Lab 6 Part 2

Question 1

preparation techniques for emulsions vary based on what?

Answer 1

the quantity of the preparation and consistency of the ointment base

Question 2

true or false

when preparing an ointment, the water soluble ingredients are mixed in the oil phase and the oil soluble ingredients are mixed in the water

Answer 2

FALSE

water soluble mixed with water and oil soluble mixed in oil phase

Question 3

the bottle method of preparation is used for….

Answer 3

volatile oils

Question 4

___ and ___ are the 2 common methods used for small scale ointments containing fixed oils and hydrocarbons

Answer 4

levigation and fusion

Question 5

why is an excess of ointment generally prepared?

Answer 5

to compensate for some loss of product during transfer

10% more of required amt is prepared (3g in this lab)

Question 6

levigation is generally used when the drug to be incorporated is __________

Answer 6

an insoluble powder

Question 7

what is a levigating agent

Answer 7

the intervening liquid that is used to grind the powder between the spatula and paper to form a smooth paste

Question 8

the levigating agent must be miscible with the _____ phase of the ointment

Answer 8

EXTERNAL PHASE

Question 9

for preparations using:
water in oil emulsion bases
oleaginous and absorption bases

what should be used as the levigating agent

Answer 9

mineral oil

Question 10

for water soluble bases and o/w emulsion, what should be used as the levigating agent

Answer 10

water
glycerin
alcohol
or propylene glycol

Question 11

in what scenario can the drug powder be directly incorporated in the ointment WITHOUT using a levigating agent?

Answer 11

when the drug quantity is small

Question 12

explain the process for when the drug quantity is small and can be incorporated into the ointment without use of a levigating agent

Answer 12

an amt of ointment base that is approximately equal in size to the powder is added to the powder and the mixture is levigated to a smooth mass.

this smooth mass is further diluted with the ointment base using geometric dilution and spatulation to obtain homogeneous and smooth product

Question 13

true or false

levigation can be used to incorporate a small quantity of miscible liquids

Answer 13

TRUE

Question 14

drugs can be dissolved in ______ and then incorporated into the ____ using levigation

Answer 14

drugs can be dissolved in a small quantity of SOLVENT (which must be miscible with the external phase) and then incorporated into the base using levigation

Question 15

the levigating agent or solvent should not exceed ____% of the formulation

Answer 15

5%

Question 16

which are used – large metal spatulas or smaller metal spatulas?
why?

Answer 16

large metal spatulas are used bc they have the proper combination of flexibility and strength for adequate shearing and mixing

Question 17

when are rubber spatulas used

Answer 17

only when the ingredients are incompatible with the metal

Question 18

define geometric dilution

Answer 18

the stepwise dilution process used to obtain a homogeneous mixture after a smooth levigated mixture is obtained

Question 19

define spatulation

Answer 19

the process of incorporating ingredients using a spatula

Question 20

true or false

size reduction occurs during spatulation

Answer 20

FALSE – does not occur

thus, the ingredient must be levigated before spatulation

Question 21

name the 3 types of movements used to mix the ingredients during spatulation

Answer 21

S shape
#8
flat movement

Question 22

most ingredients used in ointment bases liquefy around….

Answer 22

70 degrees celsius

Question 23

what are 2 other names for the fusion method

Answer 23

beaker method
bottle method

Question 24

explain how the bottle method works

Answer 24

ingredients first separated as water soluble and oil soluble.

water soluble ingredients mixed together in the aqueous phase and oil soluble ingredients in the oil phase BEFORE HEATING

the hot internal phase is added to the external phase and mixed with constant stirring to room temp and a smooth homogeneous mixture is obtained.

mixing is performed in a beaker, mortar, or the dispensing jar/bottle

Question 25

name an important consideration when using the bottle method

Answer 25

thermostability

the drug must be stable at melting/heating temp

volatile ingredients such as oils, flavors, or heat unstable drugs should be added when the melt is still fluid enough for adequate mixing BUT NOT HOT ENOUGH TO EVAPORATE OR DEGRADE THE INGREDIENT

Question 26

To minimize water loss through evaporation and enhance thermostability of the product………..
(bottle method)

Answer 26

the lowest possible temperature should be used and the heating time kept as short as possible

Question 27

the ingredients with the _ melting point are melted first.
then…..

