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Proposed Definitions and Decision Tree for

Topical Dosage Forms

Advisory Committee forPharmaceutical Science

March 12, 2003

Chi-wan Chen, Ph.D.Director, DNDCIII/ONDC/OPS

CDER/FDA

2

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

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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

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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

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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

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Ointment


• 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

7

Cream


• 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

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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

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Decision Tree

A topical dosage form for dermatological

application

What kind is it?

Topical d.f.

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Test 1

Is it a liquid emulsionor a semisolid emulsion or suspension?

• If no, it is a solution, aerosol, powder, or suspension

• If yes, go to Test 2

1

2 3

4

5a

5b

Solution aerosol powder

suspension

N

Y

Topical d.f.

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Test 2

Doesit contain

sufficient quantitiesof a gelling agent

to form a 3Dmatrix?

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

Gel

1

2 3

4 5b

5a

Topical d.f.


suspension

NY

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Test 3

Doesit contain

a large proportion(20-50%) of

dispersedsolids?

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

4 5b

5a

32

1

Gel Paste

Topical d.f.


suspension

N

Y

13

Test 4

Doesit contain

> 50% of volatiles(as measured by

LOD)?

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

4 5b

5a

32

1

Gel Paste

Topical d.f.


suspension

N

Y

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Test 5a

Is ita pourable liquid

with a viscosity of< 30,000 cps)?

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

4 5b

5a

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1

Gel

Cream

Lotion

Paste

Topical d.f.


suspension

N

Y

15

Test 5b

Does itcontain (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

Ointment4 5b

5a

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1

Gel

Cream

Lotion

Paste

Topical d.f.


suspension

N

Y

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