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The AAPS Journal

, 22:2 | Cite as

Analysis of the Regulatory Divergence of Comparative Dissolution Requirements for Post-Approval Manufacturing Changes of Modified Release Solid Oral Dosage Forms

  • Connie LangerEmail author
  • Dorys Argelia Diaz
  • Leslie Van Alstine
  • Nagesh Bandi
  • Sarah Fitzgerald
  • Stephen Colgan
Research Article
  • 44 Downloads

ABSTRACT

This manuscript discusses global regulatory divergence of dissolution requirements for modified release solid oral dosage forms and the obstacles that must be addressed to be compliant with evolving guidance and legislation. The proliferation of local guidance documents, changing regulatory expectations, and increased legal enforcement has resulted in mismatched country-specific dissolution testing requirements and similarity criteria, and heightens industry’s challenges with registration of modified release solid oral dosage forms. The lack of global harmonization and the complexity added by minor regional adaptations contributes to inefficiencies and hinders industry’s goal of developing and delivering medicines. Awareness of country-specific similarity requirements and alignment between industry leaders and regulators is needed to facilitate global harmonization which will enable delivering new and improved medicines. The purpose of this manuscript is to compare and contrast in vitro conditions stated in local regulatory guidelines, raise awareness of the need to work toward harmonization of global requirements, and propose an initial study design toward that aspiration.

KEY WORDS

dissolution harmonization modified release 

Notes

ACKNOWLEDGMENTS

The authors would like to thank Roger Nosal, Michael Likar, John Groskoph, Beth Kendsersky, Loren Wrisley, Ron Ogilvie, Michael Cohen, Megan McMahon, Ling Zhang, and Gregg Kelly for reviewing and providing helpful comments on this paper.

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Copyright information

© American Association of Pharmaceutical Scientists 2019

Authors and Affiliations

  • Connie Langer
    • 1
    Email author
  • Dorys Argelia Diaz
    • 1
  • Leslie Van Alstine
    • 2
  • Nagesh Bandi
    • 3
  • Sarah Fitzgerald
    • 4
  • Stephen Colgan
    • 1
  1. 1.Global Product Development, Global Chemistry, Manufacturing & ControlsPfizer Inc.GrotonUSA
  2. 2.Global Product Development, Analytical Research & DevelopmentPfizer Inc.GrotonUSA
  3. 3.GRACS - CMC; Pre-approval Pharm & New ProductsMerck & Co. Inc.RahwayUSA
  4. 4.Chemistry, Manufacturing & ControlsAlexion Pharmaceuticals Inc.BostonUSA

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