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Drug Delivery > Exam 3- YOU NEED AN A > Flashcards

Exam 3- YOU NEED AN A Flashcards

1
Q

What is the difference between transdermal and topical application?

A

Transdermal application is a drug delivery to the systemic circulation through the skin. Topical delivery is delivery on the skin for a local effect.

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2
Q

Is transdermal always a patch?

A

No it can be gel, ointment, etc.

If it is applied on the skin with a systemic target it is transdermal.

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3
Q

Equilibrium

A

No net flux or diffusion
Rate of drug delivery same on both sides
Concentration same on both sides

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4
Q

Why does equilibrium not happen in drug delivery?

A

Because when the drug molecule reaches the other side it gets into the blood which takes it throughout systemic circulation.
Drug stays on left hand side most of the time in topical and transdermal delivery.

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5
Q

Larger surface area=

A

Higher rate of transport (diffusion)

Increased drug delivery

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6
Q

Definition of flux

A

J= amount/ SA x time

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7
Q

Rate of transport

A

Amount transported per unit time

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8
Q

When is flux used over rate of transport?

A

When you need to compare topical and transdermal formulations if different surface areas are used in different labs during testing.
Flux has SA added to the denominator, it is easier to compare

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9
Q

Is flux dependent on SA?

A

No, flux is independent of SA
Even though SA is in the equation, flux is not dependent on it.
When the SA changes the amount delivered is doubled so the effect is cancelled out.

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10
Q

If there are two systems, one with a large SA and another with a small SA, which has the higher flux?

A

The fluxes are the same. Flux is independent of SA

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11
Q

Rate of transport=

A

J x A

proportional to the area of the membrane

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12
Q

Compare the rate of transport and flux to two transdermal patches one of which is half the size of the other.

A

Bigger patch compared to smaller one deliver twice the amount of drug however the flux of the patches remains the same

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13
Q

Compare the transport rate and flux of two transdermal patches of the same SA.
One patch has a higher drug concentration than the other.

A

Rate of transport- Increased with the patch with the higher concentration
Flux- The patch with the higher concentration has a higher flux

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14
Q

Compare the transport rate and flux of two transdermal patches of the same drug concentration.
One patch has a higher SA than the other.

A

Flux= same

Rate of transport= Higher with a higher SA

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15
Q

Flux is proportional to:

A

Concentration of the dosage form

J= (constant) x Concentration in dosage form

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16
Q

What is permeability coefficient?

A 
A parameter independent of concentration  and surface area 
P or Kp
J=PCd
J= (constant) Cd
P=D/ h(thickness of membrane)
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17
Q

Flux is normalized by:

A

Driving force i.e concentration

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18
Q

What is the determining factors of permeability?

A

Permeability of a membrane like skin is a function of the membrane properties, drug properties, and formulation

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19
Q

What does permeability tell you?

A

How leaky a membrane is.

Higher permeability= leakier membrane, more permeable

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20
Q

Some useful values of P (permeability)

A

P= flux normalized by concentration
P for the cornea and buccal is higher
P for the mucosal/monolayer is higher
P is lowest in skin because it functions as a barrier

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21
Q

Flux is inversely proportional to

A

The thickness of the membrane and r (the permeant molecular radius)

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22
Q

What situation has a higher flux?

Same SA of membrane and same concentration. One side has larger molecules in the concentration

A

Flux is higher with the smaller molecules

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23
Q

Diffusion coefficient

A

Proportional to the flux

Related to temperature, viscosity of medium, and molecular size

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24
Q

Relationship of diffusion coefficient with MW of a molecule, viscosity of a medium, temp in a nonaqueous medium

A

MW- inverse relationship with D
Viscosity- inverse relationship with D
Temp- direct relationship with D

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25
Q

Partition coefficient

A

The membrane concentration is not the same as the drug concentration.
The higher K (partition coefficient) is the higher drug concentration
Lipophilic drugs have a higher K

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26
Q

Relationship between maximum flux and solubility

A

Flux is limited by the solubility of a drug
As flux increases it can reach the saturation region Slope between flux and solubiiltiy is P (permeability coefficicent)
You will reach max flux when the solubility is reached

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27
Q

Transdermal delivery requirements

A

Zeroth order delivery- drug depletion in the patch or in the dosage form
Amount of drug delivered (dose): transdermal flux of a drug!

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28
Q

What is zeroth order delivery?

A

If you have a concentration/time (y/x axis) for a zero order delivery if you plot the amount delivered across against time then you will see a linear relationship
Flux against time will also be linear relationship
Clearance rate same as absorption

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29
Q

What is 1st order?

A

See an increase then a decrease

Clearance rate faster than absorption/ delivery rate

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30
Q

Why are most patches assumed or claimed to be zero order?

A

Because the patch has an infinite supply of drug so you remain a constant concentration.
We try to make transdermal delivery zero order but it is actually first order.
We can remove patch and replace it with new one to remain zero order delivery

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31
Q

GI products vs transdermal

A

first order because concentration is eliminated over time
We cannot replace GI products like we can transdermal.
Most drugs have >50% absorption
Transdermal systems allow higher % of drugs left in the patch.

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32
Q

What relationship do you use to calculate how long a transdermal patch will last?

A

Concentration/time= (-P/h)(Cd)

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33
Q

Requirements for slow depletion

A

Have relatively constant flux for zeroth order drug delivery
(Increase V by increasing A, no effect
Increasing Cp will increase flux)

To make the patch last longer we need to maintain zeroth order delivery so amount delivered or flux are important requirements .

