Compounding Exam - Content only

In compounded what value do you use for conversion of 1 fl oz?

• 30 mls

What do we do to make a medication more palatable?

• convert it to a suspension

What is a lollipop?

• hard lozenge

Why is a lollipop convenient and patient friendly?

• can be sweetened or flavored

• smooth surface area and texture

Why are lollipops good for local and systemic administration?

• provides slow, uniform drug dissolution over 5-10 mins

  • don’t chew or bite the lollipop for consistent drug release

What do lollipops usually weigh?

• 1.5-4.5 each

What is the Hard Crack phase?

• 300-310 F (149C)

  • syrup cracks if you try to mold it

  • necessary for hard lozenges

What is soft crack?

• 270-290F

  • firm form but pliable threads

What is caramelization?

• >310 F

  • yellowing of the formula

  • overheating

What happens with improper storage of lollipops?

• gummy outside

• improper drug dissolution

What happens if you use a heat sensitive API in lollipops?

• patient harm due to changes in medication (heat-labile medication)

What happens if there is a uniformity error in a lollipop size?

• variations in patient’s dose

What happens if a lollipop is underheated?

• will be soft

What are the ingredients of a lollipop?

• base (sucrose, carb, water)

• API

• acidifier (citric acid)

• flavoring/coloring

Hard lozenges are _______, so keep in the dispensing container, away from extreme ______.

hygroscopic (absorb water); humidity

What does a satisfactory hard lozenge look like?

• solid and cannot be bent w/o heat application

What is a troche?

• lozenge

What are temp are soft lozenges prepared at?

• low compared to hard lozenges

How are soft lozenges taken?

• slowly dissolved in the mouth or chewed, depending on action desired for the particular incorporated API

What is an example of a chewable lozenge?

• gummy

Characteristics of chewable (gummy) lozenges:

• highly flavored with a slightly acidic taste

• easy to prep

• many can use gummy product as base

What agents are used in chewable lozenges?

• xanthan gum = thickening agent

• glycerin USP = wetting agent

Positives of medication sticks:

• easily transportable

• convenient

What are medication sticks used for?

• anesthetics

• sunscreens

• oncology meds

• antivirals

• antibiotics

Characteristics of a good med stick:

• spreads easily

• doesn’t sweat, crumble or crack

• appears uniform and stable

What are hard medication sticks?

• crystalline powders fused together by heat or held w/ binder

• must be “activated” with moisture

  • ex. styptic pencil

What are soft medication sticks?

• blend of high and low melting points as base

• melt w/ application (body heat

• ex. lip balm

What are the clear bases for soft sticks?

• sodium stearate

• glycerin

• propylene glycol

What are the opaque bases for soft sticks?

• petroleum or petrolatum

• cocoa butter

• PEG

How are ingredients added when making lipbalms?

• in order of highest to lowest melting temperatures

What does a lubricant do?

• minimizes the coherence of the waxes and provides easy spreading qualities

What does penetration enhancer do?

• inc. the amount of transdermal drug delivery

What does beeswax do?

• serves as the stiffening agent for sticks

Higher temp. melting points _____ the product. Lower temp. melting points _____ the product.

stiffen; soften

What does cocoa butter do?

• melts upon application at about body temperature

  • ideal for soft med sticks

What is blending in flavoring?

• adding a flavor with similar properties to improve the taste

• use of a flavor that “blends” with the drug taste

Bitter taste can be blended with what flavor to taste better?

• salt/sweet/sour

Acidic taste can be blended with what flavor to taste better?

• citrus fruit flavors

What is overshadowing/masking in flavoring?

• involves the use of a flavor with a stronger intensity and longer residence time in the mouth

Vanilla has a _____ residence time.

longer

Mint is both _____ and ___ residence time.

intense; long

What are physical methods of flavoring?

• insoluble compounds in a suspension

• emulsification in the internal phase

• effervescence so sensation overcomes taste

• high-viscosity fluids (syrups)

What are chemical methods of flavoring?

