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Biopharmaceutics > 8 - Parenteral > Flashcards

8 - Parenteral Flashcards

1
Q

Advantages of parenteral administration?

A
  • fast action
  • complete/better absorption
  • predictable outcomes
  • drug targeting
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2
Q

Disadvantages of parenteral administration?

A
  • short action
  • invasive administration
  • poor patient compliance
  • hospital visits
  • high cost
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3
Q

What are “dispersed systems” ?

A
  • a thermodynamic, interfacial system in which one component is dispersed in the other
  • pharmaceutical colloids in nature
  • stability, interfacial phenomena, mass transfer
  • higher quality requirements that counterpart preparations for oral delivery
  • complex and expensive formulation
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4
Q

List 3 dispersion types

A

1) Lyophilic
2) Lyophobic
3) Association

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5
Q

Dispersion type:

Describe Lyophilic

A

a soluble dispersed phase in a continuous phase as in emulsions

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6
Q

Dispersion type:

Describe Lyophobic

A

an insoluble dispersed phase in a continuous phase as in suspensions

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7
Q

Dispersion type:

Describe Association

A

a soluble dispersed phase that is also “self-assemble” in a continuous phase as in liposomes

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8
Q

List different depot formulations

A
  • suspensions (aqueous or oil)
  • IM or SC administration
  • drug reservoirs
  • controlled drug release rate from injection site
  • prolonged therapeutic effects
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9
Q

What is the difference between dissolution and solubility?

A

Dissolution: how fast is that compound going to dissolve (relates to rate)

Solubility: does not relate to rate, just how much is going to dissolve in the solvent

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10
Q

Describe dissolution depots

A
  • salts and complexes with low solubility
  • suspensions of microcrystals
  • slow drug dissolution from formulation or into biological fluid
  • dissolution could be alone or in combination with vehicle
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11
Q

The _____ the particle size, the more the depot (deposit?)

A

larger

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12
Q

What are adsorption depots?

A
  • drug-absorbent binding
  • unbound absorption
  • continuous equilibrium
  • force of binding and ratio of drug vs. absorbent
  • aluminum hydroxide gels
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13
Q

Describe esterification depots

A
  • bioconvertible prodrugs (esters)
  • interfacial partition and prodrug bioconversion
  • relatively easy formulation and manufacture
  • actual commercial products
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14
Q

Describe encapsulation depots

A
  • microcapsules, microparticles, liposomes, nanoparticles
  • polymers or macromolecules
  • barrier permeation or biodegradation
  • novel drug delivery systems
  • complex procedures
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15
Q

Describe injectable emulsions

A
  • aqueous and oil phases
  • emulsifiers
  • internal and external phases
  • W/O or O/W or W/O/W or O/W/O
  • drug can be in either phase
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16
Q

What kind of parenteral nutrition can be given for terminally ill patients?

A

amino acids, dextrose, electrolytes, minerals, vitamins, fatty acids

*can also have parenteral preparations for candidates with poor or no solubility in water

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17
Q

Describe multiple emulsion

A
  • hydrophilic & hydrophobic emulsifiers
  • W/O/W or O/W/O
  • two internal phases
  • more stable
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18
Q

Describe microemulsion

A
  • small particles (< 1000 nm)
  • transparent
  • most parenteral emulsions belong to this category
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19
Q

Most parenteral emulsions belong to which category?

A

microemulsion

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20
Q

Describe some characteristics of emulsions

A
  • Internal phase: stability, solubility
  • Sustained release
  • Drug targeting
  • Particle size/stability
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21
Q

List some side effects of emulsions

A
  • Emboli in lung/liver/kidney/brain

- Headache/fever/chill/BP change/liver damage

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22
Q

List some physicochemical requirements of emulsions

A
  • stable
  • uniform
  • sterile
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23
Q

List some biological requirements of emulsions

A
  • endotoxin-free
  • non-antigenic
  • low side effects
  • metabolizable
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24
Q

List some practical requirements of emulsions

A
  • storage tolerance
  • easy processing
  • reasonable cost
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25
Q

List an example of an emulsifier

A
  • Lecithins
  • Pluronic
  • phosphatidylcholine
  • glycerol/propylene glycol
  • polysorbate
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26
Q

List examples of oil phases

A
  • soybean oil

- safflower oil

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27
Q

What is the aqueous phase?

