PHM 652: Exam 1 Flashcards

1
Q

what are ointments (USP) definition

A

semisolid preparations intended for external application to the skin or mucous membranes.

also an umbrella term often used loosely to include : pastes, creams, gels, plasters, poultices

basically ALL SEMISOLID TOPICALS

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2
Q

specific definition of ointments

characteristics

A

an unofficial specific classification for oleaginous topicals (petrolatum, lanolin, or other semisolid oil/greese based preparations

insoluble in water
emolient
occlusive
greasy

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3
Q

incorporation in terms of ointments

A

the process of combining semi-solid masses

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4
Q

when levigating, how much of the levigating agent should we use?

A

a minimal amount

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5
Q

Levigating agents for ointments

A

powder must be insoluble in agent

ideal a LMW version of the base itself or a low viscosity agents compatible with the base

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6
Q

examples of levigating agents for common ung. bases

What is the purpose of these?

A

mineral oil (for use with petrolatum)

glycerin (for use with PEG)

LMW PEG ( for use with PEG)

to help with levigation to incorporate into the base
ideal a LMW version of the base itself or a low viscosity agents compatible with the base

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7
Q

solubilization agents

A

agents that aid the incorporation of drugs that are soluble in the ointment base.

should be compatible with the absorption base

powder must be soluble in the solubilization agent and ung. base.

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8
Q

creams

A

same usp definition for ung.. BUT

separate usp classification used for WATER-REMOVABLE/ SOLUBLE UNG

usually not termed an ung.

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9
Q

gels

A

semisolid systems consisting of either suspensions made up of small inorganic particles or large organic molecules interpenetrated by a liquid

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10
Q

pastes

A

similar to usp definitin

general high viscosity
stiff
protective property
generally an ung with >20% w/w powder

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11
Q

what’s the diff btw topical vs transdermal

A

same location of application.

topical: applies to the tissues where ailment exists
transdermal: intent for active ingredient to be systemically distributed into the blood

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12
Q

emolient

A

substance that promotes the moisturization of tissues

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13
Q

use of ointment as a term

general

specific

A

general: ointment= semisolid
specific: oleagenous/ hydrocarbon base class (5 main classes)

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14
Q

ideal ointment

if there was such a thing

A

spreads easily

compatible with tissues

a. non irritating
b. hypoallergenic
b. non abrasive
b. isotonic

stable ( physical, chemical, microbiologic)

smooth and pliable

softens and melts at body room tmep

easily removed

ready release of medication

doesn’t stain clothing

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15
Q

5 main classes of ointment bases

A
  1. hydrocarbon/ oleaginous
  2. anhydrous absorption
  3. water in oil emulsion
  4. oil in water emulsion
  5. water soluble
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16
Q

ointment base characteristics

hydrocarbon oleaginous bases

water soluble:
water washable: 
anhydrous: 
absorbs water: 
emollient: 
occlusive:
greasy:
A
water soluble:   no
water washable: no
anhydrous: yes
absorbs water: no
emollient: yes
occlusive: yes
greasy: yes
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17
Q

ointment base characteristics

anhydrous absorption bases

water soluble:
water washable: 
anhydrous: 
absorbs water: 
emollient: 
occlusive:
greasy:
A
water soluble: no
water washable: no
anhydrous: yes
absorbs water: yes
emollient: yes
occlusive: yes
greasy: yes
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18
Q

ointment base characteristics

water in oil emulsion absorption bases

water soluble:
water washable: 
anhydrous: 
absorbs water: 
emollient: 
occlusive:
greasy:
A

water soluble: no
water washable: no
anhydrous: no (meaning they contain water)
absorbs water: yes (somewhat b/c they are an emulsion and already contain some water)
emollient: yes
occlusive: yes
greasy: yes

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19
Q

ointment base characteristics

oil in water emulsion, water-removable bases

water soluble:
water washable: 
anhydrous: 
absorbs water: 
emollient: 
occlusive:
greasy:
A

water soluble: no
water washable: yes
anhydrous: no (meaning they contain water)
absorbs water: yes (somewhat b/c they are an emulsion and already contain some water)
emollient: no
occlusive: no
greasy: no

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20
Q

ointment base characteristics

water soluble bases

water soluble:
water washable: 
anhydrous: 
absorbs water: 
emollient: 
occlusive:
greasy:
A
water soluble: yes
water washable: yes
anhydrous: yes
absorbs water: yes (somewhat)
emollient: no
occlusive: no
greasy: no
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21
Q

hydrocarbon/ oleaginous bases detailes

when is it useful?
examples:
notes:

A

when used: useful when high % of powder is to be incorporated into base
(10-25%)

ex: petroleum (petrolatum, vaseline)
a. high viscosity
b. will not become rancid

animal fats/ oils) (lard, sweat ( sheep fat), lanolin derivatives(secretion of sebaceous glands of sheep).
a. may become rancid

vegetable oils (crisco)

a. useful as an additive to lower melting point and soften product
b. may be hydrogenated to promote solidification @ room temp
c. may become rancid

