PHA 326: Topicals

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1

USP Ointment classification

  • Oleaginous or hydrocarbon bases
  • Absorption bases
  • Water-removable bases
  • Water-soluble bases
2

Ointments can be:

  • Medicated (used as vehicle)
  • Non-medicated (used as emollient/lubricant)
  • Pastes (large percentage of solid material)
3

Example of non-medicated ointment

Zinc oxide

4

Examples of oleaginous of hydrocarbon bases

  • Petrolatum alone (petroleum)
  • Petrolatum modified by waxes / liquid petrolatum (mineral oil)
5

Example of semisolid hydrocarbons

Yellow petrolatum

6

Example of solid hydrocarbon

  • Vaseline (white / decolorized yellow petrolatum)
  • paraffin wax
7

Oleaginous/hydrocarbon bases have _______ (bad/good) occlusive, emollient properties allowing them to lock moisture in.

Good

8

Oleaginous/hydrocarbon bases are ____________, making them difficult to wash off

Anhydrous

9

_________________ are w/o emulsion or anhydrous bases that convert to w/o emulsion

Absorption bases

10

True/False: Absorption bases are occlusive (less so than hydrocarbons) and emollient.

True

11

True/False: Absorption bases are difficult to wash off.

True

12

Example of anhydrous absorption bases

Hydrophilic petrolatum (i.e. Aquaphor)

13

Example of w/o emulsion absorption bases

Lanolin (obtained from sheep wool)

14

What is Aquaphor made of?

  • Cholesterol (30g)
  • Stearyl alcohol (30g)
  • White wax (80g)
  • White petrolatum (860g)
15

Example of a semisolid absorption bases

Cold cream

16

What two components in cold cream combine to form a sodium soap?

Beeswax and sodium borate

17

o/w emulsion that easily washes off

Water-removable bases

18

Example of a product using water-removable bases

Hydrophilic ointment

19

What are the preservatives in hydrophilic ointment?

  • Methylparaben
  • Propylparaben
20

What are the oleaginous components of hydrophilic ointment?

  • Stearyl alcohol
  • White petrolatum
21

What is the continuous phase in products with water-removable bases?

Water

22

"greaseless" bases with water-soluble components.

Water-soluble bases

23

Example of a water soluble base

Polyethylene glycol ointment (composed of PEG 3350 and PEG 400)

24

PEG 3350 is a ___________ at room temp

semisolid

25

PEG 400 is a ____________ at room temp

liquid

26

If you wanted a polyethylene glycol ointment that was less viscous, how would you change the proportions of PEG 3350 and/or PEG 400?

Increase the proportion of PEG400

27

Reduce particle size by grinding (trituration) or by first incorporation a liquid/wetting agent (levigation or spatulation if ointment slab/spatula used)

Comminution

28

Process of slowly adding powder to a solution to allow it to mix properly.

Geometric dilution

29

Process of heating and cooling (mix/melt); used for vaccine material

Fusion

30

What are oinment mills used for?

Reduce grittiness

31

You can create an emulsion by combining melted ___________ components and heated __________ components

Oleginous; aqueous

32

Products applied topically must be free of ________________

  • P aeruginosa
  • S aureus
33

Products intended for rectal, urethral, or vaginal use should be tested for:

  • Yeasts
  • Molds
34

Evaluate need for preservatives in oinment bases using what?

Preservative efficacy test

35

True/False: All emulsions require an antimicrobial agent.

True

36

How large are ointment jars typically?

5-30g

37

What are ointment tubes typically made out of?

  • HDPE (High Density Polyethylene)
  • LDPE
  • PP
  • PET
38

__________ are semisolid viscous emulsions of o/w or w/o type

Creams

39

Vanishing cream is ____ (o/w or w/o)

o/w

40

Vanishing cream is also known as _________

Stearate creams

41

Which part of vanishing cream is melted?

Oily part:

  • Lanolin
  • Cetyl alcohol
  • Mineral oil
  • Stearic acid
42

Which part of vanishing cream is heated?

Aqueous part:

  • Pot. hydroxide
  • Propylene glycol
  • Purified water
43

Jelly like dispersions with the addition of a gelling agent

Gels

44

Examples of gels

  • Carbopols
  • Hydroxyethylcellulose (HEC)
  • PLO (pluronic lecithin organogel)
45

Isopropyl myristate is a ___________ enhancer in androgel

Chemical

46

What is the neutralizing compound in androgel?

Sodium hydroxide

47

Card that tells you how much gel to use

Dosing card

48

As alcohol evaporates, particles remain dissolved in remaining liquid creating ___________

Supersaturation effect

49

True/False: Androgel is considered very flammable because it contains a lot of alcohol.

True

50

How can a greasy product like vaseline help keep skin moist?

Locks in moisture

51

List the steps of gel preparation

  1. API mixed with co-solvent w/ part of the solvent
  2. Polymer added to walls of the vortex solvent mix
  3. API solution mix added to the polymer solution mix
  4. Neutralizer added to the final solution mix
  5. Gel formation after neutralization
52

These mixtures combine ingredients with different melting points, and result in the overall melting point of the mixture to change

Eutectic mixtures

53

Example of a eutectic mixture

Emla cream (lidocain and prolocaine mix)

54

Irritation testing involves a numerical score ranging from 0-4 where 0 indicates ______________ and 4 indicates _____________

No reaction; worst reaction

55

What kind of animal irritation testing is performed?

Draize dermal irritation tests on rabbits (shave back and observe)

56

What kind of cell culture irritation testing is performed?

MatTek Epiderm model

57

Measures redness of the skin

Chromameter

58

TEWL

Transepidermal water loss

59

True/False: Irritation causes TEWL to decrease.

False

60

Method used to determine how much drug is in hair follicles

Differential tape stripping