Answer 27

the ingredients with the highest melting point are melted first and then the heat is reduced to melt the ingredients with the lowest melting points

Question 28

which is heated a few degrees higher and why – the aqueous phase or the oil phase?

Answer 28

the aqueous phase is heated a few degrees higher bc the aqueous phase tends to cool faster and may cause premature solidification of some ingredients upon mixing

Question 29

the ____ Step is an important step in the ointment compounding process.
what is an important consideration

Answer 29

cooling step

should not be accelerated by putting the melt in water or ice as this will change the consistency of the final product and make it more stiff

Question 30

how are creams and lotions formulated?

Answer 30

using oils from mineral and vegetable sources and from fatty alcohols, fatty acids, and fatty esters

Question 31

explain the preparation of creams and lotions

Answer 31

the ingredients are separated to lipid and aqueous solubility

the oil components are melted in order of their melting temp (highest to lowest) to avoid overheating and to ensure stability of thermo sensitive ingredients

aqueous mixture heated separately a few degrees higher than the lipid mixture – preparation may turn lumpy if not

phase continually mixed until room mtemo of a smooth uniform mixture is obtained

Question 32

when mixing, the ___ mixture is generally added to the____ mixture, but the addition may be reversed to obtain equally good results

Answer 32

normally aqueous mixture is added to lipid mixture

Question 33

thermo unstable products such as volatiles must be added only when…….

Answer 33

the mixture has cooled sufficiently

Question 34

when should the particle size of solid powders be reduced?

Answer 34

before/during incorporation

Question 35

for small scale preparation, ___ is used

Answer 35

levigation

Question 36

for large scale manufacture, what types of homogenation equipment are used?

Answer 36

ointment mills

Question 37

homogenation equipment can improve….

Answer 37

the long term stability of the product

Question 38

for creams, when may the solid powders be added?

Answer 38

as the beginning (during the melting process) OR may be incorporated later using pulverization and dispersion process (levigation, ointment mills, or homogenizers)

Question 39

for LIQUID emulsions (lotions/oral emulsions) when are the fine solids added?

Answer 39

during the melting process

Question 40

when selecting the container for semisolid products, where should the contents reach?

Answer 40

near the top but not touch the lid

Question 41

how many spatulas should be used when filling ointments?

Answer 41

2

Question 42

mineral oil emulsions are generally prepared in ___ steps:

Answer 42

2 steps:

-prepare primary emulsion – internal phase is finely dispersed in part of the external phase

-dilute the primary emulsion with the external phase

Question 43

preparing a primary emulsion is critical for what?

Answer 43

preparing a stable emulsion

Question 44

true or false

the proportion of oil, water, and emulsifier for the primary emulsion varies with the amount and type of oil

what are these proportions important for?

Answer 44

true

important to prevent the emulsion from breaking down during dilution and storage

Question 45

WET GUM METHOD

Answer 45

internal oily phase is added to external aqueous phase

Question 46

DRY GUM METHOD

Answer 46

external aqueous phase is added to internal oily phase

Question 47

in the preparation of emulsions, the 2 phases are melted with the aid of heat _______ mixing

Answer 47

BEFORE

Question 48

in the preparation of emulsions, how can the primary emulsion step be avoided

Answer 48

by mixing the 2 phases alternatively in small portions to form the emulsion

Question 49

wet and dry gum methods are used when preparing ___ emulsions

melting the 2 phases with the aid of heat before mixing and avoiding the primary emulsion step are more common for what products?

Answer 49

wet and dry gum = oral emulsions

other 2 methods = for topical products

Question 50

which method is preferred and why – wet or dry gum

Answer 50

wet gum is preferred bc it has a lower failure rate

Question 51

what is the simplest technique for mixing

Answer 51

trituration using a mortar and pestle

Question 52

the simplest technique for mixing is trituration using a mortar and pestle.

what are other methods that can be used

Answer 52

beaker and bottle methods

homogenizers and other high speed equipment are faster and less laborious

Question 53

often, losses are anticipated due to the transfer of material after preparation

name 2 ways that this issue can be resolved

Answer 53

-preparing more than required (and dispensing the quantity requested)

-calibrating the container with water and making up the final volume in the calbrated container