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Suppositories made by a method typically used for cocoa butter bases that does not require special equipment or molds

hand rolled suppositories

Suppository base material that is soft and rubbery, is hygroscopic, and should contain a preservative

glycerinated gelatin base

Ingredient added to a suppository base that helps the base to break apart more easily and spread more effectively over the target tissue

dispersing agent

Suppository base that is insoluble in water, non-irritating to tissues, and sometimes gives poor and erratic release of some of the drugs from the base

cocoa butter base

Suppository base material comprised of nonionic surfactants used alone or in combination with other suppository base materials to create suppositories that can have desirable consistencies and melting points

water-dispersible base

Solid bodies of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the body.

suppository

Usually weigh 1 gram

pediatric rectal suppository

Non-disposible suppository mold that must be lubricated prior to use

aluminum mold

A cocoa butter substitute base for suppositories whose melting point range is 32 - 36 degrees C.

Fattibase

Method of making suppositories that requires careful heating and special equipments and molds

fusion method

Give 2 uses of suppositories

1. when a local effect is needed in the rectum, vagina, or urethra
2. when a patient cannot take drugs orally

Give 2 examples of suppository base types that dissolve in the orifice

1. polyethylene glycol (PEG)
2. glycerinated gelatin base

Give 2 examples of base types that melt at body temperature

1. cocoa butter
2. cocoa butter substitutes

List the 5 general classes of suppository bases

1. cocoa butter
2. cocoa butter substitutes
3. glycerinated gelatin
4. polyethylene glycol (PEG)
5. surfactant base

Although suppositories have a local effect in the rectum, vagina, and urethra, they only have a systemic effect in the ____ and ____.

rectum and vagina

____ ____ is a mellow yellowish solid with mild odor and melting point of 31 to 34°C.

cocoa butter

Does cocoa butter contain emulsifiers?

no

Cocoa butter absorbs a limited amount of water. What can be added to help?

Tween 61

Cocoa butter is incompatible with some drugs. What can be added to overcome this?

white wax or cetyl esters wax

What are 4 advantages of cocoa butter?

1. bland and nonsensitizing to membrane tissues
2. readily available; can be hand rolled
3. solidification temperature is 12-13° below its melting point (easy to pour before hardens)
4. available grated or in bricks

What are 3 disadvantages of cocoa butter?

1. must be kept in refrigerator or controlled room temperature (bc of the low melting point)
2. has several polymorphic forms that have even lower melting points (18°, 24°, and 28-31°C)
3. poor and erratic release of some medications

What happens if you overheat cocoa butter?

it solidifies as a lower melting polymorph that won't set up properly or melt in the hand prior to insertion

How do you know if cocoa butter has been overheated?

it will turn a clear straw color

____ ____ ____ are fat-type suppository bases that can be produced from vegetable oils modified by esterification, hydrogenation, and fractionation to obtain products of varying compositions and melting points.

cocoa butter substitutes

What are 2 examples of cocoa butter substitutes?

Witepsol and Fattibase

Why do pharmacists tend to like Fattibase?

it's easier to work with than the cocoa butter (is not as sensitive to the melting range)

Are cocoa butter substitutes soluble in water?

no

What are 2 advantages of cocoa butter substitutes?

1. bland and non-irritating
2. easier to work with than cocoa butter

What are 2 disadvantages of cocoa butter substitutes?

1. must be kept at controlled room temperature or refrigerated (bc of low melting point)
2. may give poor release of water insoluble drugs

Why are glycerinated gelatin bases not used a lot?

because they are hard to make and have limited advantages

How are glycerinated gelatin bases used?

vaginally (and they MUST be moistened before insertion)

Do glycerinated gelatin bases melt?

no, they dissolve slowly in the vaginal secretions

Do PEG bases melt?

no, they dissolve

What are 3 advantages of PEG bases?

1. easy to make by fusion
2. work with hydrophilic and hydrophobic drugs because they dissolve in body fluids (don't melt)
3. can control melting points with different blends so storage is not an issue

What are 3 disadvantages of PEG bases?

1. are irritating to body cavity tissues
2. incompatible with a lot of drugs
3. will interact if they come into contact with polystyrene prescription vials (must be wrapped with foil before placed in these bags)

____ or ____-____ bases are hard to formulate, but can have desirable melting points and consistencies.

surfactant or water-dispersible

How do we pick which suppository base to use?

Consider the following:
1. systemic or local effect
2. route of administration
3. patient comfort
4. compatibility and stability

____ bases are preferred for rectal administration, but ____ bases are preferred for vaginal and urethral administration. ____ bases are another option for vaginal administration.

fatty, PEG, glycerinated

The systemic effect of suppositories depends on the amount of ____ in the orifice.

fluid

What are the two methods of making suppositories?

hand rolling and fusion

What are the advantages of hand rolling suppositories?

no special calculations or special equipment; only cocoa butter can be used

What are the disadvantages of hand rolling suppositories?

requires experience and good technique; are not very elegant, even when made well

What are the advantages of making suppositories with the fusion method?

no aquired special technique; have elegant professional appearance

What are the disadvantages of making suppositories with the fusion method?

need mold and can't use with drugs that are heat sensitive; requires special calculations

Adult rectal suppositories should weigh ___g and pediatric rectal suppositories should weigh ___g.

2g; 1g

How much should vaginal suppositories weigh?

2g - 5g

Male urethral suppositories should weigh ___g and femal urethral suppositories should weigh ___g.

4g; 2g

When is the double casting method used?

when the drug makes up a considerable amount of the dosage unit and there is no reported density factor for this drug in this base

What is the BUD for suppositories made with a manufactured dosage form?

6 months or 25% of the time remaining until the product's expiration date, whichever is earlier

What is the BUD for suppositories made with USP or NF ingredients?

6 months (unless one of the ingredients expires before that)

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