303 Lab Final Exam Flashcards

1
Q

Verbal Rx’s must be given by:

A

Physician/ RN (in hospital if co-signed by doctor)

– CANNOT be given by office personnel

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2
Q

Verbal Rx’s must be received by:

A
  • Pharmacist or pharmacy intern (under supervision)
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3
Q

Verbal Rx’s must include (in addition to other requirements):

A
  • Pharmacist’s initials
  • V/O (indication of verbal)
  • date the verbal Rx was received
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4
Q

When checking a Rx, check the following: (10)

A
  • pt name (cross reference)
  • drug name
  • drug strength
  • DIN (label and stock bottle)
  • SIG
  • Quantity
  • Days supply
  • Refills
  • Doctors name
  • Final Product (med. in vial, elegant?)
    • SIGN the store copy once satisfied
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5
Q

Soft lozenges are effective dosage forms to deliver medication to the:

A

Buccal cavity

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6
Q

A MAJOR ingredient in a hard lozenge base is:

A

Sugar

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7
Q

A MAJOR ingredient in a soft lozenge base is:

A

PEG

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8
Q

a MAJOR ingredient in a chewable gummy lozenge base is:

A

Glycerinated gelatin

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9
Q

One disadvantage of lozenges is that:

A

children can mistake them for candy

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10
Q

What is the approximate melting point for PEG 1450?

A

43-46 degrees Celsius

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11
Q

Why is it important to use geometric dilution when adding powders to lozenges?

A

To ensure homogeneity and consistent doses

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12
Q

What is the purpose of sieving powders?

A

To ensure even particle size

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13
Q

Why is it important to add the powders very slowly to the melted PEG, stirring after each addition?

A

To ensure the powder has been wet (prevent clumping) and will have uniform powder distribution in the PEG

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14
Q

When is the molten base/powder mixture ready to pour into the mold?

A

When it is just warm to the back of the hand

    • uncomfortably hot = wait longer
    • wait too long = congealing, hard to pour
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15
Q

Why is it important to slightly overfill each cavity of the lozenge mold?

A

The mixture contracts as it congeals and thus will be fill when solid

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16
Q

Are any auxiliary labels required for Diphenhydramine lozenges, if so which ones?

A
  • may cause drowsiness

- keep out of reach of children

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17
Q

List three uses of semi-solid dosage forms

A
  • protect skin/mucus membrane from irritants; allowing skin to heal
  • emollient effect, hydrating skin
  • topical vehicle for medication for local, transdermal or systemic effect
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18
Q

When compounding an ointment, is a glass ointment slab or pad preferable? Why?

A

A glass slab is preferred because it is hard, non-absorbable. Ointment pads can absorb ointment or tear causing product loss

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19
Q

What kind of spatula should be used when compounding an ointment? Why?

A

Large metal spatulas should be used because they provide both flexibility and enough force to incorporate ingredients (adequate shearing/mixing)

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20
Q

For what would you use a small metal spatula?

A

To remove preparation from large spatulas or to transfer preparation to jar and impart a professional finish to the product

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21
Q

Why can’t you add salicylic acid to the alcohol first (instead of alcohol to coal tar solution and then add SA)?

A

To allow for a large enough volume to dissolve the SA into, the alcohol volume (solubility) is not large enough alone

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22
Q

What is the synonym of polysorbate 80?

A

Tween 80

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23
Q

How do you incorporate a liquid into an ointment base using a slab?

A

Place 1/2 the ointment base on slab and create a depression, carefully pour in liquid, spatulate small portion of liquid into the base, keep area contained (remove all chunks before incorporating more base), once chunk free add the rest of the base

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24
Q

List 5 classes of ointment bases and given an example of each:

A
oleaginous - white pet
absorptive - anhydrous lanolin
O/W emulsion - dermabase
W/O emulsion - cold cream
water soluble - PEG ointment
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25
Q

Generally, which class of ointment base will release drug more rapidly, oleaginous or water miscible?

A

Water miscible - because water can penetrate into the base to dissolve the drug

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26
Q

Would you expect the Coal Tar Ointment you prepare to be greasy? Easily spreadable? Washable? Occlusive?