A

water for injection

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28
Q

What other components of emulsifiers are controlled by other additives?

A
  • pH
  • osmolarity
  • viscosity
  • oxidation
  • microbial growth
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29
Q

What does microfluidization do?

A

decreases particle size

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30
Q

What factors are considered in quality control?

A

1) pH = 6.6 - 6.8
2) Particle size = 0.2 - 0.5 micro meters
3) Surface charge (stability related, higher is preferable)
4) Stability
- Physical: particle change, creaming, coalescence, separation
- Chemical: Drug activity, hydrolysis, oxidation, pH change
- Microbiological: bacterial/fungal growth

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31
Q

Parabens are ______

A

preservatives

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32
Q

Describe administration of parenterals

A
  • mostly IV injection (could be SC or IM I think)
  • components of total nutrient admixture
  • hospital applications
  • storage in fridge for better stability
  • incompatibility likely if admixing inappropriately
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33
Q

Hospital Dispensing:

IV lipid emulsions can be administered in combo with _____ and ____ _____

A

dextrose and amino acids

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34
Q

Hospital Dispensing:

____ are generally not added to the admixtures, with rare exceptions (ex. heparin, insulin, ranitidine)

A

Drugs

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35
Q

Hospital Dispensing:

What is the major concern?

A

physical stability

ex. phase separation, precipitation

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36
Q

Describe Injectable Suspensions

A
  • Insoluble drug particles
  • Aqueous or non aqueous medium
  • Suspending agents
  • Most difficult formulation in terms of stability and production
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37
Q

Why are injectable suspensions the most difficult to formulate?

A
  • drugs with limited aqueous solubility
  • solubilization with pharmacological or toxicological compromise
  • requirements for sustained drug release
  • requirements for long-term local drug effects
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38
Q

Characteristics of injectable suspensions?

A
  • Increase drug stability profiles due to insolubility
  • Controlled release action
  • Depot release
  • Formulation stability issues
  • Difficulty in formulation and production
  • Discomfort to patients
  • Dose accuracy
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39
Q

List some physicochemical requirements of injectable suspensions

A
  • stable
  • uniform
  • sterile
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40
Q

List some biological requirements of injectable suspensions

A
  • pyrogen-free
  • non-irritating
  • low side effects
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41
Q

List some practical requirements of injectable suspensions

A
  • resuspendability
  • syringeability
  • injectability
  • easy production
  • easy administration
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42
Q

What is syringeability?

A
  • passing through needles
  • no clogging
  • dose accuracy
  • less than 5 micro meters
  • 0.5-5% solids
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43
Q

What is injectability?

A
  • good flow
  • even pressure
  • clogging-free
  • less discomfort
  • viscosity-related
  • excipient-related
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44
Q

Injectable suspensions:

What are some flocculating/suspending agents?

A
  • surfactants
  • polymers/colloids
  • electrolytes
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45
Q

Injectable suspensions:

What is a wetting agent?

A

surfactant

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46
Q

Injectable suspensions:

Contain _______ to prevent microbial growth

A

preservatives

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47
Q

Injectable suspensions:

What are some stabilizers

A
  • antioxidants

- chelating agents

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48
Q

Injectable suspensions:

What are some adjustors?

A
  • buffering agents

- tonicity agents

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49
Q

Injectable suspensions:

What are some solvents?

A

either water or oil

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50
Q

What are some requirements for oils for injection?

A
  • pure
  • biodegradable
  • IM injection only as a vehicle
  • IV injection as an emulsion
  • mainly for steroids, hormones and vitamins
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51
Q

What are some types of oils for injection

A
  • soybean oil
  • safflower oil
  • peanut oil
  • cottonseed oil
  • corn oil
  • olive oil
  • sesame oil
  • apricot kernel oil
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52
Q

What is included in chemical quality control?