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34
Q

To increase drug delivered per day we can increase

A

SA and P

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35
Q

Max flux at Cd=

A

Cs

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36
Q

Why are the doses of commercial transdermal products (patches) proportional to their size (area)?

A

Manufacturers can just cut out area of a large pass for dose. A higher dose patch will have a higher area

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37
Q

maximum flux

A

Max drug concentration at solubility

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38
Q

What is the effect on the maximum flux of increasing the solubility by 10 times by the addition of a cosolvent

A

No effect on the maximum flux
Increasing the solubility (K) will also decrease the drug permeability coefficient cancelling out the effect
The permeability decreases due to the partition coefficient decrease

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39
Q

Even though adding a cosolvent does not affect the flux, what is the benefit?

A

Increasing duration of transdermal product

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40
Q

What do P and hp (or V at a constant SA) affect in transdermal delivery?

A

Depletion; for maintaining rate constant of drug delivery, 0th order

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41
Q

Increasing P for drug delivery _______depletion.

A

Increases

This is why most scientists only look at P instead of depletion

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42
Q

Transdermal delivery, to maintain constant delivery hp can be _________

A

Increased

However, a thick patch can lead to discomfort and is not patient friendly. Also easier to come off

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43
Q

Transdermal delivery- To increase rate of delivery SA can be _________

A

increase

But a large patch is not very patient friendly.

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44
Q

Increasing drug concentration in a transdermal patch does not affect______

A

Depletion because the flux also increases

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45
Q

Drug loading in the patch can be increased by increasing the ________

A

concentration in the patch without affecting the flux
Cosolvent can increase solubility but does not effect maximum flux
Suspension, emulsion, matrix systems of two or more phases can increase total drug delivery in the system but do not affect concentration that drives drug transport

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46
Q

Can we predict the permeability coefficients of drugs by their physiochemical properties?

A

Yes

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47
Q

Stratum corneum

A

Basic barrier of skin

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48
Q

Viable epidermis

A

Stratus granulosum
Stratum spinosum
Stratum basale

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49
Q

Dermis layers

A

Papillary and Reticular layers

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50
Q

What layer of skin has the lowest permeability coefficient?

A

Stratum corneum

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51
Q

Is stratum corneum a rate limiting barrier?

A

Yes

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52
Q

Why is the stratum corneum the strongest barrier?

A

Each layer (10-15) has about 5 lamellae between them. It has 60-75 lipid layers of the barrier

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53
Q

Is the stratum corneum thick?

A

No it is very thin.

10-20 microns

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54
Q

What is the top layer of the stratum corneum?

A

Stratum disjunctum

Loose desquamated layer of horny cells

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55
Q

How long does it take to regenerate new stratum corneum?

A

about 2 weeks

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56
Q

What happens if materials penetrate stratum corneum?

A

They will remain until new stratum corneum is regenerated.

Think of permanent markers not washed off

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57
Q

Stratum granulosum

A

3-5 layers of flattened cells
Presence of various sized densely packed granular cells
Process of becoming stratum corneum

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58
Q

Stratum spinosum

A

Several layers of irregular polyhedral cells

Become flattened in outmost layers

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59
Q

Stratum basale

A

Single row of columnar epithelial cells above the papillae

Growing layer, cells produced in this layer displace the cells above; takes about 30 days to get to the top

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60
Q

Dermis

A

Generally about 1-2 mm thick
Divided into papillary dermis and reticular dermis
Papillary dermis- outmost part of dermis consisting of connective tissue with collagen, blood capillaries, lymph, and nerves
Reticular dermis- lower and more densely fibered layer. Denser connective tissue and collagenous fibers

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61
Q

Does the epidermis contain any blood?

A

No

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62
Q

Microneedles

A

Only go through epidermis an do not touch blood and nerves in dermis. Why they are not painful.
Either a wafer-thin array of microneedles on a patch or drug crystals coated with microneedles
After applying the microneedles to the skin you have to use an activator to provide constant energy, creating hundreds of aqueous channels in the stratum corneum.

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63
Q

Appendages

A

Hair follicles
Sebaceous glands
Sweat glands
Formed by specialized cells in fetal life; epidermis loses its capacity to generate new hair follicles after birth

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64
Q

Where are skin stem cells?

A

Hair follicles and stratum basal layer

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65
Q

Sebaceous glands are attached to _______

A

hair follicle

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66
Q

Hair follicles

A

Hair is made of slender keratinous filaments and grows in the follicular shaft developed from the epidermal epithelium
Extends down from the tubular opening into the dermis
Inner epithelial component lining of the hair follicle consists of epithelial cells similar to those of the epidermis

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67
Q

Sebaceous glands

A

Cluster of 2 to 5 alveoli (single layer of cell on alveoli wall) with a single duct
In the dermis with their excretory ducts open into the necks of hair follicles
Filled with fat secretion
No sebaceous glands in palms and soles (no hair)

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68
Q

Sebaceous glands are storage for what?

A

Sebum

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69
Q

Sweat glands

A

Simple coiled tubing
Tubes end into a ball as the secretory portion
Sweat glands do not have storage
Greatest number on palms and soles and least in the neck and on back

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70
Q

You have a higher density of hair follicles and sweat glands on the _____________as compared to the trunk and leg

A

Face, forehead

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71
Q

Why is the density of hair follicles and sweat glands higher on the forehead and face?

