A

-Efficacy
-Sterility
-Side effects
-Pain on injection

44
Q

What are the formulation concerns for biologics in solution?

A

All Clinical Concerns and:
-Stability
-Manufacturability

45
Q

What are the formulation variables for biologics in solution?

A

-Solution properties
-Container/closure
-Storage conditions

46
Q

What is the affect of additives on stability?

A

They make stability worse

47
Q

What is the affect of higher concentration on aggregation?

A

Higher concentration = higher aggregation

48
Q

What is the relationship between turbidity and aggregation?

A

More aggregation = more turbidity

49
Q

How does subcutaneous delivery (SC) affect MAb aggregation?

A

Since SC delivery requires small volumes, MAb concentration is pushed to 100mg/mL which increases its aggregation risk

(need a higher concentration of MAb in a smaller about so it increases risk of aggregation)

50
Q

What are the three ways that proteins aggregate?

A

Chemical reactions
—Cross-linking between protein molecules

Colloidal Interactions
—Molecules stick together without change in structure

Unfolding
—Molecules unfold which puts them at risk of undergoing a chemical reaction or colloidal interactions

51
Q

What are excipients used for?

A

To stabilize the protein

52
Q

What is a necessary feature of excipients in order for them to stabilize a protein?

A

Excipients that are preferentially excluded from the protein surface promote interactions with water and stabilize the native protein structure

53
Q

What is the effect of preferential binding by excipients on proteins?

A

Excipients that bind to proteins can lead to denaturation of the protein

54
Q

What is the one exception with protein and excipient binding?

A

Protein binding to ligands can result in a stabilized native structure

55
Q

Should you shake biologics before use?

A

NO, never shake/agitate biologics
(Can lead to aggregation)

56
Q

What is an important point about prefilled syringes, pens, and autoinjectors?

A

They are NOT formulations

The pen (physical device) is the “medical device”

The solution inside the pen is the “formulation”

Together they are the “combination product”

57
Q

What are the advantages of pre-filled syringes, pens, and autoinjectors?

A

-Convenient and easy to use
-Easy to transport
-Discrete
-Increased patient compliance
-Reduced risk of dosage error
-Reduced risk of product contamination

58
Q

What are the disadvantages of pre-filled syringes, pens, and autoinjectors?

A

-High cost
-Cannot mix two drugs
-Drug waste from priming
-Large surface-to-volume ratio and lubricants can induce aggregation of proteins

59
Q

What are the special concerns associated with pre-filled syringes, autoinjectors, and pens?

A

-High surface-to-volume ratio
-Low total volume
-Syringe lubricant and oils

60
Q

Proteins are surfactants, what does this mean?

A

Proteins can unfold when exposed to surfaces or interfaces

61
Q

What are the advantages of lyophilized powders?

A

-Lower rates of chemical and physical degradation
-Better stability and longer shelf-life
-Do not need to be refrigerated
-Can be used in pre-filled syringes, pens, and auto-injectors (dual-chamber)

62
Q

What are the disadvantages of lyophilized powders?

A

-Require reconstitution
-Expensive and time-consuming to manufacture

63
Q

What is lyophilization and what is its benefit?

A

AKA freeze-drying

-Is gentler than other methods at removing water

64
Q

What is the process that lyophilization uses to remove water called?

A

sublimation

65
Q

In what conditions does sublimation occur?

A

-Low temperature
-Low pressure

66
Q

What are the four stages of lyophilization and in what conditions do they occur?

A
  1. Freezing
    (high pressure (atmospheric) is maintained, temperature decreases)
  2. Vacuum
    (pressure decreases, low temperature maintained)
  3. Sublimation
    (low pressure maintained, low temperature but increasing)
  4. Dry powder to ambient
    (increase pressure back to atmospheric, increase temperature back to atmospheric)
67
Q

What are the ways that lyophilization can cause instability?

A

-Freeze-concentration can promote aggregation
-Disulfide bond scrambling can be accelerated
-Protein structure can be perturbed
-Aggregated or degraded protein can be seen with reconstitution

68
Q

What does lyophilization tell us about the stability of a protein?

A

If a protein is lyophilized, this means it IS NOT STABLE IN SOLUTION

69
Q

What excipients can be used to prevent a protein structure from being perturbed during lyophilization?

A

-Lyoprotectants
-Cryoprotectants

70
Q

What is the outermost layer of skin?

A

stratum corneum

71
Q

What are the “bricks” and “mortar” in the stratum corneum?

A

Bricks: dead cells
Mortar: lipid

72
Q

Are dead cells permeable?

