Proposed Definitions and

Decision Tree for

Topical Dosage Forms
Advisory Committee for
Pharmaceutical Science
March 12, 2003
Chi-wan Chen, Ph.D.
Director, DNDCIII/ONDC/OPS
CDER/FDA

Scope
Dermatological application only
Five topical dosage forms, i.e., lotion, gel,
cream, ointment, paste, because the existing
definitions are less than adequate and because
they cannot readily distinguish between

lotion vs cream
Gel vs cream/lotion
Ointment vs cream
Paste vs ointment
2

Gel
A semisolid emulsion or suspension
Contains a gelling agent in sufficient
quantities to impart a 3-dimensional,
cross-linked matrix
Provides a cooling sensation when
applied to the skin
Usually translucent and non-greasy
3

Paste
A semisolid suspension
Contains a large proportion (i.e., 20-50%)
of solids finely dispersed in an aqueous
or fatty vehicle
Opaque, viscous, greasy to mildly greasy
Adheres well to the skin, forming a
protective layer
4

Lotion
A liquid emulsion
Generally contains a water-based vehicle
with > 50% of volatiles
Has sufficiently low viscosity that it may
be poured
Opaque and non-greasy
Tends to evaporate rapidly with a cooling
sensation when applied to the skin
5

Ointment
A semisolid emulsion or suspension
Generally contains > 50% of
hydrocarbons or PEGs as the vehicle
and < 20% of volatiles
Opaque or translucent, viscous, greasy
Tends not to evaporate or be absorbed
when applied to the skin
6

Cream
A semisolid emulsion or suspension
Generally contains < 50% of
hydrocarbons or PEGs as the vehicle
and/or > 20% of volatiles
Opaque, viscous, non-greasy to mildly
greasy
Tends to mostly evaporate or be absorbed
when applied to the skin
Can be hydrophilic or lipophilic
7

Decision Tree
Intended to be a tool
to help determine the
correct topical
dosage form
Includes several key
tests based on
NDA/ANDA data
and FDA lab results
8

Decision Tree
A topical dosage form
for dermatological
application

Topical
d.f.

What kind
is it?

Test 1
Topical
d.f.

Is it a
liquid emulsion
or a semisolid
emulsion or
suspension?

If no, it is a solution,
aerosol, powder, or
suspension
If yes, go to Test 2

Solution
aerosol
powder
suspension

3
4

5b

5a
10

Test 2
Topical
d.f.

Does
it contain
sufficient quantities
of a gelling agent
to form a 3D
matrix?

Solution
aerosol
powder
suspension

1
Gel

3
4

If yes, it is a gel
If no, go to Test 3

5b

5a
11

Test 3
Topical
d.f.

Does
it contain
a large proportion
(20-50%) of
dispersed
solids?

Solution
aerosol
powder
suspension

1
Gel

Paste

If yes, it is a paste
If no, go to Test 4

5b

5a
12

Test 4
Topical
d.f.

Does
it contain
> 50% of volatiles
(as measured by
LOD)?

Solution
aerosol
powder
suspension

1
Gel

3
4

If yes, go to Test 5a
If no, go to Test 5b

Paste

5b

5a
13

Test 5a
Topical
d.f.

Is it
a pourable liquid
with a viscosity of
< 30,000 cps)?

Solution
aerosol
powder
suspension

1
Gel

3
4

If yes, it is a lotion
If no, it is a cream

Lotio
n

Paste

5b

5a
N
Cream

14

Test 5b
Topical
d.f.

Does it
contain (1) > 50%
of hydrocarbons or
PEG as the vehicle
and (2) < 20% of
volatiles?

If yes to both, it is an
ointment
If no to either or both,
it is a cream

Solution
aerosol
powder
suspension

1
Gel

3
4

Lotion

5a
Cream

Paste

5b

Ointment

15