A

Because a person is unable to grow new hair follicles or sweat glands after birth. The face and forehead do not increase SA with growth of the child as much as the other areas of the body.

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72
Q

Stem cell and wound healing

A

Stem cells are located in stratum basal layer and in the hair follicles
If you have skin damage and the area is small then the area of growing of the basal layer is fast. The stem cells from the basal layer will grow up fast.

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73
Q

Langerhans Cells

A

Local immune system to process microbial antigens locally in skin infection and travel to T-cell to mature

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74
Q

Melanocytes

A

Produce melanin, the skin pigment

Skin pigmentation is due to melanocyte activity (lesser to number of melanocytes)

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75
Q

What is suntan a result of?

A

Damaged DNA triggering the release of a hormone that binds to melanocytes to produce melanin

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76
Q

Where are langerhans and melanocytes located?

A

The viable epidermis

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77
Q

Corneocytes

A

Hexagonal in shape, the skin is not flat

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78
Q

Why is the skin not flat?

A

Due to the corneocytes on the top layer of the stratum corneum

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79
Q

Intracellular pathway

A

When a drug is put on the surface of the skin it goes inbetween the cells
Major route

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80
Q

Transcellular pathway

A

Drug goes directly through corneocytes

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81
Q

Stratum corneum intracellular lipids

A

No phospholipides

Common- Ceramides, cholesterol, fatty acids

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82
Q

Strata basal main lipids

A

Polar lipids

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83
Q

Strata gransulosum main lipids

A

Neutral lipids (surface lipids, wax esters, fatty acids, triglycerides, sterols)

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84
Q

Stratum corneum main lipids

A

Neutral lipids (surface lipids, wax esters, fatty acids, triglycerides, sterols)
and
Ceramides/ sphingolipids

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85
Q

As the strata basal creates new cells, the polar lipids present are converted into what?

A

Ceramides

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86
Q

Main component of lipids in the skin

A

Ceramides

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87
Q

In addition of protection, what does the stratum corneum do?

A

Prevents our own cells from going out

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88
Q

When you put a drug on the skin, what happens?

A

It goes through stratum corneum and will:
Topical delivery- provide therapeutic effect on the epidermis and dermis
Transdermal- Provide a systemic effect

Metabolism in epidermal and dermal level to remove drug

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89
Q

Advantages of transdermal delivery

A

Nothing PO pts
Eliminate food effects
Avoid metabolism in GI and hepatic first pass metabolism
Delivery can be terminated with product removal
Pt compliance
Controlled release (zero order input until drug is depleted from patch)
Good for short half-life therapeutic agent

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90
Q

Obstacles and disadvantages of transdermal delivery

A

Potent drug required
Smaller molecular size of drug
Log Koct around 0-2 (measure of lipophilicity, cannot be too polar or lipophilic)
Permeability coefficient of stratum corneum
Local irritancy and allergy
High local drug concentration (toxicity)
Local first-pass metabolism
Patch can fall off, potential hazard for children, drug can remain in patch and be misused
Cost

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91
Q

What drug potency is required for transdermal delivery?

A

dose <10mg/day

Potent drug required due to low permeability of stratum corneum

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92
Q

What molecular size is required for transdermal delivery?

A

<800Da

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93
Q

Toxicity concentration is related to

A

Dose concentration

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94
Q

How do you avoid a toxic concentration?

A

Rotate site of administration

Usually stratum basal layer will replace itself

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95
Q

You get a new stratum corneum every _______and a new dermis every _______

A

2 weeks

month

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96
Q

Why is toxicity due to high amount of drug a problem with transdermal delivery but not delivery to GI tract?

A

GI tract has a large SA and the local exposure time is short.
Transdermal is always on same tissue

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97
Q

What is tape stripping?

A

When you put adhesive tape on the skin and peel it off. By peeling it off you get a layer of the stratum corneum pulling off. By continuing to do this you get more stratum corneum pulled off. By measuring this you know the drug concentration in the stratum corneum
Used for topical delivery

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98
Q

Transepidermal water loss (TEWL

A

Measures barrier properties of skin after topical drug administration
Evaporimeter, vapometer placed on the skin
Passive diffusion of water, water is leaving surface.
Mainly for evaluation of barrier disruption and repair

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99
Q

Side-by-side diffusion cells

A

Two sides. You put the drug concentration on one side and the receiver solution on the other. Circulating temp control center.
Basic studies

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100
Q

Vertical Franz diffusion cells

A

Top is formulation, middle skin, bottom chamber
Put formulation in top that is exposed to atmosphere
Done for formulation testing and screening as well as quality control
More common than side by side
Measure amount that reaches bottom chamber
Slope of plot is flux value

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101
Q

In formulation and transdermal system testing, what skin is used?

A

Human skin

  • cadaver
  • skin from surgery

Expensive

Preferred in vivo testing, but expensive and time consuming

Animal skin commonly used (hairless rats and mice have hair follicles still)

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102
Q

Is the stratum corneum thickness the same between different species?

A

No
Only pig skin is a good model for human skin

Whole skin thickness difference is different as well

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103
Q

You have to correct for______when testing transdermal products in mice

A

Body size

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104
Q

Are rodents good models for transdermal products?

A

no

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105
Q

Back, abdomen, arm, thigh permeability

A

Comparable

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106
Q

Face, scalp, genitalia permeability

A

High

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107
Q

Palmar/plantar (sole)

A

Thick, but high water permeability

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108
Q

Water hydration can_______permeation

A

Enhance

Soaking your hand in water swells the stratum corneum

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109
Q

Normal rate of passive diffusion of water through skin

A

4-15g/m^2/hr

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110
Q

Skin transport model: lipophilic drugs go through what?

