Topical Dermatologic Dosage

Forms and Vehicle Properties:

Issues and Opportunities

Jonathan Wilkin, M.D.

Director, Division of Dermatologic and
Dental Drug Products, FDA
 Background I

If its dry, wet it.

If its wet, dry it.

Paleodermatologic aphorism.

2
 Background II

Originally, no active ingredient.

Therapeutic choice based on physical and

sensory properties.

3
 Background III

In the 1800s
Active ingredients began to be added

Topical dosage formulations grouped under

commonly used terms.

4
 Background IV

Powder (crystals) for bath solution

Colloid baths
Bath oils (including bath tars)
Solutions or suspensions for wet dressings and soaks
Shake lotions - shake to disperse powders
Creamy-type lotions - (w/o and o/w)
Creams
Ointments

5
 Background IV (contd)

Pastes
Solutions
Tinctures
Suspensions (shake lotions)
Varnishes
Powders

6
 Background V

Later additions:
Gels
Foams
Emollient creams

7
 Problems

FDA and USP dosage forms insufficiently

defined

Manufacturers produce dosage form

intergrades, e.g., between creams and
lotions that resist classification

8
 Opportunities
Creation of mutually exclusive definitions
for dosage forms and consistent terminology
Summary of relevant vehicle properties in
the Description section of product
labeling
Provide clinically important information to
health care providers choosing among
topical dermatologic products

9
 Relevant Vehicle Properties

Dosage form - a rough guide

Description section - specific information

10
 Examples of Potential, Relevant
Vehicle Properties
Viscosity - could be an ordinal classification
and nonlinear
Spreadability - spread value in mm 2 in 10 minutes
Wash and rub resistance
Skin smoothness - time curve
Usual appearance of product, incl. color
Odor of product

11
 Examples of Potential, Relevant
Vehicle Properties (contd)

Permanence on skin surface - residue at 10

minutes
Moisturization - TEWL time curve
Volatilization - time curve

12
13
14
15
 Salka, Barry A.
Choosing emollients.
Cosmetics & Toiletries
112:101-106, 1997

16
 Vehicle Choice

Important factor in patient compliance

Prescribing physician needs relevant information:

well-defined dosage forms

description of relevant vehicle properties

17
 Impact on Stakeholders
Innovators - more specific description of
product may reduce generic competition
Generics - better defined target leads to
greater sameness of generic product
Health care providers - better choice among
products
Patients - product acceptability improves
compliance leading to better outcomes
18
 Looking Ahead
1. Definitions and Classification of Topical
Dermatologic Dosage Forms

Need industry, academia, professional

scientific societies, USP and FDA
consensus

19
2. Development of Consistent Methodology
and Terminology to Describe Relevant
Vehicle Properties (for Description
Section of Labeling)
Industry may already have the methods
and terminology. Industry must decide if
this is desirable. If so, they must be
leaders in this effort.

20