A

Non-greasy, easily spreadable, washable, non-occlusive (because it is O/W)

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27
Q

How is coal tar obtained?

A

By product during destructive distillation of bituminous coal

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28
Q

How is coal tar solution made?

A

Mix 200g coal tar with 500g washed sand and 50g Tween 80 and 700mL alcohol - macerate for 7 days with aggitation, filter and rinse with alcohol, add enough alcohol to qs to 1000mL

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29
Q

What does LCD stand for?

A

Liquor Cabonis Detergens

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30
Q

How much crude coal tar is in Coal Tar Solution USP?

A

200g/1000mL = 20%

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31
Q

Why is Tween included in preparations containing crude coal tar?

A

Works as a surfactant to aid in incorporation of coal tar

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32
Q

What is the therapeutic use of Coal Tar?

A

local irritant - decreases itching, scaling, dryness, for treatment of chronic skin diseases, suppresses hyperplasia

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33
Q

What are the adverse effects of Coal Tar?

A

Rash, burning, photosensitization, potential staining of clothing and skin

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34
Q

Determine strength of coal tar solution (v/w) in the coal tar ointment. What is the (w/w) percentage of crude coal tar in 50g of coal tar ointment? Based on formulation, 5.5mL of coal tar solution is used for 55g of coal tar ointment.

A
5.5mL/55g = 10% v/w
200/1000 = x/5.5mL = 1.1g       1.1g/55g = 2% w/w
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35
Q

Saskatchewan Prescription Regulations state that a prescription must include: (10)

A
  • Date
  • Physician’s Name and signature
  • Patients Name
  • Full name of medication
  • Medication concentration/strength when appropriate
  • Dosage
  • Amount prescribed/duration of treatment
  • administration route if not oral
  • Explicit instructions for pt usage
  • number of refills when required
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36
Q

What is a paste?

A

A formulation containing greater than 20% solid, stiffer than an ointment, used mostly for protective action and absorption of serous discharge from lesions, prepared using oleaginous bases, additional levigating agents aren’t used because the large volume required would produce a runny paste

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37
Q

What is the difference between a paste and an ointment?

A

Pastes are more stiff, have less percutaneous absorption of drugs incorporated and remain in place longer than ointments

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38
Q

Why is it important that the drug be in the finest state possible before incorporating into a base?

A

to increase the smoothness of the paste (no chunks) and to make it easier to combine homogenously

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39
Q

What are 4 methods used to decrease particle size?

A

levigation
trituration with mortar and pestle
pulverization by intervention
dissolution of drug in a suitable solvent that can be taken up by the base

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40
Q

Define levigation

A

reducing particle size of a solid by trituration in a mortar/pestle or spatulating with a small amount of insoluble base/liquid

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41
Q

What is the purpose of a levigating agent?

A

Wet the solids to help decrease particle size

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42
Q

What properties should a good levigating agent have?

A
chemically similar to base
viscous, low surface tension
compatible with all ingredients
preferably something already in the formulation
non-sensitizing, non-allergenic
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43
Q

If the prescribed formula does not have a suitable levigating agent, is it acceptable to add an auxiliary agent?

A

Yes

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44
Q

When is a levigating agent generally NOT added?

A

solid has very fine particles
the quantity of solid is very small
the ointment base is soft
the final preparation is intended to be a stiff paste

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45
Q

Assuming no compatibility issues, what is a suitable levigating agent for:
a- oleaginous, absorption and W/O emulsion bases
b- water soluble and O/W emulsion bases
c- Coal Tar
d- Peruvian Balsam

A

a- mineral oil
b- glycerin
c- Tween 80
d- Castor Oil

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46
Q

If you are adding an auxiliary levigating agent do you need to:
a- determine the weight of the levigating agent and make a corresponding deduction of weight from the base
b- document the name of the levigating agent and quantity used on the front of the Rx
c- Both

A

C

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47
Q

When adding an auxiliary levigating agent, an appropriate amount to use is:

A

the minimum amount required to lubricate the powders so that a consistency similar to putty is achieved

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48
Q

For the Calamine Emulsion base made in lab, a portion of the base was used to levigate. If you used an auxiliary levigating agent, what would be suitable? Why?