A

Pore pathway and lipid pathway

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111
Q

Skin transport model: hydrophilic drugs go through what?

A

Pore pathway

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112
Q

Maximum flux is independent of cosolvent system

T/F

A

True

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113
Q

Butrans

A

Pain management

Cannot take oral due to N

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114
Q

Catapres

A

7 day delivery system for HTN

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115
Q

Reservoir patch

A

Traditional
Backinf, drug reservoir, control membrane, protective peel strip
Cannot cut

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116
Q

Androderm system

A

reservoir patch

You will see a drug resorvoir

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117
Q

Selegiline (emsam)

A

Adhesive patch

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118
Q

What is the difference in an adhesive patch and matrix patch?

A

An adhesive patch has drug in the adhesive a matrix patch has drug in the matric

119
Q

1st gen of transdermal delivery

A

Reservoir patch

120
Q

Daytrana

A

matrix patch
Apply for only 9 hours
Systemic half life of drug is 2-3 hours

121
Q

Adhesive patches are easier to make T/F

A

T

122
Q

Problem with adhesive patch

A

Potential problem of drug and excipients interacting with adhesive

123
Q

Selegiline (Emsam)

A

Adhesive patch

124
Q

Estrogel

A

Transdermal estradiol gel
Once daily application of 2.5g (each arm, wrist to shoulder (750cm^2 skin area))
Dries in 2 to 5 minutes

125
Q

Testim, Androgel, Vogelxo

A

1% transdermal testosterone gel
Once daily administration
About 10% of applied dose is absorbed over 24 hours

126
Q

Estrasorb

A

2.5mg estradiol/g emulsion micellar transdermal system
Once daily application of 2 foil packages, rub on thigh or calf
Provides 0.05mg/day

127
Q

Disadvantages of EstroGel

A

Applying to large SA

Remains on skin for 2-5 minutes

128
Q

Transdermal spray

A

Testosterone and estradiol metered dose transdermal spray
Luramist testosterone and EvaMist estradiol

MDTS places against the skin to release a spray that dries quickly (need a 2 minute wait before dressing and 30 minute wait before washing.
Forms a drug depot
Once daily administration
Less AE than patches

129
Q

Fentanyl systems

A

9 different transdermal products

Pts need to be careful with size of patches

130
Q

Transdermal products are usually new active ingredients T/F

A

F

They are usually made out of existing drugs

131
Q

Free medium

A

What is touching the skin

132
Q

Methods for enhancing skin transport

A 
Physical enhancers (for controlled delivery of larger and less lipophilic drugs)
Iontophoresis
Sonophoresis
High electrical field electroporation
Punctuation and mechanical methods
heat
Chemical enhancers
133
Q

Iontophoresis

A

The enhances transport of a drug across a biomembrane under the assistance of an electric field.
the movement of a charged molecule
Apply positive polarity

134
Q

Problems with iontophoresis

A

Unwanted skin rxns at current >0.5mA/cm^2 and long tx: edema, erythema, irritation, contact dermatitis, sunburn
Electrochemical products at the electrode surface can affect skin (pH or silver burn)
Sensation
Power supply
Flux variability

135
Q

Iomed: lidocaine

A

Iontophoresis

For topical, not transdermal delivery

136
Q

Why is epinephrine used in combination with lidocaine for local topical delivery?

A

Epi is a vasoconstrictor so it enhances duration of the lidocaine numbing effect to the skin
Epi also reduces skin clearance at the local site

137
Q

Iontophoresis: You put positively charged drugs in the ________side

A

Positive

138
Q

Iontophoresis- what can you deliver?

A 
Methylene phosphates (dexamethasone)
or local numbing (lidocaine)
139
Q

Two main advantages of iontophoresis compared to oil:

A

Quick onset of action (reduce onset time)

Enhance penetration

140
Q

Ionsys

A

Needle free, patient friendly
Iontophoresis Fentanyl
Button for breakthrough pain- push it and it goes transdermally. Applies electric current to enhance delivery

141
Q

Glucowatch problems

A

Permeability- not accurate

Can say normal when pt is actually hypoglycemic

142
Q

Sonophoresis

A

The enhancement of a drug/compound transport across a biomembrane under the assistance of ultrasound
Mech of enhancement: Pore induction (membrane alteration due to cavitation, convection, stratum corneum lipid modification)

143
Q

Sontra medical

A

Apply ultrasound then cream
Ultrasound to the skin for a period of seconds to create reversible microchannels through stratum corneum
Used for rapid anesthesia in 5 minutes from 4% lidocaine
Transdermal glucose and vaccine under development

144
Q

Potential problems with sonophoresis

A 
Heat
Feasibility (enhancers like SDS are needed)
Variability of energy
Unpredictable flux
Skin to skin variability
145
Q

Electroporation

A

The enhanced transport of a drug/compound across a biomembrane under the assistance of high electric field short pulses
Similar to static sparks
Mech of enhancement are similar to those of iontophoresis with a major contribution from electropermeabilization (membrane alteration, pore induction)

146
Q

Potential problems with electroporation

A

Similar concerns to iontophoresis

In addition- sensation, tissue damage, muscle reflux and reaction

147
Q

How do you reduce current across the muscle with electroporation?