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22
Q

main examples for ung classes

  1. hydrocarbon /oleaginour
  2. anhydrous
  3. water in oil emulsion
  4. oil in water
  5. water soluble
A
  1. petrolatum
  2. aquaphor
  3. eucerin
  4. hydrophilic ointment
  5. PEG
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23
Q

anhydrous bases

when are they useful?
examples:
notes:

A

useful: for incorporation of aqueous liquids and/or water soluble drugs to the emulsions internal phase

examples:
origin: petrolatum( aquaphor, hydrophilic petrolatum), lanolin USP (has allergic tendencies)

notes: can absorption up to 2x their weight in water.
1:1 ratio in lab policy tho.
will also absorb oil based substances also

will not dissolve in water

not emulsions by themselves

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24
Q

water in oil emulsion absorption bases

when are they useful?
examples:
notes:

A

useful: often used for emollient properties alone but can also be a vehicle for ingredients

ex: anhydrous lanolin
cold cream
rose water ointment
eucerin 
hydrocream
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25
Q

oil in water emulsion water-removable bases

examples:
notes:

A

ex: hydrophilic ointment (35-375)
vanishing cream
dermabase
unibase

notes: water washable
dries out easily. feels

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26
Q

water soluble ung bases

examples:
notes:

A

ex: PEG

notes: wide range of viscosity
doesn’t contain oil or water

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27
Q

what happens when the asource material provided to compound an ung. is an ung.

A
  1. calculate the regular amounts needed based on rx

2. calculate amount of source ung. that contains the amount of active ingredient needed

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28
Q

purpose of suppository

A

altenrate administration route for..
NPO pts
unconscious pts
infant

  1. non invasive alternative to IV
29
Q

disadvantages of suppository

A
  1. PO vs PR
    dignity, comfort, convenience
  2. privacy. cant be administered in public
30
Q

usp definition of suppositories

what are some indications

A

solid, unit dosage forms intended for admin of medications into variety of orificies of the body . ie. recum, vagina, or urethra

melt or dissolve in body cavity

indicated for admin. of drugs to infants/ small children, severely debilitated pts.

31
Q

indications for suppositories

local

systemic

A

local: hemmorhoids
itching
infections

systemic

analgesics
anti-nausea
antihistamine

32
Q

types of suppositories (where they can be inserted)

A

rectal

a. adult: 2 grams
b. children: 1 gram, more pencil shaped

vaginal- pessaries

urethral- bougies

nasal

aural (into ear)

33
Q

rectal suppositorie purposes

A

local effect
laxation effect
systemic effects

34
Q

ex of vaginal suppository purposes

A

fertility (progesterone 25mg-400 mg)

35
Q

ideal suppository base charcateristics

A

stable

non irritating

chemically and physiologically inert

compatible with all drugs

melt or dissolve in rectal fluids

solid below 98.6 F. liquid aloe 98.6

not bind or interfere w. release of drug substances

36
Q

suppository bases

cocoa butter

what is the prefferebale form. why?

A

aka theobroma oil

no longer the base of choice when other is specified

4 possible polymorphic forms.
BETA shown suitable for compounding of suppositories b/c melting pt is above room temperature

when over heated, it can slip into other non suitable polymorphic forms

soften at 30 C, melts at 34 C

37
Q

suppository base properties

fattibase

A

similar to cocoa butter, but no special storage conditions, doesn’t have overheating problem

38
Q

suppository base properties

PEG

A

water soluble

base of choice when none other is specified

39
Q

suppository base properties

GLYCERIN

A

WATERSOLUBLE

40
Q

types of suppository bases

A
  1. cocoa butter
  2. fattibase
  3. PEG
  4. glycerin
41
Q

methods of making suppositories

A
  1. hand rolling
  2. compression (injection mold)
  3. fusion
    - mold reparation
    - prepration of base
    - preparation of drug
    - heating, mixing and pouring
    - cooling and finishing
42
Q

when drug/base used in a suppository is a suspension…. what should you do

A

levigation/ geometric combo may be necessary

constant stirring during pouring is necessary

pour at relatively cool temps

43
Q

types of molds for supossitories

A

metal mold

disposable plastic mold

44
Q

considerations for using metal molds for suppositories

A

need to use an ejection agent

important that the ejection agents is not soluble in the base

use a q-tip applicator to coat the inner surface of the metal mold with the ejection agent

