Topical Dosage Forms Classification/Nomenclature

1
Topical Dosage FormsClassification/Nomenclature

• Advisory Committee of Pharmaceutical Science
  Meeting
• March 12, 2003
• Yuan-yuan Chiu, Ph.D.
• ONDC/OPS/CDER/FDA

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Objective

• To develop a clear, concise, and science-based
  classification (nomenclature) system for topical
  dosage forms where the existing system is not
  adequate

3
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)

4
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

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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.

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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