A

No

73
Q

How does permeation of the skin occurs and how does this relate to hydration?

A

Permeation occurs by partitioning through the lipids (mortar) between dead cells (bricks)

-State of hydration is directly related to the ease of permeation

74
Q

What is the second layer of the skin (moving from outward to in)?

A

living epidermis

75
Q

What distinguishes the epidermis from the dermis?

A

The epidermis is living cells without capillaries

*also the source of skin color and tanning

76
Q

What layer of skin much drug reach to have systemic action?

A

Dermis

77
Q

What characteristics distinguish the dermis from the other layers of skin?

A

-Contains capillaries**
-Contains pain, thermal, and tactile sensors
-Injury must reach dermis to scar!

78
Q

What is the purpose of hair follicles and sweat glands in absorption?

A

They are a secondary route of absorption that bypasses the stratum corneum

79
Q

What is emolliency?

A

The softening of horny tissue
(stratum corneum topical effect)

80
Q

What is keratolysis?

A

Chemical digestion and removal of horny tissue
(stratum corneum topical effect)

81
Q

What is an example of an antiperspirant and how does it work?

A

Aluminum Chloride

-irritates and closes the orfices of eccrine glands to impede sweat flow

82
Q

What is an example of a topical medication used for acne treatment?

A

Retinoids

-reset the process of epidermal proliferation and differentiation
-prevent lesion formation

83
Q

Rank the bases of ointments from most hydrophobic to most hydrophilic

A

Hydrophobic

-Hydrocarbon bases
-Silicone bases
-Absorption bases
-Water bases

Hydrophilic

84
Q

What are examples of hydrocarbon bases?

A

-Petrolatum
-Polyethylene dissolved in mineral oil

85
Q

What do silicone bases contain?

A

Polydimethylsiloxane oil

86
Q

What do absorption bases contain?

A

W/O emulsifiers
(emulsion with aqueous solution of drug)

87
Q

What is an example of a water soluble base?

A

Polyethylene glycol ointment

88
Q

What is a paste?

A

An ointment with a high concentration of insoluble particulate solids added

89
Q

What are the two types of creams?

A

O/W or W/O emulsion

90
Q

What is a gel?

A

A liquid phase trapped in a matrix of natural or synthetic polymer

91
Q

What is a rigid foam?

A

Air or other gas emulsified in a liquid phase
*liquid phase may contain drug

Ex: aerosol shaving cream, antiseptic foam

92
Q

How does hydration affect drug permeability?

A

More hydrated = more drug permeability

93
Q

How does iontophoresis work to enhance penetration?

A

Uses low voltage electrical current to drive charged drugs through skin

94
Q

How does electroporation work to enhance penetration?

A

Uses high voltage to create transient pores in skin

95
Q

How does ultrasound work to enhance penetration?

A

Uses low frequency ultrasonic energy to disrupt the stratum corneum

96
Q

How do ionic surfactants work as penetration enhancers?

A

Disorder the lipid layer of the stratum corneum to swell and leach out structural components, reducing diffusional resistance

97
Q

How do reducing agents work as penetration enhancers and what are some examples?

A

Disrupt disulfide bonds of proteins in keratinized cells

-Ascorbate and Dithiothreitol

98
Q

What is azone and how does it work as a penetration enhancer?

A

-Nonpolar oily liquid that fluidizes the lipid region of the stratum corneum

99
Q

What is DMSO and how does it work as a penetration enhancer?

A

-Dipolar solvent
It enters the aqueous region of the stratum corneum and interacts with the lipid polar heads to expand the hydrophilic region between the polar heads

100
Q

What are microneedles used as?

A

-Pretreatment to increase skin permeability before a drug patch is applied

-Coated with drug that is released from the needles after they are embedded into the skin

101
Q

What is it called when microneedles are used right before applying a drug-loaded patch?

A

“poke with patch”

102
Q

What is it called when microneedles are coated with a drug and then embedded into the skin?

A

“coat and poke”

103
Q

What are some common errors in transdermal patch administration?

A

-Preparation
-Removal
-Application
-Monitoring
-Storage and disposal

104
Q

What are the black box warnings for the Xulane patch?

A

-Cigarette smoking and serious cardiovascular risk
-Risk of venous thromboembolism
-PK profile of ethinyl estradiol

Compared to women that take oral contraceptives:
-Higher steady state concentration and lower peak concentration
-AUC and Css are 60% higher
-Cmax is 25% lower

105
Q

What factors affect drug solubility?

A

-Hydration (more hydrated, greater permeability)
-Solubility of drug in stratum corneum
-Excipients
-pH

Dosage Exams (2 decks)

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