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NAPLEX > Non Sterile compounding > Flashcards

Non Sterile compounding Flashcards

1
Q

Simple compounding

A

Reconstituting a commercially avail product by adding one or more ingredients as directed by the mfg

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2
Q

Moderate compounding

A

Requires calculations and procedures to determine the quantities of components needed for each dose

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3
Q

Complex compounding

A

requires special training, environment, facilities, equipment and procedures

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4
Q

The wider the mouth of a graduated cyclinder, the higher or lower the accuracy?

A

Lower

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5
Q

A compounding pharmacy needs at least which 2 types of mortar and pestels?

A

One glass and one wedgwood/porcelain

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6
Q

What are glass mortar and pestels used for?

A

Liquids (susp and solutions), good for compounds that are oily or can stain

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7
Q

What are wedgwood mortar and pestels used for?

A

They are rougher surface than porcelain and are preferred for grinding dry crystals or hard powders

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8
Q

What are porcelain mortar and pestels used for?

A

Have a smoother surface relative to wedgwood and are preferred for bleding powders and pulverizing gummy consistencies.

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9
Q

Pill tiles can be used as?

A

Ointment slabs

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10
Q

What are the names of the 2 most important records of documentation of compounding? What information is found on these records?

A

Master formulation record: Recipe that provides ingredients and instruction on how to prepare the compounded product.
Compounding record: References the master formulation record and details the components with source, lot, exp date, BUD and description of final product.

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11
Q

Where should the patient and pharmacist report an ADR related to a compounded drug?

A

Patient should report to the pharmacy and pharmacist will record the ADR in the compounding record and then they should update the ADR in patient profile

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12
Q

What is communition?

A

Reduce solids from an average particle size to a smaller average particle size by crushing, grinding and similar process.

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13
Q

Trituration and levigation are 2 common ways in which communition are done. What does trituration and levigation mean?

A

Trituration: Grinding powder into smaller, finer particles with mortar and pestel
Levigation: trituration with one main difference. Pharmacist adds liquid (wetting or levigating agent) to help with grinding process. Will turn into paste.

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14
Q

Geometric dilution

A

Used to make smooth and uniform mixture by mixing equal amounts at a time.

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15
Q

If any component used for compounding does not come from the FDA, what must be documented?

A

Certificate of analysis

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16
Q

What expiration date should be assigned to any compounding ingredient that arrives to the pharmacy without an expiration date?

A

No more than 3 years

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17
Q

Magnesium strearate is considered what type of agent and is used to improve the flowability of what type of compounds?

A

Is considered a glidant/lubricant and improves the flowability of powders

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18
Q

Sodium lauryl sulfate is considered what type of agent and is used to neutralize the static charge and keep what types of compounds from floating away?

A

Surfactant used to neutralize charge and prevent powders from flowing away

19
Q

What does eutectic mean?

A

In reference to compounding powders, it means that when 2 components are mixed together will melt at a lower temperature than any individual melting points

20
Q

Capsules are soluble shells made of one of which 2 types of substances?

A

Gelatin (animal)

Hypromellose (vegetable)

21
Q

What 2 agents are used as plasticizers to make capsules less brittle and more flexible?

A

Glycerol and sorbitol (soft shell capsules, used more commonly for oils)

22
Q

What bases are used to prepare hard lozenges or troches?
Soft lozenges or troches?
Chewable lozenges?

A

Hard lozenges: Sucrose or syrup
Soft: PEG
Chewable: Glycerin or gelatin

23
Q

Lotions are mostly what?

A

Water

24
Q

Ointments are classified into 5 types depending on the base. what are these 5 types?

A 
Oleaginous (oily/greasy)
absorption
Water in oil
oil in water
Water soluble
25
Q

PLO gel is commonly used for what type of drug delivery systems?

A

Transdermal

26
Q

Water soluble bases used to make suppositories include what 2 agents?

A

PEG polymers or gelatin

27
Q

Describe the 3 methods used to prepare suppositories?

A

Hand molding: Used when only few supp are needed using cocoa butter as the base (not melted)
Fusion molding: Base gently heated and ingredients are added and then poured into room temperature mold.
Compression molding: Know the weight of each mold and drugs density factor and pour into cold compression mold.

28
Q

2 lubricants used for oil based suppositories? Water based suppositories?

A

Oil based: Glycerin or Propylene glycol

Water baseD: Mineral oil or vegetable oil

29
Q

What is an emulsion? Examples of emulsifying agents?

A

Liquid dispersed in liquid, 2 phase heterogenous mixture
Oil and water don’t mix–> need emulsifying agent (acacia,, agar, carbomers, glyceryl monostearate, pectin, PEG, SLS, span or tween)
Need HLB value

30
Q

What is a suspension? What agents are used to incorporate an insoluble drug into solution?

A

Solid dispersed in liquid. 2 phase heterogeneous mixture.

Levigating agents/wetting agents: Glycerin, mineral oil, PEG, propylene glycol

31
Q

What is a solution?

A

Solute dissolved in solvent (homogeneous mixture)

32
Q

What are surfactants?

A

Used to help 2 compounds which resist each other to move closer together by reducing the surface tension between them (used in emulsions)

33
Q

What is the HLB number? Explain the HLB scale

A

Hydrophilic lipophilic balance number.
HLB scale 0-20.
Low HLB (< 10): More oil soluble, used for water in oil
High HLB (> 10): More water soluble, used for oil in water

34
Q

2 examples of adsorbents used to keep powders dry?

A

Mag oxide/carbonate, kaolin

35
Q

Example of an anti foaming agent?

A

Simethicone

36
Q

Example of an antioxidant?

A

Ascorbic acid

37
Q

Examples of coatings to prevent degradation?

A

shellac, gelatin, gluten

38
Q

What are examples of diluents? (6)

A

Starches, calcium salts, lactose, mannitol, sorbitol and cellulose

39
Q

Examples of disintegrants?

A

Alginic acid, polacrilin potassium, cellulose, starches

40
Q

Example of an emollient?

A

Petroleum jelly

aquaphor, vaseline, eucerin, etc

41
Q

What is used for enteric coating?

A

Cellulose acetate phthalate, shellac

42
Q

Examples of flavoring agents (sweetener)?

A

Sugar free (artificial): aspartame,saccharin

Glycerin, dextrose, lactose, mannitol, sorbitol, phenylalanine, stevia, xylitol

43
Q

Thickening agents?

A

Agar, alginates, guar gums, acacia, bentanite, carbomer

44
Q

Storage recommendations and BUD for nonaqueous formulations? Aqueous oral formulations? Water containing topical/dermal products?

A

Non-aqueous (ointment): any API or 6 months, whichever sooner, store at room temp
Aqueous oral: 14 days refrigeration
Water containing topical/dermal (creams and lotions): 30 days at room temp

NAPLEX (30 decks)

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