A

Microarray electrodes
Helps decrease current from reaching the muscle
Or pull skin away from body surface

148
Q

Microneedles

A

Physically punctuate the stratum corneum to create micropores
Water-soluble drugs and macromolecules
No pain

149
Q

4 types of microneedles

A

Solid-permeabilizing skin and drug patch
Solid coated with drug or vaccine
Dissolvable polymeric microneedles encapsulated drug or vaccine
Hollow for injection of drug solution

150
Q

Microporation: heat

A

Create a pore across the stratum corneum by heat
Melts stratum corneum lipids to create pores
In trial for insulin, pain, and GLP agonists
Increases permeability, rate, and transdermal delivery

151
Q

Physical enhancers are more useful for

A

Polar, ionic, macromolecules

152
Q

Chemical enhancers are more useful for

A

Moderately lipophilic, normal small molecule drug

153
Q

Low energy heat

A

Increase skin permeability
-Skin structural changes

Increases rate of release of the drug from local skin tissue into systemic circulation
Increases body circulation
Improves solubility of most drugs

154
Q

Most transdermal patches have a warning to avoid heat because______

A

it can lead to overdose

155
Q

Heat can significantly ________the delivery rates or penetration of the drug through the skin into systemic circulation

A

Increase

156
Q

FDA approvals of medical devices

A

Premarket approval application (PMA)- new or high-risk medical devices that require a more rigorous premarket review than the 510(k) pathway. PMA is similar to NDA but is used for medical devices

157
Q

510 (k) clearances

A

New devices that are substantially equivalent to a device that is already legally marketed for the same use

158
Q

Investigational device exemption (IDE)

A

Investigational device to be used in a clinical study to collect safety and efficacy data

159
Q

Chemical enhancers

A 
Adding an inactive ingredient to transdermal products to increase the penetration to the skin 
Sulfoxides
Alcohols- long chain fatty alcohol 
Fatty acids
Fatty acid esters 
Surfactants
160
Q

What is the most common chemical enhancer? For enhancing penetration of drug throughout the skin

A

Fatty acid esters

Isopropyl palmitate

161
Q

Mechanisms of chemical permeation enhancers

A

Fludization of the intercellular lipid lamellae of the stratum corneum
Alteration of the chemical microenvironment in the intercellular lipid lamellae (solvent penetrates and increases the solubility of drug in skin)
Lipid extraction
Enhance the penetration of permeation enhancers

162
Q

Considerations for effective permeation enhancement

A

Physiochemical properties of the drug
-polar or lipohilic?
Concentration of enhancer and nature of mechanism (target of enhancers is lipids not target of drug)
Depletion of vehicle and enhancers due to evaporation of skin penetration
Nature/mechanism of the permeation enhancer

163
Q

Properties of good chemical enhancers

A 
Significant flux enhancement 
Pharmacologically inert
Nonirritating, nonallergenic, nontoxic, 
Rapid onset of action and long duration
Reversible effect
Compatible, both chemically and physically 
Odorless, colorless, inexpensive
Cosmetically acceptable
164
Q

Topical delivery

A

Target site: epidermis or dermis

Less amount required to be delivered vs transdermal

165
Q

Topical delivery: drugs need to be

A

Not too large in MW
Not too hydrophilic
Not skin irritant or allergy

166
Q

Types of topical products

A

Medicated- contains therapeutic agents, dissolved or suspended.
Nonmedicated- protectants or lubricants
Medical indication- drug regulated by FDA

167
Q

Topical dosage forms

A

Solution, suspension, lotion, ointment, cream, gel, paste

168
Q

Topical semisolids

A

Melting point and solid state at room temperature

Ointment, cream, gel, paste

169
Q

Topical aerosol or non-aerosol pump foams

A

Liquid in storage, foams when dispensing

170
Q

Epidermic base

A

None or very little skin permeation
Oleaginous base
Epidermic refers to external layer of the skin or epidermis

171
Q

Endodermic base

A

Into dermis skin permeation
Absorption base
Endodermic refers to internal layer of the skin or epidermis

172
Q

Diadermic base

A

Into and through skin permeation
Emulsion, water soluble base
Diadermic refers to going through the skin

173
Q

Oleaginous base

A 
Insoluble in water, will not absorb water
Emollient
Greasy 
Occlusive
White petrolatum and white ointment
174
Q

Absorption base

A 
Insoluble in water, will absorb water
Emollient
Occlusive
Anhydrous 
Greasy
Hydophilic petrolatum, aquabase, aquaphor, polysorbate
175
Q

Emulsion; water in oil

A 
Insoluble in water, will absorb water
Contains water
Emollient
Greasy 
Occlusive
Cold cream, lanolin, hydrocream, eucerin, nivea
176
Q

Emulsion; oil in water

A 
Insoluble in water, will absorb water
Water washable
Contains water
Nonocclusive
Nongreasy
Hydrophilic ointment, unibase, velvachol, dermabase
177
Q

Water soluble base

A 
Water soluble, washable
Will absorb water
Anhydrous or hydrous
Nonocclusive
Nongreasy 
Lipid-free
Polyethylene glycol ointment
178
Q

Creams

A

Dissolved or dispersed in emulsions (oil-in-water) or water-washable base
Semisolid
Creamy white appearance
Easier to spread and remove than ointments

179
Q

Gels

A

Dispersions in an aqueous jelly-like liquid vehicle (normally water) with a gelling agent
Can be considered either a single-phase or 2 phase
Gel of macromolecules
May be formulated with cosolvent such as alcohol and propylene glycol