A

Glycerin or propylene glycol could be used because it matches properties of the base (O/W)

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49
Q

What type of emulsifier is Span 80?

A

W/O

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50
Q

What type of emulsifier is formed when stearic acid and triethanolamine are combined?

A

Triethanolamine stearate is formed - O/W

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51
Q

What type of emulsifier is Acacia?

A

O/W

52
Q

Describe how to perform a dye test on an emulsion

A

Add water soluble due to emulsion and mix

  • if a uniform colour is produced = O/W
  • if globular distribution = W/O
53
Q

Describe how to perform a dilution test on an emulsion

A

Dilute some emulsion with equal portion of water

  • stable, diluted = O/W
  • break/separate into layers = W/O
54
Q

Describe how to perform a drop test on an emulsion

A

Put a drop of emulsion onto water

  • spreads = O/W (miscible)
  • stays a drop/balls up = W/O
55
Q

You perform a dye test on an emulsion using a water soluble dye. This results in a uniform colour. What type of emulsion is it?

A

O/W

56
Q

You perform a dilution test on an emulsion and it breaks and separates into layers. What type of emulsion is it?

A

W/O

57
Q

You perform a drop test on an emulsion and the drop spreads out. What type of emulsion is it?

A

O/W

58
Q

What is the use of HC?

A

an anti-inflammatory topical agent for skin conditions such as rash, redness, inflammation

59
Q

How would you tell a patient to apply the HC application stick?

A

HC is a steroid and must be applied sparingly

60
Q

Why do you give the melted base and HC one final stir before pouring into applicator?

A

To ensure homogenous HC particle distribution and dose

61
Q

How could you stiffen the formula of the application stick?

A

Add less mineral oil

62
Q

Acacia is indicated as a suspending agent on the formulation record for the application stick. Why else is it being used?

A

It helps the smoothness of the application stick

63
Q

What is the synonym for mineral oil? Cetyl Esters Wax?

A

Mineral oil - liquid paraffin

Cetyl Esters Wax - synthetic spermaceti

64
Q

Who must give a verbal Rx and who must receive it? Why?

A

Physician must give, pharmacist/intern must receive

  • pharmacist may wish to discuss an aspect of the drug therapy prior to dispensing
  • prescriber may wish to ask pharmacist questions about medications/medication history, compliance, pattern of drug use, etc.
65
Q

Outline the procedure for making suppositories using the fusion method (not including calibration)

A

Melt the suppository base then disperse/dissolve drug into melted base, remove from heat and pour into suppository mold. once congealed remove from mold

66
Q
What is the therapeutic use for:
a- acetaminophen
b- hydrocortisone
c- aminophylline
d- diphenhydramine
A

a- analgesic
b- anti-itch
c- bronchodilator
d- anti-histamine

67
Q

What auxiliary labels are required for rectal suppositores?

A

For Rectal Use Only

68
Q

Are PEG bases water soluble for fatty bases? Witepsol?

A

PEG - water soluble

Witepsol - Fatty

69
Q

Which would you use as a lubricating agent for PEG suppositories: mineral oil or glycerin? For Witepsol?

A

PEG - mineral oil

Witepsol - glycerin

70
Q

How long does it take for an oleaginous base to melt within the rectum?

A

3-7 minutes

71
Q

How long dies it take for PEG bases to dissolve within the rectum?

A

30-40 minutes

72
Q

What are 4 disadvantages of PEG bases?

A
  • produce stinging/burning in sensitive tissues
  • can cause defecation reflex
  • incompatibility with drugs
  • not stored in polystyrene vials - react
73
Q

If a pts rectal suppository keeps melting in their fingers before insertion, would you suspect the suppositories were made from fatty or water soluble base? Why?

A

Fatty base - because PEG dissolve more slowly

- fatty bases have lower melting points

74
Q

Why should you not pour suppositories into a cold aluminum mold?

A

It can cause fracture/fissure in the suppository

75
Q

Why should you pour suppositories more slowly?

