Ch 4: Non-Sterile Compounding Flashcards by Sally Lewis

Simple compounding involves _____ or manipulating a commercial product by adding one or more ingredients (such as water or alcohol) as directed by the manufacturer.

Reconstitution

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True or False: If the same product is available commercially, or if it was withdrawn from the market for safety reasons, then the compounded product should not be made.

True

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________ compounding requires calculations or procedures to determine the quantities of components needed for each dose.

A. Simple
B. Moderate
C. Complex

B. Moderate

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True or False: Reconstituting may not be considered compounding in all states.

True

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________ compounding requires special training, environment, facilities, equipment, and procedures.

A. Simple
B. Moderate
C. Complex

C. Complex

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True or False: compounding space must be separate from the rest of the pharmacy.

True

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True or False: The sterile compounding area does not have to be separate from the non-sterile compounding area.

FALSE! They must be separate.

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True or False: The wider the mouth of a measuring equipment (such as a conical graduate), the lower the measure accuracy.

True

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Which of the following is the most accurate for measuring small volumes?

A. Graduated cylinder
B. Conical graduate
C. Syringe

C. Syringe

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Another name for an electronic balance is _______.

Analytical balance

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Another name for a class III torsion balance is __________

Class A balance

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True or False: A top-loading electronic balance is simple to use and has higher sensitivity than a torsion balance.

True (can weigh small amounts accurately)

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A compounding pharmacy needs at least one glass and one Wedgewood or porcelain mortar and pestle. Which is preferred for liquids and for mixing compounds that are oily or can stain?

Glass mortar and pestle

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A compounding pharmacy needs at least one glass and one Wedgewood or porcelain mortar and pestle. Which is preferred for grinding dry crystals and hard powders?

Wedgewood or porcelain mortar and pestle

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Torsion balances have a sensitivity requirement of ___ mg, meaning that amount must be added or removed before the final moves 1 division.

6 mg

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This type of mortar and pestle is preferred for blending powders.

Porcelain mortars and pestles

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True or False: decreasing the particle size increases the surface area and speeds up absorption.

True

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True or False: either a steel or plastic spatula can be used to make a mixture that contains metallic ions.

FALSE! A steel (metal) spatula should not be used if making a mixture that contains metallic ions.

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Another name for an electric mortar and pestle is _______.

Homogenizer

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What are the documentation records that each compounded product must have?

Master formulation record and compounding record

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This record is referred to as the “recipe” that provides the ingredients and instructions on how to prepare the compounded product.

Master formulation record

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When a compound is logged in the compounding log/record, all of the following must be included except:
A. Components
B. Bottle size of each component
C. Lot numbers
D. Expiration dates of each component
E. The compounder
F. Control or prescription number
G. Beyond use date

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2 common ways by which comminution is done are trituration and levigation. Which of the above terms means grinding powder not smaller, finer particles and adding a liquid to help with the grinding process?

Levigation

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All medications, whether compounded or not, include the drug (called the active pharmaceutical ingredients or APIs) and the _________, which are all the other ingredients.

Excipients

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Another name for lozenges is ______

Troches

True or False: lotions contain more water than creams.

True

________ contain more than 20% water and less than 50% oil. A. Cream B. Ointment

Cream

________ contain less than 20% water and more than 50% oil. A. Cream B. Ointment

B. Ointment

True or False: ointments contain the most water, more than creams and lotions.

False! They contain the least water.

Ointments are classified into 5 types depending on the base. Name the 5 types.

1. Oleaginous (oily/greasy) bases 2. Absorption bases 3. Water in oil (w/o) emulsion base 4. Oil in water (o/w) emulsion base 5. Water soluble bases

Put the following in order of thickness (thickest to least thick): Lotion, paste, cream, ointment

Paste, ointment, cream, lotion

Pluronic lecithin organogel, or _____ gel, is commonly used for transdermal drug delivery of gels.

PLO gel

A suppository base is either _____ or _______.

Oil soluble (oleaginous) or water soluble.

Oil soluble bases for suppositories include hydrogenated vegetable oils (palm, palm kernel, and coconut oils) and theobroma oil (also known as _____).

Cocoa butter

List 2 water soluble bases for suppositories.

Polyethylene glycol (PEG) polymers and glycerinated gelatin.

For suppositories, the drug added will displace part of the base. If the drug has the same density as the base, it will displace an equal amount of volume. If the density is greater, it will displace less, and if lower, it will displace more. To calculate the amount of drug displaced, the density factor is needed, which is: ________.