180
Q

Paste

A

Contains larger proportion of solid materials (insoluble solids) than ointments
Stiffer
Less base used: Less greasy than ointments
Zinc oxide paste

181
Q

Problems with topical dosage form classification

A 
Not consistent, none are official
Not quantitative, based on opinion
Can overlap (non exclusive)
182
Q

FDA approved bioequivalence test

A

Vasoconstrictor assay for topical corticosteroids (look at blanching of skin (change in color))
Case by case basis-
Absorption studies using tape stripping
Absorption studies using skin biopsy
PK studies (systemic) if a significant amount of a drug is absorbed into systemic circulation- apply drug on skin and measure plasma conc.
Diffusion cells- transport experiments (drug in formulation in donor and receiver measured)
Transepidermal water loss (TEWL)
Microdialysis (tubing in skin)

183
Q

Bioequivalence

A

No significant difference in the rate and extent to which an active ingredient becoming available at the site of drug action when administered
Cmax and AUC same
Purpose: to establish therapeutic equivalence so physicians can treat patients with the alternative medication without further monitoring
The rate and extent of absorption of the test drug do not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient.

184
Q

Requirements of BE

A

90% confidence interval must fall between:
Dichotomized +/- 0.2 of the innovator
Numerical- 80%-125% of the innovator
Superior to placebo demonstrated

185
Q

Q1,Q2,Q3 for BE

A

Generic equivalent to get approved without clinical trials
When two products are Q1, Q2, and Q3 equivalent they are considered to be BE
Q1- same components
Q2- same components in same concentration
Q3- same components in same concentration and same microstructure

186
Q

Zecuity

A

Sumatriptan succinate
Iontophoretic transdermal system (TDS)
Caused skin irritation, no longer on market

187
Q

LidoSite (Vyteris)

A

Pre-filled iontophoresis system of lidocaine/ epi
Treatment of migraine
Wet
Needle free

188
Q

Relationship between fentanyl delivery and electric current

A

Linear

189
Q

Lipid membrane electroporation

A

Spontaneous formation of metastable pore due to energy in electric field
Minimum voltage- around 0.2-1.0 V per bilayer, depending on bilayer composition. Need about 50V based on the number of bilayers.

190
Q

Microporation lasers

A

Creates pore with laser

P.L.E.A.S.E system

191
Q

Chrono therapeutics

A

Iontophoresis system
Delivers acyclovir to local skin area
Delivers steroids locally to treat acne and psoriasis
SmartStop- for smokers to deliver nicotine during cravings

192
Q

What are microneedles used to deliver?

A

Water-soluble drugs and macromolecules

193
Q

Alza macroflux microneedle system

A

Desmopressin- hormone found naturally in the body for increasing urine concentration and decreasing urine production

194
Q

Rapidly dissolving microneedles

A

Dissolve in 60 minutes

195
Q

3M Microneedle system

A

polyclonal antibody delivery

196
Q

Microporation: RF-wave

A

Radiofrequency (RF) to porate skin similar to radiofrequency scalpel
Creates RF- microchannels
GLP-1 agonist and osteoporosis

197
Q

PassPort system

A

Single-use disposable patch with a re-useable applicator with an array of metallic filaments. Converts electrical energy/pulse to thermal energy that ablates the stratum corneum to create microchannels. The patch is then placed on the skin.
A type of heat microporation.

198
Q

Abrasive pads (sandpaper device) to enhance transdermal delivery

A

TEWL and efficacy of transdermal application were found to increase after treatment

199
Q

ZARS

A

Controlled heat assisted drug delivery (CHADD) system

Fentanyl

200
Q

What topical dosage form is not a liquid

A

Aerosol
Powder
Patch

201
Q

What dosage form is a clear and homogenous liquid?

A

Solutions

202
Q

What dosage form is a solid dispersed liquid?

A

Suspension

203
Q

What dosage form is an emulsion?

A

Lotion

204
Q

What dosage form is a semisolid that contains >50% LOD and is a solution or colloidal dispersion?

A

Gel

205
Q

What dosage form is a semisolid contains >50% LOD an is an emulsion?

A

Cream

206
Q

What dosage form is a semisolid that contains a large proportion (20-50%) of dispersed solids?

A

Paste

207
Q

What dosage form is a semisolid that contains >50% of hydrocarbons, waxes. or PEG and <20% LOD?

A

Ointment

208
Q

Evaluation of topical systems that have been FDA approved or considered

A

Controlled clinical trials to test efficacy against disease (for new and generic products)
For generic products- tests to establish bioequivalence

209
Q

Therapeutic equivalent

A

Have the same clinical effect and safety profile when administered to patients under the conditions specified in labeling
It is an FDA term used for the evaluation of generic drugs. It is used to answer the question: are the generic and innovator products the same for all intents and purposes? Do they show the same performance?

210
Q

When are products considered to be therapeutic equivalent?

