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Pharmaceutics 2 > Exam 2 > Flashcards

Exam 2 Flashcards

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1
Q

Suspensions

A

type of dispersed system containing finely divided solid particles in water

insoluble drug particles suspended in solvent

thermodynamically unstable

particle size greater than 500nm

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2
Q

Dispersed phase

A

internal phase of suspensions (particles)

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3
Q

Dispersion medium

A

external phase of the suspension (solvent)

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4
Q

Examples of pharmaceutical suspensions

A

orally-administered mixtures
externally applied lotions
injectable preparations

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5
Q

Why are suspensions useful?

A

Drugs with limited solubility in water (25-100 mg/mL)

taste-masking

improved chemical stability than solutions

longer-acting drugs; slower drug absorption from suspensions

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6
Q

Short (regular) insulin is a solution with a high efficacy after x hours?

A

2

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7
Q

Intermediate (NPH/long acting form) is a suspension with a high efficacy after x hours

A

4

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8
Q

Duration of NPR

A

less than 6 hours

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9
Q

Duration of NPH

A

up to 14 hours

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10
Q

Desirable characteristics of a suspension

A

adequate dispersion of particles in solvent

minimal aggregation/clumping of particles in suspension

prevent caking (formation of sedimentation that can’t be resuspended)

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11
Q

Formulation of a suspension has to be prepared such that it can be suspended upon?

A

moderate agitation/shaking

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12
Q

v= {d^2 x (pi-pe) x g} / 18n

A

stokes equation; relates sedimentation velocity to particle size and density, and solvent viscosity

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13
Q

As solvent viscosity increases, sedimentation velocity…

A

decreases

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14
Q

What are the 2 key approaches to improve suspension stability

A

use a viscosifier: MC/HPMC

use a flocculating agents: electrolytes such as aluminum chloride, polymers, surfactants

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15
Q

Flocs

A

loosely bound particle clusters
stabilized by weak H-H bonds and van der Waals forces

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16
Q

Flocculated suspensions structure and redispersion

A

structure: scaffold-like, weak bonds

redispersion: easy

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17
Q

Deflocculated suspensions structure and redispersion

A

structure: closely packed, cake

redispersion: difficult/impossible

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18
Q

Suspending agent

A

increases viscosity

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19
Q

wetting agent

A

disperse hydrophobic drug particles
decrease interfacial tension

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20
Q

Antioxidants

A

prevent oxidation

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21
Q

Buffers maintain

A

pH

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22
Q

Biologics

A

derived from biological organisms/biological material
have action specificity
require lower doses compared to traditional small molecule APIs
improved safety profile of protein drugs

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23
Q

How would you describe biologics approval over time?