A

No air bubbles are produced

76
Q

Why should you pour suppositories continuously?

A

To prevent layering

77
Q

Should you slightly overfill each cavity before moving on to the next one? Why?

A

Yes, overfill because the suppositories contract when congealing can you cannot go back and add more because it will produce layering

78
Q

What is an appropriate size of foil to use to wrap suppositories?

A

depends, but usually 1 inch square

79
Q
What would this formulation make:
Drug
Saccharin
Acacia
PEG 1450
A

Soft Lozenge (Troche)

80
Q

Explain the steps to making a Soft Lozenge (after calibration):

A
  1. Turn hotplate to ~60, weigh ingredients, place PEG 1450 into a small breaker and begin heating
  2. Mix the remaining powders using geometric dilution in mortar with pestle
  3. Once the PEG has melted, reduce heat, sprinkle in powders ensure each addition is wet (stir well), once all powder is added add colour
  4. Allow to cool to just warm to back of hand, pour into mold, quickly, overfilling (contracts)
  5. Move a stainless steel spatula over the mold just touching the melted mixture
  6. Polish with hot air gun, if available, add wax paper on top and close package
81
Q

How do you store soft lozenges?

A

At room temperature

82
Q

What auxiliary label is required for the Diphenhydramine lozenges made in lab?

A

May cause drowsiness

83
Q
What would the following formulation make:
Coal Tar Solution USP
Salicylic Acid USP
Polysorbate 80 NF
Ethyl Alcohol USP
Dermabase
A

Coal Tar Ointment

84
Q

Steps to compounding coal tar ointment:

A
  1. Weight SA and dermabase
  2. Add alcohol to the coal tar solution
  3. Add SA and dissolve in the coal tar-alcohol mixture
  4. Add polysorbate 80
  5. incorporate liquid mixture above into a portion of dermabase
  6. Using geometric dilution incorporate remaining dermabase
  7. Package in plastic ointment jar
85
Q

What are the storage conditions for coal tar ointment?

A

room temperature

86
Q

What auxiliary labels are required for coal tar ointment?

A

For external use only

87
Q
What would the following make:
Salicylic Acid USP
Zinc Oxide USP
Starch
White Petrolatum
A

Salicylic Acid, Zinc Oxide Paste

88
Q

How do you prepare the ZnO, SA paste made in lab?

A
  1. Accurately weight ingredients
  2. Levigate each powder with a small portion of base to form a smooth paste, free of grit
  3. Combine three levigated piles
  4. incorporate the remaining portion of the base using geometric dilution, package into ointment jar
89
Q

What are the storage requirements for a paste?

A

Room Temperature

90
Q

What auxiliary labels are required for pastes?

A

For External Use only

91
Q
What would the following formulation make:
Active Ingredient USP
Cetyl alcohol
Stearic Acid
White Pet
Glycerin
Emulsifiers
Methylparaben 
Water
A

(Calamine) Topical Cream

92
Q

How do you prepare Calamine Topical Cream?

A
  1. weigh ingredients
  2. make base: melt oil phase (white pet, cetyl alcohol, stearic acid) in increasing melting points to ~55. Span and Tween can be added to this phase
    - in a second beaker heat aqueous phase (glycerin, methylparaben, water) to 5 degrees hotter than oil phase; remove from heat
    - add water to oil phase slowly, qs to 95g with water; stir until congealed
  3. Levigate calamine with small portions of base to produce smooth paste; once incorporated add remaining base with geometric dilution
93
Q

How do you store Calamine topical cream?

A

Room temperature

94
Q

What auxiliary labels are required for Calamine Topical Cream?

A

External Use Only

95
Q
What would the following formulation make:
Active Ingredient USP
White beeswax
Cetyl esters wax
Mineral Oil
Acacia
A

(HC) Application Stick

96
Q

How do you prepare the HC application stick?

A
  1. weigh powders
  2. Heat to melt beeswax and cetyl esters wax in increasing mp (cetyl esters wax then beeswax); remove from heat, add HC, acacia and mineral oil
  3. Once dispersed, cool until just warm to back of hand, stir one final time; fill application stick, if a hole develops, smooth with a warm spatula
97
Q

What are the storage requirements for the HC application stick?