A

Pharmaceutical equivalent and bioequivalent
Safe and effective
Adequately labeled and manufactured in compliance with good manufacturing practice
Pharmaceutical equivalent and bioequivalent are the two key components

211
Q

Pharmaceutical equivalents

A

Contain identical amounts of the same active drug ingredient in the same dosage form and route of administration
and
meet compendial or other applicable standards of strength, quality, purity, and identity

212
Q

Current practice of equivalence

A

Pharmaceutical equivalence + Bioequivalence= Therapeutic equivalence

213
Q

BE tests

A

Actives in biological fluid in patients (plasma)
PD comparison (Check BP for HTN/ cholesterol for cholesterol meds)
Clinical comparisons (clinical endpoints, cure of disease/remission)
Other in vitro tests deemed adequate by FDA

214
Q

BE for local delivery

A

Different than the BE for systemic (bioavailability)
Small sample mass (eye, ear wax, etc)
Samples may not be easy to reach
Poor systemic absorption, intended for local delivery
Examples- inhalation, topical, eye, locally acting GI products

215
Q

Q3 identical products are ________

A

bioequivalent

Ex- topical solutions

216
Q

Direct demonstration for Q3 equivalence is difficult in ______

A

formulations more complex than solutions

Ex.- creams, ointments, gels

217
Q

Q1 and Q2 are identical

A

There may be differences in Q3 due to manufacturing process

Requires additional evaluations of rheology, in vitro release (diffusion) and in vitro tests

218
Q

Differences in Q1 and Q2

A

May be required because of formulation patents
When products differ in Q1 and Q2 additional tests are required for BE
Dosage for classification is uncertain which may be a barrier for generic evaluation

219
Q

Active ingredient

A

Any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, prevention, cure

220
Q

Inactive ingredient (excipients)

A

Any component of a drug other than the active ingredient.
Ingredients that physically or chemically combine with an active ingredient to facilitate drug transport
Can be considered active under different circumstances (alcohol)

221
Q

Oral powder and granules

A

Direct use- dissolved in solution
Traditional, simple
Used for large doses that cannot be administered as a tablet or a capsule

222
Q

Oral tablets

A

SImple compressed tablet (uncoated)
Coated- coated by sugar, film, or enteric
Chewable- rapid disintegration when chewed

223
Q

Direct commpression

A

Tablets are prepared by direct compression of a drug powder mixed with other excipients

224
Q

Oral capsule

A

Gelatin or hypromellose capsule
Hard shell capsule- filled with powder, granulate, paste
Soft gel capsule- gelatin with glycerin or polyhydric alcohol usually filled with oil

225
Q

Gelatin

A

Protein
Obtained by hydrolysis of collagen from skin, white connective tissue, and bones of animals
Soluble in warm water and digested by enzymes and absorbed
Stable

226
Q

Types of excipients

A

Fillers (diluents), binders, disintegrants, lubricants, glidants, antiadherents, colors, flavors, sweeteners

227
Q

Diluents

A

Added to increase bulk of preparation
Must be compatible with drugs
Water-soluble diluents are recommended for use with drugs that have low water solubility to avoid precipitation

228
Q

Binders

A

Increase cohesive qualities of powdered materials
Ensure that the tablet will remain intact after compression
Too much or too strong a binder can delay tablet disintegration
More effective if used in wet rather than dispersed in dry form

229
Q

Microcrystalline cellulose

A

Excipient

Diluent and binder

230
Q

Lubricants

A

Reduce friction at the interface of tablet and die wall during compression and ejection
PEG 4000, magnesium

231
Q

Antiadherents

A

Prevent sticking to the punch and to the die wall

talc, magnesium stearate

232
Q

Glidants

A

Improve flow characteristics of granulate

corn starch, amorphous silica

233
Q

Magnesium lauryl sulfate

A

Used as a tablet or capsule lubricant (wetting agent)
Functions as an anionic surfactant, detergent, emulsifying agent
Incompatible with cationic surfactants and salts of polyvalent metal ions (zine, aluminum, tin, lead)
Widely used, safe

234
Q

Disintegrants

A

Facilitates tablet breakup after administration, hence improve dissolution
cross-linked cellulose

235
Q

Colorants

A

appearance appeal and identification

236
Q

How to find excipients?

A

The FDA has a database

Inactive Ingredient Search for Approved Drug Products

237
Q

GRAS

A

Generally recognized as safe

Commonly used as excipients

238
Q

Chemical bulk ingredients

A 
USP
NF
FCC
COA
Chemically pure, analytical reagent grade before printed expiration date when stored in original container
239
Q

Quality testing

A

Manufacturer is required to demonstrate to the FDA that each dosage unit in a batch has a drug content within the range on the label
Uniformity of dosage unit- demonstrated by content uniformity or weight variation
Not applied to suspensions, emulsions, or gels in unit-dose container intended for external administration

240
Q

Content uniformity test

A

An assay of the individual content of drug substance in a number of dosage units to determine whether the individual content is within the limits set
Mostly destructive and consumes the drug using wet chemical analysis

241
Q

Weight variation test

A

An assay of the drug substance based on weight

242
Q

USP 905 uniformity of dosage unit

A

The uniformity of dosage units can be demonstrated by either content uniformity or weight variation

243
Q

The orange book

A

Approved drugs with therapeutic equivalence both OTC and Rx
Cumulative
FDA resource

244
Q

Iontophoresis current

A

Less than 0.5mA/cm^2
Very small electric current
Unwanted skin reactions occur when current >0.5mA/cm^2

245
Q

When you apply an electric field across the skin, the electrical resistance of the skin _________

A

Decreases to about 1-2kOms/cm
The electrical resistance is usually high (100kOm/cm)
This is why we get shocked

246
Q

Companion 80 and Hybresis

A

Iontophoresis

Has batteries

247
Q

WEDD

A

Iontophoresis
No batteries
Utilize different metals in the electrodes
Potato example
Cannot control voltage as well but is more patient friendly

248
Q

Lidocaine is _______charged and methylene phosphate is ______ charged

A

Positively

Negatively

249
Q

What is the advantage of the dry iontophoresis

A

You can use a drug off label (dexamethasone)

Do not have to get approved by FDA

250
Q

2 main advantages for transdermal delivery (iontophoresis)

A

Reduce onset time

Increase penetration

251
Q

What is the main advantage of wet iontophoresis

A

Electrode may reduce stability of drug in storage with dry delivery.
This is not an issue with wet.

