Topical Dosage Forms

Classification/Nomenclature

Advisory Committee of Pharmaceutical Science

Meeting
March 12, 2003

Yuan-yuan Chiu, Ph.D.

ONDC/OPS/CDER/FDA
 Objective
• To develop a clear, concise, and science-
based classification (nomenclature) system
for topical dosage forms where the existing
system is not adequate
 Scope
• Dermatological topical administration
• Dosage forms included: Liquid emulsion,
semi-solid emulsion, and semi-solid
suspension
– Lotion, Cream, Ointment, Paste, and Gel
• Dosage forms excluded: Solution, liquid
suspension, powder, aerosol (including
foams)
 Steps Taken
• Identified current practices in labeling and
specifications at FDA and USP
• Reviewed properties and formulations of
approved NDA/ANDA drugs
• Clarified with CDER medical staff any
efficacy significance associated with
definitions of topical dosage forms
• Consulted textbooks and literature
• Evaluated OTC and NDA/ANDA drugs for
physical properties in CDER laboratory
 Agenda
• Introduction Yuan-yuan Chiu, Ph.D.
• Remarks from a Medical Perspective
Jonathan Wilkin, M.D.
• FDA Laboratory Data Lucinda Buhse, Ph.D.
• FDA Proposal - Definitions and Decision Tree
Chi-wan Chen, Ph.D.
• USP Nomenclature for Topical Dosage Forms
Herb Carlin, Ph.D.
• Questions to Committee Yuan-yuan Chiu, Ph.D.
 Contributors to the Project
• Daniel Boring Lucinda Buhse
• Chi-wan Chen Yuan-yuan Chiu
• Wilson DeCamp James Fan
• Mamta Gautam-Basak Charles Hoiberg
• Gil Jong Kang Hon Sum Ko
• Richard Kolinski Markham Luke
• Lisa Mathis Moheb Nasr
• Saleh Turujman Benjamin Westenberger
• Jonathan Wilkin Anna Wokovich