PHM 652: Exam 1

Question 1

what are ointments (USP) definition

Answer 1

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

Question 2

specific definition of ointments

characteristics

Answer 2

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

insoluble in water
emolient
occlusive
greasy

Question 3

incorporation in terms of ointments

Answer 3

the process of combining semi-solid masses

Question 4

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

Answer 4

a minimal amount

Question 5

Levigating agents for ointments

Answer 5

powder must be insoluble in agent

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

Question 6

examples of levigating agents for common ung. bases

What is the purpose of these?

Answer 6

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

Question 7

solubilization agents

Answer 7

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.

Question 8

creams

Answer 8

same usp definition for ung.. BUT

separate usp classification used for WATER-REMOVABLE/ SOLUBLE UNG

usually not termed an ung.

Question 9

gels

Answer 9

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

Question 10

pastes

Answer 10

similar to usp definitin

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

Question 11

what’s the diff btw topical vs transdermal

Answer 11

same location of application.

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

Question 12

emolient

Answer 12

substance that promotes the moisturization of tissues

Question 13

use of ointment as a term

general

specific

Answer 13

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

Question 14

ideal ointment

if there was such a thing

Answer 14

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

Question 15

5 main classes of ointment bases

Answer 15

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

Question 16

ointment base characteristics

hydrocarbon oleaginous bases

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

Answer 16

water soluble:   no
water washable: no
anhydrous: yes
absorbs water: no
emollient: yes
occlusive: yes
greasy: yes

Question 17

ointment base characteristics

anhydrous absorption bases

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

Answer 17

water soluble: no
water washable: no
anhydrous: yes
absorbs water: yes
emollient: yes
occlusive: yes
greasy: yes

Question 18

ointment base characteristics

water in oil emulsion absorption bases

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

Answer 18

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

Question 19

ointment base characteristics

oil in water emulsion, water-removable bases

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

Answer 19

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

Question 20

ointment base characteristics

water soluble bases

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

Answer 20

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

Question 21

hydrocarbon/ oleaginous bases detailes

when is it useful?
examples:
notes:

Answer 21

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

Question 22

main examples for ung classes

1. hydrocarbon /oleaginour
2. anhydrous
3. water in oil emulsion
4. oil in water
5. water soluble

Answer 22

1. petrolatum
2. aquaphor
3. eucerin
4. hydrophilic ointment
5. PEG

Question 23

anhydrous bases

when are they useful?
examples:
notes:

Answer 23

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

Question 24

water in oil emulsion absorption bases

when are they useful?
examples:
notes:

Answer 24

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

Question 25

oil in water emulsion water-removable bases examples: notes:

Answer 25

ex: hydrophilic ointment (35-375) vanishing cream dermabase unibase notes: water washable dries out easily. feels

Question 26

water soluble ung bases examples: notes:

Answer 26

ex: PEG notes: wide range of viscosity doesn't contain oil or water

Question 27

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

Answer 27

1. calculate the regular amounts needed based on rx | 2. calculate amount of source ung. that contains the amount of active ingredient needed

Question 28

purpose of suppository

Answer 28

altenrate administration route for.. NPO pts unconscious pts infant 2. non invasive alternative to IV

Question 29

disadvantages of suppository

Answer 29

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

Question 30

usp definition of suppositories what are some indications

Answer 30

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.

Question 31

indications for suppositories local systemic

Answer 31

local: hemmorhoids itching infections systemic analgesics anti-nausea antihistamine

Question 32

types of suppositories (where they can be inserted)

Answer 32

rectal a. adult: 2 grams b. children: 1 gram, more pencil shaped vaginal- pessaries urethral- bougies nasal aural (into ear)

Question 33

rectal suppositorie purposes

Answer 33

local effect laxation effect systemic effects

Question 34

ex of vaginal suppository purposes

Answer 34

fertility (progesterone 25mg-400 mg)

Question 35

ideal suppository base charcateristics

Answer 35

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

Question 36

suppository bases cocoa butter what is the prefferebale form. why?

Answer 36

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

Question 37

suppository base properties fattibase

Answer 37

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

Question 38

suppository base properties PEG

Answer 38

water soluble | base of choice when none other is specified

Question 39

suppository base properties GLYCERIN

Answer 39

WATERSOLUBLE

Question 40

types of suppository bases

Answer 40

1. cocoa butter 2. fattibase 3. PEG 4. glycerin

Question 41

methods of making suppositories

Answer 41

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

Question 42

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

Answer 42

levigation/ geometric combo may be necessary constant stirring during pouring is necessary pour at relatively cool temps

Question 43

types of molds for supossitories

Answer 43

metal mold disposable plastic mold

Question 44

considerations for using metal molds for suppositories

Answer 44

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

Question 45

proper ejection agents for suppository bases

Answer 45

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

Question 46

why should water be avoided in compounding of suppositories

Answer 46

oxidation of fats increase degredaion support micro. growth dissolved drugs may crystallize when water evaporates viscosity brittleness

Question 47

suppository compounding considertions

Answer 47

density of incorporated materials volume contraction example incompatibilities

Question 48

in a suppository, PEG isn't compatible with

Answer 48

aspirin benzocaine

Question 49

rate of drug release times for bases cocobautter fatti base glycerinated gelatin PEG

Answer 49

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

Question 50

drug absorption rates drug: oil soluble base: oily

Answer 50

SLOW

Question 51

drug absorption rates drug: WATER SOLUBLE base: oily

Answer 51

rapid

Question 52

drug absorption rates drug: oil soluble base: water miscible

Answer 52

moderate

Question 53

drug absorption rates drug: water soluble base: water miscible

Answer 53

moderate

Question 54

how do bases release drugs OILY- water soluble bases-

Answer 54

melt (cocoa butter, fattibase) dissolve (PEG, glycerin)

Question 55

what is the mold calibration value? what is this value specific to?

Answer 55

average mass of one pure base suppository cast in the mold mold specific base specific not specific to drug

Question 56

how to find mold calibration value

Answer 56

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

Question 57

density factor in suppositories? what is this value specific to

Answer 57

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

Question 58

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

Answer 58

mass of drug: 1 g amount of supp. base displaced: 0.8g ``` X= 1g/0.8g X= 1.25 ``` UNITLESS

Question 59

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

Answer 59

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

Question 60

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

Answer 60

a drug (powder) in a base

Question 61

pharmacy lab policy for suppositories

Answer 61

calculate and compound mass for 2 extra suppositories. refrigerate your mold, don't freeze don't pre refrigerate mold write down your mold #

Question 62

DIV notation vs DTD notation

Answer 62

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

Question 63

notes for calculations of suppository ingredients

Answer 63

**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

Question 64

compounding procedure notes for making suppositories

Answer 64

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.

Question 65

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

Answer 65

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

Question 66

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

Answer 66

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

Question 67

density factor conversion

Answer 67

(density of base A)/(density of base B)= | DF of drugs in base b)/ (DF of Drug x in base A

Question 68

density of.. polybase fattibase

Answer 68

1. 77 g/mL | 0. 9 g/mL