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Pharmacy Practice Lab II > Lab 11 > Flashcards

Lab 11 Flashcards

1
Q

Suppositories are _____ dosage forms. where are they inserted

A

solid dosage forms inserted into body orifices (rectum, vagina, and urethra)

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2
Q

how is the shape of suppositories designed/molded?

A

so that it can be easily inserted and retained in the intended orifice

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3
Q

do suppositories exhibit local or systemic effects?

A

can be local and can be systemic. effects produced upon melting/dissolving

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4
Q

name some types of drugs that are formulated as suppositories for LOCAL effects (give 4 examples)

A

antiseptics
anti-infectives
astringents

also used for local action in lower GI tract and the genitourinary system

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5
Q

give an example of when a suppository would be used over oral administration

A

when the drug cannot reach the target sight after oral administration due to first pass effects (liver metabolism) or is destroyed by gastric or intestinal pH/enzymes

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6
Q

when are suppositories used for systemic action?

A

when the pt can’t swallow (is unconscious/vomiting/seizures) or has GI disorders

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7
Q

name 2 examples of types of drugs that are used in suppositories for systemic action

A

analgesics for pain relief
anti-emetics for vomiting

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8
Q

the drug is mixed with __ for molding

A

a suitable suppository base

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9
Q

how are suppository bases classified

A

into 3 types:

-fatty or oleaginous
-water soluble or water miscible
-misc base

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10
Q

give an example of a fatty/oleaginous base

A

cocoa butter

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11
Q

give an example of a water soluble/water miscible base

A

PEG (polyethylene glycol)

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12
Q

give an example of a miscellaneous base

A

blends of fatty and water soluble/water miscible bases

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13
Q

give 3 advantages of fatty/oleaginous bases (cocoa butter)

A

-non-irritating to sensitive tissues

-less reactive and has less stability issues

-contains surfactants/emulsifying agents that enhance the release of hydrophobic drugs

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14
Q

what type of base is preferred for rectal suppositories?

A

fatty/oleaginous base

it’s non-irritating to sensitive tissues

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15
Q

name 4 disadvantages of fatty/oleaginous base suppositories

A

-may leak out of body cavity – not good choice for vaginal and urethral

-melting point may be lowered by adding other components/drugs. therefore, must be stored in fridge/controlled temp

-poor release of hydrophobic drugs (unless emulsifying agent/surfactant is added)

-may manifest polymorphism

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16
Q

which type of suppository base is preferred for vaginal and urethral use?

A

water soluble/water miscible bases (PEG bases)

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17
Q

name 3 advantages of water soluble/water miscible bases

A

-does not leak

-may not melt at fairly warm room temp

-more reliable release of hydrophobic drugs because it slowly DISSOLVES into the aqueous secretions of the body cavity

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18
Q

which base provides a more reliable release of hydrophobic drugs and why

A

water soluble/water miscible base slowly DISSOLVES in the aqueous secretions

fatty/oleaginous MELTS and can provide hydrophobic drug release only by the addition of an emulsifying agent or surfactant

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19
Q

name 3 disadvantages of water miscible bases (PEG)

A

-may cause stinging or burning. defecating reflex when used rectally (that’s why oleaginous/fatty base is preferred for rectal)

-must be dipped into water b4 use if it contains less than 20% water

-may cause chemical incompatibility with some drugs

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20
Q

the release of drugs from suppositories is dependent on what (3)

A

the nature of the suppository base

the use of surfactants or other additives

the solubility of the drug in the suppository base

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21
Q

for effectiveness, when should the drug be released from the suppository

A

should be released before the suppository is expelled from the patient (by defecation or urination)

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22
Q

true or false

drug solubility is an important factor for drug release

A

true

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23
Q

what kind of bases have a better release for water soluble drugs?

A

oleaginous bases

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24
Q

water soluble and water miscible bases are preferred for what kind of drugs

A

water insoluble drugs

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25
Q

true or false

the suppository base used should be therapeutically inert and exhibit polymorphism

A

FALSE

therapeutically inert and NOT exhibit polymorphism

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26
Q

why must a suppository base NOT exhibit polymorphism

A

bc polymorphism can alter the melting properties of the base

(fatty/oleaginous base may exhibit polymorphism)

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27
Q

true or false

the drug must be stable and compatible in the base

A

true

28
Q

the base must be non ___, non____, and non____

A

non toxic
non sensitizing
non irritating

29
Q

true or false

suppository bases must be free of objectionable odor

A

true

30
Q

explain the state of matter that suppository bases should be

A

should be SOLID at room temp but melt/soften/dissolve at body temp

31
Q

true or false

the drug release from suppositories is more predictable than oral and parenteral drugs

A

FALSE

drug release from suppositories is less predictable bc there is no environment for absorption in the rectum

32
Q

which has more surface area for absorption and why – the rectum or the small intestine

A

the small intestine has more because it has villi

33
Q

in suppositories, how much of the drug bypasses 1st pass metabolism?
how much is actually absorbed rectally?