A

Room temperature (avoid heat)

98
Q

What Auxiliary label is required for the HC application stick?

A

For External Use Only

99
Q

What would the following formula make:
Acetaminophen
PEG 1450
PEG 8000

A

Rectal Suppository

100
Q

What would the following formulation make:
Diphenhydramine
Witepsol

A

Rectal Suppository

101
Q

How do you prepare rectal suppositories?

A
  1. Weigh ingredients, melt base, remove from heat, add active ingredient, cool until warm to back of hand, pour into mold (overfilling), allow to harden, heat spatula, clean off excess base from top, remove from mold and wrap in foil.
102
Q

What auxiliary labels are required for rectal supp.?

A

For Rectal Use Only

103
Q

Suppository Troubleshooting:
Problem: splitting, pitting and cracking
Explain the cause and solution

A

Cause: excipients contract strongly, too great temp. difference between temp. of pouring and cooling
Solution: Use excipient that crystallizes more slowly, reduce differential temp. by dropping pouring temp. or increase cooling temp. or both

104
Q

Supp. Troubleshooting
Problem: Sticking to mold
Explain Cause and Solution

A

Cause: improper molds/alveoli, premature removal from mold, excipients contract weakly, insufficient cooling
Solution: use appropriate equipment, prolong molding period, use excipients that crystallize more rapidlu, reduce cooling temperature

105
Q

Supp. Troubleshooting:
Problem: Thickening prior to pouring
Explain Cause and Solution

A

Cause: solid active ingredients that partially solubilize hot in excipient with time, high proportion of finely powdered active ingredient
Solution: Use a mass containing an anti-crystallizing agent

106
Q

Supp. Troubleshooting:
Problem: Poor product homogeneity
Explain Cause and Solution

A

Cause: insufficient stirring, pouring temp. too high, cooling too slow or too weak
Solution: Improve technique, reduce pouring temp. or increase cooling temp.

107
Q

Supp. Troubleshooting:
Problem: Product insufficiently solid
Explain Cause and Solution

A

Cause: inclusion of air, improper excipient
Solution: check stirring level and type, use excipient having high mechanical resistance

108
Q

Supp. Troubleshooting:
Problem: Surface anomalies (fat bloom, whitening)
Explain Cause and Solution

A

Cause: excipient mp more than 60 degrees, incorrect excipient/active ratio
Solution: reduce mp temp. check behaviour of active ingredient, reformulate aqueous solutions, use excipient containing an emulsifier

109
Q

What is the therapeutic use of diphenhydramine hydrochloride?

A

sedative antihistamine

110
Q

What is the purpose of adding saccharin to a formulation?

A

Sweetener

111
Q

What is the propose of adding acacia to a formulation?

A

Surfactant (emulsifier), binder, smoothness

112
Q

What is the purpose of adding PEG to a formulation?

A

Vehicle

113
Q

What is the purpose of adding SA to a formulation?

A

local irritant

114
Q

What type of emulsifier is Tween 80?

A

O/W

115
Q

What is the purpose of adding ethyl alcohol to a formulation?

A

Solvent

116
Q

What is the purpose of adding zinc oxide to a formulation?

A

Astringent, soothing, protectant

117
Q

What is the purpose of starch?

A

Absorbant

118
Q

What is the purpose of adding calamine to a formulation?

A

Astringent, anti-itch

119
Q

What is the purpose for adding glycerin to a formulation?

A

Hydroscopic (keeps water in skin), lubrication

120
Q

What is the purpose of adding methylparaben to a formulation?

A

Preservative

121
Q

What is the purpose for adding white beeswax to a formulation?

A

Oil soluble base (vehicle) and a stiffening agent

122
Q

What is the purpose for adding Cetyl esters wax to a formulation?

A

Oil soluble vehicle, stiffening agent

123
Q

Review how to do calculations for HLB

A

See paper

124
Q

Review how to do calibration calculation for suppository molds

A

see paper

125
Q

Review how to do lozenge calculations

A

see lozenge formulation record