Density factor = B/A-C+B ``` A = Weight of the suppository blank B = weight of medication per suppository C = Weight of medicated suppository ```

What are the 3 methods to prepare suppositories?

``` Hand molding Fusion molding (base is heated) Compression molding (must know drug's density factor) ```

B. Less

An emulsion is a liquid dispersed in a _____.

Liquid

True or False: An emulsion is a two-phase heterogenous mixture.

True; emulsions are either water in oil or oil in water

True or False: An emulsifier must be used in emulsions to reduce the surface tension between oil and water.

True

An emulsion is: A. A solid dispersed in a liquid. It's a two phase heterogenous mixture. B. A liquid dispersed in a liquid. It's a two phase heterogenous mixture. C. A solute dispersed in a solvent. It's a homogenous mixture.

B. A liquid dispersed in a liquid. It's a two phase heterogenous mixture.

A solution is: A. A solid dispersed in a liquid. It's a two phase heterogenous mixture. B. A liquid dispersed in a liquid. It's a two phase heterogenous mixture. C. A solute dispersed in a solvent. It's a homogenous mixture.

C. A solute dispersed in a solvent. It's a homogenous mixture.

A suspension is: A. A solid dispersed in a liquid. It's a two phase heterogenous mixture. B. A liquid dispersed in a liquid. It's a two phase heterogenous mixture. C. A solute dispersed in a solvent. It's a homogenous mixture.

A. A solid dispersed in a liquid. It's a two phase heterogenous mixture

____ requires a wetting agent/levigating agent. A. Emulsion B. Solution C. Suspension

C. Suspension

______ are used to help two compounds that resist each other to move closer together by reducing the surface tension. In emulsions, they're referred to as emulsifiers (reduce tension between oil and water). In suspensions, they're referred to as wetting agents or levigating agents (reduce surface tension between an insoluble solid particle drug and a liquid).

Surfactants

The _____ number is used to describe how hydrophilic or lipophilic a surfactant is, and is used to choose the right surfactant for a preparation. The HLB scale range is 0-20. The midpoint is 10. Agents with a low HLB number (<10) are more oil-soluble and are used for water-in-oil (w/o) emulsions. Agents with a high HLB number (>10) are more water-soluble and are used for oil-in-water (o/w) emulsions.

Hydrophilic-Lipophilic Balance (HLB) number

Agents with a high HLB number (>10) are more water-soluble and are used for _______ emulsions. A. Water-in-oil (w/o) B. Oil-in-water (o/w)

B. Oil-in-water (o/w)

Agents with a low HLB number (<10) are more oil-soluble and are used for ______ emulsions. A. Water-in-oil (w/o) B. Oil-in-water (o/w)

A. Water-in-oil (w/o)

The ratio for making an emulsion is: | _ parts oil: _ parts water: _ parts emulsifier

4:2:1

Adsorbents are used to keep powders dry. Select all the examples of adsorbents listed below: ``` A. Magnesium oxide B. Simethicone C. Gelatin D. Magnesium carbonate E. Kaolin ```

A. Magnesium oxide D. Magnesium carbonate E. Kaolin

_____ are used to keep powders dry. ``` A. Anti-foaming agent B. Antioxidants C. Buffers D. Preservatives E. Adsorbents ```

E. Adsorbents

_______ breaks up and inhibits the formation of foams. ``` A. Anti-foaming agent B. Antioxidants C. Buffers D. Preservatives E. Adsorbents ```

A. Anti-foaming agent

____ prevent oxidation. ``` A. Anti-foaming agent B. Antioxidants C. Buffers D. Preservatives E. Adsorbents ```

B. Antioxidants

_____ maintain the formulation within the acceptable pH range. ``` A. Anti-foaming agent B. Antioxidants C. Buffers D. Preservatives E. Adsorbents ```

C. Buffers

______ prevent degradation due to oxygen, light, moisture, and mask unpalatable taste.

Coatings (regular)

______ provides color to the compounded product. The color sometimes correlates with the flavor (cherry-flavored syrup with red coloring).

Coloring agent

_____ are used to prevent growth of bacteria or other pathogens. ``` A. Anti-foaming agent B. Antioxidants C. Buffers D. Preservatives E. Adsorbents ```

D. Preservatives

List 2 examples of anti-foaming agents

Simethicone | Dimethicone

Ascorbic acid is added to a medication as a ____. ``` A. Anti-foaming agent B. Antioxidant C. Buffer D. Preservative E. Adsorbent ```

B. Antioxidant

Shellac, gelatin, and gluten (food grade) are examples of: ``` A. Anti-foaming agent B. Antioxidants C. Buffers D. Preservatives E. Adsorbents F. Coloring agents G. Coatings (regular) H. Lubricants ```

G. Coatings (regular)

_____ are used to add size to very small dosages. In liquids, it also helps suspend the drug, and can help it disintegrate. ``` A. Adsorbents B. Emollients C. Disintegrants D. Glidant E. Humectant F. Levigating (wetting) agent G. Lubricant H. Diluents (fillers) ```

H. Diluents (fillers)