45
Q

proper ejection agents for suppository bases

A
  1. Green soap:
    a. Cocoa butter
    b. Fatibase
  2. Mineral oil
    a. glycerin
    b. PEG
46
Q

why should water be avoided in compounding of suppositories

A

oxidation of fats

increase degredaion

support micro. growth

dissolved drugs may crystallize when water evaporates

viscosity

brittleness

47
Q

suppository compounding considertions

A

density of incorporated materials

volume contraction

example incompatibilities

48
Q

in a suppository, PEG isn’t compatible with

A

aspirin

benzocaine

49
Q

rate of drug release times for bases

cocobautter
fatti base
glycerinated gelatin
PEG

A
  1. 3-7 min
  2. 3-7 min
    release by meltinggg
  3. 30-40 min
  4. 30-40 min
    release by dissolving
50
Q

drug absorption rates

drug: oil soluble
base: oily

A

SLOW

51
Q

drug absorption rates

drug: WATER SOLUBLE
base: oily

A

rapid

52
Q

drug absorption rates

drug: oil soluble
base: water miscible

A

moderate

53
Q

drug absorption rates

drug: water soluble
base: water miscible

A

moderate

54
Q

how do bases release drugs

OILY-
water soluble bases-

A

melt (cocoa butter, fattibase)

dissolve (PEG, glycerin)

55
Q

what is the mold calibration value?

what is this value specific to?

A

average mass of one pure base suppository cast in the mold

mold specific
base specific
not specific to drug

56
Q

how to find mold calibration value

A
  1. prepare pure base suppositories
  2. weight total quantity
  3. divide total mass by # of suppositories.
57
Q

density factor in suppositories?

what is this value specific to

A

ratio of unit mass of drug powder to the amount of suppository base displaced by the powder

NOT mold specific
is base specific
is drug specific

58
Q

ex of how to calculate density factor

if 1 g of drug powder displaces 0.8 g of suppository base, what is the density factor

what are the units of density factor

A

mass of drug: 1 g
amount of supp. base displaced: 0.8g

X= 1g/0.8g
X= 1.25

UNITLESS

59
Q

how to calculate how much base to remove when given the drug amount and the Density factor (DF)

ex problem: a suppository is to contain 200 mg of drug in a suitable base. DF is 1.25. .
how much base will be displaced by the drug

A

df= 1.25

1.25/1=200/x
x=200/1.25
x=160 mg of base will be displaced

60
Q

when talking about density factor, discussed in respect to what..

A

a drug (powder) in a base

61
Q

pharmacy lab policy for suppositories

A

calculate and compound mass for 2 extra suppositories.

refrigerate your mold, don’t freeze

don’t pre refrigerate mold

write down your mold #

62
Q

DIV notation vs DTD notation

A

DIV: the dose of drug is to be divided into # specified on rx

DTD: each drug is to contain a dose of the one specified above in the rx

63
Q

notes for calculations of suppository ingredients

A

must have mold calibration value.

  1. CALCULATE HOW MUCH PURE BASE NEEDED: calculate the amount of pure base needed to compound prescription (+2 extra) by multiplying # of suppositories by the mold calibration value.
  2. FIND THE DISPLACEMENT VALUE: divide the amount of drug needed by the DF of that drug in base to get the displacement.
  3. ACTUAL MASS OF BASE NEEDED: subtract the displacement from the total mass of base needed originally. this will give actual amount of base needed
64
Q

compounding procedure notes for making suppositories

A

need to set up a steam bath

apply a thin later of mold ejection agent to the inner surface of mold

place drug in casserole dish

warm up casserole dish

levigate drug in minimal amount of base. facilitate with a glasswork stirring rod until homogenous and smooth

pour into suppository into mold cavities with continual mixing pour/ fill

allow to fully cool. shave tops with razor blade

remove finished suppositories from mold.

65
Q

if given a plastic suppository mold on a test, how do you keep them upright?

A

can use the metal mold to hold the plastic molds upright. loosen the metal molds, place the ends of plastic mold inside, and clamp

66
Q

how to determine DFwhen given unknown drug and base in lab (df exercise)

A
  1. create pure base supp.
  2. weigh total. divide by # of supp. . this is the mold calibration value
  3. remelt the suppositories. incorporate drug powder corresponding to 20% of the total support. mass. levigate with base and create new suppositories
  4. weight out toal mass of recast suppositories
  5. calculate total compounded mass (mass of pure base supp. + mass of drug powder added)
  6. calculate how much powder mass would be contained in the recast supposed by setting up a ratio
  7. calculate mass of supp. base contained in the recast supp. by subtracting powder mass in recast from total recast mass.
  8. calculate the amount of displaced base by subtracting original pure base mass minus the pure base mass in recasted supp.
  9. DF= drug amount/ amount of base displaced
67
Q

density factor conversion

A

(density of base A)/(density of base B)=

DF of drugs in base b)/ (DF of Drug x in base A

68
Q

density of..

polybase
fattibase

A
  1. 77 g/mL

0. 9 g/mL