A

steady rise

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24
Q

Major PO delivery factors of biologics

A
  1. high molecular mass means lower membrane permeability
  2. relative hydrophilicity/hydrophobicity balance
  3. ionic charge- function of proteins hydrophilicity and pH environment
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25
5 challenges to delivery of polypeptide drugs
1. lower permeability across biological membranes 2. lower solubility of hydrophobic proteins 3. smaller molecular mass/particle diameter means rapid kidney clearance 4. immunogenicity of recombinant proteins 5. susceptibility to proteolytic degradation
26
Advantages of Oral protein and peptide delivery systems
protect drug from enzymatic degradation and decrease systemic clearance increased cargo solubility controlled release and minimize undesirable side effects improve biodistribution, decrease non specific uptake low immunogenicity
27
3 characteristics of PEGylated proteins
1. increase in size to reduce kidney filtration 2. increase in solubility due to PEG hydrophilicity 3. decreased accessibility for proteolytic enzymes and antibodies
28
Pegylated protein advantages
sustained absorption increased half life decreased systemic clearance
29
How does PEGylation affect dosing?
decreases dosing intervals increases patient compliance
30
What are challenges for nucleic acid delivery?
hydrophilic molecules limit permeation into hydrophobic membrane have a high molecular mass
31
Short interfering RNA (SiRNA)
interferes with the translation of mRNA into a protein
32
Vectors
carry nucleic acids to their sites of action
33
What are the extracellular steps in nucleic acid delivery?
circulation accumulation penetration
34
Intracellular steps in nucleic acid delivery
fusion endocytosis release endo/lysome escape nuclear localization mRNA delivery siRNA delivery DNA delivery
35
What barriers can carriers overcome?
extracellular and intracellular barriers
36
Where are DNA drugs delivered?
nucleus
37
Where are mRNA drugs and SiRNA delivered?
cytoplasm
38
Gene therapy
clinical application of DNA molecules replacement of mutated copy of the gene with a healthy/normal DNA copy
39
What does ADA deficiency cause?
SCID
40
What drives the need for safer alternative gene delivery?
limited packaging capacity of viral vectors and their immunogenicity
41
What are the 3 main extracellular barriers/challenges to nanoparticle delivery of nucleic acids?
renal filtration non-specific uptake by the liver/spleen nuclease degradation
42
What are the 3 main intracellular barriers/challenges to nanoparticle delivery of nucleic acids?
cellular entry endosomal escape nuclear uptake
43
10-100 nm are useful as?
drug carriers
44
Endosome
acidic compartments
45
Polymers and lipids used for nanoparticle formation for nucleic acid delivery are ?
cationic chemical groups amino groups are the most common
46
What do amino groups in carriers bind to?
phosphate groups in nucleic acids
47
What can go into a lipid nanoparticle?
DNA siRNA mRNA Proteins small molecules
48
What does CAR stand for?
Chimeric Antigen Receptor
49
CAR T-Cell Therapies
involve engineering the patient’s own immune cells to treat their cancer
50
The CAR gene can be delivered to the patient’s T-cell using what?
a viral/non viral NP carrier
51
What will CAR-T bind to ?
the patient’s cancer cell antigen
52
CAR has improved over time for the?
Expansion of CAR-Ts after infusion persistence of injected CAR-T
53
What does the the extracellular domain of CAR do?
recognition/binding of a specific antigen by a T cell
54
What does the intracellular domain of CAR do?
stimulate T-cell proliferation, cytolysis, and cytokine secretion to eliminate the target cell
55
CD19
antigen present on cancer cells
56
anti CD-19 CAR
binds to CD-19 on cancer cells
57
Are CAR-T therapies patient specific?
yes
58
Biological challenges of CAR-T therapies
on target toxicity; CAR-T struggles to tell the difference between normal and cancerous B cells off target toxicity; cytokine release syndrome
59
Manufacturing Challenges of CAR-T cell therapies
high cost heterogeneity of personalized products
60
What does Kymriah treat?
pediatric leukemia
61
What does Yescarta treat?
adult B cell lymphoma
62
How is ER different from IR dosage forms?
1. maintains steady [drug] compared to immediate release dosage forms 2. avoids fluctuations in plasma
63
Eneteric polymers are usually polyacids with a pKa around?
5
64
Which dosage forms are always coated with enteric polymers?
DR
65
Purposes of DR dosage forms?
1. protect the acid-sensitive API from degrading in the stomach 2. protect stomach mucosa against the irritating effects of the drug 3. local delivery effects in the small intestine
66
Characteristics of ER systems
1. prolong duration of drug release 2. avoids fluctuations of [drug] and increases patient compliance
67
controlled release membrane
mechanism where release of API is extended/ controlled over prolonged periods
68
Diffusion mechanism
tablet core surrounded by ethyl/methyl cellulose asymmetric/porous membrane water soluble portion of the membrane dissolves away leaving pores through which water and drug diffuse
69
Dissolution based er drugs
dissolution of the polymetric matrix in addition to dissolution of the API molecules
70
PLGA
poly(lacticacid)- co-glycolic acid
71
Key factors that control the rate of drug release
1. molecular mass of the PLGA polymer 2. [API/drug] that’s loaded in the PLGA polymer matrix
72
Osmotic release oral system
1. GI fluid enters through semipermeable membrane, hydrates the push layer containing an osmogen 2. Osmogen creates the osmotic pressure 3. osmotic pressure is the driving force for zero-order drug release
73
Factors affecting rate of drug degradation
temperature pH light intensity excipients solvents
74
reaction rate
speed or velocity of the reaction expressed in terms of changes in reactant/product concentration over time
75
rate law
a quantitative relationship between the reaction rate and the concentration of reactants and other species present
76
reaction order
describes the concentration dependence of a reaction rate on the concentration of reactants
77
In a zero order reaction, rate is independent of?
concentration
78
First order
rate = k [A]
79
Second order
rate = k[A]^2 OR k [A][B]
80
Third Order
rate = k[A]^2[B] or k[A][B][C]
81
What type of dosage forms are useful to formulate high drug concentrations or drugs with limited water solubility?
suspensions
82
As a drug solubilizes in solution, more drug is released so that concentration stays?
constant
83
half-life
time it takes for a drug to decompose to half of its original concentration
84
You should pick the R^2 value closest to which number?
1
85
A0
starting/ initial [drug]
86
K
rate constant
87
shelf life
time a drug product is expected to remain within its approved specification
88
t90
used to widely indicate shelf life

Pharmaceutics 2 (6 decks)

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