_____, such as alginic acid, polacrilin potassium such as amberlite, starches, and cellulose products are used in oral products to absorb water, causing the tablet to swell and burst so that it is dissolved and absorbed. ``` A. Adsorbents B. Emollients C. Disintegrants D. Glidant E. Humectant F. Levigating (wetting) agent G. Lubricant H. Diluents (fillers) ```

C. Disintegrants

Nu-Tab is an example of compressible sugar that is used as a ______. ``` A. Adsorbent B. Emollient C. Disintegrant D. Glidant E. Humectant F. Levigating (wetting) agent G. Lubricant H. Diluent (filler) ```

C. Disintegrant

Common examples of _____ are petroleum jelly, Aquaphor, Vaseline, Cetaphil, and Eucerin.

emollients

_______ soften and soothe the skin or mucous membranes, provide a barrier, and act as a vehicle for drug delivery. ``` A. Adsorbents B. Emollients C. Disintegrants D. Glidant E. Humectant F. Levigating (wetting) agent G. Lubricant H. Diluents (fillers) ```

B. Emollients

Most drugs dissolve in the stomach and are absorbed in the small intestine. Some drugs would be destroyed by the stomach acid and require an acid-resistant protective layer to prevent dissolution in the stomach. This coating, called ______, can also be used to mask poor taste.

Enteric-coating

Cellulose acetate phthalate and Shellac (a natural polymer resin from insects) are used to make ______.

Enteric-coating

Agar, alginates, guar gus, acacia (a natural gum), gelatins, tragacanth, bentonite (a type of clay), Carbomer, cellulose, starches are all types of ______ used to increase viscosity of a substance and can stabilize the mixture. Gelatin and bentonite are the most commonly used.

Gelling (thickening) agent, stabilizer

_____ improves flow of properties of the powder mixture in tablet and capsule formulations by reducing interparticle friction. Common examples are colloidal silica and magnesium stearate. ``` A. Adsorbents B. Emollients C. Disintegrants D. Glidant E. Humectant F. Levigating (wetting) agent G. Lubricant H. Diluents (fillers) ```

D. Glidant

_______ prevents preparations from becoming dry and brittle. ``` A. Adsorbents B. Emollients C. Disintegrants D. Glidant E. Humectant F. Levigating (wetting) agent G. Lubricant H. Diluents (fillers) ```

E. Humectant

PEG and alcohols are _______. A. Hydrophobic solvents B. Hydrophilic solvents

B. Hydrophilic solvents

Oils and fats are _________. A. Hydrophobic solvents B. Hydrophilic solvents

A. Hydrophobic solvents

True or False: Mineral oil and glycerin are examples of levigating (wetting) agents.

True

Magnesium stearate is an example of ______, which help keep ingredients from sticking to each other and equipment. This can be useful for tablet molds and punches, suppository molds, and capsule filling. ``` A. Adsorbents B. Emollients C. Disintegrants D. Glidant E. Humectant F. Levigating (wetting) agent G. Lubricant H. Diluents (fillers) ```

G. Lubricant

All of the following are used as preservatives EXCEPT: ``` A. Chlorhexidine B. EDTA C. Magnesium stearate D. Sodium benzoate E. Benzylkonium chloride F. Thimerosal ```

C. Magnesium stearate

All of the following are used as suppository bases EXCEPT: A. Aspartame B. Gelatin C. Hydrogenated vegetable oils D. Cocoa butter

A. Aspartame

Polybase is a ____ mixture that is commonly used as a suppository base as it is a good delivery vehicle and slides out of molds without the need for a lubricant.

PEG

The beyond use date (BUD) of nonaqueous formulations such as a drug in petrolatum is _____.

Not later than the time remain until the earliest expiration date of any API or 6 months, whichever is earlier.

How should nonaqueous formulations be stored?

At room temperature

The beyond use date (BUD) of water containing oral formulations such as oral suspension is _____.

Not later than 14 days when stored at controlled cold temperatures. Store in refrigerator

How should water containing oral formulations such as oral suspension be stored?

Refrigerator

The beyond use date (BUD) of water containing topical/dermal and mucosal liquid and semisolid formulations such as creams or lotions is _____.

Not later than 30 days

How should water containing topical/dermal and mucosal liquid and semisolid formulations such as creams or lotions be stored?

Store at room temperature

True or False: If any ingredient expires before the BUD, the product is still good until the BUD.

False! Use the earlier expiration date

True or False: BUDS may be extended if stability data is obtained that determines the drug is stable for a longer period.

True

True or False: The labeling of all compounded products must include the BUD and storage and handling information.

True