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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 it’s dry, wet it. If it’s wet, dry it. Paleodermatologic aphorism. Background II.

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Topical dermatologic dosage forms and vehicle properties issues and opportunities

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
Background I Issues and Opportunities

If it’s dry, wet it.

If it’s wet, dry it.

Paleodermatologic aphorism.


Background ii
Background II Issues and Opportunities

Originally, no “active” ingredient.

Therapeutic choice based on physical and sensory properties.


Background iii
Background III Issues and Opportunities

In the 1800s

  • “Active” ingredients began to be added

  • Topical dosage formulations grouped under commonly used terms.


Background iv
Background IV Issues and Opportunities

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


Background iv cont d
Background IV (cont’d) Issues and Opportunities

Pastes

Solutions

Tinctures

Suspensions (shake lotions)

Varnishes

Powders


Background v
Background V Issues and Opportunities

Later additions:

Gels

Foams

Emollient creams


Problems
Problems Issues and Opportunities

FDA and USP dosage forms insufficiently defined

Manufacturers produce dosage form intergrades, e.g., between creams and lotions that resist classification


Opportunities
Opportunities Issues and 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


Relevant vehicle properties
Relevant Vehicle Properties Issues and Opportunities

  • Dosage form - a rough guide

  • Description section - specific information


Examples of potential relevant vehicle properties
Examples of Potential, Relevant Vehicle Properties Issues and Opportunities

Viscosity - could be an ordinal classification and nonlinear

Spreadability - spread value in mm2 in 10 minutes

Wash and rub resistance

Skin smoothness - time curve

Usual appearance of product, incl. color

Odor of product


Examples of potential relevant vehicle properties cont d
Examples of Potential, Relevant Vehicle Properties (cont’d)

Permanence on skin surface - residue at 10 minutes

Moisturization - TEWL time curve

Volatilization - time curve


Salka, Barry A. (cont’d)

Choosing emollients.

Cosmetics&Toiletries

112:101-106, 1997


Vehicle choice
Vehicle Choice (cont’d)

  • Important factor in patient compliance

  • Prescribing physician needs relevant information:

    well-defined dosage forms

    description of relevant vehicle properties


Impact on stakeholders
Impact on Stakeholders (cont’d)

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


Looking ahead
Looking Ahead (cont’d)

1. Definitions and Classification of Topical Dermatologic Dosage Forms

Need industry, academia, professional scientific societies, USP and FDA consensus


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.


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