A
  • active ingredients
  • degradation
  • preservatives
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53
Q

What is included in biological quality control?

A
  • sterility test
  • pyrogen test
  • preservative action
54
Q

What is included in physical quality control?

A
  • resuspendibility
  • sedimentation
  • syringeability
  • crystal growth
  • size distribution
  • zeta potential
  • rheology
  • pH
  • dissolution
55
Q

What are pyrogens?

A

Fever-inducing agents

-Can cause a rise in temp of more than 0.6 degrees celsius

56
Q

Pyrogens can result in ____ and _____

A

shock and death

57
Q

What is an example of a pyrogen

A

bacterial LPS

58
Q

Describe administration of injectable suspensions

A
  • Mostly IM and SC injections
  • slow/controleld release actions
  • withdrawal from the ampoules
  • discomfort to injection site
  • not co-administered with other medications
59
Q

Describe what pharmaceutical implants are

A
  • devices in dermal/subdermal tissues for extended period of time
  • sustained drug release profiles
  • alternatives for long-term drug uses
  • surfical implant and removal
60
Q

Good characteristics of pharmaceutical implants?

A
  • long-term actions
  • steady drug concentrations
  • one administration
  • various release mechanisms
  • compliance
61
Q

Bad characteristics of pharmaceutical implants?

A
  • surgical procedures
  • complications
  • difficult retrieval
  • inflexibility
  • complex production
  • high unit cost
62
Q

What is the objectives/purpose of pharmaceutical implants?

A
  • delivering controlled drug release
  • simplifying administration procedure
  • minimizing medical implications
  • reducing unauthorized misuse
  • improving patient compliance
63
Q

Pharmaceutical implants can either be permeation-controlled, diffusion-controlled or partition-controlled:

Describe premeation-controlled

A
  • rate-controlling polymer membrane

- permeation in/out of the system

64
Q

Pharmaceutical implants can either be permeation-controlled, diffusion-controlled or partition-controlled:

Describe diffusion-controlled

A
  • polymer matrix
  • insoluble polymers
  • diffusion in/out of the system
65
Q

What is Norplant 2?

A
  • membrane-matrix hybrid

- both permeation and diffusion

66
Q

Pharmaceutical implants can either be permeation-controlled, diffusion-controlled or partition-controlled:

Describe partition-controlled

A
  • dispersed drug microreservoirs

- drug partition through the system

67
Q

What is an osmotic pump?

A
  • osmotic-producing agnet
  • universal formulation
  • custom-made possible
68
Q

Describe “Magnetic Activated”

A
  • In vivo device
  • In vitro control
  • Both triggering and nontriggering
  • Prototype
69
Q

Describe the Application of magnetic activated

A
  • decreasing use in humans
  • research-based studies in animals
  • long-term drug studies
  • veterinary applications
70
Q

Why are liposomes used in cosmetics?

A

Liposomes are lipid based and our skin has a high percentage of lipids so this will increase absorption

*If you apply lipids to other lipids (like dissolves like) and there will be a higher amount of drug delivery

71
Q

What are liposomes?

A
  • A structure consisting of lipid bilayers (to mimic our skin for best drug delivery) separated by aqueous compartments (vesicles)
  • Heterogeneous disperse systems
  • Wide particle size distribution
  • Phospholipids and cholesterol
72
Q

List the 3 types of liposome vesicles

A
  • large unilaminar vesicle
  • small unilaminar vesicle
  • multi-laminar vesicle
73
Q

What does sonication do?

A

breaks up particles

74
Q

What does a vortex do?

A

causes high vibration rates and shakes the products to reduce particle size

75
Q

What does reverse phase evaporation do?

A

solubilizes in an organic solvent, add water at higher temp allowing it to boil off

76
Q

What does the french press method do?

A

uses high pressure to push particles through filter

77
Q

Bonus question on exam!!!!

What was the car brand used in the asthma commercial?

A

Volvo

78
Q

Bonus question on exam!!!!