• adsorbing or complexing the drug with an ingredient chemically (if an option)

What are physiological methods of flavoring?

• utilizing sensation to create a competing reaction to overcome/overpower the taste

Clove and cinnamon cause what reaction?

• mild pain reaction of heat and numbness

Peppermint and spearmint cause what reaction?

• cooling sensation

effervescent tablets cause what reaction?

• tingling sensation

What total amount of flavoring should be used?

• 1-3%

What is the definition of DDF?

• Density Displacement factor

• how much base a drug will displace for a particular API to that particular base

• how much API moves 1 g of base

20 drops =

1 ml

A solution is a ____ route of administration.

versatile

What is the BUD for solutions usually?

• 14 days in the fridge

Do you need to make extra when compounding a solution?

• no

What does PLO stand for?

• Pluronic Lecithin Organogel

PLO is thermoreversible so it….

• liquid at cold temps and semisolid at room temp

What are the Base ingredients of PLO gel?

• pluronic gel

• lecithin - stoarted at room temp

• isopropyl palmitate

What is the BUD of PLO gel?

• 180 days at room temp

Even though PLO gel is a topical medication, there is what at a reduced rate? what can it cause?

• systemic absorption

  • stomach irritation

What is PLO Gel considered? This is why we don’t need to make extra product when compounding

• closed system (no loss occurs)

What are the layers of the epidermis from top to bottom?

• stratum corneum - most impermeable

• stratum lucidum

• stratum granulosum

• stratum spinosum

• stratum basale

What is a suppository?

• solid body compounded to be inserted into the rectum, vagina, or urethra

What do suppositories act as?

• protectant locally or API for local/systemic delivery

We DO make ____ extra to accommodate for loss of product in troches, suppositories, and topicals.

10%

What populations are suppositories used for?

• infants/small children

• cannot take meds by mouth

• don’t have proper IV access

• specific conditions (constipation for rectal suppositories)

What considerations should be made about suppositories?

• size (rectal vs. vaginal)

• previous use of suppositories

• conditions it is being used for

• conditions that prevent the use of a suppository

What is the fusion method?

• API is dispersed inside of melted base

• most common method of suppository compounding

• used if high MP are involved, cooling time is necessary

When is double casting method for suppositories/troches used?

• DF is unknown

What should be in the SIG code for suppositories?

• unwrap and insert

What is Aw (water activity)?

• amount of “free” or available water in a formulation that microorganisms can use to grow

• the higher a Aw#, the more likely microorganisms will grow

if Aw = 1?

• pure water

if Aw = 0?

• completely drug (no water content)

What is an ointment?

• semisolid preparation intended for external application to the skin or mucous membranes

What are the reasons to use an ointment?

• protect injured external areas from environment to promote healing

• providing skin with proper hydration to promote healing

• a medium for drug delivery, either locally or systemic

Rank topicals in order of most protective to least protective:

• paste

• ointment

• cream

• lotion

Rank topicals in order of most spreadable to least spreadable:

• lotion

• cream

• ointment

• paste

What are levigating agents?

• liquids used during titration of powders in topical formulations to help incorporate insoluble solid drugs smoothly into the base

  • mineral oil’s role in nifedipine ointment

• helps powder mix evenly with other ingredients

What do levigating agents help?

• reduce particle size of powder

• wet the powder particles

• prevent grittiness

• allow uniform distribution of the drug in the topical base

What is an Oleaginous base?

• oil-souble

What are the characteristics of an oleaginous base?

• mild and non-irritating to mucosa

• don’t usually require lubrication

• melt quickly in the mucosa

• quick drug release

• preferably intert

What are examples of oleaginous bases?

• cocoa butter

• hydrogenated veggie oils

What are characteristics of water-miscible bases?

• release of drug is more on dissolution rather than melting

• some require a lubricated mold

• more rapid release than oleaginous

Examples of water-miscible bases:

• glycerinated gelatin

• polyethylene glycol

• polybase