A

2/3 of the drug bypasses 1st pass metabolism

only 1/3 is absorbed rectally is taken to the liver via hepatic portal system and may be metabolized before reaching the site of action (1st pass)

34
Q

true or false

rectal fluids have POOR buffering capacity

A

true

35
Q

rectal _______ may affect drug absorption and stability

A

pH

36
Q

what is the acetaminophen density factor for PEG

A

2.5

37
Q

how much PEG is displaced by 200mg of acetaminophen?

also give the formula

A

2.5 = 200/x

x = 80mg

density factor = mg drug/weight of base displaced

38
Q

what is an important step when considering the amount of PEG base + acetaminophen to use in preparing suppositories

A

prepare for 1 extra suppository (x+1)

39
Q

give the formula to calculate density factor

A

DF = weight of drug/weight of base displaced

40
Q

what is ALWAYS the density factor when the drug has the same density as the base?
what does this mean?

A

DF = 1

this means that the drug will replace an equal weight of the base.
therefore, the weight of the drug can be directly subtracted from the weight of the base

41
Q

when the drug has a higher or lower density than the base, what is the density factor

A

either >1 or < 1 respectively

42
Q

true or false

when the drug has a higher density than the base, the DF will be less than 1

A

false – greater than 1

43
Q

to obtain the weight of the base required for preparation, what must be done?

A

the weight of base displaced by volume of the drug must be calculated and then substracted from the weight of a blank suppository (without drug)

44
Q

true or false

suppository molds have a fixed volume

A

TRUE

45
Q

suppository molds are formulated by ____ since they have a fixed volume

A

weight

46
Q

the _____ displaces a volume of the __

A

drug displaces a volume of the base

47
Q

density of cocoa butter = 0.86g/mL

12mL of cocoa butter required to fill a suppository mold

the drug (500mg) in the formula takes up 2.8mL of the mold

CALCULATE THE DENSITY FACTOR

HOW MANY GRAMS OF COCOA BUTTER ARE REQUIRED TO PREPARE 4 SUPPOSITORIES

A

12mL-2.8mL = 9.2mL remaining

9.2mL * 0.86g/mL = 7.91g of cocoa butter

48
Q

relative density factor is used to calculate what

A

the quantity of base displaced when the density factor for the required base is KNOWN and the density factor for 2 other bases is known

49
Q

give the formula for relative density factor

A

RDF = density of base )used in preparation) / density of base with KNOWN drug density factor

50
Q

the density factors for many drugs and bases in ____ is known

A

cocoa butter

51
Q

name 2 preparation techniques for suppositories

A

fusion method
double casting

52
Q

what method of preparing suppositories is generally used in small-scale manufacture

A

fusion method

53
Q

explain how the fusion method for preparing suppositories works

A

the base is melted

drug is uniformly dispersed or dissolved in the base

melted mixture is poured into the mold

suppository is removed once it is solidified

54
Q

what is the usual size for an adult rectal suppository

A

~2g

55
Q

the ingredients for suppositores are usually given using _____ but are poured into a mold of specified ____

A

weight

volume

56
Q

true or false

the densities of the drug and the base are the same

A

false - they may differ

57
Q

the quantity of base used must be adjusted for what?

A

the volume of base that will be displaced by the drug

58
Q

explain the double casting method of preparing suppositories

A

suppositories are manually casted/molded and remelted to a uniformly dispersed suppository base

can be used instead of the calculation method

59
Q

suppositories must be inspected for quality before packaging and dispensing

they must be observed for what?

A

excessive hardening or softening, and for the uniformity of drug distribution

smooth even shape with no indentation at the top or the sides

60
Q

what USP chapter recommends the beyond use date of suppositories
what do they state?

A

USP 795

25% of the time remaining until the product’s exp date OR 6 months
(whichever is earlier)

61
Q

when are shorter beyond use times than those used in 795 recommended?

A

when the stability of the product is a concern based on the manufacturing process, etc

62
Q

how must suppositories be stored

A

protected from heat
stored under refrigeration (NOT frozen)

63
Q

which suppositories must be stored in airtight containers and why?

A

PEG suppositories bc they are hygroscopic

64
Q

true or false

cocoa butter suppositories do not require refrigeration

A

FALSE

PEG suppositories do not require refrigeration

65
Q
A

Pharmacy Practice Lab II (12 decks)

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