Something about how tumours can be used to enhance drug delivery??

A
  • tumor’s vasculature is very good

- has enhanced permeation and retention effect

79
Q

______ = stabilizer of liposomes

A

Cholesterol

80
Q

Using products with liposomes does scare some people about increasing their cholesterol. Is this a legitimate concern?

A

No - the amount of cholesterol used is very minimal

81
Q

How does cholesterol stabilize liposomes?

A
  • Decreases bilayer fluidity/viscosity
  • Reducing membrane permeability
  • Minimizes interaction with biological fluids
82
Q

________ = naturally existing, abundant in vivo

A

Cholesterol

83
Q

Cholesterol is also _______, ________, and ________

A

biocompatible, biodegradable and bioabsorbable

84
Q

How are liposomes eliminated from the body?

A
  • through the liver, but not in the traditional sense
  • If it does get to liver or blood, immune cells with recognize liposomes and will start ingesting it
  • macrophages of the liver with ingest liposomes and render them useless
  • *they are going to the target tissue but not being effective because they are getting ingested

???? doesn’t really make sense, but that’s all I wrote down

85
Q

What are some other components in liposomes?

A

-polymers, surfactants, stabilizers

86
Q

What are liposomes used mainly in?

A

cosmetic and topical liposomes formulations

87
Q

Caution use of liposomes in ??

A

parenteral formulations due to safety concerns

88
Q

Where do hydrophilic drugs load?

A

aqueous compartments

89
Q

Where do lipophilic drugs load?

A

within lipid bilayers

90
Q

Where do amphipathic drugs load?

A

depending on PC

91
Q

Where do large molecules load?

A

surfaces

92
Q

Overall, drug loading in liposomes is relatively ____

A

low

93
Q

Describe “Drug Entrapment”

A
  • Entrapment dependent on internal volume
  • Charged lipids increase volume by repulsion
  • Diluted solutions show higher entrapment
  • Drug leachability is common with liposomes
94
Q

Liposomes:

In vitro fate of particle size?

A
  • physical stability
  • uniformity
  • drug loading
95
Q

Liposomes:

______ particle size distribution is preferable

A

Narrower

96
Q

Liposomes:

In vivo fate of particle size?

A
  • interaction with blood components

- uptake by tissues and cells

97
Q

Liposomes:

_____ targeting possible by sorting particle size

A

Specific

98
Q

What is the typical formula of a liposome?

A
  • Egg lecithin 45%
  • Phosphatidylserine 9.9%
  • Cholesterol 45%
  • Vitamin E 0.1%
99
Q

Describe physical in vitro stability of liposomes

A
  • dynamically instable
  • particle aggregation
  • particle fusion
  • phase change (don’t want fusion or phase change)
  • drug leaching

*don’t want aggregation or it to break apart

100
Q

Describe chemical in vitro stability of liposomes

A
  • hydrolysis
  • oxidation
  • pH
  • membrane permeability
  • drug delivery

-environmental related (light, air, temperature, etc)

101
Q

Describe in vivo stability of liposomes

A
  • various interactions in vivo
  • instability due to protein transfer
  • size and preparation related
  • drug loss dramatic
  • specific targeting possible but mechanisms not well studied and understood (leaky vasculature is a proposed theory)
  • biggest challenge for medical application
102
Q

Why do we create stealth liposomes?

A

Trying to allow liposomes to hide from the immune system therefore they would be allowed to reach the target tissue !!!

103
Q

Describe Stealth Liposomes

A
  • polymer attachment
  • “invisible” to immune system in vivo
  • increased retention and stability
  • more site-targeting
  • challenging formulation
  • the longer the stage in blood, the more it can target cancer cells
  • want to increase half life therefore allowing more particles to reach target site (cancer tumor)
104
Q

We need to sterilize nanoparticles, what is the max size of nanoparticles for filtration?

