Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles

AAPS PharmSciTech. 2012 Mar;13(1):218-30. doi: 10.1208/s12249-011-9740-9. Epub 2012 Jan 4.

Abstract

In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery Systems Scale-Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration's Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on in vitro-in vivo correlation considerations for transdermal systems.

Publication types

  • Review

MeSH terms

  • Administration, Cutaneous
  • Animals
  • Chemistry, Pharmaceutical / methods*
  • Drug Delivery Systems* / methods
  • Drug Delivery Systems* / trends
  • Drug Discovery / methods*
  • Drug Industry / methods*
  • Education
  • Humans
  • Pharmaceutical Preparations / administration & dosage
  • Pharmaceutical Preparations / chemistry*
  • Pharmaceutical Preparations / metabolism

Substances

  • Pharmaceutical Preparations