252
Q

What is more effective, ITS or PCA?

A

comparable

253
Q

In addition to delivering a drug to the body, what can iontophoresis do?

A

Extract materials from the body

Think glucose monitoring system

254
Q

What is the main difference between ultrasound for diagnosis and sonophoresis?

A

Power- much higher power to break down the skin in sonophoresis
Frequency- Diagnosis ultrasound is very high and sonophoresis is low

255
Q

Does iontophoresis or electroporation increase delivery more?

A

Iontophoresis

highest delivery is combination of the 2

256
Q

Which microneedle system injects the drug?

A

Hollow

257
Q

What are the methods to put wholes in the corneum?

A

Heat
Microneedles
Lasers
RF

258
Q

Physical enhancers are more useful for

A

Polar, ionic, macromolecules

259
Q

Heat can significantly increase

A

Delivery rates and penetration of drug in transdermal delivery
Can lead to OD

260
Q

How much can the stratum corneum swell?

A

3x

261
Q

Does having the same Cmax and AUC indicate that you have the same concentration in the skin tissue?

A

No

262
Q

Topical BE cannot be assessed by _______-

A

Blood circulation

You can have different tissue and plasma concentrations

263
Q

What are you measuring with in vitro diffusion cell with full thickness skin

A

Full skin assay

264
Q

What are you measuring with systemic PK and skin biopsy

A

To the dermis

265
Q

What are you measuring with TEWL

A

Through the viable epidermis

266
Q

What are you measuring with Tape- stripping

A

SC

267
Q

What is the purpose of Q1,Q2, and Q3?

A

To not have clinical trials to establish BE

268
Q

Q3 equivalence is needed for what?

A

Creams oitments

Semisolids

269
Q

Q2 is considered BE for what?

A

Solutions

270
Q

Dibasic calcium phosphate dehydrate

A

Diluent

271
Q

Lactose, calcium sulfate dehydrate

A

diluent

272
Q

microcrystalline cellulose, starch

A

diluent

273
Q

sucrose based diluents, mannitol NaCl

A

diluent

274
Q

cellular derivatives

A

binder

275
Q

PEG, starch paste, synthetic gums

A

binder

276
Q

If you have a small dose of a drug you will see

A

diluents, fillers

277
Q

If you have a large dose of a drug you will see

A

Binders

278
Q

PEG 4000, magnesium or Na lauryl sulfate, stearic acid

A

lubricants

279
Q

talc, magnesium stearate

A

Antiadherents

280
Q

Corn starch, amorphous silica

A

Glidants

281
Q

cross-linked cellulose, cross-linked polyvinyl pyrrolidone, modified corn starch

A

disintegrants

282
Q

iron oxide, titanium oxide

A

colorants

283
Q 
Advil inactive ingredients:
silicon dioxide
corn starch
croscarmellose
microcrystalline cellulose
sodium lauryl sulfate and steric acid
titanium dioxide
parabens and sodium benzoate
A

silicon dioxide- glidant
corn starch- glidant
croscarmellose- disintegrant
microcrystalline cellulose- binder
sodium lauryl sulfate and steric acid- lubricant/antiadherent
titanium dioxide- colorant
parabens and sodium benzoate- preservatives

284
Q 
DILAUDID inactive ingredients
lactose anhydrous
magnesium stearate
d&amp;C dyes
sodium metabisulfite
A

lactose anhydrous- diluent
magnesium stearate- lubricant
d&C dyes- colorant
sodium metabisulfite- preservative

285
Q 
Tetracycline hydrochloride inactive ingredients
Gelatin and propylene glycol
Pregelatinized starch
Sodium dioxide
Stearic acid
Titanium dioxide
D&amp;C and DD&amp;C dyes
A 
Gelatin and propylene glycol- capsule
Pregelatinized starch- diluent
Sodium dioxide- glidant
Stearic acid- lubricant
Titanium dioxide- colorant
D&amp;C and DD&amp;C dyes- colorant
286
Q

Are there any binders in capsules?

A

No

287
Q 
Pennsaid, diclofenac 2% inactive ingredients
dimethyl sulfoxide
ethanol
water
propylene glycol
hydroxypropyl cellulose
A

dimethyl sulfoxide- solvent
ethanol- solvent
water- solvent
propylene glycol- polymer to increase viscosity
hydroxypropyl cellulose- polymer to increase viscosity

288
Q

Most inactive ingredients in patches are

A

adhesives

289
Q

Porous microsphere

A

Put in gels to capture the lipophilic drugs. Needed because of poor aqueous solubility.
Methyl methacrylate/glycol

290
Q

Why are polymers added to gels?

A

To increase viscosity

291
Q

Carbomer 940

A

Polymer in gel

292
Q

hydroxypropyl cellulose

A

Polymer in increase viscosity

293
Q

If an inactive ingredient is in the GRAS database no additional tests need to be conducted before use T/F

A

T

294
Q

WV means

A

You can use weight variation or content verification

Drug Delivery (2 decks)

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