A
  1. 22 microns

* Anything small can be filtered as a form of sterilization

105
Q

Sterilization of liposomes:

_____-_____ filtration for final sterilization

A

microbial-retentive

106
Q

Sterilization of liposomes:

_______ should not affect liposome structure

A

filtration

107
Q

Sterilization of liposomes:

_____ and ______ sterilization could compromise structure integrity and drug activity

A

thermal and radiation

108
Q

Sterilization of liposomes:

______ manufacturing expensive and difficult in validation

A

Aseptic

109
Q

Characteristics of liposomes?

A
  • biocompatibility
  • biodegradability
  • small particles
  • diverse drug loading
  • parenteral use
  • drug targeting
  • instability
  • high material cost
  • large-scale production difficulties
110
Q

What are the medical applications of liposomes?

A
  • site-specific delivery
  • site-avoidance delivery
  • sustained/controlled drug release
  • passive drug targeting to tumors
  • protein/peptide/gene delivery
111
Q

Describe nanotechnology

A
  • Buzzword, promising potentials
  • A broad range of topics: colloidal sciences, supramolecular chemistry, device physics, engineering, etc.
  • Multidisciplinary and interdisciplinary
  • More marketing strategies than actual applications
112
Q

Pharmaceutical applications of nanotechnology?

A
  • controlled release
  • taste masking
  • stability improvement
113
Q

Food applications of nanotechnology?

A
  • nutrient protections
  • ingredient isolations
  • odor/taste masking
114
Q

Agriculture applications of nanotechnology?

A
  • pesticides/fertilizers
  • veterinary use
  • chemical biodegradation
115
Q

Commercial/industrial applications of nanotechnology?

A
  • fragrance release
  • detergent isolation
  • thermal release
116
Q

List some polymeric dispersions

A
  • microcapsules
  • microspheres
  • nanocapsules
  • nanospheres
  • nanoparticles
117
Q

Difficulties with nanoparticles?

A
  • use of organic, toxic solvents
  • operator protection
  • environmental pollution/protection
  • large-scale production
  • production cost
118
Q

Describe the separation of nanoparticles

A
  • solvents
  • free drugs
  • polymers
  • additives
119
Q

Describe the purification of nanoparticles

A
  • stability
  • toxicity
  • quality
  • injectability
120
Q

What is ultracentrifugation?

A
  • spin it at high rates and separate particles

- once nanoparticles settle to the bottom, we can separation the organic solvent from it

121
Q

How can the principle of dialysis be related to separation of nanoparticles

A

Put nanoparticles in the bag and spin it in the beaker.
Buffer = water in this case
(water is considered low salt/low solute)

Organic solvents want to come out of the bag (follow concentration gradient).
Dialysis bag is semi-permeable membrane and nanoparticles that are too big to leave the bag while everything else smaller than that is able to leave the bag

*just using a barrier (dialysis bag) to separate particles based on size

122
Q

What is included in physical quality control?

A
  • Size & distribution (dynamic light scattering)
  • Morphology (SEM)
  • Drug loading
  • Drug release
  • Physical states
123
Q

What is included in chemical quality control?

A
  • Drug activity (functional assays)
  • Degradation (HPLC)
  • Byproducts
  • Additives (HPLC)
  • Interactions
124
Q

How can the drug be released from nanoparticles?

A
  • Hydrophilic polymers facilitate faster drug release than lipophilic polymers
  • Drug solubility, diffusivity, molecular weight and particle size influence drug release rate and extent
  • Controlle released is achievable by formulation strategies

Drug can release by:

1) nanoparticles eroding
2) drug diffuses out of nanoparticles
3) temp changes could increase or decrease drug release

125
Q

In vitro = ?

A

outside of body (test tube)

126
Q

In vivo = ?

A

in the body

127
Q

Describe in vitro studies

A
  • interaction with blood components
  • uptake by cells
  • stability
  • toxicity
128
Q

Describe in vivo studies

A
  • animal models
  • drug targeting
  • drug activity
  • drug toxicity
  • overall outcomes
129
Q

Liposomes are ___ based

A

lipid

130
Q

Nanoparticles are _____ based

A

polymer

Biopharmaceutics (4 decks)

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